Efficacy and Safety of Daily Tadalafil in Men with Erectile Dysfunction Previously Unresponsive to On‐Demand Tadalafil

ABSTRACT

Objective

To assess the efficacy and safety of daily tadalafil, a potent selective phosphodiesterase 5 inhibitor, for the treatment of erectile dysfunction (ED) in men previously unresponsive to on‐demand tadalafil.

Materials and Methods

A total of 112 men with a mean age of 63 (range 21–79) and moderate to severe ED of various aetiologies were treated with tadalafil, taken on a daily basis at flexible daily doses of 10 and 20 mg for 12 weeks. The three primary outcomes were changes from the pretreatment and on‐demand tadalafil baseline in the erectile function domain of the International Index of Erectile Function and the proportion of yes responses to questions 2 and 3 of the Sexual Encounter Profile. Additional efficacy instruments included a Global Assessment Question administered at completion of the study.

Results

Compared with pretreatment and on‐demand tadalafil baseline, daily dosed tadalafil significantly enhanced all efficacy outcome variables. Patients receiving daily tadalafil (10 mg) experienced a significant mean improvement of 12.8 and 8.2 in the International Index of Erectile Function erectile function domain score from baseline (P < 0.001) and from on‐demand tadalafil, respectively (P < 0.001). Fifty‐eight percent of intercourse attempts (Sexual Encounter Profile question 3) were successfully completed (P < 0.001 vs. pretreatment baseline, P < 0.001 vs. on‐demand tadalafil). Improved erections at end point were reported by 69% of men compared with 42% of men with on‐demand tadalafil. Daily tadalafil was well tolerated with headache, dyspepsia, and facial flushing as the most frequent adverse events.

Conclusion

Daily tadalafil (10/20 mg) was effective and well tolerated in this study population and is an effective salvage for previous on‐demand tadalafil nonresponders.

Male Primary Care Perspective in Treatment of Sexual Dysfunction, Male Oral Vasoactive Agents, Male Diabetes Mellitus and Sexual Dysfunction

© International Society for Sexual Medicine 2004