Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01270711
Collaborator
(none)
22,014
27
Study Details
Study Description
Brief Summary
The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.
Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
does not involve random selection
Study Design
Study Type:
Observational
Actual Enrollment
:
22014 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Feb 1, 2013
Actual Study Completion Date
:
Feb 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cabergoline users cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012) |
Drug: Study Drug
non interventional study - usage as per usual care
|
Outcome Measures
Primary Outcome Measures
- Number of Cabergoline Prescriptions by Database and Indication: Year 1 [Year 1 (Year 2006)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Number of Cabergoline Prescriptions by Database and Indication: Year 2 [Year 2 (Year 2007)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Number of Cabergoline Prescriptions by Database and Indication: Year 3 [Year 3 (Year 2008)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Number of Cabergoline Prescriptions by Database and Indication: Year 4 [Year 4 (Year 2009)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Number of Cabergoline Prescriptions by Database and Indication: Year 5 [Year 5 (Year 2010)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Number of Cabergoline Prescriptions by Database and Indication: Year 6 [Year 6 (Year 2011)]
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 [Year 1 (Year 2006)]
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 [Year 2 (Year 2007)]
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 [Year 3 (Year 2008)]
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 [Year 4 (Year 2009)]
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 [Year 5 (Year 2010)]
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 [Year 6 (Year 2011)]
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 [Year 1 (Year 2006)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 [Year 2 (Year 2007)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 [Year 3 (Year 2008)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 [Year 4 (Year 2009)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 [Year 5 (Year 2010)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 [Year 6 (Year 2011)]
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
- Total Number of Echocardiography Examinations in Cabergoline Users [Baseline (Week 1) up to Week 339]
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
- Incidence of Valvular Fibrosis [Baseline (Week 1) up to Week 339]
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
- Prevalence of Valvular Fibrosis [Baseline (Week 1) up to Week 339]
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention
Exclusion Criteria:
- Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01270711
Other Study ID Numbers:
- A7231030
First Posted:
Jan 5, 2011
Last Update Posted:
May 2, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy. |
|---|---|
| Pre-assignment Detail | Part 1 assessed adherence (compliance) with prescribing guidelines (PG) by using automated health care data which had information on strength, indication, referrals for echocardiography, recognized reputation in area of drug utilization, safety research. Part 2 assessed effectiveness of PG for cabergoline in participants with Parkinson's disease. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. |
| Period Title: Part 1: Compliance | ||||||||
| STARTED | 7537 | 6580 | 326 | 5486 | 2024 | 0 | 0 | 0 |
| COMPLETED | 7537 | 6580 | 326 | 5486 | 2024 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Part 1: Compliance | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 11 | 2 | 48 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 11 | 2 | 48 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. | Total of all reporting groups |
| Overall Participants | 7537 | 6580 | 326 | 5486 | 2024 | 11 | 2 | 48 | 22014 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |||||||||
| Part 1, Compliance: G02CB03 |
33.6
(10.7)
|
39.0
(12.3)
|
42.1
(14.0)
|
41.3
(15.8)
|
47.1
(16.2)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
40.8
(14.8)
|
| Part 1, Compliance: N04BC06 |
66.4
(13.2)
|
73.1
(11.3)
|
NA
(NA)
|
NA
(NA)
|
69.7
(13.6)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
70.4
(13.0)
|
| Part 2, Effectiveness |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
62.7
(5.6)
|
58.7
(8.5)
|
63.7
(13.9)
|
63.3
(12.5)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
7429
98.6%
|
6180
93.9%
|
288
88.3%
|
5180
94.4%
|
1468
72.5%
|
2
18.2%
|
0
0%
|
13
27.1%
|
20560
93.4%
|
| Male |
108
1.4%
|
400
6.1%
|
38
11.7%
|
306
5.6%
|
556
27.5%
|
9
81.8%
|
2
100%
|
35
72.9%
|
1454
6.6%
|
Outcome Measures
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 1 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 1 (Year 2006) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 81 | 854 | 5 | 277 | 370 |
| G02CB03 |
17
|
1782
|
6
|
293
|
198
|
| N04BC06 |
87
|
1483
|
0
|
0
|
577
|
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 2 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 2 (Year 2007) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1446 | 1475 | 31 | 1231 | 756 |
| G02CB03 |
1925
|
3616
|
64
|
2698
|
3537
|
| N04BC06 |
741
|
2139
|
0
|
0
|
3325
|
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 3 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 3 (Year 2008) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1469 | 1089 | 59 | 1081 | 279 |
| G02CB03 |
2098
|
3493
|
152
|
2621
|
3556
|
| N04BC06 |
507
|
807
|
0
|
0
|
1656
|
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 4 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 4 (Year 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1539 | 1146 | 87 | 1039 | 220 |
| G02CB03 |
2260
|
3629
|
226
|
2684
|
3240
|
| N04BC06 |
306
|
463
|
0
|
0
|
1119
|
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 5 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 5 (Year 2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1539 | 1050 | 88 | 1005 | 201 |
| G02CB03 |
2395
|
3793
|
283
|
2752
|
3170
|
| N04BC06 |
201
|
274
|
0
|
0
|
981
|
| Title | Number of Cabergoline Prescriptions by Database and Indication: Year 6 |
|---|---|
| Description | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Time Frame | Year 6 (Year 2011) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1463 | 966 | 56 | 853 | 198 |
| G02CB03 |
2286
|
3686
|
183
|
2660
|
3212
|
| N04BC06 |
141
|
143
|
0
|
0
|
859
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 1 (Year 2006) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 64 | 231 | 242 |
| Number [percentage of prescriptions] |
0
|
0
|
0
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 2 (Year 2007) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 49 | 139 | 75 |
| Number [percentage of prescriptions] |
4
|
10
|
10
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 3 (Year 2008) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 13 | 18 | 28 |
| Number [percentage of prescriptions] |
20
|
39
|
23
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 4 (Year 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 9 | 4 | 20 |
| Number [percentage of prescriptions] |
7
|
22
|
12
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 5 (Year 2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 6 | 4 | 13 |
| Number [percentage of prescriptions] |
18
|
43
|
21
|
| Title | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 |
|---|---|
| Description | Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Time Frame | Year 6 (Year 2011) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | THIN [Part 1] |
|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 2 | 2 | 6 |
| Number [percentage of prescriptions] |
11
|
67
|
0
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 1 (Year 2006) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 81 | 854 | 5 | 277 | 370 |
| Number [percentage of prescriptions] |
0
|
5
|
0
|
0
|
17
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 2 (Year 2007) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1446 | 1475 | 31 | 1231 | 756 |
| Number [percentage of prescriptions] |
0.2
|
5
|
2
|
0
|
13
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 3 (Year 2008) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1469 | 1089 | 59 | 1081 | 279 |
| Number [percentage of prescriptions] |
0
|
3
|
5
|
0
|
7
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 4 (Year 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1539 | 1146 | 87 | 1039 | 220 |
| Number [percentage of prescriptions] |
0
|
2
|
1
|
0
|
5
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 5 (Year 2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1539 | 1050 | 88 | 1005 | 201 |
| Number [percentage of prescriptions] |
0
|
3
|
1
|
0
|
2
|
| Title | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 |
|---|---|
| Description | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Time Frame | Year 6 (Year 2011) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| Measure Participants | 1463 | 966 | 56 | 853 | 198 |
| Number [percentage of prescriptions] |
0
|
1
|
0
|
0
|
2
|
| Title | Total Number of Echocardiography Examinations in Cabergoline Users |
|---|---|
| Description | The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography. |
| Time Frame | Baseline (Week 1) up to Week 339 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period. |
| Arm/Group Title | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Arm/Group Description | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC. |
| Measure Participants | 11 | 2 | 48 |
| Number [echocardiography examinations] |
11
|
3
|
68
|
| Title | Incidence of Valvular Fibrosis |
|---|---|
| Description | Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported. |
| Time Frame | Baseline (Week 1) up to Week 339 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during study period. |
| Arm/Group Title | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Arm/Group Description | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC. |
| Measure Participants | 11 | 2 | 48 |
| Number [percentage of participants] |
100
1.3%
|
0
0%
|
57.1
17.5%
|
| Title | Prevalence of Valvular Fibrosis |
|---|---|
| Description | Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported. |
| Time Frame | Baseline (Week 1) up to Week 339 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period. |
| Arm/Group Title | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] |
|---|---|---|---|
| Arm/Group Description | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC. |
| Measure Participants | 11 | 2 | 48 |
| Number [percentage of participants] |
57.2
0.8%
|
50.0
0.8%
|
55.9
17.1%
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This retrospective study used participant-level electronic health related databases, in which adverse events (AEs) were not reportable as an individual AE report because an AE data for individual participant was not available. | |||||||||||||||
| Arm/Group Title | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | ||||||||
| Arm/Group Description | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. | ||||||||
All Cause Mortality |
||||||||||||||||
| Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
Limitations/Caveats
Results not reported for Year 2012 (Year 7) since several databases did not contribute data for Year 7 and amount of person-time of follow-up dropped in all databases. Designation of primary and secondary endpoints was based on study team's input.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01270711
Other Study ID Numbers:
- A7231030
First Posted:
Jan 5, 2011
Last Update Posted:
May 2, 2014
Last Verified:
Feb 1, 2014