Viadur

Health & Medical Editors/Writers

PHILADELPHIA--(BW HealthWire)--June 25, 2001

First Phase III Data Show 72 Percent Response Rate in Men With

Diabetes, A Difficult-to-Treat Population

The first Phase III results for vardenafil, Bayer's investigational treatment to improve erectile function, showed statistically significant improvement in erectile function for men with diabetes, one of the most difficult-to-treat populations. Men with diabetes are three times more likely to have impaired erectile function than other men because of complications related to their condition. The data was presented today at the 61st Annual American Diabetes Association Scientific Sessions.

"The study data showed positive results in the erection response rate of 72 percent in patients with type 1 and type 2 diabetes," said Jerome Fischer, M.D., an endocrinologist with the San Antonio, Texas-based Diabetes and Glandular Disease Research Group, and co-author of the study. "Men with diabetes are usually less responsive to oral ED treatments."

In this placebo-controlled study of 452 men, 72 percent of participants in the 20 mg vardenafil group reported a statistically significant improvement in erectile function, compared to 13 percent in the placebo group (p<0.0001). In addition, in the study 64 percent reported erections were hard enough for penetration as compared to 36 percent in the placebo group. Fifty-four percent were able to maintain their erections to successfully complete intercourse versus 23 percent in the placebo group.

Approximately 7.5 million American males -- more than eight percent of all men in the United States -- have diabetes. Prevalence of impaired erectile function in men with diabetes over the age of 50 is reported to be as high as 50 to 60 percent.

"The study data shows that men with diabetes were able to complete sexual intercourse with vardenafil," said co-author Jay M. Young, M.D., medical director of South Orange County Medical Research Center

Vardenafil is an oral treatment currently under investigation to improve erectile function. Bayer plans to submit a new drug application (NDA) for this compound to the U.S. Food and Drug Administration later this year.

Study Design and Findings

The study involved 452 men, ages 18 and older, with type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes mellitus and mild to severe impaired erectile function for six months or longer. The patients were randomized into three groups and were given a 10 mg or 20 mg oral tablet of vardenafil hydrochloride (a phosphodiesterase-5 (PDE-5) inhibitor) or placebo on demand. The data for the 10 mg group also showed positive results with a 57 percent response rate in improved erectile function (p<0.0001) as compared to 13 percent for the placebo group.

Participants were asked to track their attempts at intercourse in a patient diary. After a four-week baseline period and again at the end of 12 weeks, the patients were asked if treatment had improved their erections over the previous four weeks. In addition to the diary, study participants were evaluated using the erectile function domain of the International Index of Erectile Function (IIEF). The IIEF is a standard sexual function questionnaire used by urologists. It includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse.

The most commonly reported drug-related adverse events in this study included headaches, flushing, and nasal congestion.

Bayer Committed to Men's Health

Bayer is committed to improving men's health. Bayer Corporation already has established itself as a credible force in men's health with Cipro(R)(a) (ciprofloxacin HCl) to treat chronic bacterial prostatitis due to E. coli and P mirabilis. Bayer also is marketing Viadur(TM)(b), the first and only, once-yearly, continuous testosterone suppression therapy to treat symptoms of advanced prostate cancer. Other men's health products include One-A-Day(R) Men's High Potency Multivitamin/Multimineral Supplement, One-A-Day(R) Prostate Health, and Bayer Immuno 1(TM) System Complexed Prostate Specific Antigen (cPSA) -- an assay used to measure prostate-specific antigen levels at the time of diagnosis and to monitor them over time.

Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of health care, life sciences, and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability, and improve people's lives.

Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2000, and is one of Fortune magazine's Most Admired Companies. The company employs 23,200 people. It is a member of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. The Bayer Group (BAYG.DE) stock is a component of the DAX, and is listed on multiple foreign exchanges.

(a) View prescribing information for Cipro(R) at ciprousa.com.

(b) View prescribing information for Viadur(TM) at viadur.com.

COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group