Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: 5ARI + AB

Study type: Observational

Funder types: Industry

Identifiers

NCT01332487

114461

Details and patient eligibility

About

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

Enrollment: 4,068 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• aged 50 years or older
• diagnostic claim for BPH
• prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
• continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion criteria

• prostate or bladder cancer during the study period
• any prostate-related surgical procedure within 5 months of the index prescription date
• prescription claim for finasteride 1 mg for male pattern baldness during the study period
• 5ARI therapy prior to initiation of AB therapy

Trial design

4,068 participants in 2 patient groups

Early initiation of 5ARI therapy

Description:

Patients starting 5ARI therapy within 30 days of initiating AB therapy

Treatment:

Drug: 5ARI + AB

Delayed initiation of 5ARI therapy

Description:

Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy

Treatment:

Drug: 5ARI + AB