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

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

Abbreviations

ADR, adverse drug reactions; alpha-blockers, alpha-adrenoreceptor antagonists; 5-ARIs, 5-alpha reductase inhibitors; BPH, benign prostatic hyperplasia; CI, confidence interval; CRF, case report form; IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms; PDE-5i, phosphodiesterase type 5 inhibitor; LOCF, last observation carried forward; QOL, quality of life; PVR, post-voiding residual urine volume; Q_max, maximum urinary flow rate; SD, standard deviation.

Acknowledgments

We would like to thank all patients, physicians, and institutions who participated in this post-marketing surveillance study.

Disclosure

HY, NT, MKoy, MCK, and MKom are current employees of Eli Lilly Japan K.K.; and KT is an employee of Nippon Shinyaku Co., Ltd. Both companies were involved in the preparation of the manuscript and sponsored the study. The authors report no other conflicts of interest in this work.