Safety and efficacy of Alprostadil Sterile Powder (S. Po.. CAVERJECT (R)) in diabetic patients with erectile dysfunction

Objectives: To evaluate the long-term efficacy and safety of intracavernosa l alprostadil (CAVER-JECT(R)) in diabetic patients with erectile dysfunctio n (ED). Patients and Methods: This study included 31 diabetic men (aged 44-75 years ) with ED of greater than or equal to 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 mu g. After the optimal dose wa s determined and the patient was well trained, the self-injection home phas e was followed for 6 months. The efficacy and adverse events were documente d. Results: An optimal dose was determined for 29 men (93.5%) and in 16 men (5 5%) it was greater than or equal to 20 mu g. During the home phase, 76.5% o f injections assessed by the patients resulted in satisfactory sexual activ ity and 72.5% of injections assessed by partners resulted in satisfactory i ntercourse. 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 o f efficacy (n = 3, all in the home phase), intolerable penile pain (1 in th e 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 occur red 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 hemorrhag e in the last month, and this was considered to be caused by underlying hyp ertension and not drug-related. Conclusion: Despite the high incidence of penile pain, most of the occurren ces were tolerable. Despite a higher withdrawal rate in this study, intraca vernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is esta blished by titration and patients are trained in the self-injection techniq ue with period supervision. Copyright (C) 2000 S. Karger AG. Basel.