Jae Hoon Chung1, Cheol Young Oh2, Jae Heon Kim3, U-Syn Ha4, Tae Hyo Kim5, Seung Hwan Lee6, Jun Hyun Han2, Jae Hyun Bae7, In Ho Chang8, Deok Hyun Han9, Tag Keun Yoo10, Jae Il Chung11, Sae Woong Kim12, Jina Jung13, Yong-Il Kim13, Seung Wook Lee1. 1. a Department of Urology , Hanyang University College of Medicine , Seoul , Korea. 2. b Department of Urology , Hallym University College of Medicine , Seoul , Korea. 3. c Department of Urology , Soonchunhyang University College of Medicine , Seoul , Korea. 4. d Department of Urology, College of Medicine , The Catholic University of Korea, Yeoido St Mary's Hospital , Seoul , Korea. 5. e Department of Urology , Dong-A University College of Medicine , Busan , Korea. 6. f Department of Urology , Yonsei University College of Medicine , Seoul , Korea. 7. g Department of Urology , Korea University College of Medicine , Seoul , Korea. 8. h Department of Urology , Chung-Ang University College of Medicine , Seoul , Korea. 9. i Department of Urology , Sungkyunkwan University School of Medicine, Samsung Medical Center , Seoul , Korea. 10. j Department of Urology , Eulji University College of Medicine , Seoul , Korea. 11. k Department of Urology , Inje University College of Medicine , Seoul , Korea. 12. l Department of Urology, College of Medicine , The Catholic University of Korea, Seoul St Mary's Hospital , Seoul , Korea. 13. m Hanmi Pharmaceutical Co. Ltd. , Seoul , Korea.
Abstract
OBJECTIVE: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks. RESULTS: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups. CONCLUSIONS:Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882.
RCT Entities:
OBJECTIVE: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks. RESULTS: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups. CONCLUSIONS:Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882.