Cialis (Tadalafil) Shows Consistent Effect in Men With Erectile Dysfunction
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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.