Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT) in diabetic patients with erectile dysfunction.
OBJECTIVE
To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT((R))) in diabetic patients with erectile dysfunction (ED).


METHODS
This study included 31 diabetic men (aged 44-75 years) with ED of >/=4 months duration. All patients were initially instructed in the self-injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 microg. After the optimal dose was determined and the patient was well trained, the self-injection home phase was followed for 6 months. The efficacy and adverse events were documented.


RESULTS
An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was >/=20 microg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3. 2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related.


CONCLUSIONS
Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision.
Tsai
Y S
YS
Department of Urology, National Cheng Kung University Medical College and Hospital, Tainan, Taiwan.
Lin
J S
JS
Lin
Y M
YM
D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000627:therapeutic use*; D048909:Diabetes Complications; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011208:Powders; D014665:Vasodilator Agents / Q000627:therapeutic use*
D011208:Powders; D014665:Vasodilator Agents; D000527:Alprostadil