The Effects of Dutasteride, Tamsulosin and Combination Therapy on Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia and Prostatic Enlargement: 2-Year Results From the CombAT Study
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Abstract
Purpose:
We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses.
Materials and Methods:
The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline.
Results:
Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy.
Conclusions:
In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.
References
- 1 : Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology2003; 61: 119. Google Scholar
- 2 : The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N Engl J Med1996; 335: 533. Google Scholar
- 3 : The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med2003; 349: 2387. Crossref, Medline, Google Scholar
- 4 : Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5 alpha-reductase inhibitor. J Clin Endocrinol Metab2004; 89: 2179. Google Scholar
- 5 : Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart® and Tamsulosin) trial rationale and study design. Contemp Clin Trials2007; 28: 770. Google Scholar
- 6 : Intraoperative floppy-iris syndrome associated with alpha1-adrenoreceptors: comparison of tamsulosin and alfuzosin. J Cataract Refract Surg2007; 33: 1227. Google Scholar
- 7 : Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology2002; 60: 434. Google Scholar
- 8 : Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers. J Urol2006; 176: 1529. Link, Google Scholar
- 9 : The effect of 5alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrinol Metab2007; 92: 1659. Google Scholar
- 10 : Effect of dutasteride on the detection of prostate cancer in men with benign prostatic hyperplasia. Urology2004; 64: 537. Google Scholar
- 11 : Chemoprevention of prostate cancer in men at high risk: rationale and design of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. J Urol2004; 172: 1314. Link, Google Scholar
- 12 : Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol2006; 175: 217. Link, Google Scholar
