Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01323998
• Collaborator: (none)
• Enrollment: 35,032
• Duration (Months): 2

Study Details

Study Description

Brief Summary

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: 5ARI; Drug: AB

Study Design

• Study Type: Observational
• Actual Enrollment: 35032 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
5ARI monotherapy Patients with BPH receiving 5ARI monotherapy	Drug: 5ARI; Dutasteride or Finasteride
AB monotherapy Patients with BPH receiving AB monotherapy	Drug: AB; Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Early combination (5ARI + AB) therapy Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy	Drug: 5ARI; Dutasteride or Finasteride; Drug: AB; Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed combination (5ARI + AB) therapy Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy	Drug: 5ARI; Dutasteride or Finasteride; Drug: AB; Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Outcome Measures

Primary Outcome Measures

1. Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis [4 years]

   The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male

• aged 50 years or older

• a diagnostic claim for BPH

• at least one prescription claim for a 5ARI or AB in the enrollment period

• continuous eligibility for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

• diagnosis of prostate or bladder cancer during the study period

• any prostate-related surgical procedure within 1 month of the index prescription date

• prescription claim for finasteride 1 mg for male pattern baldness during the study period

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01323998
• Other Study ID Numbers: 114462
• First Posted: Mar 28, 2011
• Last Update Posted: Jul 6, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by GlaxoSmithKline: enlarged prostate; Benign prostatic hyperplasia; alpha-blocker; 5-alpha-reductase inhibitor
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Hypertrophy

Study Results

Participant Flow

Pre-assignment Detail	Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.

Arm/Group Title	Alpha-blocker (AB) Monotherapy	5 Alpha Reductase Inhibitor (5ARI) Monotherapy	AB Plus 5ARI Combination Therapy, Early 5ARI Starters	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters	5ARI Plus AB Combination Therapy
Arm/Group Description	Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
Period Title: Overall Study
STARTED	200631	18681	10294	12052	6735
COMPLETED	200631	18681	10294	12052	6735
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Alpha-blocker (AB) Monotherapy	5 Alpha Reductase Inhibitor (5ARI) Monotherapy	AB Plus 5ARI Combination Therapy, Early 5ARI Starters	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters	5ARI Plus AB Combination Therapy	Total
Arm/Group Description	Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Total of all reporting groups
Overall Participants	200631	18681	10294	12052	6735	248393
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.2 (10.4)	67.6 (10.4)	68.8 (10.3)	68.0 (10.1)	68.9 (10.1)	67.4 (10.4)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	200631 100%	18681 100%	10294 100%	12052 100%	6735 100%	248393 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis
Description	The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.

Arm/Group Title	Alpha-blocker (AB) Monotherapy	5 Alpha Reductase Inhibitor (5ARI) Monotherapy	AB Plus 5ARI Combination Therapy, Early 5ARI Starters	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters	5ARI Plus AB Combination Therapy
Arm/Group Description	Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
Measure Participants	200631	18681	10294	12052	6735
Participants without a diagnosis code for BPH	122307 61%	9456 50.6%	3293 32%	3674 30.5%	2625 39%
Participants with a diagnosis code for BPH	78324 39%	9225 49.4%	7001 68%	8378 69.5%	4110 61%

Adverse Events

Adverse Event Reporting Description	This was a survey of participants, and adverse event/serious adverse event information was not captured in the study.
Arm/Group Title	Alpha-blocker (AB) Monotherapy		5 Alpha Reductase Inhibitor (5ARI) Monotherapy		AB Plus 5ARI Combination Therapy, Early 5ARI Starters		AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters		5ARI Plus AB Combination Therapy
Arm/Group Description	Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery		Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery		Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery		Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery		Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
All Cause Mortality
	Alpha-blocker (AB) Monotherapy		5 Alpha Reductase Inhibitor (5ARI) Monotherapy		AB Plus 5ARI Combination Therapy, Early 5ARI Starters		AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters		5ARI Plus AB Combination Therapy
	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)
Serious Adverse Events
	Alpha-blocker (AB) Monotherapy		5 Alpha Reductase Inhibitor (5ARI) Monotherapy		AB Plus 5ARI Combination Therapy, Early 5ARI Starters		AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters		5ARI Plus AB Combination Therapy
	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)
Other (Not Including Serious) Adverse Events
	Alpha-blocker (AB) Monotherapy		5 Alpha Reductase Inhibitor (5ARI) Monotherapy		AB Plus 5ARI Combination Therapy, Early 5ARI Starters		AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters		5ARI Plus AB Combination Therapy
	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)

Limitations/Caveats

[Not Specified]

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.