ED 09. Safety and efficacy of tadalafil 5 mg administered once daily in men with erectile dysfunction and lower urinary tract symptoms

Objectives: Recent data suggest that there may be an association between erectile dysfunction (ED) and lower urinary tract symptoms (LUTS). Increasing evidence also indicates that the clinical use of phosphodiesterase type 5 (PDE5) inhibitors provides relief from LUTS. The purpose of our study is to investigate the safety and effects of Tadalafil 5 mg once daily in men with ED and LUTS.

Design and Methods: This study included a total of 89 patients who complained of ED and LUTS and who were given tadalafil 5 mg once daily for eight weeks between September 2009 and February 2011. The International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF)- 5 questionnaire information were obtained prior to treatment (V1), and again following treatment with Tadalafil 5 mg once a day (weeks 4 (V2) and 12 (V3) after treatment began). We also evaluated any adverse effects of Tadalafil 5 mg when it was administered once daily during the follow-up period.

Results: A total, of 60 patients (67.4%) completed the eightweek clinical study. The mean patient age was 57.0±9.2 years. Regarding subjective symptoms, there were 48 patients (80.0%) who experienced improvement of their ED and 43 patients (71.7%) who experienced the improvement of their LUTS. The IPSS values were 15.33±8.32 (V1), 11.78±7.69 (V2), and 9.91±7.77 (V3), with significant improvement (V1 vs. V2, P=0.042, V1 vs. V3, P=0.006). The IIEF-5 values were 8.34±5.33 (V1), 15.74±8.99 (V2), and 18.72±19.58 (V3), with significant improvement (V1 vs. V2, P=0.001, V1 vs. V3, P=0.001). A total of three patients (5.0%) reported adverse effects, i.e. two patients experienced facial flushing and one patient had mild chest discomfort.

Conclusions: Treatment with Tadalafil 5 mg once daily was beneficial for the treatment of both ED and LUTS. Adverse effects on the cardiovascular system were minimal in our study. Therefore, we believe that taking Tadalafil 5 mg once daily is safe for patients with ED and LUTS.