Efficacy and safety of dutasteride for the treatment of symptomatic benign prostatic hyperplasia (BPH): a systematic review and meta-analysis.
OBJECTIVE
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.
College of Pharmacy, University of Minnesota, 7-170 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN, 55455, USA, parkx672@umn.edu.
Taehwan
T
Park
Jae-Young
JY
Choi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001378:Azasteroids / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000068538:Dutasteride; D018120:Finasteride / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D011467:Prostate / Q000187:drug effects / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D013449:Sulfonamides / Q000494:pharmacology / Q000627:therapeutic use; D000077409:Tamsulosin; D016896:Treatment Outcome; D064804:Urological Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*
D001378:Azasteroids; D013449:Sulfonamides; D064804:Urological Agents; D018120:Finasteride; D000077409:Tamsulosin; D000068538:Dutasteride