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).
A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. The 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.
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, the 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 < 0.0001). In addition, in the patients with severe symptom (IPSS ≥ 20), the total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < 0.0001). 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.
Tamsulosin 0.4 mg and 0.2 mg appears 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 a favorable efficacy and tolerability in Asian men with symptomatic BPH.
Current medical research and opinion. 2018 Feb 28 [Epub ahead of print]
Jae Hoon Chung, Cheol Young Oh, Jae Heon Kim, U-Syn Ha, Tae Hyo Kim, Seung Hwan Lee, Jun Hyun Han, Jae Hyun Bae, In Ho Chang, Deok Hyun Han, Tag Keun Yoo, Jae Il Chung, Sae Woong Kim, Jina Jung, Yong-Il Kim, Seung Wook Lee
a Department of Urology , Hanyang University College of Medicine , Seoul , Korea., b Department of Urology , Hallym University College of Medicine , Seoul , Korea., c Department of Urology , Soonchunhyang University College of Medicine , Seoul , Korea., d Department of Urology , College of Medicine, The Catholic University of Korea, Yeoido St Mary's hospital , Seoul , Korea., e Department of Urology , Dong-A University College of Medicine , Busan , Korea., f Department of Urology , Yonsei University College of Medicine , Seoul , Korea., g Department of Urology , Korea University College of Medicine , Seoul , Korea., h Department of Urology , Chung-Ang University College of Medicine , Seoul , Korea., i Department of Urology , Sungkyunkwan University School of Medicine, Samsung Medical Center , Seoul , Korea., j Department of Urology , Eulji University College of Medicine , Seoul , Korea., k Department of Urology , Inje University College of Medicine , Seoul , Korea., l Department of Urology , College of Medicine, The Catholic University of Korea, Seoul St Mary's hospital , Seoul , Korea., m Hanmi Pharmaceutical Co., Ltd. , Seoul , Korea.