A multicenter, double-blind, placebo-controlled study of sildenafil citrate in Canadian men with erectile dysfunction and untreated symptoms of depression, in the absence of major depressive disorder

Abstract

Depression and erectile dysfunction (ED) often co-occur. Phosphodiesterase type 5 inhibitors are effective in men with ED and untreated depression, or ED secondary to antidepressants. This study evaluated sildenafil treatment in Canadian men with clinically diagnosed ED (Sexual Health Inventory for Men score ≤ 21) and mild-to-moderate untreated depressive symptoms [Beck Depression Inventory II (BDI-II) score 14-28], but excluding major depressive disorder. Pretreatment screening using the Sexual Health Inventory for Men and BDI-II showed that men with ED were more likely to have depression than men without ED, and ED severity was a predictor of depression (P=0.0226). Two hundred and two men were randomized to 6 weeks of double-blind treatment with placebo (n=98) or sildenafil (n=104), initial dose of 50 mg, adjustable to 25 or 100 mg. The men were evaluated on all domains of the International Index of Erectile Function and the Sex Effects Questionnaire, Global Efficacy Questions, and Event-log data. Compared with placebo, patients treated with sildenafil had significantly greater changes from baseline in BDI-II scores (P<0.001). All International Index of Erectile Function domains and the Sex Effects Questionnaire components were also significantly improved in sildenafil group (P<0.01). The most common adverse events included headache, dyspepsia, vasodilatation, and respiratory tract infections and were generally mild in intensity.

A Systematic Review of the Psychosocial Outcomes Associated with Erectile Dysfunction: Does the Impact of Erectile Dysfunction Extend Beyond a Man's Inability to Have Sex?

“…The 40 included publications reported findings from 32 RCTs of PDE5 inhibitor treatment of men with ED. There were 28 single‐ or double‐blind, placebo‐controlled, parallel‐group trials [9,16,20–45], one treatment‐controlled, parallel group trial [46], and three open‐label trials [15,47,48]. In addition, there were five pooled analyses of RCT data [14,49–52] and three secondary or subgroup analyses of RCT data [53–55].…”

“…Most studies were conducted in men with clinically diagnosed ED who were in a stable relationship and who were treated with a PDE5 inhibitor for 6 to 12 weeks (Tables and ). Only three publications [30,31,43] did not report relationship stability as an eligibility criterion. All publications reported that men had ED for at least 6 months (where relevant), and most men had ED for at least 3 years (Tables and ).…”

“…All publications reported that men had ED for at least 6 months (where relevant), and most men had ED for at least 3 years (Tables and ). Disease duration was not reported as an eligibility criterion for 24 of the 40 publications [9,14,21,23,25–33,41,43,44,47–49,51–55]. The mean age of men with ED varied from 45 to 62 years [21,26], and most had ED of mixed or organic etiology [9,14,15,20–22,24–29,32–41,44,46–48,50–53,55,71].…”

Erectile Dysfunction in the Elderly: An Old Widespread Issue with Novel Treatment Perspectives

“…Men with severe depression have a twofold probability for ED compared to nondepressed subjects [57]. Depression as the consequence of ED was assessed in a recent Canadian study together with the effect of sildenafil citrate, PDE5-I, in patients with untreated depressive symptoms [58]. …”

The impact of severe mental disorders and psychotropic medications on sexual health and its implications for clinical management

“…Studies of men with erectile dysfunction and depressive symptoms (but not undergoing antidepressant treatment) also show that prescription of PDE-5 inhibitors is often accompanied by a reduction in depressive symptoms, enhanced quality of life, and improved interpersonal relationships [112][113][114] . Furthermore, preclinical studies suggest that nitric oxide activity is an important vulnerability factor in the Flinders rat depressive phenotype 115 , that passage of PDE-5 inhibitors across the blood-brain barrier can occur 116 , and that sildenafil has antidepressant-like effects after central muscarinic receptor blockade 117 .…”