Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Study Details
Study Description
Brief Summary
This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Early 5ARI Initiation Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) |
Drug: 5ARI
Dutasteride or Finasteride
Other Names:
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
|
| Late 5ARI Initiation Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB) |
Drug: 5ARI
Dutasteride or Finasteride
Other Names:
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Clinical Progression [3 months prior to and 12 months following index date]
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Secondary Outcome Measures
- Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month [3 months prior to and 12 months following index date]
EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males
-
aged 50 years or older
-
medical claim of EP
-
prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
-
continuously eligible for 3 months prior to and at least 5 months after their index prescription date.
Exclusion Criteria:
-
Patients with prostate or bladder cancer
-
any prostate-related surgical procedure within 5 months of index date
-
prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 112599
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Early Cohort | Delayed Cohort |
|---|---|---|
| Arm/Group Description | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
| Period Title: Overall Study | ||
| STARTED | 264 | 68 |
| COMPLETED | 264 | 68 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Early Cohort | Delayed Cohort | Total |
|---|---|---|---|
| Arm/Group Description | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) | Total of all reporting groups |
| Overall Participants | 264 | 68 | 332 |
| Age, Customized (participants) [Number] | |||
| >=50 years old |
264
100%
|
68
100%
|
332
100%
|
| <50 years old |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
264
100%
|
68
100%
|
332
100%
|
Outcome Measures
| Title | Number of Participants With Clinical Progression |
|---|---|
| Description | Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery. |
| Time Frame | 3 months prior to and 12 months following index date |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID. |
| Arm/Group Title | Early Cohort | Delayed Cohort |
|---|---|---|
| Arm/Group Description | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
| Measure Participants | 264 | 68 |
| Number [participants] |
14
5.3%
|
5
7.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Early Cohort, Delayed Cohort |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0128 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 3.406 | |
| Confidence Interval |
(2-Sided) 95% 1.297 to 8.941 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month |
|---|---|
| Description | EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample. |
| Time Frame | 3 months prior to and 12 months following index date |
Outcome Measure Data
| Analysis Population Description |
|---|
| Enrolled Population |
| Arm/Group Title | Early Cohort | Delayed Cohort |
|---|---|---|
| Arm/Group Description | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) |
| Measure Participants | 264 | 68 |
| Mean (95% Confidence Interval) [dollars] |
129.14
|
254.51
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Early Cohort, Delayed Cohort |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | Generalized linear model | |
| Comments | Gamma distribution with log-link function was used. | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | This was a retrospective database study, and adverse event/serious adverse event information was not captured in the study. | |||
| Arm/Group Title | Early Cohort | Delayed Cohort | ||
| Arm/Group Description | Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) | Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) | ||
All Cause Mortality |
||||
| Early Cohort | Delayed Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Early Cohort | Delayed Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Early Cohort | Delayed Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- 112599