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| |  ESSIR: Caverject (Alprostadil for Injection) Shows Promise in Erectile Dysfunction ROME, ITALY -- October 16, 2001 -- Results from a clinical trial of men with erectile dysfunction (ED) found a reoccurrence of spontaneous erections reported by 85 percent of 54 men treated with Caverject® (alprostadil for injection) over a 12-month period. Study lead investigator, Gerald Brock, MD, associate professor, Department of Urology, University of Western Ontario, St. Joseph’s Health Care London, Ontario, Canada, was among several leading researchers and specialists in the field of urology/sexual dysfunction from Spain, Denmark, the United States and England who presented these findings at a symposium on injectable therapy in the treatment of ED. The return of spontaneous erections in men diagnosed with ED and ways in which to improve patient/physician communication, patient outcomes and compliance were key topics of discussion at the European Society for Sexual and Impotence Research (ESSIR) meeting. The objective of the symposium was to clarify exactly how injectable therapy fits in to the ED armamentarium and when it is best used as a safe and effective treatment option for men who suffer from ED. Because an estimated 30 percent of patients with ED treated with oral therapies, such as sildenafil, fail to achieve the desired results, issues such as the physical and psychological impact of treatment failure was at the forefront of discussion. "It is important for physicians to be aware of all efficacious treatment options and to understand where injection therapy fits in to the treatment process especially because of the important number of patients with ED who fail with oral therapy, said Francesco Montorsi, MD, Chairman, Organizing Committee ESSIR, 2001 and associate professor of Urology, University San Raffaele. The open-label study enrolled 70 men with documented arteriogenic erectile dysfunction, of which 63 entered a 12-month self-treatment phase. Researchers measured the improvements in penile circulation and the reported reoccurrence of spontaneous erections experienced at four, eight and 12 months from baseline with regular use of alprostadil for injection. During the self-treatment period, 85 percent of the men (46 of 54) reported experiencing spontaneous erections, a significant improvement from a baseline of 37 percent, with 74 percent of these episodes resulting in satisfactory intercourse as reported by the men and their partners. Results of the study were published in the March issue of Urology (57:536-541, 2001). "These data as well as the other topics discussed at today’s symposium are of great interest for both specialists and non-specialists who treat men with difficulty obtaining desired results with current oral therapies for erectile dysfunction, or those who can not take oral medications due to a pre-existing condition," said Dr. Brock. "The results of this study suggest that long-term administration of alprostadil for injection may promote the reoccurrence of spontaneous erections, an important consideration for the treatment of erectile dysfunction patients." Most men experience occasional erectile failures during their lives, usually as a result of fatigue, temporary stress or excessive alcohol consumption. Temporary loss of erectile capability usually is not something to worry about. However, when the condition persists or interferes with a man’s normal sexual activity, medical advice should be sought. Experts believe that up to 70 percent of all ED cases may be due to physical (organic) conditions, with psychological factors accounting for the remaining 30 percent. In many cases, however, there are both psychological and physical reasons for the condition. Adverse events after administration of alprostadil for injection were generally regarded as tolerable, with temporary penile or injection site pain the most frequently reported side effect (23 percent) in the trial. Six percent (four men) reported prolonged erection lasting four to six hours, of which two men experienced priapism, defined as an erection lasting more than six hours. All these episodes resolved spontaneously. Caverject should not be used in men who have conditions that might predispose them to priapism (erections lasting longer than six hours that can cause permanent tissue damage if untreated), or in men with anatomical deformation of the penis or penile implants. SOURCE: St. Joseph’s Health Care London
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