Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia
Objectives: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). Methods: This was a randomized, double‐blind, placebo‐controlled, parallel‐group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IP...
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| Published in | International journal of urology Vol. 16; no. 9; pp. 745 - 750 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
Melbourne, Australia
Blackwell Publishing Asia
01.09.2009
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0919-8172 1442-2042 1442-2042 |
| DOI | 10.1111/j.1442-2042.2009.02357.x |
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| Abstract | Objectives: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
Methods: This was a randomized, double‐blind, placebo‐controlled, parallel‐group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.
Results: Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug‐related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.
Conclusions: Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one‐year treatment period. |
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| AbstractList | To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.
Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.
Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period. To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).OBJECTIVESTo assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.METHODSThis was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.RESULTSContinued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period.CONCLUSIONSDutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period. Objectives: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). Methods: This was a randomized, double‐blind, placebo‐controlled, parallel‐group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated. Results: Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug‐related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting. Conclusions: Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one‐year treatment period. Objectives: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). Methods: This was a randomized, double‐blind, placebo‐controlled, parallel‐group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated. Results: Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug‐related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting. Conclusions: Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one‐year treatment period. |
| Author | Endo, Yukihiro Narita, Michiro Tsukamoto, Taiji |
| Author_xml | – sequence: 1 givenname: Taiji surname: Tsukamoto fullname: Tsukamoto, Taiji email: taijit@sapmed.ac.jp organization: Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, and – sequence: 2 givenname: Yukihiro surname: Endo fullname: Endo, Yukihiro organization: Development and Medical Affairs Division, GlaxoSmithKline, Tokyo, Japan – sequence: 3 givenname: Michiro surname: Narita fullname: Narita, Michiro organization: Development and Medical Affairs Division, GlaxoSmithKline, Tokyo, Japan |
| BackLink | https://cir.nii.ac.jp/crid/1572261550789303168$$DView record in CiNii https://www.ncbi.nlm.nih.gov/pubmed/19674165$$D View this record in MEDLINE/PubMed |
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| References | Tsukamoto T, Endo Y, Narita M. Assessment of recommended dose of dutasteride on Japanese men with benign prostatic hyperplasia: a randomized, double-blind, placebo-controlled, parallel-group, dose response study. Acta Urol. Jpn. 2009; 55: 209-14. Guess HA, Heyse JF, Gormley GJ, Stoner E, Oesterling JE. Effect of finasteride on serum PSA concentration in men with benign prostatic hyperplasia: results from the North American Phase III clinical trial. Urol. Clin. North Am. 1993; 20: 627-36. Tsukamoto T, Masumori N, Rahman M, Crane MM. Change in International Prostate Symptom Score, prostate-specific antigen and prostate volume in patients with benign prostatic hyperplasia followed longitudinally. Int. J. Urol. 2007; 14: 321-4. Gormley GJ, Stoner E, Bruskewitz RC et al. The effect of finasteride in men with benign prostatic hyperplasia. N. Eng. J. Med. 1992; 327: 1185-91. Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology. 1996; 48: 398-405. Roehrborn CG, Boyle P, Nickel JC, Hoefner K, Andriole G. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002; 60: 434-41. Roehrborn CG, Siami P, Barkin J et al. The influence of baseline parameters on changes in International Prostate Symptom Score with dutasteride, tamsulosin, and combination therapy among men with symptomatic benign prostatic hyperplasia and an enlarged prostate: 2-year data from the CombAT study. Eur. Urol. 2009; 55: 461-71. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of α1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur. Urol. 1999; 36: 1-13. McConnell JD, Bruskewitz R, Walsh P et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N. Engl. J. Med. 1998; 338: 557-63. Andriole GL, Marberger M, Roehrborn CG. Clinical usefulness of serum prostate specific antigen for the detection of prostate cancer is preserved in men receiving the dual 5α-reductase inhibitor dutasteride. J. Urol. 2006; 175: 1657-62. Bramson HN, Hermann D, Batchelor KW, Lee FW, James MK, Frye SV. Unique preclinical characteristics of GG745, a potent dual inhibitor of 5AR. J. Pharmacol. Exp. Ther. 1997; 282: 1496-502. Debruyne F, Barkin J, Van Erps P, Reis M, Tammela TLJ, Roehrborn C. Efficacy and safety of long-term treatment with the dual 5α-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur. Urol. 2004; 46: 488-95. Boyle P, Robertson C, Manski R, Padley RJ, Roehrborn CG. Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia. Urology 2001; 58: 717-22. McConnell JD, Roehrborn CG, Bautista OM et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N. Engl. J. Med. 2003; 349: 2387-98. Andriole GL, Kirby R. Safety and tolerability of the dual 5α-reductase inhibitor dutasteride in the treatment of benign prostatic hyperplasia. Eur. Urol. 2003; 44: 82-8. Roehrborn CG, Siami P, Barkin J et al. 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. J. Urol. 2008; 179: 616-21. Roehrborn CG, Marks LS, Fenter T et al. Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Urology 2004; 63: 709-15. Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5α-reductase inhibitor. J. Clin. Endocrinol. Metab. 2004; 89: 2179-84. Barry MJ, Williford WO, Chang Y et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association Symptom Index and the Benign Prostatic Hyperplasia Impact Index is perceptible to patients? J. Urol. 1995; 154: 1770-4. Guess HA, Gormley GJ, Stoner E, Oesterling JE. The effect of finasteride on prostate specific antigen: review of available data. J. Urol. 1996; 155: 3-9. 2009; 55 2004; 63 2003; 349 1997; 282 2004; 89 1993; 20 1999; 36 2004; 46 1998; 338 1992; 327 2006; 175 1996; 155 2002; 60 2008; 179 1995; 154 2001; 58 1996; 48 2007; 14 2003; 44 Bramson HN (e_1_2_6_7_2) 1997; 282 e_1_2_6_8_2 Tsukamoto T (e_1_2_6_12_2) 2009; 55 e_1_2_6_18_2 e_1_2_6_9_2 e_1_2_6_19_2 e_1_2_6_4_2 e_1_2_6_3_2 e_1_2_6_6_2 e_1_2_6_5_2 e_1_2_6_13_2 e_1_2_6_10_2 e_1_2_6_11_2 Guess HA (e_1_2_6_20_2) 1993; 20 e_1_2_6_21_2 Djavan B (e_1_2_6_2_2) 1999; 36 e_1_2_6_16_2 e_1_2_6_17_2 e_1_2_6_14_2 e_1_2_6_15_2 |
| References_xml | – reference: McConnell JD, Roehrborn CG, Bautista OM et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N. Engl. J. Med. 2003; 349: 2387-98. – reference: Gormley GJ, Stoner E, Bruskewitz RC et al. The effect of finasteride in men with benign prostatic hyperplasia. N. Eng. J. Med. 1992; 327: 1185-91. – reference: Tsukamoto T, Masumori N, Rahman M, Crane MM. Change in International Prostate Symptom Score, prostate-specific antigen and prostate volume in patients with benign prostatic hyperplasia followed longitudinally. Int. J. Urol. 2007; 14: 321-4. – reference: Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5α-reductase inhibitor. J. Clin. Endocrinol. Metab. 2004; 89: 2179-84. – reference: McConnell JD, Bruskewitz R, Walsh P et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N. Engl. J. Med. 1998; 338: 557-63. – reference: Roehrborn CG, Siami P, Barkin J et al. 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. J. Urol. 2008; 179: 616-21. – reference: Andriole GL, Kirby R. Safety and tolerability of the dual 5α-reductase inhibitor dutasteride in the treatment of benign prostatic hyperplasia. Eur. Urol. 2003; 44: 82-8. – reference: Andriole GL, Marberger M, Roehrborn CG. Clinical usefulness of serum prostate specific antigen for the detection of prostate cancer is preserved in men receiving the dual 5α-reductase inhibitor dutasteride. J. Urol. 2006; 175: 1657-62. – reference: Roehrborn CG, Boyle P, Nickel JC, Hoefner K, Andriole G. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002; 60: 434-41. – reference: Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of α1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur. Urol. 1999; 36: 1-13. – reference: Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology. 1996; 48: 398-405. – reference: Bramson HN, Hermann D, Batchelor KW, Lee FW, James MK, Frye SV. Unique preclinical characteristics of GG745, a potent dual inhibitor of 5AR. J. Pharmacol. Exp. Ther. 1997; 282: 1496-502. – reference: Barry MJ, Williford WO, Chang Y et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association Symptom Index and the Benign Prostatic Hyperplasia Impact Index is perceptible to patients? J. Urol. 1995; 154: 1770-4. – reference: Roehrborn CG, Marks LS, Fenter T et al. Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Urology 2004; 63: 709-15. – reference: Guess HA, Heyse JF, Gormley GJ, Stoner E, Oesterling JE. Effect of finasteride on serum PSA concentration in men with benign prostatic hyperplasia: results from the North American Phase III clinical trial. Urol. Clin. North Am. 1993; 20: 627-36. – reference: Boyle P, Robertson C, Manski R, Padley RJ, Roehrborn CG. Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia. Urology 2001; 58: 717-22. – reference: Tsukamoto T, Endo Y, Narita M. 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Methods: This was a randomized,... Objectives: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). Methods: This was a randomized,... To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). This was a randomized, double-blind,... To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).OBJECTIVESTo assess the efficacy and safety of... |
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| SubjectTerms | 5-alpha reductase inhibitor Adrenergic alpha-Antagonists - therapeutic use Aged Aged, 80 and over Asian Continental Ancestry Group Azasteroids - adverse effects Azasteroids - therapeutic use benign prostatic hyperplasia Double-Blind Method Dutasteride Enzyme Inhibitors - therapeutic use Humans Japanese Male Middle Aged Prostate - anatomy & histology Prostate - drug effects Prostate-Specific Antigen - blood Prostatic Hyperplasia - drug therapy Prostatic Hyperplasia - physiopathology Prostatism - drug therapy Sulfonamides - adverse effects Sulfonamides - therapeutic use tamsulosin Treatment Outcome Ultrasound, High-Intensity Focused, Transrectal Urodynamics |
| Title | Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia |
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