Efficacy and safety of sildenafil citrate in the treatment of erectile dysfunction in patients with ischemic heart disease

Erectile dysfunction is a common condition in men with cardiovascular disea se, probably as a result of shared factors that impair hemodynamic mechanis ms in the penile and ischemic vasculature. Sildenafil citrate, an orally ac tive, selective inhibitor of phosphodiesterase type 5 (PDE5), has demonstra ted excellent efficacy and safety profiles in men with erectile dysfunction of various etiologies. Sildenafil administration is contraindicated in pat ients who are taking nitrates or nitric oxide donors. This retrospective su banalysis of data from double-blind, placebo-controlled studies assessed th e efficacy (9 studies) and safety (11 studies) of sildenafil in patients wi th erectile dysfunction and ischemic heart disease who were not taking nitr ates. Of 3,672 patients randomized to receive sildenafil (5-200 mg) or plac ebo for 4-24 weeks in 11 double-blind, placebo-controlled studies, 357 (10% ) reported a history (past or present) of ischemic heart disease and were n ot taking nitrates. Efficacy was assessed using end-of-treatment responses to Question 3 (ability to achieve an erection) and Question 4 (ability to m aintain an erection) of the International Index of Erectile Function (IIEF) , scores for the 5 domains of male sexual function assessed by the IIEF (er ectile function, orgasmic function, sexual desire, intercourse satisfaction , and overall satisfaction), and responses to a global efficacy question (" Did the treatment improve your erections?"). The responses to the 2 IIEF qu estions were graded on a scale of 1 (almost never or never) to 5 (almost al ways or always), with a score of 0 indicating no attempt at sexual intercou rse. At the end of treatment, the mean scores for Question 3 and Question 4 of the IIEF for patients with erectile dysfunction and ischemic heart dise ase were significantly higher for the sildenafil group than for the placebo group (p < 0.0001). Mean end-of-treatment scores for the IIEF domains also demonstrated significant increases for sildenafil-treated patients compare d with those receiving placebo (p < 0.05). At the end of treatment, improve d erections were reported by 70% of patients who received sildenafil and by 20% of those in the placebo group (p < 0.0001). For the sildenafil group, the incidences of the most common adverse events (headache 25%, flushing 14 %, and dyspepsia 12%) for patients with ischemic heart disease were similar to those in patients without this concomitant illness (21%, 15%, and 10%, respectively). Moreover, the overall incidence of cardiovascular adverse ev ents other than flushing was comparable in patients with and without ischem ic heart disease for both treatment groups. Since there is a degree of card iac risk associated with sexual activity, clinicians should consider the pa tient's cardiovascular status before initiating any treatment for erectile dysfunction. Physicians should be aware that patients with underlying cardi ovascular disease could be adversely affected by the vasodilator effects of sildenafil, especially in combination with sexual activity. The results of the present subanalysis indicate that oral sildenafil significantly improv es erectile function and is well tolerated in patients with erectile dysfun ction and ischemic heart disease who are not taking nitrate therapy. (C) 19 99 by Excerpta Medica, Inc.