The long-term safety of alprostadil (prostaglandin-E1) in patients with erectile dysfunction. The European Alprostadil Study Group.

Objective: To evaluate the long-term safety and efficacy of intracavernosal alprostadil (prostaglandin E1, PGE1) 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 > or =4 months' duration. The initial home-use dose of alprostadil, defined as a dose producing an erection satisfactory for intercourse and lasting for > or =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 < or = 20 microg. 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 <1% of patients and were not considered to be clinically relevant.

Conclusion: Intracavernosal alprostadil is an effective and safe therapy for ED, provided that the individual dose is established by titration, patients are trained in the self-injection technique and supervised periodically.