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Clinical Findings of Vardenafil Show Satisfaction With Sexual Experience
WEST HAVEN, Conn. and PHILADELPHIA, April 28 /PRNewswire-FirstCall/ -- New clinical findings on men's perceptions of their sexual experiences showed that men with erectile dysfunction (ED) who were taking 10 mg or 20 mg of the oral investigational drug LEVITRA® (vardenafil HCl) [pronounced luh-VEE-tra] reported significantly improved satisfaction with erection hardness, orgasmic function and overall sexual experience.(1) LEVITRA is being co-developed and co-promoted by Bayer and GlaxoSmithKline. Results from the clinical trial were presented today at the annual meeting of the American Urological Association (AUA) in Chicago.
"For men, erectile function isn't only about penetration, it's also about the quality of their erection -- their ability to get an erection that is sufficiently hard and lasts long enough for sexual intercourse," said Myron Murdock, M.D., national medical director of hisandherhealth.com. "Ultimately, it's the quality of the erection that can lead to a satisfying sexual experience. These findings showed that LEVITRA improved the quality of erection and improved a man's overall satisfaction with his sexual experience compared with placebo."
Study Participants Taking LEVITRA Reported Up To a Three-Fold Increase in Satisfaction with Erection Hardness
In this phase III, multicenter, double-blind clinical trial, 805 men with ED were randomized to LEVITRA 5 mg, 10 mg or 20 mg or placebo.
Results showed that after 26 weeks: * Men taking LEVITRA 20 mg on average reported a satisfaction rate three times higher than men taking placebo for erection hardness (58 percent vs. 18 percent). Men taking LEVITRA 10 mg on average reported a satisfaction rate three times higher than men taking placebo for erection hardness (52 percent vs. 18 percent).(1) * Significant improvements also were noted in intercourse satisfaction, orgasmic function and overall sexual experience in men taking 10 mg or 20 mg of LEVITRA compared with men taking placebo.(1) * The most common adverse events were generally mild to moderate and included headache, flushing and rhinitis (nasal congestion).(1) Sexual Response Reported as Early as 16 Minutes in Separate LEVITRA Study
In a separate randomized, double-blind study, men with mild to severe ED received a four-week supply of LEVITRA 20 mg or placebo and were asked to start sexual activity immediately after dosing. Results showed that:
* Significantly more men taking LEVITRA 20 mg experienced an erection adequate for completion of successful intercourse as early as 16 minutes after dosing compared with men taking placebo (34 percent vs. 24 percent, respectively).(2) * The most commonly reported adverse events were headache and flushing.(2)
"The finding that LEVITRA worked as soon as 16 minutes in some men who took the drug in an at-home study is important because patients tell me that time of onset is an important consideration in their choice of therapy," added Dr. Murdock.
ED and LEVITRA
Erectile dysfunction (ED) -- the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance(3) -- is a common health 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(4) -- 152 million men worldwide(5) and 30 million men in the United States alone.(6) Despite the high prevalence of sexual dysfunction, nine out of 10 men in the U.S. have not yet sought treatment from a physician.(7)
Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for LEVITRA in November 2001. The U.S. Food and Drug Administration (FDA) issued an approvable letter for LEVITRA in July 2002. LEVITRA was approved on March 6, 2003, by the European Commission based on the quality, safety and efficacy data submitted.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry.
Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.
Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
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.
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, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are discussed under risk factors in the Company's Preliminary Announcement of Results for the Year Ended 31st December 2002.
REFERENCES: (1) Donatucci C, Pommerville P, Niederberger C, et al. Vardenafil improved patient satisfaction with erection hardness, orgasmic function and sexual experience in men with erectile dysfunction. Presented at the 2003 Annual Meeting of the American Urological Association, April 28, 2003, Chicago. (2) Padma-Nathan H, Kaufman J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. Presented at a satellite symposium at the 2003 Annual Meeting of the American Urological Association, April 25, 2003, Chicago. (3) Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-Sponsored by the World Health Organization (WHO), International Consultation on Urological Diseases (ICUD) and Societe Internationale d'Urologie (SIU) and held July 1-3, 1999, Paris. 2000, p. 713. (4) 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. (5) Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999;84:50-56. (6) 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. (accessed 8/26/02). (7) Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544.