Purpose: To determine the efficacy and safety of dutasteride, alone or in combination, versus a placebo or control, used for the treatment of benign prostatic hyperplasia.
Methods: Pubmed(®) and the Cochrane Library were searched for randomized controlled trials longer than 6 months in duration. The subjects in the trials were men aged 40 or over, with moderate to severe symptoms of benign prostatic hyperplasia (BPH) as determined by International Prostate Symptom Score (IPSS). We pooled data from a total of nine different clinical trials.
Results: Dutasteride was superior to placebo in improving urinary symptoms measured by IPSS (∆ = -1.78, 95 % CI -3.01 to -0.55), peak urinary flow (Q max) (∆ = 1.27 mL/s, 95 % CI 0.97-1.57), and change in total prostate volume (TPV) (∆ = -17.40 cm(3), 95 % CI -25.77 to -9.02) while it resulted in more frequent drug-related adverse events (RR 1.35, 95 % CI 1.19-1.54). Combination therapy with dutasteride and tamsulosin resulted in significantly greater improvements in IPSS and Q max than tamsulosin monotherapy (∆ = -1.80 mL/s, 95 % CI -1.81 to -1.79 and ∆ = 1.60 mL/s, 95 % CI 1.59-1.61, respectively). When comparing dutasteride with finasteride, no significant differences in symptom improvement or the rate of adverse events were observed.
Conclusions: Dutasteride can be used to improve urinary symptoms (IPSS and Q max) and reduce TPV but with awareness of its potential adverse events. Combination therapy with tamsulosin can be considered when further improvements in symptoms are desired.