EFFICACY AND SAFETY OF INTRACAVERNOSAL ALPROSTADIL IN MEN WITH ERECTILE DYSFUNCTION

Background. Erectile dysfunction is a common medical problem affecting many men. Although several intracavernosal therapies are available, t heir efficacy and safety have not been studied systematically. Methods . We investigated the. efficacy and safety of alprostadil formulated f or intracavernosal treatment in three separate multi-institutional, pr ospective studies in men with erectile dysfunction of vasculogenic, ne urogenic, psychogenic, and mixed causes. Clinical and laboratory evalu ations of erection and the feasibility and satisfactoriness of sexual activity as assessed both by the men and by their partners were the pr imary measures of efficacy. Results. In a dose-response study of 296 m en, all doses of alprostadil were superior to placebo and there was a significant dose-response relation (P less than or equal to 0.001), re sulting in higher response rates with increasing doses of alprostadil (from 2.5 to 20 mu g). In a dose-finding study of 201 men, the minimal effective dose was less than or equal to 2 mu g in 23, 20, 38, and 23 percent of men with erectile dysfunction of neurogenic, vasculogenic, psychogenic, or mixed causes, respectively. In a six-month self-injec tion study in 683 men, the participants reported being able to have se xual activity after 94 percent of the injections. The men and their pa rtners rated the sexual activity as satisfactory after 87 and 86 perce nt of the injections, respectively. Penile pain, usually mild, occurre d in 50 percent of the men at some time but after only II percent of t he injections. Prolonged erections occurred in 5 percent of the men, p riapism in 1 percent, penile fibrotic complications in 2 percent, and hematoma or ecchymosis in 8 percent. Conclusions. In men with erectile dysfunction, intracavernosal injection of alprostadil is an effective therapy with tolerable side effects.