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Sildenafil Citrate (VIAGRA^®) Improves Erectile Function in Elderly Patients With Erectile Dysfunction

A Subgroup Analysis

^a University of Copenhagen, Division of Sexual Physiology, Denmark
^b Divisione di Urologia, Istituto San Raffaele, Italy
^c Newport Beach, California
^d Pfizer Ltd., Sandwich, Kent, United Kingdom

Gorm Wagner, Division of Sexual Physiology, University of Copenhagen, RIGSHOSPITALET, Suite 7121, 9, Blegdamsvej, DK-2100 Copenhagen, Denmark.

Decision Editor: William B. Ersler, MD

Background. The prevalence of erectile dysfunction (ED) increases with advancing age, with a particularly high prevalence of ED in elderly patients with diabetes. In the United States it is estimated that approximately 45% of men aged 65 to 69 years have moderate or complete ED. The efficacy and safety of oral sildenafil (VIAGRA^®) for treating ED in elderly men (aged 65 years or older) were assessed.

Methods. We analyzed data obtained from five double-blind, placebo-controlled studies of the efficacy and tolerability of oral sildenafil taken as required (but not more than once daily) over a 12-week to 6-month period. Two subgroups were evaluated: (i) elderly patients with ED of broad-spectrum etiology (n = 411), and (ii) elderly patients with ED and diabetes (n = 71). Efficacy was assessed using a global efficacy question, questions 3 and 4 of the International Index of Erectile Function (IIEF), and the five sexual function domains of the IIEF.

Results. All efficacy assessments indicated that sildenafil significantly improved erectile function both in elderly patients with ED of broad-spectrum etiology and in elderly patients with ED and diabetes. The most common adverse events were mild-to-moderate headache, flushing, and dyspepsia. The rates of discontinuation due to adverse events were low and were comparable to the rates with placebo.

Conclusions. Sildenafil is an efficacious and well-tolerated treatment for ED in elderly men.

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