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| |  AUA: Cialis (IC351) Provides Extended Period of Responsiveness In Men With Erectile Dysfunction INDIANAPOLIS, IN - May 1, 2001 -- According to results of clinical trials released today on CialisTM, a new PDE5 inhibitor in development by Lilly ICOS LLC to treat erectile dysfunction (ED), men reported an improved ability to achieve erections even 24 hours after taking the drug. These data will be presented for the first time at the 96th Annual Meeting of the American Urological Association in Anaheim, California, in June. "Cialis has the potential to be a valuable new treatment option for men with ED and their partners," said Dr. Harin Padma-Nathan, urologist and lead investigator of the study. "A therapy that allows a man with ED to engage in intercourse within a 24-hour window permits the couple to regain spontaneity in their sexual relationship." Cialis provided extended duration of responsiveness and worked promptly. In the first of two trials to measure responsiveness, 61 men with mild-to-severe ED were randomized to receive Cialis 10 mg or placebo in a clinical setting. After taking Cialis, men underwent RigiScanTM (a device for measuring the firmness and duration of erections) evaluations during exposure to visual sexual stimulation. Men in the Cialis group were significantly more successful in achieving erections than men in the placebo group, even when evaluated at 24 hours postdosing. To measure the onset of responsiveness in a more natural setting, 223 men received Cialis (up to 20 mg) or placebo in a second, home-based study. The men were instructed to take the medication immediately before engaging in sexual activity and to use a stopwatch to record the elapsed time until they achieved an erection sufficient for successful intercourse. In this trial, the ability to achieve an erection after sexual stimulation was statistically superior in the group taking Cialis compared with the placebo group at 16 minutes postdosing. Patients on Cialis in this study also recorded statistically significantly more success at second sexual encounters than did patients on placebo for a period of up to 24 hours after dosing. There were no treatment-related serious adverse events. The most commonly reported adverse event was headache. "The side effects in the trials are consistent with other large-scale trials conducted to date with Cialis," said Dr. Padma-Nathan. "Importantly, the extended duration of responsiveness does not appear to increase the rate of side effects or their severity. This is further supported by the fact that very few men chose to discontinue Cialis treatment due to side effects." Dr. Padma-Nathan said that these results are especially encouraging in light of a recent Harris Interactive survey of 256 men with ED in which 88 percent of the men surveyed indicated the duration of responsiveness was either “very important” or “extremely important” in selecting a treatment. In a previously released Phase II placebo controlled study, Cialis improved erectile function in up to 88 percent of men with varying degrees of ED. In a placebo controlled Phase III study in men with difficult-to-treat diabetes-related ED, up to 64 percent of men reported improved erections. The trials demonstrated good tolerability over the entire duration of the medication’s effect with headache and dyspepsia the most commonly reported side effects. The reported side effects were transient, generally considered mild to moderate, and their occurrence diminished with continued treatment. In addition, there were no serious treatment related adverse events. Erectile dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It affects an estimated 152 million men and their partners worldwide with many cases caused by physical conditions, including cardiovascular disease and diabetes. SOURCE: Lilly ICOS LLC
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