Real-World Safety and Effectiveness of Tadalafil in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Japanese Post-Marketing Surveillance Study

References

• Homma Y, Gotoh M, Kawauchi A, et al. Clinical guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia. Int J Urol. 2017;24(10):716–729. doi:10.1111/iju.13401
   PubMed Web of Science ®Google Scholar
• Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2015;67(6):1099–1109. doi:10.1016/j.eururo.2014.12.038
   PubMed Web of Science ®Google Scholar
• AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: diagnosis and treatment recommendations. J Urol. 2003;170(2):530–547. doi:10.1097/01.ju.0000078083.38675.79
   PubMed Web of Science ®Google Scholar
• Welch G, Weinger K, Barry MJ. Quality-of-life impact of lower urinary tract symptom severity: results from the health professionals follow-up study. Urology. 2002;59(2):245–250. doi:10.1016/S0090-4295(01)01506-0
   PubMed Web of Science ®Google Scholar
• Japanese Ministry of Health, Labour and Welfare. The results of the 2017 patient survey. Japanese government official statistics of Japan website. [ Updated March 29, 2019]. Available from: https://www.e-stat.go.jp/dbview?sid=0003318621. Accessed July 17, 2019.
   Google Scholar
• Gacci M, Andersson KE, Chapple C, et al. Latest evidence on the use of phosphodiesterase type 5 inhibitors for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2016;70(1):124–133. doi:10.1016/j.eururo.2015.12.048
   Web of Science ®Google Scholar
• Yokoyama O, Igawa Y, Takeda M, Yamaguchi T, Murakami M, Viktrup L. Tadalafil for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a review of clinical data in Asian men and an update on the mechanism of action. Ther Adv Urol. 2015;7(5):249–264. doi:10.1177/1756287215589238
   PubMed Web of Science ®Google Scholar
• Takeda M, Nishizawa O, Imaoka T, Morisaki Y, Viktrup L. Tadalafil for the treatment of lower urinary tract symptoms in Japanese men with benign prostatic hyperplasia: results from a 12-week placebo-controlled dose-finding study with a 42-week open-label extension. Low Urin Tract Symptoms. 2012;4(3):110–119. doi:10.1111/j.1757-5672.2012.00144.x
   Web of Science ®Google Scholar
• 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. doi:10.1111/j.1442-2042.2012.03130.x
   Web of Science ®Google Scholar
• Takeda M, Yokoyama O, Lee SW, Murakami M, Morisaki Y, Viktrup L. 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):670–675. doi:10.1111/iju.12410
   Web of Science ®Google Scholar
• Nishizawa O, Yoshida M, Takeda M, et al. Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: analyses of data pooled from three randomized, double-blind, placebo-controlled studies. Int J Urol. 2015;22(4):378–384. doi:10.1111/iju.12699
   Web of Science ®Google Scholar
• Zhang Z, Li H, Zhang X, et al. Efficacy and safety of tadalafil 5 mg once-daily in Asian men with both lower urinary tract symptoms associated with benign prostatic hyperplasia and erectile dysfunction: a phase 3, randomized, double-blind, parallel, placebo- and tamsulosin-controlled study. Int J Urol. 2019;26(2):192–200. doi:10.1111/iju.13828
   Web of Science ®Google Scholar
• Porst H, Kim ED, Casabé AR, et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60(5):1105–1113. doi:10.1016/j.eururo.2011.08.005
   PubMed Web of Science ®Google Scholar
• Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012;61(5):917–925. doi:10.1016/j.eururo.2012.01.013
   PubMed Web of Science ®Google Scholar
• Oelke M, Wagg A, Takita Y, Büttner H, Viktrup L. Efficacy and safety of tadalafil 5 mg once daily in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in men aged ≥75 years: integrated analyses of pooled data from multinational, randomized, placebo-controlled clinical studies. BJU Int. 2017;119(5):793–803. doi:10.1111/bju.13744
   PubMed Web of Science ®Google Scholar
• Homma Y, Tsukamoto T, Yasuda K, Ozono S, Yoshida M, Shinji M. Linguistic validation of Japanese version of international prostate symptom score and BPH impact index. Jpn J Urol. 2002;93(6):669–680. doi:10.5980/jpnjurol1989.93.669
   Google Scholar
• Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica. 2012;2012:723678. doi:10.6064/2012/723678
   PubMedGoogle Scholar
• Matsukawa Y, Takai S, Majima T, et al. Objective impacts of tadalafil on storage and voiding function in male patients with benign prostatic hyperplasia: 1-year outcomes from a prospective urodynamic study. World J Urol. 2019;37(5):867–872. doi:10.1007/s00345-018-2453-x
   Web of Science ®Google Scholar
• Won JE, Chu JY, Choi HC, Chen Y, Park HJ, Dueñas HJ. Safety and effectiveness of once-daily tadalafil (5 mg) therapy in Korean men with benign prostatic hyperplasia/lower urinary tract symptoms in a real-world clinical setting: results from a post-marketing surveillance study. World J Mens Health. 2018;36(2):161–170. doi:10.5534/wjmh.17017
   Google Scholar