1. ¹Department of Urology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA
2. ²Division of Urology, Cook County Hospital, Chicago, IL, USA

Correspondence: Dr CG Roehrborn, Department of Urology, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., J8-130, Dallas, TX 75390-9110, USA. E-mail: Claus.Roehrborn@UTSouthwestern.edu

Received 8 June 2006; Accepted 20 July 2006; Published online 19 September 2006.

Abstract

The efficacy and tolerability of dutasteride (0.5 mg daily for 2 years) in African-Americans (n=161), compared with Caucasians (n=3961), was assessed in a post hoc analysis of data from three Phase III clinical trials. Dutasteride significantly reduced serum dihydrotestosterone levels by >90% and significantly improved subjective (symptom score) and objective (prostate volume, peak urinary flow rate, risk of benign prostatic hyperplasia-related surgery and acute urinary retention) outcomes in both African-Americans and Caucasians. For all efficacy measures, there was no statistically significant treatment-by-race interaction and dutasteride was well tolerated in both racial groups. Therefore, dutasteride demonstrated similar efficacy and safety profiles in African-Americans and Caucasians.