N/A
Completed N=332
Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT01386983 ↗
Enrolled (actual)
332
Serious AEs
—
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Clinical Progression — 14; 5 participants — p=0.0128
Summary
This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Progression |
14; 5 | 0.0128 sig |
| SECONDARY Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month |
129.14; 254.51 | 0.0002 sig |
Eligibility Criteria
Inclusion Criteria
- Males
- aged 50 years or older
- medical claim of EP
- prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
- continuously eligible for 3 months prior to and at least 5 months after their index prescription date.
Exclusion Criteria
- Patients with prostate or bladder cancer
- any prostate-related surgical procedure within 5 months of index date
- prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
Data sourced from ClinicalTrials.gov (NCT01386983). 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.