Efficacy and safety of sildenafil citrate (Viagra®) in men with serotonergic antidepressant-associated erectile dysfunction: Results from a randomized, double-blind, placebo-controlled trial

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.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 02/2006; 67(2):240-6. DOI: 10.4088/JCP.v67n0210
Source: PubMed


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.

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    • "The understanding of pharmacological interactions between sildenafil and antidepressant drugs is extremely important because of the fact that depression and erectile dysfunctions frequently occur concomitantly. A number of clinical trials demonstrated that sildenafil is effective in treating erectile dysfunctions in patients with depressive symptoms including those taking antidepressant drugs (Fava et al., 2006; Tignol et al., 2004; Nurnberg et al., 2001, 2002). Although sildenafil displays psychotropic action both in humans and animals (Hotchkiss et al., 2005; Kurt et al., 2004; Milman and Arnold, 2002), its effect on the neurobiology of depression and the activity of antidepressant drugs is as yet unidentified. "
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    ABSTRACT: Recent studies highlight the involvement of the nitrergic system in the mechanism of action of antidepressant drugs. Sildenafil, a selective PDE5 inhibitor, was shown to abolish the anti-immobility effects of bupropion, venlafaxine and s-citalopram in mice. In this study we assessed the effects of sildenafil on the activity of bupropion and venlafaxine in the forced swim test in mice. Swim trials were conducted by placing mice in glass cylinders filled with water for 6min and the duration of the behavioral immobility during the last 4min of the test was evaluated. Locomotor activity was evaluated with photoresistor actimeters. Brain and serum concentrations of the studied antidepressants were determined by HPLC method. Sildenafil at a dose of 20mg/kg, but not 5 and 10mg/kg, significantly increased the anti-immobility action of bupropion (20mg/kg). The antidepressant activity of venlafaxine (2mg/kg) was potentiated by joint administration with sildenafil at doses of 10 and 20mg/kg. Since the combined treatments did not increase the locomotor activity, the antidepressant-like effects were not related to non-specific behavioral activation. Data from pharmacokinetic studies revealed that sildenafil increased bupropion and venlafaxine levels in serum without affecting their concentrations in the brain. The present study demonstrates the enhancement of anti-immobility action of bupropion and venlafaxine by sildenafil co-administration. The observed changes might have been partly due to pharmacokinetic interactions. However, mechanisms underlying the effects of sildenafil on the antidepressant activity of bupropion and venlafaxine should be carefully evaluated in further studies.
    Pharmacology Biochemistry and Behavior 08/2012; 103(2):273-278. DOI:10.1016/j.pbb.2012.08.012 · 2.78 Impact Factor
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    • "hypertension (Feldman et al ., 1999), spinal cord injuries (Hultling et al ., 2000; Deforge et al ., 2006), multiple sclerosis (Fowler et al ., 2005), depression (Seidman et al ., 2001; Rosen et al ., 2004; Tignol et al ., 2004; Fava et al ., 2006), PTSD (Orr et al ., 2006), and schizophrenia (Aviv et al ., 2004; Gopalakrishnan et al ., 2006), men after resection of the prostate or radical prostatectomy (Nandipati et al ., 2006), after renal transplant (Sharma et al ., 2006), men on dialysis (Dachille et al ., 2006), and men aged 65 years and older (Wagner et al ., 2001; Carson, 2004). To our knowledge, there has been no investigation of the effects of sildenafil on ED in men with AD. "
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    ABSTRACT: Alcohol-dependent men commonly suffer from erectile dysfunction (ED) and men with ED are frequently chronic alcohol addicts. Sildenafil is used for treatment of ED caused by diverse factors. The aim of this study was to examine (i) the effect of sildenafil citrate (VIAGRA) on ED in alcohol dependent men, and (ii) whether the effective treatment of ED with sildenafil improves the patient's QoL and related emotional distress. Fifty-four men with an ICD-10 diagnosis of alcohol dependence (AD) and concomitant ED agreed to enter an open-label trial, in which they were assigned to take 50 mg of sildenafil as add-on to a standard treatment for AD for 12 weeks. Fifty patients (92.3%) completed all baseline and endpoint assessments. Efficacy was evaluated using the International Index of Erectile Function (IIEF), Quality of Life Enjoyment and Satisfaction Questionnaire and General Health Questionnaire. At endpoint, total IIEF scores had improved significantly (Delta=16.9), reflecting a 42% improvement (P<0.0001). A significant increase in the mean scores of each sexual function domain was also noted among all subjects. Sildenafil's positive effect was accompanied by a significant improvement (P<0.001) in satisfaction with overall QoL and specific life-domains, as well as a significant reduction in emotional distress scores (P<0.001). The sildenafil add-on evaluated in this trial had a marked beneficial effect on ED and QoL, and was associated with a significant reduction in emotional distress among men with AD. The information obtained is valuable for both clinicians and policymakers in developing innovative therapeutic strategies for men with AD.
    Alcohol and Alcoholism 05/2007; 42(4):340-6. DOI:10.1093/alcalc/agm041 · 2.89 Impact Factor
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