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

GlaxoSmithKline332 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Prostatic Hyperplasia

Interventions

5ARIDRUG

Dutasteride or Finasteride

5ARI + ABDRUG

5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Clinical Progression

Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

Time frame: 3 months prior to and 12 months following index date

Secondary Outcomes

Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month

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.

Time frame: 3 months prior to and 12 months following index date

Data from ClinicalTrials.gov

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