The objective of this post hoc analysis was to evaluate tadalafil, a treatment indicated for erectile dysfunction (ED), in men on antidepressants.
A retrospective, pooled analysis of 19 double-blind, placebo-controlled trials (N = 3864) identified 205 men with ED, mean age of 55 years (range, 27-79 years) receiving antidepressants and tadalafil 10 mg (n = 38), tadalafil 20 mg (n = 113), or placebo (n = 54). Efficacy was measured by the International Index of Erectile Function erectile function domain score, the Sexual Encounter Profile diary, and a Global Assessment Question. Tolerability was assessed via collection and analysis of treatment-emergent adverse events.
Patients on antidepressants who were treated with tadalafil showed significantly greater baseline-to-end point improvement on the International Index of Erectile Function score compared with placebo (end point: tadalafil 10 mg, 21.7; tadalafil 20 mg, 21.8; placebo, 14.5; both P < 0.01). The mean per-patient percent successful intercourse postbaseline was also greater with tadalafil 10 mg (54%) and tadalafil 20 mg (59%) than placebo (29%, both P < 0.05). Patients taking tadalafil 10 (72%) and 20 (76%) mg both reported significant improvement in erections on the Global Assessment Question compared with placebo (33%, both P < 0.01). The incidence of treatment-emergent adverse events was low in all treatment groups with the most common being headache, dyspepsia, and back pain.
Tadalafil was well tolerated and improved erectile function in patients taking antidepressant medications.
*Case Western University, Cleveland, OH; †University of Calgary, Calgary, Canada; ‡University of British Columbia, Vancouver, Canada; §Lilly Research, Laboratories, Indianapolis, Indiana and ∥Eli Lilly Canada, Toronto, Canada.
Received September 14, 2005; accepted after revision November 2, 2006.
Wei Christine Wang is now with the Amgen Inc, Thousand Oaks, CA.
This work was supported by Lilly ICOS LLC.
Some of the material in this article was presented in posters at the American Psychiatric Association, the Canadian Urological Association, and the Canadian Psychiatric Association in 2004.
Address correspondence and reprint requests to Ruth A. Dickson, MD, FRCPC, 3650 Danforth Avenue, Toronto, Ontario, Canada M1N 2E8. E-mail: email@example.com.