Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: 5ARI; Drug: AB

Study type: Observational

Funder types: Industry

Identifiers

NCT01323998

114462

Details and patient eligibility

About

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

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 for BPH
• at least one prescription claim for a 5ARI or AB in the enrollment period
• continuous eligibility for 6 months prior to and 12 months after index prescription date

Exclusion criteria

• diagnosis of prostate or bladder cancer during the study period
• any prostate-related surgical procedure within 1 month of the index prescription date
• prescription claim for finasteride 1 mg for male pattern baldness during the study period

Trial design

35,032 participants in 4 patient groups

5ARI monotherapy

Description:

Patients with BPH receiving 5ARI monotherapy

Treatment:

Drug: 5ARI

AB monotherapy

Description:

Patients with BPH receiving AB monotherapy

Treatment:

Drug: AB

Early combination (5ARI + AB) therapy

Description:

Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy

Treatment:

Drug: AB

Drug: 5ARI

Delayed combination (5ARI + AB) therapy

Description:

Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy

Treatment:

Drug: AB

Drug: 5ARI