Tadalafil for treatment of erectile dysfunction in men on antidepressants.

Objective: The objective of this post hoc analysis was to evaluate tadalafil, a treatment indicated for erectile dysfunction (ED), in men on antidepressants.

Method: 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.

Results: 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.

Conclusion: Tadalafil was well tolerated and improved erectile function in patients taking antidepressant medications.