Tadalafil Is Efficacious and Well Tolerated in the Treatment of Erectile Dysfunction (ED) in Men over 65 Years of Age: Results from Multiple Observations in Men with ED in National Tadalafil Study in the United States

Abstract

Erectile dysfunction is increasingly common with advancing age, yet sexual activity and intimacy are important to elderly men. To assess the efficacy and tolerability of tadalafil in men over the age of 65 years. In this multicenter open-label study, 188 men (mean age = 71.6 years) who were over age 65 and did not have diabetes mellitus or clinical depression received tadalafil 20 mg, taken on demand, for up to 12 weeks. Efficacy was assessed using the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP). Psychosocial outcomes were evaluated using the Psychological and Interpersonal Relationship Scale (PAIRS). Tadalafil treatment significantly improved all domains of the IIEF from baseline, including the erectile function (EF) domain (change = 8.8, end point = 21.6; P < 0.001). Mean per-patient percentage of "yes" responses to SEP questions concerning successful penetration (SEP2; change = 33.5%, end point = 73.5%; P < 0.001) and successful intercourse (SEP3; change = 39.6%, end point = 59.6%; P < 0.001) also improved significantly from baseline. Forty percent of the patients with baseline EF scores < 26 had normal EF (IIEF-EF domain scores > or = 26) at end point, and 81% reported improved erections in the Global Assessment Questionnaire. At least 56% of attempts at sexual intercourse were successfully completed (SEP3) at all time intervals up to 36 hours after tadalafil administration. The patients also experienced significant improvement in both the sexual self-confidence and spontaneity domains of the PAIRS. Tadalafil was well tolerated, with < 5% of the patients discontinuing because of adverse events. Tadalafil 20 mg was effective and well tolerated in elderly men with ED.