The long-term safety of alprostadil (prostaglandin-E-1) in patients with erectile dysfunction

Objective To evaluate the long-term safety and efficacy of intracavernosal alprostadil (prostaglandin E-1, PGE(1)) in patients with erectile dysfunction [ED) and assess the feasibility of self-injection treatment, Patients and methods The study included 848 men (aged 18-75 years) with ED of greater than or equal to 4 months' duration. The initial home-use dose of alprostadil, defined as a dose producing an erection satisfactory for intercourse and lasting for greater than or equal to 20 min, was determined for each patient in the investigator's clinic and in the patient's home. This dose-finding phase was followed by a 6-month, self-injection, home-maintenance phase. The efficacy and adverse effects were documented. Results An initial home-use dose was determined for 93% of the patients and in most (86%) it was less than or equal to 20 mu g. During the 6-month study period, 88% of injections assessed by the patients resulted in satisfactory sexual activity (intercourse or masturbation) and 90% of injections assessed, by partners resulted in satisfactory intercourse. Penile pain occurred in 44% of patients, but this incidence decreased with time. In 52% of patients with pain it was mild and only 3% of patients discontinued the study because of pain. Prolonged erection and priapism occurred in 8% and 0.9% of patients, respectively, Penile fibrosis occurred in 4% of patients. Drug-related systemic medical events occurred in 5%, of patients and none of these were serious. Haemodynamic events occurred in <I% of patients and were not considered to be clinically relevant. Conclusion Intracavernosal alprostadil is an effective and safe therapy for EU, provided that the individual dose is established by titration, patients are trained in the self-injection technique and supervised periodically.