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

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: 5ARI + AB

• Study Type: Observational
• Enrollment (Actual): 4068

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early initiation of 5ARI therapy; Patients starting 5ARI therapy within 30 days of initiating AB therapy	Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed initiation of 5ARI therapy; Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy	Drug: 5ARI + AB; 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Progression of Disease	The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.	Up to 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery	6 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Benign prostatic hyperplasia; enlarged prostate; 5-alpha-reductase inhibitor; prostate surgery; alpha-blocker; acute urinary retention
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 114461