To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: EAU: Cialis (IC351) Improves Sexual Function In Diabetic Men With Erectile Dysfunction URL: http://www.pslgroup.com/dg/1F73FE.htm Doctor's Guide April 6, 2001
TORONTO, ON -- April 6, 2001 -- The first Phase 3 study for IC351 (Cialis™), a new PDE5 inhibitor being developed by Lilly ICOS LLC to treat erectile dysfunction (ED), showed strong results among one of the most difficult to treat populations of men with ED. The findings-to be released tomorrow at the European Association of Urology Meeting (EAU)-demonstrated that 64 percent of men with diabetes-related ED taking IC351 20 mg on-demand reported improved erections. This rate of response is considered high given the difficulties associated with treating diabetes-related ED. "The impairment of the nerves and blood vessels that accompanies diabetes makes ED prevalent and particularly difficult to treat in this population," said Dr. Gerald Brock, a urologist from St. Joseph's Health Centre in London, Ontario. "This study, alongside previously released data, suggests that on-demand Cialis may help most men with ED regain sexual function, regardless of cause or severity." In this Phase 3 study, 216 men with mild-to-severe diabetes-related ED were randomized to receive either placebo or IC351 at doses of up to 20 mg for 12 weeks. Results indicated 64 percent of men taking IC351 20 mg reported improved erections, compared to 25 percent for placebo. Treatment with IC351 significantly improved sexual function compared to placebo across all primary and secondary study endpoints, regardless of patient age, duration and severity of ED or diabetes. Importantly, study participants reflected a broad cross-section of men with diabetes and included those with poor glucose control, diabetic retinopathy (damage to the retina in the eyes), and diabetic kidney disease. Despite including men with these diabetes-related complications, few side effects were reported in this study. Headache and dyspepsia (stomach upset following meals) were the only side effects reported by greater than five percent of study participants. Researchers observed no significant changes in clinical laboratory values, ECGs (electrocardiograms) or blood pressure in this trial. In addition, IC351 use was not associated with disturbances in color vision for men in the study, including those with diabetic retinopathy. Of the side effects that were reported, the majority were mild-to-moderate and appeared to diminish with continued treatment. Few patients discontinued treatment due to side effects. Additional results from the IC351 global Phase 3 program will be presented at scientific meetings later this year. Findings from a IC351 Phase 2 study are also to be presented at the European Association of Urology Meeting (EAU). In this study, a broad population of ED sufferers of varying severity and causes (including men with diabetes) took IC351 on-demand at doses of up to 25 mg for eight weeks. Results indicated that up to 88 percent of men taking IC351 reported significantly improved erections, compared with 28 percent of those taking placebo. Headache and dyspepsia were the only side effects reported by greater than five percent of all IC351-treated study participants. Men participating in both studies completed the International Index of Erectile Function (IIEF), a standard sexual function questionnaire used by urologists, which includes questions on a man's ability to achieve and maintain an erection. To evaluate IC351's effect versus placebo, researchers compared baseline scores with scores reported after treatment. Additionally, men and their partners completed sexual encounter profile (SEP) diaries, indicating their perceptions on the success and satisfaction of each sexual attempt. Data reported to date from Phase 2 and Phase 3 studies show treatment with IC351 significantly increased the number of successful and satisfying intercourse attempts reported by both men and their partners, relative to placebo. IC351 was well tolerated and there were no treatment-related serious adverse events. It is estimated that 150 million adults worldwide have diabetes. Experts suggest that between 25-75 percent of men with diabetes also have ED. Diabetes can cause vascular complications which, in addition to ED, can lead to blindness, kidney failure, heart disease and nerve damage. According to a recently published study in the British Journal of Urology, ED is a highly prevalent condition that affects an estimated 152 million men worldwide. The disorder is associated with a range of behavioral risk factors, such as cigarette smoking and excessive alcohol consumption, as well as numerous other medical conditions, notably diabetes and cardiovascular disease. As a result of these often age-related co-morbidities, there is a higher prevalence of ED in older men. Between the ages of 40 and 70 years, for example, the incidence of severe ED triples from five percent to 15 percent, while the probability of moderate ED doubles from 17 to 34 percent. SOURCE; Eli Lilly Canada Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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