Efficacy and tolerability of the dual 5alpha-reductase inhibitor, dutasteride, in the treatment of benign prostatic hyperplasia in African-American men.
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.
Roehrborn
C G
CG
Department of Urology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390, USA. Claus.Roehrborn@UTSouthwestern.edu
Ray
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D058891:5-alpha Reductase Inhibitors; D000208:Acute Disease; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D001378:Azasteroids / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology* / Q000601:surgery; D012720:Severity of Illness Index; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome; D016055:Urinary Retention / Q000517:prevention & control; D014554:Urination / Q000187:drug effects; D014563:Urodynamics / Q000187:drug effects; D013521:Urologic Surgical Procedures, Male; D044465:White People
D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D015415:Biomarkers; D004791:Enzyme Inhibitors; D013196:Dihydrotestosterone; D013739:Testosterone; D017430:Prostate-Specific Antigen; D000068538:Dutasteride