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
Authors Yamazaki H, Tsujimoto N, Koyanagi M, Katoh MC, Tajima K, Komori M
Received 18 November 2019
Accepted for publication 13 March 2020
Published 4 May 2020 Volume 2020:11 Pages 45—54
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Professor David Price
Hiroyoshi Yamazaki,1 Naoto Tsujimoto,1 Momoha Koyanagi,1 Megumi C Katoh,1 Koyuki Tajima,2 Mika Komori1
1Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan; 2Post Marketing Surveillance Clinical Research Department, Nippon Shinyaku Co., Ltd., Kyoto, Japan
Correspondence: Hiroyoshi Yamazaki
Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Lilly Plaza One Bldg., 5-1-28, Isogamidori, Chuo-ku, Kobe 651-0086, Japan
Tel +81 78 242 4391
Fax +81 78 242 9299
Objective: To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥ 75 years.
Patients and Methods: This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.
Results: Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged < 75 and ≥ 75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (P < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (P < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was − 9.8 mL at 18 months (P < 0.001); there were no significant differences from baseline in maximum urinary flow rate.
Conclusion: This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥ 75 years were similar to patients aged < 75 years.
Keywords: elderly patient, long-term, observational study, phosphodiesterase type 5 inhibitor
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