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,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, JapanCorrespondence: Hiroyoshi YamazakiMedicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Lilly Plaza One Bldg., 5-1-28, Isogamidori, Chuo-ku, Kobe 651-0086, JapanTel +81 78 242 4391Fax +81 78 242 9299Email yamazaki_hiroyoshi@lilly.comObjective: 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 su