Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalCurrent Medical Research and Opinion
DOIs
Publication statusAccepted/In press - 2018 Apr 6

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tamsulosin
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Safety
Prostate
Placebos
Therapeutics
Residual Volume
Least-Squares Analysis

Keywords

  • Alpha-blocker
  • benign prostatic hyperplasia
  • lower urinary tract symptom
  • therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms : a randomized, double-blind, phase 3 trial. / Chung, Jae Hoon; Oh, Cheol Young; Kim, Jae Heon; Ha, U. Syn; Kim, Tae Hyo; Lee, Seung Hwan; Han, Jun Hyun; Bae, Jae Hyun; Chang, In Ho; Han, Deok Hyun; Yoo, Tag Keun; Chung, Jae Il; Kim, Sae Woong; Jung, Jina; Kim, Yong Il; Lee, Seung Wook.

In: Current Medical Research and Opinion, 06.04.2018, p. 1-9.

Research output: Contribution to journalArticle

Chung, Jae Hoon ; Oh, Cheol Young ; Kim, Jae Heon ; Ha, U. Syn ; Kim, Tae Hyo ; Lee, Seung Hwan ; Han, Jun Hyun ; Bae, Jae Hyun ; Chang, In Ho ; Han, Deok Hyun ; Yoo, Tag Keun ; Chung, Jae Il ; Kim, Sae Woong ; Jung, Jina ; Kim, Yong Il ; Lee, Seung Wook. / Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms : a randomized, double-blind, phase 3 trial. In: Current Medical Research and Opinion. 2018 ; pp. 1-9.
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title = "Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial",
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.",
keywords = "Alpha-blocker, benign prostatic hyperplasia, lower urinary tract symptom, therapeutics",
author = "Chung, {Jae Hoon} and Oh, {Cheol Young} and Kim, {Jae Heon} and Ha, {U. Syn} and Kim, {Tae Hyo} and Lee, {Seung Hwan} and Han, {Jun Hyun} and Bae, {Jae Hyun} and Chang, {In Ho} and Han, {Deok Hyun} and Yoo, {Tag Keun} and Chung, {Jae Il} and Kim, {Sae Woong} and Jina Jung and Kim, {Yong Il} and Lee, {Seung Wook}",
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T1 - Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

T2 - a randomized, double-blind, phase 3 trial

AU - Chung, Jae Hoon

AU - Oh, Cheol Young

AU - Kim, Jae Heon

AU - Ha, U. Syn

AU - Kim, Tae Hyo

AU - Lee, Seung Hwan

AU - Han, Jun Hyun

AU - Bae, Jae Hyun

AU - Chang, In Ho

AU - Han, Deok Hyun

AU - Yoo, Tag Keun

AU - Chung, Jae Il

AU - Kim, Sae Woong

AU - Jung, Jina

AU - Kim, Yong Il

AU - Lee, Seung Wook

PY - 2018/4/6

Y1 - 2018/4/6

N2 - 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.

AB - 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.

KW - Alpha-blocker

KW - benign prostatic hyperplasia

KW - lower urinary tract symptom

KW - therapeutics

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