N/A
N=8,617
Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01332487 ↗Enrolled (actual)
8,617
Serious AEs
—
Results posted
Feb 2012
Primary outcome: Primary: Number of Participants Who Experienced Progression of Disease — 589; 393; 280; 212 participants — p=0.002
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 5ARI + AB (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Progression of Disease |
589; 393; 280; 212; 86; 52 | 0.002 sig |
| SECONDARY Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery |
37; 27; 54; 35; 85; 51 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01332487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.