ORIGINAL RESEARCH—PHARMACOTHERAPY FOR ED: Efficacy and Safety of Daily Tadalafil in Men with Erectile Dysfunction Previously Unresponsive to On-demand Tadalafil
Article first published online: 13 OCT 2004
The Journal of Sexual Medicine
Volume 1, Issue 3, pages 292–300, November 2004
How to Cite
McMahon, C. (2004), ORIGINAL RESEARCH—PHARMACOTHERAPY FOR ED: Efficacy and Safety of Daily Tadalafil in Men with Erectile Dysfunction Previously Unresponsive to On-demand Tadalafil. Journal of Sexual Medicine, 1: 292–300. doi: 10.1111/j.1743-6109.04042.x
- Issue published online: 13 OCT 2004
- Article first published online: 13 OCT 2004
- Male Primary Care Perspective in Treatment of Sexual Dysfunction;
- Male Oral Vasoactive Agents;
- Male Diabetes Mellitus and Sexual Dysfunction
Conflict of Interest. Dr. McMahon is a paid consultant and/or investigator and/or member of speakers panel for Pfizer, Bayer, GlaxoSmithKline, Eli Lilly, Icos Corp., American Medical Systems, and Johnson & Johnson.
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.