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Analyses of Vardenafil Clinical Trial Data Report Positive Results in Improving Erectile Function Regardless of Cause, Severity or Presence of Co-Existing Conditions: Presented at AUA

Significant Proportion of Men Reported Erectile Function Restored Within Normal Range

ORLANDO, FL -- May 27, 2002 -- This week at the American Urological Association (AUA) Annual Meeting, physicians will be presenting clinical trial data on the efficacy of vardenafil, an investigational drug under review for the treatment of erectile dysfunction (ED). These studies were conducted in a wide range of men with ED, including those with hypertension, hyperlipidemia or diabetes. It has been shown that ED is commonly found in men with these conditions.(1) The prevalence of ED in diabetic men is reported to be as high as 55 percent among those over age 60.(1)

Several analyses were conducted of pooled data from two phase III clinical trials in approximately 1,400 men. The data indicated that:

* vardenafil treatment improved erectile function as reported by a wide range of patients, including those with mild, moderate and severe ED, compared with placebo;
* a significant proportion of men reported vardenafil treatment improved their erectile function regardless of whether their condition was organic, psychogenic or of a mixed cause, compared with placebo;
* patients with ED and co-existing hypertension, hyperlipidemia or diabetes reported a marked improvement in erectile function with vardenafil, compared with men with ED who were treated with placebo;
* in men with ED, including those with severe ED, vardenafil treatment restored erectile function to the normal range (as measured by the International Index of Erectile Function [IIEF] Erectile Function [EF] domain score of > or equal to 26).

One of the two studies included in the pooled data is being presented separately at the meeting as a late-breaker. That presentation will report results from a North American pivotal phase III trial of vardenafil, which indicated that after 26 weeks, 85 percent of men taking vardenafil 20 mg reported improved erections compared with 28 percent of those taking placebo.

In the analyses of the pooled data, the most common adverse events were generally mild to moderate in intensity and included headache, flushing, rhinitis and dyspepsia.

"We have an extensive clinical development program in place to evaluate the efficacy, safety and pharmacokinetics of vardenafil in a broad range of patients with ED, including those who are difficult to treat," said Paul MacCarthy, M.D., vice president, U.S. Medical Science, Bayer Corporation. "We are encouraged by the vardenafil clinical trial data presented at the AUA because we believe there is a need for new ED treatments. Many of the men who suffer from this medically important and common condition are unfortunately not receiving treatment or are dissatisfied with currently available therapies."

Significant Improvement in Erectile Function Reported Regardless of ED Cause or Severity
To evaluate the efficacy and safety of vardenafil in a broad population of men with ED of various causes and severities, investigators pooled data from two randomized, double-blind, placebo-controlled, phase III trials of approximately 1,400 men with ED for six months or more. The investigators analyzed the primary endpoint (the erectile function [EF] domain of the International Index of Erectile Function [IIEF], a standard sexual function questionnaire used by urologists that includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse) within patient subgroups defined by the cause of the patient's ED and the patient's baseline ED severity.

The study data indicated significant improvement in erectile function inpatients treated with vardenafil (at all doses) compared with placebo, regardless of the cause of their ED. The vardenafil patients reported significant improvement in their ability to achieve and maintain erections to the completion of sexual intercourse, regardless of the baseline severity of their condition.

"These findings are important in that improvement in erectile function was observed in patients regardless of whether their ED had an organic cause [such as diabetes or another vascular cause], a psychogenic cause [such as depression or feelings of inadequacy] or a mixed cause," said Craig Donatucci, M.D., lead study investigator and a urologist with Duke University Medical Center. Improvement in Erectile Function Reported by Men with Common Co-Existing Conditions

Given the common association between ED and diseases such as hypertension, hyperlipidemia and diabetes mellitus,(1) investigators evaluated vardenafil over a 12-week period in men with ED and these common conditions using pooled data from two randomized, double-blind, placebo-controlled, phase III trials of approximately 1,400 men. Study participants were evaluated using the EF domain of the IIEF.

The investigators reported that men who had hyperlipidemia, diabetes or who were taking anti-hypertensive therapy reported significant improvement in erectile function (as measured by EF domain scores) compared with men taking placebo. The reported effect of vardenafil was not as robust in patients with diabetes or those receiving antihypertensive medication as the effect seen inpatients without these co-existing conditions. However, patients reported improvement with vardenafil 10 and 20 mg at rates significantly higher than with placebo.

"The men with ED who come to my urology practice seeking treatment often have high blood pressure, diabetes or lipid disorders," said Evan Goldfischer, M.D., lead study investigator and a urologist with Hudson Valley Urology in Poughkeepsie, NY. "That's why it is so important that we investigate new treatments for ED in patients with these co-existing conditions."

Improved Erectile Function Reported in Significant Proportion of Men with ED
To determine the proportion of men treated with vardenafil who regained erectile function within the normal range, investigators pooled data from two randomized, double-blind phase III trials. In the trials, approximately 1,400 men with ED ranging from mild to severe had taken vardenafil 5, 10 or 20 mg or placebo for 12 weeks. Study participants were evaluated using the EF domain of the IIEF.

The investigators reported that 49 percent of men treated with vardenafil20 mg and 43 percent of those treated with 10 mg regained erectile function within the normal range, compared with 10 percent of men taking placebo. While most of the study population included men with moderate to severe ED, a small subset (n=89) suffered from mild ED. An interesting finding in the mild cohort was that two out of three men treated with vardenafil reported restored erectile function within the normal range. Additionally, 40 percent of the men with severe ED who received vardenafil 20 mg (n=138) returned to the normal range of erectile function.

"This is the first time we have looked at vardenafil data to determine whether men using the compound actually reported erectile function within the normal range," said Harin Padma-Nathan, M.D., lead study investigator and aurologist with The Male Clinic in Beverly Hills, Calif. "We were pleased to observe that a significant proportion of men regained erectile function within the normal range."

North American Pivotal Trial Findings Presented as Late-Breaker
Results from a North American pivotal phase III trial of vardenafil were presented at the AUA by Wayne J.G. Hellstrom, M.D., of Tulane University Health Sciences Center. This multicenter, placebo-controlled, double-blind study was designed to evaluate the effect of vardenafil over 26 weeks in abroad population of men with ED. A total of 805 patients who had experienced erectile difficulties for at least six months were randomized to placebo or vardenafil 5, 10 or 20 mg.

After 26 weeks, 85 percent of men taking vardenafil 20 mg reported improved erections, compared with 28 percent of patients taking placebo. All doses of vardenafil were significantly better than placebo for the EF domain score. The average successful penetration rate for men taking vardenafil20 mg was 81 percent compared with 52 percent for the placebo group(p<0.0001). According to study findings, the average successful penetration rate to maintain an erection long enough for successful intercourse was 67 percent for those taking vardenafil 20 mg compared with 33 percent for those in the placebo group (p<0.0001).

In this North American pivotal trial, adverse events were mild to moderate and transient in nature. The most commonly reported adverse events were headache, flushing, rhinitis and dyspepsia. "In this pivotal phase III trial of vardenafil, positive responses in erectile function were consistently observed in a broad range of patients with ED," said Dr. Hellstrom, lead study investigator and professor of urology and chief of the Section of Andrology at Tulane University School of Medicine, New Orleans.

Erectile Dysfunction and Vardenafil Erectile dysfunction (ED) -- the persistent inability to attain and maintain an erection adequate to permit satisfactory sexual performance -- is a major medical condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 40(1) -- 30 million men in the United States.(2) Despite the high prevalence, a very low percentage of men with ED are currently being treated. Analysis of the National Health and Social Life Survey has shown that only about 1 in 10 American men with ED between ages 18 and 59 actually went to a physician to discuss their sexual dysfunction.(3)

Vardenafil, researched and discovered by Bayer AG, is being co-developed with GlaxoSmithKline (GSK) and will be co-promoted by Bayer and GSK upon U.S.Food and Drug Administration approval. Vardenafil is being evaluated clinically in a broad range of patients with ED.

About Bayer
Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of health care, crop protection, polymer 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 2001 and is one of Fortune magazine's Most Admired Companies. The company employs 21,500 people. It is a member of the worldwide Bayer Group, a$27 billion international health care and chemicals group based in Leverkusen, Germany. The Bayer Group stock is a component of the DAX and is listed on the New York Stock Exchange (ticker symbol: BAY).This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

About GSK
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GlaxoSmithKline cautions investors that any forward-looking statements or projections made by GSK, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the company's operations are discussed in the section "Cautionary factors that may affect future results" in GSK's results announcement for the year ended 31 December 2001, filed with the U.S. Securities and Exchange Commission.

References:
1. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61.
2. National Institutes of Health, Consensus Development Conference Statement, December 7-9, 1992. Online data: http://odp.od.nih.gov/consensus/cons/091/091_statement.htm
3. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544


SOURCE: Bayer Corporation; GlaxoSmithKline

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