Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial.
ABSTRACT To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED).
Men (aged>or=18 years) with major depressive disorder (MDD; DSM-IV criteria) in remission and taking SRIs who experienced SRI-associated ED were enrolled in this multicenter, 6-week, randomized, flexible-dose, double-blind, placebo-controlled trial. The primary study measures were questions 3 (Q3: frequency of penetration) and 4 (Q4: frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF) questionnaire. Secondary study measures were all other questions and domains of the IIEF, the Erectile Dysfunction Index of Treatment Satisfaction (EDITS), a global efficacy questionnaire (GEQ), and a patient-maintained event log of sexual activity.
Patients receiving sildenafil (N=71) versus placebo (N=71) reported significantly higher mean+/-SE scores on Q3 (3.9+/-0.2 vs. 3.1+/-0.2, p=.003) and Q4 (3.7+/-0.2 vs. 2.8+/-0.2, p<.001) of the IIEF and significantly higher scores on all domains of the IIEF. Patients receiving sildenafil also reported significantly improved scores on all questions of the EDITS questionnaire (p<.02) and the GEQ (p<.0001) and an increased number of successful sexual intercourse attempts per week (p<.0001) compared with patients receiving placebo. All patients remained in MDD remission (score<or=10 on the Hamilton Rating Scale for Depression). Adverse events in patients taking sildenafil (vs. placebo) were headache (9% vs. 9%), dyspepsia (9% vs. 1%), anxiety (6% vs. 4%), and abnormal vision (3% vs. 0%).
Short-term (6-week) administration of sildenafil was well tolerated and significantly improved erectile function and overall sexual satisfaction in men with ED associated with SRI therapy for MDD. Sildenafil may be successfully used to treat SRI-associated ED without interruption of antidepressant therapy.
- [Show abstract] [Hide abstract]
ABSTRACT: Antidepressant-induced sexual dysfunction (ADISD) is a common problem and is associated with a significant risk of nonadherence. Serotonergic antidepressants are associated with a substantial risk of ADISD. Bupropion, transdermal selegiline, nefazodone, and moclobemide are associated with a lower risk of ADISD, and early data suggests that this may also be true for vilazodone. Only 10 % of patients show spontaneous improvement in ADISD on waiting and watching. This strategy should be reserved for patients earlier in the course of the adverse effect. When possible, switching to an antidepressant with a lower incidence of ADISD is a recommended strategy. When continuation of the offending antidepressant is essential, addition of an antidote may be tried. While early data were not encouraging, two large randomized, controlled trials have provided strong evidence supporting the use of bupropion as an antidote for ADISD. Phosphodiesterase-5 inhibitors like sildenafil and tadalafil have been shown to be efficacious in a substantial proportion of patients. Attention to ADISD is very important given that it is an important cause of nonadherence to antidepressants.Current Sexual Health Reports 09/2014; 6(3).
- Journal of psychiatry & neuroscience: JPN 09/2013; 38(5):E27-8. · 7.49 Impact Factor