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Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men.
Int J Urol. 2013 Feb; 20(2):193-201.IJ

Abstract

OBJECTIVES

To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

METHODS

Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n=154), tadalafil 2.5 mg (n=151), tadalafil 5.0 mg (n=155) or tamsulosin 0.2 mg (active control, n=152) for 12 weeks.

RESULTS

Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg (-4.8, P=0.003) and 5 mg (-4.7, P=0.004) versus placebo (-3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements (P<0.05) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg (-1.7, P=0.021), but not tadalafil 2.5 mg (-1.5, P=0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles.

CONCLUSIONS

Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Authors+Show Affiliations

Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22958078

Citation

Yokoyama, Osamu, et al. "Tadalafil once Daily for Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: a Randomized Placebo- and Tamsulosin-controlled 12-week Study in Asian Men." International Journal of Urology : Official Journal of the Japanese Urological Association, vol. 20, no. 2, 2013, pp. 193-201.
Yokoyama O, Yoshida M, Kim SC, et al. Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men. Int J Urol. 2013;20(2):193-201.
Yokoyama, O., Yoshida, M., Kim, S. C., Wang, C. J., Imaoka, T., Morisaki, Y., & Viktrup, L. (2013). Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men. International Journal of Urology : Official Journal of the Japanese Urological Association, 20(2), 193-201. https://doi.org/10.1111/j.1442-2042.2012.03130.x
Yokoyama O, et al. Tadalafil once Daily for Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: a Randomized Placebo- and Tamsulosin-controlled 12-week Study in Asian Men. Int J Urol. 2013;20(2):193-201. PubMed PMID: 22958078.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men. AU - Yokoyama,Osamu, AU - Yoshida,Masaki, AU - Kim,Sae Chul, AU - Wang,Chii-Jye, AU - Imaoka,Takeshi, AU - Morisaki,Yoji, AU - Viktrup,Lars, Y1 - 2012/09/07/ PY - 2012/03/13/received PY - 2012/07/26/accepted PY - 2012/9/11/entrez PY - 2012/9/11/pubmed PY - 2013/8/14/medline SP - 193 EP - 201 JF - International journal of urology : official journal of the Japanese Urological Association JO - Int J Urol VL - 20 IS - 2 N2 - OBJECTIVES: To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. METHODS: Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n=154), tadalafil 2.5 mg (n=151), tadalafil 5.0 mg (n=155) or tamsulosin 0.2 mg (active control, n=152) for 12 weeks. RESULTS: Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg (-4.8, P=0.003) and 5 mg (-4.7, P=0.004) versus placebo (-3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements (P<0.05) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg (-1.7, P=0.021), but not tadalafil 2.5 mg (-1.5, P=0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles. CONCLUSIONS: Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. SN - 1442-2042 UR - https://www.unboundmedicine.com/medline/citation/22958078/Tadalafil_once_daily_for_lower_urinary_tract_symptoms_suggestive_of_benign_prostatic_hyperplasia:_a_randomized_placebo__and_tamsulosin_controlled_12_week_study_in_Asian_men_ L2 - https://doi.org/10.1111/j.1442-2042.2012.03130.x DB - PRIME DP - Unbound Medicine ER -