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| |  ESSIR: Cialis (Tadalafil) Shows Consistent Effect in Men With Erectile Dysfunction ROME, ITALY -- October 2, 2001 -- The first presentation of large-scale integrated analysis of Phase III data on CialisÔ (tadalafil), a new oral treatment for erectile dysfunction (ED) being developed by Lilly ICOS LLC, shows a consistent response to the investigational treatment. Eighty-one percent of patients treated with 20 mg Cialis (n=165) reported improved erections (1). This analysis, taken from studies of 972 men with ED (711 Cialis, 261 placebo), and other new research - including a study that shows Cialis’s absorption was not decreased by food intake (2) - were presented today at the 4th Congress of the European Society for Sexual and Impotence Research (ESSIR) in Rome. “With each new data analysis, we continue to see consistent and robust scientific evidence that Cialis has an attractive profile,” said Charles Beasley, M.D., medical director, Eli Lilly and Company. “The many findings from these Phase III analyses suggest Cialis has the potential to be a valuable treatment for a large number of men who have ED, regardless of severity. Cialis has other attributes that may also be clinically important.” Several studies were conducted to evaluate Cialis absorption by the body. Pharmacokinetic studies are important because they can identify differences in drug absorption and elimination in the body between various patient populations. These studies investigated, among other characteristics, the impact of age, diabetes, renal function, and liver function on the pharmacokinetics of Cialis. There were no clinically significant differences in extent of drug exposure among these diverse groups. In addition, Cialis’s absorption was not decreased by food intake (3). “These findings suggest that dosing for Cialis should be simple and uncomplicated, which is important from a health care professional standpoint,” said Hartmut Porst, associate professor of the urological department of the medical university in Bonn, Germany, and secretary general of the ESSIR. “From a patient’s point of view, it is the absence of food effect that I find most interesting. These data suggest that a man can have a normal, romantic dinner with his partner without diminishing the effect of Cialis.” The integrated Phase III analysis included randomised, placebo-controlled studies involving 972 men with ED of various causes and severity. Men were treated with Cialis (ranging up to 20 mg) or placebo for 12 weeks. Improved erections, as assessed by the Global Assessment Questionnaire (GAQ), were reported by 81 percent of patients taking 20 mg Cialis (35 percent placebo) (4). The Phase III integrated analysis showed Cialis improved erections in 76 percent of the subset of men with diabetes taking a 20 mg dose (5). Diabetes-related ED is often more difficult to treat than ED caused by other factors. Erectile dysfunction is a common complication of diabetes, affecting between 27 and 75 percent of men with the disease (6). The World Health Organization estimates 151 million people worldwide have diabetes (7). In the Phase III studies, participants were instructed to take study medication at the time of their choosing prior to sexual activity, with no more than one dose daily. No instructions were given with regard to food or alcohol consumption and time of dosing. Two separate studies, presented in Europe for the first time, showed Cialis works for up to 24 hours and as early as 16 minutes after taking the pill (8). In the first study, 61 men with mild-to-severe ED were randomised to take Cialis or placebo and underwent RigiScanÒ (device for measuring firmness and duration of erections) evaluations during exposure to visual sexual stimulation. Men taking Cialis experienced significantly more success in improvement of erectile function than men in the placebo group, even when evaluated 24 hours after dosing. In the second study, designed to measure the drug’s onset, 223 men took Cialis or placebo and used a stopwatch to record the elapsed time until they achieved an erection sufficient for intercourse. The ability to achieve an erection (with sexual stimulation) was statistically superior in the group taking Cialis 20 mg, compared with the placebo group, at 16 minutes after dosing, and the majority of men taking Cialis were able to respond within 30 minutes. “This period of responsiveness may be an important attribute for emerging ED treatments, as it may enable a man and his partner to have sex whenever they choose within a 24-hour period,” Professor Porst said. Throughout the Phase III trials, Cialis was well tolerated, with generally mild-to-moderate side effects that diminished in frequency with continued treatment. The most commonly reported side effects throughout the Phase III trials were headache, upset stomach, backache, muscle aches, flushing and nasal congestion. The discontinuation rate due to side effects in these trials was comparable to that with placebo. Cialis is currently under review for marketing approval by the European Agency for the Evaluation of Medicinal Products (EMEA) and the US Food and Drug Administration (FDA). 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 (9). References: (1) Symposium, “Expanding treatment options for male impotence.” 4th Congress of the European Society for Sexual and Impotence Research. October 2, 2001. (2) Patterson, B et al. “The effect of intrinsic and extrinsic factors on the pharmacokinetic properties of tadalafil (IC351).” Poster presentation at the 4th Congress of the European Society for Sexual and Impotence Research. Poster presented 08.00-09.00 October 3, 2001. (3) Ibid. (4) CME symposium, “Expanding treatment options for male impotence.” 4th Congress of the European Society for Sexual and Impotence Research. October 2, 2001. (5) Ibid. (6) Guay A. Treatment of erection dysfunction in men with diabetes. Diabetes Spectrum 1998; 11: 2 (7) International Diabetes Federation. Diabetes Atlas 2000. (8) Padma-Nathan, H. “Tadalafil (IC351) provides prompt response and extended period of responsiveness for the treatment of men with ED.” Poster presentation at the 4th Congress of the European Society for Sexual and Impotence Research. Poster presented 08.00-09.00 October 1, 2001. (9) Aytac et al. The Likely Worldwide Increase in Erectile Dysfunction Between 1995 and 2025 and Some Possible Policy Consequences. BJU International. 1999; 84:50-56. SOURCE: Lilly Icos
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