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

Transparency

Declaration of funding

This trial was funded by Hanmi Pharmaceutical. Hanmi Pharmaceutical had no involvement in the design or conduct of the study; collection, management, analysis or interpretation of the data; preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication.

Author contributions: S.W.L. and S.W.K. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: S.W.K., J.I.C., T.K.Y., D.H.H. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: J.H.C. Critical revision of the manuscript for important intellectual content: C.Y.O., J.H.K., U-S.H., T.H.K., S.H.L., J.H.H., J.H.B., I.H.Ch. Statistical analysis: J.J. Obtained funding: S.W.K. Administrative, technical or material support: J.J., Y.-I.K. Supervision: S.W.K., J.I.C., T.K.Y.

Declaration of financial/other relationships

S.W.K. has disclosed that he received grant funding from Hanmi Pharmaceutical. J.J. and Y.-I.K. have disclosed that they are employees of Hanmi Pharmaceutical.

J.H.C., C.Y.O., J.H.K., U-S.H.,T.H.K., S.H.L., J.H.H., J.H.B., I.H.C., D.H.H., T.K.Y., J.I.C. and S.W.L. have no conflict of interest or financial ties to disclose.

A CMRO peer reviewer on this manuscript has disclosed that they were a previous employee of Boehringer Ingelheim with tasks related to tamsulosin until mid-2016. Other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

None reported.