Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: 5ARI (Drug); 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
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).
Clinical Details
Official title: Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Number of Participants With Clinical Progression
Secondary outcome: Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: March 2009
Last updated: August 11, 2011
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