Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
Completed
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: 5ARI + AB
- Registration Number
- NCT01332487
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4068
Inclusion Criteria
- Male
- aged 50 years or older
- diagnostic claim for BPH
- prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
- continuously eligible for 6 months prior to and 12 months after index prescription date
Exclusion Criteria
- prostate or bladder cancer during the study period
- any prostate-related surgical procedure within 5 months of the index prescription date
- prescription claim for finasteride 1 mg for male pattern baldness during the study period
- 5ARI therapy prior to initiation of AB therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Early initiation of 5ARI therapy 5ARI + AB Patients starting 5ARI therapy within 30 days of initiating AB therapy Delayed initiation of 5ARI therapy 5ARI + AB Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Progression of Disease Up to 5 months The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.
- Secondary Outcome Measures
Name Time Method Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery 6 months