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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: 5ARI + AB

Study type: Observational

Funder types: Industry

Identifiers

NCT01332435

113984

Details and patient eligibility

About

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).

Enrollment: 6,896 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6,896 participants in 2 patient groups

Early 5ARI Initiation

Description:

Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)

Treatment:

Drug: 5ARI + AB

Late 5ARI Initiation

Description:

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)

Treatment:

Drug: 5ARI + AB