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Dutasteride/Tamsulosin Combo Produces Multiple Benefits in Men With Enlarged Prostates: Presented at EAU
By Jill Stein
MILAN, Italy -- March 27, 2008 -- Combination treatment with the dual 5 alpha-reductase inhibitor dutasteride and the alpha blocker tamsulosin results in continuous symptomatic improvement in men with benign prostatic hyperplasia (BPH) and in patient-reported quality of life, investigators said here at the 23rd Annual European Association of Urology (EAU) Congress.
Jack Barkin, MD, Assistant Professor of Surgery, University of Toronto, Toronto, Ontario, Canada, and colleagues randomised 4,800 men with moderate to severe BPH to receive the dutasteride and tamsulosin combination, dutasteride monotherapy, or tamsulosin monotherapy after a 4-week placebo run-in period.
Findings from a preplanned 2-year analysis of the 4-year Combination of Avodart and Tamsulosin trial revealed that combination therapy resulted in significantly greater improvements in symptoms and flow rate than either drug alone, said Dr. Barkin.
Secondary endpoints in the 2-year analysis included the BPH Impact Index (BII) and question 8 of the International Prostate Symptom Scale (IPSS Q8), which is a BPH-related health status/motivational scale.
Analysis of secondary endpoints found that at month 24, improvements in BII score and IPSS Q8 score from baseline were significantly greater with combination therapy compared with each monotherapy regimen (P < .001).
Improvement in BII score from baseline was significantly greater with combination therapy from month 3 versus dutasteride and from month 9 versus tamsulosin (P < .01).
Combination therapy was associated with a significant improvement from baseline in IPSS Q8 score from month 3 versus dutasteride and from month 12 versus tamsulosin (P < .001).
Results also showed a significant benefit of combination therapy over each monotherapy regimen for treatment satisfaction, which was examined using a questionnaire specifically developed for use and validation in COMBAT to assess patient treatment satisfaction (P < .001).
Dr. Barkin said this trial is the first to demonstrate the significant superiority of the combination of a 5 alpha reductase inhibitor and alpha blocker over each drug alone in improving patient-reported quality of life.
BPH is a progressive disease which has a considerable negative impact on patient quality of life. Bother and interference with daily activities are the main drivers for BPH patients to seek healthcare. The condition affects 50% of men aged more than 50 years, and more than 90% of men aged more than 80 years.
Funding for this study was provided by GlaxoSmithKline.
[Presentation title: Improvements in Patient-Reported Quality of Life With Dutasteride, Tamsulosin and the Combination: Two-Year Results From the Combination of Avodart and Tamsulosin (CombAT) Trial. Abstract 99]
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