New Clinical Data Show Patients Receiving Cialis - tadalafil - Improved Intercourse Success at 24 and 36 Hours After Dosing
-- New Clinical Safety Data for Cardiovascular Profile Being Presented --
BOTHELL, Wash.--(BW HealthWire)--May 25, 2002-- According to newly released clinical data on Cialis(TM), an investigational PDE5 inhibitor being developed by Lilly ICOS LLC for the treatment of erectile dysfunction (ED), men with ED reported a statistically significant improvement in successful intercourse attempts at 24 and 36 hours after taking the drug, compared to placebo.
These and other new findings - including a summary of cardiovascular safety data that showed no increased incidence of cardiovascular events during clinical studies - are being presented at the 97th Annual Meeting of the American Urological Association in Orlando, Florida.
Cialis Period of Effectiveness - Key Study Findings
In a Phase III clinical study designed to evaluate the efficacy of Cialis at specific time points after dosing, 348 men with mild-to-severe ED were randomly assigned to receive Cialis 20 mg (n=175) or placebo (n=173) over approximately an eight-week period. Patients were instructed to attempt intercourse with their partners on four specific occasions: on two occasions at 24 hours after dosing and on two occasions at 36 hours after dosing. The primary endpoint was the percentage of successful sexual intercourse attempts.
"Cialis was statistically superior to placebo in enabling men with ED to have successful intercourse at 24 or 36 hours after taking the drug and showed a consistent effect at both time points," said Raymond Rosen, Ph.D., study author and director of the Program in Human Sexuality at the University of Medicine and Dentistry of New Jersey and professor of psychiatry, Robert Wood Johnson Medical School, Piscataway, New Jersey. "Also, in this study, the duration of effectiveness did not appear to influence the incidence or severity of side effects."
In addition, study results show that in secondary measures of efficacy - including ability to penetrate, satisfaction with hardness of erection and overall satisfaction - Cialis was statistically superior to placebo at 24 and 36 hours.
The most commonly reported (greater than 5 percent) treatment-emergent side effects in the study were headache, flushing and upset stomach. Less than two percent of patients taking Cialis or placebo discontinued the study due to side effects. There were no treatment- emergent serious adverse events reported.
Cardiovascular Data - Key Study Findings
The overall cardiovascular profile of Cialis was summarized based on data from several Phase III pivotal clinical trials and other studies. Men with ED with a wide variety of stable cardiovascular conditions, including patients taking multiple antihypertensive medications, were included in the Phase III clinical trials. Co-administration of a nitrate with Cialis is likely to be contraindicated, pending FDA approval.
"Overall, the incidence of cardiovascular events was not statistically significantly different from placebo," said Robert A. Kloner, MD, Ph.D., professor of medicine at the University of Southern California and director of research at the Heart Institute of Good Samaritan Hospital, Los Angeles. "These newly presented clinical safety data provide further information for the cardiovascular profile demonstrated in clinical trials for Cialis."
Findings show that healthy patients taking Cialis 20 mg had no statistically significant differences in standing blood pressure and no change in heart rate, compared to placebo. In addition, the incidence of heart attack in Cialis-treated patients across all clinical studies (involving more than 4,000 patients) was not different from those receiving placebo.
Further, data collected from large-scale Phase III clinical trials involving 1,328 men with ED show that the overall incidence of cardiovascular side effects - including flushing, dizziness, hypertension and syncope (feeling faint/fainting) - in both placebo- and Cialis-treated patients was not statistically significantly different.
Erectile Dysfunction - Just the Facts
Erectile dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 152 million men and their partners worldwide and more than 30 million men in the United States, with many cases caused by physical conditions, including cardiovascular disease and diabetes.
About Lilly ICOS
Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq:ICOS - News) and Eli Lilly and Company, is developing Cialis for the treatment of sexual dysfunction.
Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
ICOS is a product-driven company that has expertise in both protein-based and small molecule therapeutics. The Company combines its capabilities in molecular, cellular and structural biology, high throughput drug screening, medicinal chemistry and gene expression profiling to develop highly innovative products with significant commercial potential. The Company applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis, pulmonary arterial hypertension and other cardiovascular diseases, and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing the Company's opportunities to market breakthrough products.
Certain of the matters discussed herein with respect to clinical studies and ICOS and Lilly's products may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the two companies' respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies. More specifically, there can be no assurance that this product will achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.
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Contact:
ICOS Corporation
Lacy Fitzpatrick, 425/415-2207
or
Eli Lilly and Company
Jill Schaefer, 317/277-3661 |
