Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Condition(s) targeted: Prostatic Hyperplasia

Intervention: 5ARI + AB (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

Official title: Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Number of Participants With Clinical Progression

Number of Participants With Acute Urinary Retention

Number of Participants Who Needed Prostate-Related Surgery

Secondary outcome:

Total BPH-related Costs

BPH-related Medical Costs

BPH-related Pharmacy Costs

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male patients aged 50 years or older

- a medical claim of EP

- a prescription claim for a 5ARI and AB (provided both are within 180 days of index

date)

- continuously eligible for 6 months prior to and at least 12 months after index

prescription date. Exclusion Criteria:

- diagnosis of prostate or bladder cancer

- any prostate-related surgical procedure within 5 months of index date

- prescription claim for finasteride indicative of male pattern baldness

- 5ARI therapy initiated prior to initiating AB therapy

Starting date: November 2009
Last updated: August 4, 2011