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Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH

Authors
 B-H Chung  ;  CG Roehrborn  ;  P Siami  ;  K Major-Walker  ;  BB Morrill  ;  TH Wilson  ;  F Montorsi 
Citation
 PROSTATE CANCER AND PROSTATIC DISEASES, Vol.12(2) : 152-159, 2009 
Journal Title
PROSTATE CANCER AND PROSTATIC DISEASES
ISSN
 1365-7852 
Issue Date
2009
MeSH
Aged ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Asian Continental Ancestry Group ; Azasteroids/administration & dosage* ; Azasteroids/adverse effects ; Double-Blind Method ; Dutasteride ; Humans ; Male ; Middle Aged ; Prostatic Hyperplasia/drug therapy* ; Sulfonamides/administration & dosage* ; Sulfonamides/adverse effects ; Treatment Outcome
Abstract
Although ethnicity-based differences in prostate size and physiology have been reported, results of benign prostatic hyperplasia (BPH) treatment trials in predominantly Caucasian patients are assumed to be applicable to non-Caucasian populations. This post hoc analysis investigated whether an Asian subpopulation of men with moderate-to-severe BPH in the CombAT study achieves treatment responses in line with those of the overall study population. In this double-blind, randomized, parallel-group trial, 325 Asian men were assigned to treatment with 0.5 mg dutasteride once daily, 0.4 mg tamsulosin once daily or the combination. Decrease in international prostate symptom score (IPSS) at month 24 from baseline (the primary endpoint) was significantly greater with combination treatment compared with tamsulosin (P<0.05), and numerically, but not statistically significantly, greater compared with dutasteride. Mean IPSS was reduced from baseline by 7.5 (+/-0.84) in the combination group, by 6.3 (+/-0.86) in the dutasteride group and by 4.5 (+/-0.78) in the tamsulosin group, resulting in respective mean IPSS at months 24 of 11.4 (+/-0.60), 12.7 (+/-0.70) and 14.3 (+/-0.74). The adverse event profile was similar to that observed in the overall CombAT population, and drug-related adverse events were more common with combination therapy (26%) than with tamsulosin (15%) or dutasteride (9%). No unexpected adverse events emerged. In conclusion, in Asian men with moderate-to-severe lower urinary tract symptoms and an enlarged prostate, combination therapy achieved significantly greater improvements from baseline BPH symptoms, flow rate, quality of life, reduced prostate volume and improved treatment satisfaction compared with tamsulosin monotherapy
Full Text
http://www.nature.com/pcan/journal/v12/n2/full/pcan200849a.html
DOI
10.1038/pcan.2008.49
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Chung, Byung Ha(정병하) ORCID logo https://orcid.org/0000-0001-9817-3660
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/105726
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