The use of alprostadil sterile powder in a home self-injection study of Asian men with erectile dysfunction.

ABSTRACT

This study evaluated the individual optimal dose of alprostadil in the office setting that could be used as the basis for effective home self-injection therapy. The study included 150 Asian men with erectile dysfunction (ED). The mean age of study participants was 48.3 years (range, 21 to 74 years), and the mean duration of ED was 3.6 years. The most common cause of ED was venogenic (24%), psychogenic (21%), arteriogenic (13%), neurogenic (0.7%), or a combination of these (41%). An optimal response was seen in 72% of patients (n = 108) in the office and 96% of patients (n = 100) at home. The mean +/- SD office dose of alprostadil was 19.4 +/- 12.8 micrograms versus 18.0 +/- 12.2 micrograms at home. More than half of the patients (57% in an office setting and 53% at home) achieved an optimal response at a dose between 5 and 15 micrograms. By the 20-micrograms dose, 82% of patients had achieved an optimal dose at home compared with 70% of patients in the office. An optimal response was seen at the same dose in the office and home in 75% of patients; the dose at home decreased from the office dose for 16% of the patients and increased for 9%. There were 24 patients who experienced adverse events penile pain after injection (18 patients), cold sweating (2 patients), pediculosis (1 patient), broken leg (1 patient), ankle pain (1 patient), and prolonged erection (1 patient). One patient discontinued the study because of penile pain. Alprostadil sterile powder offered safe and effective treatment of ED for home self-injection therapy. Once an optimal dose response had been established in the physician's office, further home adjustments were needed in 25% of patients. Penile pain, usually mild, was the most common, possibly related adverse effect reported.