Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED).


METHODS
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.


RESULTS
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%).


CONCLUSIONS
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.
Depression Clinical and Research Program, the Department of Psychiatry, Massachusetts General Hospital, Boston 02114, and the Department of Psychiatry, University of New Mexico, Albuquerque, USA. mfava@partners.org
Maurizio
M
Fava
H George
HG
Nurnberg
Stuart N
SN
Seidman
Willis
W
Holloway
Susan
S
Nicholas
Li-Jung
LJ
Tseng
Vera J
VJ
Stecher
D015106:3',5'-Cyclic-GMP Phosphodiesterases / Q000037:antagonists & inhibitors*; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000139:chemically induced* / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007391:International Cooperation; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D017060:Patient Satisfaction; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011446:Prospective Studies; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012725:Sexual Behavior / Q000523:psychology; D000068677:Sildenafil Citrate; D013450:Sulfones; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D015106:3',5'-Cyclic-GMP Phosphodiesterases; D000928:Antidepressive Agents; D010879:Piperazines; D010919:Placebos; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors; D000068677:Sildenafil Citrate; D013450:Sulfones