Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: 5ARI; Drug: 5ARI + AB

• Registration Number: NCT01386983
• Lead Sponsor: GlaxoSmithKline

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2011-02-28
• Results First Submitted: 2011-02-28
• Study First Submitted QC: 2011-06-06
• Results First Submitted QC: 2011-06-06
• Study First Posted: 2011-07-01
• Results First Posted: 2011-07-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 332

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late 5ARI Initiation	5ARI	Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)
Early 5ARI Initiation	5ARI	Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
Early 5ARI Initiation	5ARI + AB	Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
Late 5ARI Initiation	5ARI + AB	Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Progression	3 months prior to and 12 months following index date	Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

Secondary Outcome Measures

Name	Time	Method
Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month	3 months prior to and 12 months following index date	EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.