Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: 5ARI + AB; Drug: 5ARI

Study type: Observational

Funder types: Industry

Identifiers

NCT01386983

112599

Details and patient eligibility

About

This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

Enrollment: 332 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males
• aged 50 years or older
• medical claim of EP
• prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
• continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Exclusion criteria

• Patients with prostate or bladder cancer
• any prostate-related surgical procedure within 5 months of index date
• prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

Trial design

332 participants in 2 patient groups

Early 5ARI Initiation

Description:

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

Treatment:

Drug: 5ARI

Drug: 5ARI + AB

Late 5ARI Initiation

Description:

Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)

Treatment:

Drug: 5ARI

Drug: 5ARI + AB