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Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea.
Int J Urol. 2014 Jul; 21(7):670-5.IJ

Abstract

OBJECTIVES

To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

METHODS

Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5 mg (n = 306) or placebo (n = 304) for 12 weeks.

RESULTS

A significantly greater improvement (P < 0.001) in total International Prostate Symptom Score for the change from baseline (week 0) to study end-point (week 12) was observed for tadalafil (-6.0) versus placebo (-4.5). Significantly greater improvements (P < 0.01) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements (P < 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo. Significantly greater improvements (P < 0.001) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified.

CONCLUSIONS

These findings confirm the efficacy and safety profile of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Authors+Show Affiliations

Department of Urology, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Yamanashi, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24571205

Citation

Takeda, Masayuki, et al. "Tadalafil 5 Mg Once-daily Therapy for Men With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Results From a Randomized, Double-blind, Placebo-controlled Trial Carried Out in Japan and Korea." International Journal of Urology : Official Journal of the Japanese Urological Association, vol. 21, no. 7, 2014, pp. 670-5.
Takeda M, Yokoyama O, Lee SW, et al. Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea. Int J Urol. 2014;21(7):670-5.
Takeda, M., Yokoyama, O., Lee, S. W., Murakami, M., Morisaki, Y., & Viktrup, L. (2014). Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea. International Journal of Urology : Official Journal of the Japanese Urological Association, 21(7), 670-5. https://doi.org/10.1111/iju.12410
Takeda M, et al. Tadalafil 5 Mg Once-daily Therapy for Men With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Results From a Randomized, Double-blind, Placebo-controlled Trial Carried Out in Japan and Korea. Int J Urol. 2014;21(7):670-5. PubMed PMID: 24571205.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea. AU - Takeda,Masayuki, AU - Yokoyama,Osamu, AU - Lee,Sung Won, AU - Murakami,Masahiro, AU - Morisaki,Yoji, AU - Viktrup,Lars, Y1 - 2014/02/27/ PY - 2013/07/26/received PY - 2014/01/08/accepted PY - 2014/2/28/entrez PY - 2014/2/28/pubmed PY - 2015/3/31/medline KW - Asian KW - benign prostatic hyperplasia KW - lower urinary tract symptoms KW - phosphodiesterase type 5 inhibitors KW - tadalafil SP - 670 EP - 5 JF - International journal of urology : official journal of the Japanese Urological Association JO - Int. J. Urol. VL - 21 IS - 7 N2 - OBJECTIVES: To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. METHODS: Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5 mg (n = 306) or placebo (n = 304) for 12 weeks. RESULTS: A significantly greater improvement (P < 0.001) in total International Prostate Symptom Score for the change from baseline (week 0) to study end-point (week 12) was observed for tadalafil (-6.0) versus placebo (-4.5). Significantly greater improvements (P < 0.01) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements (P < 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo. Significantly greater improvements (P < 0.001) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified. CONCLUSIONS: These findings confirm the efficacy and safety profile of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. SN - 1442-2042 UR - https://www.unboundmedicine.com/medline/citation/24571205/Tadalafil_5_mg_once_daily_therapy_for_men_with_lower_urinary_tract_symptoms_suggestive_of_benign_prostatic_hyperplasia:_results_from_a_randomized_double_blind_placebo_controlled_trial_carried_out_in_Japan_and_Korea_ L2 - https://doi.org/10.1111/iju.12410 DB - PRIME DP - Unbound Medicine ER -