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

Completed

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

• Registration Number: NCT01332435
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Results First Submitted: 2011-04-14
• Results First Submitted QC: 2011-06-23
• Results First Posted: 2011-07-22
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6896

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early 5ARI Initiation	5ARI + AB	Patients with EP receiving 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 (more than 30 days but less than 6 months after initiation of AB)

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Needed Prostate-Related Surgery	Day 1 of a 1-day study	Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Number of Participants With Clinical Progression	Day 1 of a 1-day study	Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
Number of Participants With Acute Urinary Retention	Day 1 of a 1-day study	Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.

Secondary Outcome Measures

Name	Time	Method
Total BPH-related Costs	Day 1 of a 1-day study	All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
BPH-related Medical Costs	Day 1 of a 1-day study	Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
BPH-related Pharmacy Costs	Day 1 of a 1-day study	Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).