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

Hiroyoshi Yamazaki; Naoto Tsujimoto; Momoha Koyanagi; Megumi C Katoh; Koyuki Tajima; Mika Komori

doi:10.2147/POR.S237821

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

Pragmat Obs Res. 2020 May 4:11:45-54. doi: 10.2147/POR.S237821. eCollection 2020.

Authors

Hiroyoshi Yamazaki¹, Naoto Tsujimoto¹, Momoha Koyanagi¹, Megumi C Katoh¹, Koyuki Tajima², Mika Komori¹

Affiliations

¹ Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
² Post Marketing Surveillance Clinical Research Department, Nippon Shinyaku Co., Ltd., Kyoto, Japan.

Abstract

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.