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.