Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: Non-adherent to 5ARI therapy; Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01334723

114482

Details and patient eligibility

About

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).

Enrollment: 35,032 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• aged 50 years or older
• a diagnostic claim of BPH
• prescription claim for a 5ARI for at least 60 days during the observation period.
• continuously eligible for 6 months prior to and at least 6 months after index date.

Exclusion criteria

• prostate cancer
• any prostate-related surgical procedure prior to index date

Trial design

35,032 participants in 2 patient groups

Acute Urinary Retention

Description:

This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.

Treatment:

Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy

Drug: Non-adherent to 5ARI therapy

Prostate Surgery

Description:

This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.

Treatment:

Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy

Drug: Non-adherent to 5ARI therapy