Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Study Overview
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Brief Summary
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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)

Official Title
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Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: 5ARI
* Drug: AB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5ARI monotherapy<br>Patients with BPH receiving 5ARI monotherapy | Drug: 5ARI<br>* Dutasteride or Finasteride<br>|
| AB monotherapy<br>Patients with BPH receiving AB monotherapy | Drug: AB<br>* Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin<br>|
| Early combination (5ARI + AB) therapy<br>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<br>* Dutasteride or Finasteride<br>Drug: AB<br>* Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin<br>|
| Delayed combination (5ARI + AB) therapy<br>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<br>* Dutasteride or Finasteride<br>Drug: AB<br>* Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | 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. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enlarged prostate, Benign prostatic hyperplasia, alpha-blocker, 5-alpha-reductase inhibitor