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Tadalafil Shows Benefits in Men on Antidepressants: Presented at CPA

By Louise Gagnon

MONTREAL, QC -- October 21, 2004 -- Tadalafil was effective in treating erectile dysfunction (ED) in men who are taking antidepressants, suggest results from a retrospective study from more than 100 patients.

The retrospective study, which integrated results from 11 double-blind, placebo-controlled trials found that tadalafil was successful in resolving sexual dysfunction, researchers said here on October 20th at the Annual Meeting of the Canadian Psychiatric Association.

"We know depression is very common and can cause erectile dysfunction," said investigator Jay Lee, MD, a urologist at the Calgary Health Region, Calgary, Alberta, Canada. "We also know that treatments for depression can cause erectile dysfunction, and we know that people who have erectile dysfunction can start developing depressive symptoms."

The incidence of sexual dysfunction in patients on selective serotonin reuptake inhibitors has been reported to be as high as 30% in some studies, according to Dr. Lee.

Tadafil, a new treatment for ED, has an extended duration of action -- up to 36 hours post-dose -- in men taking antidepressants.

The mean age of study participants was 56 years (range being 27 to 78) who were all on antidepressant medications. The vast majority of men experienced ED for a year or more. The researchers randomised 19 men to receive 10 mg tadafil, 60 men to 20mg of tadafil, and 27 men to placebo. Five patients withdrew from the study because of adverse events or lack of efficacy.

Researchers used several measurement tools including a global assessment questionnaire to determine if there were improvements in erections, the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score, and the Sexual Encounter Profile diary.

Of the 79 men on tadalafil, 80% said they had improvement in erections compared to 30% of 29 patients on placebo, a difference that was highly statistically significant (P <.001). In addition, there was a statistically significant differences on the IIEF-EF score, with scores of 22.1 and 14.5, respectively (P <.001). There were more successful intercourse attempts at end point with tadalafil than with placebo (P <.001).

"The number of subjects is not large, but there is a very big difference between those who received medication and those who received placebo," Dr. Lee said. "This research is showing that both things --, depression and ED -- need to be treated to improve quality of life."

The most common adverse event was headache, followed by back pain, and limb pain.

Eli Lilly Inc. funded the study.


[Presentation title: "Tadalafil for Treatment of Erectile Dysfunction in Men on Antidepressants." Abstract 32]

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