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 Qmax ) and reduce TPV but with awareness of its potential adverse events .
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 .
Efficacy and Safety of Dutasteride in Chinese Adults with Symptomatic Benign Prostatic Hyperplasia
Abstract Background : Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone , which plays a key role in the aetiology and development of benign prostatic hyperplasia ( BPH ) . Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian population s. Objective : This study aim ed to evaluate the efficacy and safety of dutasteride in Chinese adults with symptomatic BPH . Methods : This was a r and omized , double-blind , parallel-group , placebo-controlled study conducted over 6 months , followed by an open-label extension of 12 months . A total of 253 BPH subjects with a total prostate volume ( TPV ) of ≥30 cm3 , a maximal urinary flow rate ( Qmax ) between 5 and 15 mL/s , and an American Urology Association Symptom Index ( AUA-SI ) score of ≥12 units were r and omized to dutasteride 0.5 mg/day orally or matching placebo treatment in a 1 : 1 ratio . After 6 months , eligible subjects who volunteered to enter the open-label extension received dutasteride 0.5 mg/day orally . Changes in TPV , Qmax and AUA-SI as well as drug safety were evaluated . Results : Dutasteride significantly reduced mean TPV compared with placebo at 3 and 6 months ( both p<0.05 ) . At 6 months , mean TPV decreased by 17.14 % versus 3.71 % in the dutasteride and placebo groups , respectively . Numerically higher improvements in Qmax and AUA-SI were observed in the dutasteride group at 3 and 6 months , but there was no statistically significant difference between treatment groups . However , ad hoc analysis indicated that , at 6 months , significantly higher proportions of subjects in the dutasteride group experienced a Qmax improvement of ≥3 mL/s , or an AUA-SI improvement of ≥1 unit , compared with the placebo group ( both p<0.05 ) . According to these criteria , the Qmax responder rates were 33.63 % and 19.83 % in the dutasteride- and placebo-treated groups , respectively , and the AUA-SI responder rates were 87.61 % and 76.92 % , respectively . During the open-label extension , continuous improvements in TPV , Qmax and AUA-SI were noted in both groups . Dutasteride was well tolerated with a low incidence of treatment-related adverse events over 18 months . Conclusion : Dutasteride was effective compared with placebo in the treatment of symptomatic BPH among Chinese patients . The efficacy data from trials involving subjects of different ethnic origins showed some similarities . Dutasteride was generally well tolerated during the study period
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 Qmax ) and reduce TPV but with awareness of its potential adverse events .
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 .