N/A
Completed N=35,032
Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT01334723 ↗
Enrolled (actual)
35,032
Serious AEs
—
Results posted
Nov 2011
Primary outcomePrimary: Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% — 2140; 1587; 481; 331 participants
Summary
This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% |
2140; 1587; 481; 331; 5511; 8055 | — |
| PRIMARY Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75% |
2755; 1277; 627; 185; 7658; 5603 | — |
| PRIMARY Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80% |
2812; 915; 627; 185; 8975; 4591 | — |
| SECONDARY Mean Length of 5-ARI Therapy |
276.8; 289.5 | — |
| SECONDARY Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70% |
23.56; 24.40; 35.25; 38.59 | — |
| SECONDARY Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75% |
27.12; 27.14; 29.64; 32.37 | — |
| SECONDARY Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80% |
24.24; 23.02; 30.83; 33.95 | — |
| SECONDARY BPH-Related Costs for Every 30 Days of 5-ARI Therapy |
28.08; 29.89 | — |
Eligibility Criteria
Inclusion Criteria
- Male
- aged 50 years or older
- a diagnostic claim of BPH
- prescription claim for a 5ARI for at least 60 days during the observation period.
- continuously eligible for 6 months prior to and at least 6 months after index date.
Exclusion Criteria
- prostate cancer
- any prostate-related surgical procedure prior to index date
Data sourced from ClinicalTrials.gov (NCT01334723). 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. Informational only — not medical advice.