December 26, 2007The Journal of Urology
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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Discussion
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Implication
Randomized double-blind trial shows superior symptom and urinary flow improvements with combination therapy in men with benign prostatic hyperplasia, indicating greater clinical efficacy.
Key Points
- To determine whether daily combination therapy with dutasteride and tamsulosin provides greater improvement in symptoms and urinary flow compared with either monotherapy alone over two years.
- Conducted a multicenter, randomized, double-blind, parallel-group trial in men aged 50 years or older with benign prostatic hyperplasia, IPSS ≥12, prostate volume ≥30 cc, PSA 1.5–10 ng/ml, and peak urinary flow >5 to ≤15 ml/s.
- Randomized participants to once-daily dutasteride 0.5 mg, tamsulosin 0.4 mg, or combination therapy for a planned duration of 4 years.
- Monitored urinary symptoms every 3 months and peak flow every 6 months, evaluating the primary endpoint of IPSS change from baseline at 2 years.
- Combination therapy produced significantly greater improvements in IPSS compared to dutasteride starting at month 3 and tamsulosin starting at month 9, with superior health status gains from months 3 and 12, respectively.
- Peak urinary flow improved significantly more with combination therapy than with either dutasteride or tamsulosin monotherapy starting from month 6.
- Drug-related adverse events occurred with significantly higher incidence in the combination therapy arm than in the monotherapy arms, but the majority did not cause discontinuation.
Cite This Study
Roehrborn et al. (2007) studied this question.