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-- Men with ED taking Levitra reported significant improvement in erectile function - - West Haven, Conn., and Philadelphia, Pa., October 9, 2003 - The first clinical study to evaluate LEVITRA® (vardenafil HCl) in men with erectile dysfunction (ED) who were unresponsive by history to Viagra® (sildenafil citrate)+ (as identified by six criteria) showed that men were three times more likely to complete sexual intercourse successfully on Levitra (pronounced Luh-VEE-trah) than on placebo.1 Results from the study, referred to as the PROVEN (Patient RespOnse with VardENafil in Sildenafil Non-Responders) trial, will be presented on October 11 at the 5th Annual Fall Research Meeting of the Sexual Medicine Society of North America (SMSNA) in Denver. The SMSNA deemed the study abstract a Prize Essay Winner.
"In my clinical experience, a number of men with ED are not successful with Viagra. Results from the PROVEN study clearly demonstrated that Levitra was effective in many men who reported lack of success with Viagra," said Culley C. Carson, III, M.D., lead study investigator and president of SMSNA. "These findings confirm the need for new treatments and support Levitra as an excellent choice for many men with ED." Dr. Carson is chief of urology at the University of North Carolina Hospital, Chapel Hill, and Rhodes distinguished professor of urology.
Levitra PROVEN Study Demonstrated Three-Fold Increase in Success Rates
This prospective, multicenter, double-blind, flexible-dose trial studied men with ED who had a documented history of non-response to Viagra. Unresponsiveness to Viagra was defined by patient reported history and they were not re-challenged with Viagra. All study participants met rigorous criteria, including failing at least four of the last six attempts at successful intercourse with Viagra and having at least one unsuccessful attempt with the highest available dose of Viagra (100 mg).* These men were considered to be unresponsive to Viagra in the medical opinion of the study physician. A total of 463 men with moderate to severe ED were randomized to Levitra 10 mg or placebo for four weeks. At weeks four and eight of the trial, physicians could adjust the starting dose of Levitra 10 mg to 20 mg or 5 mg based on the efficacy and tolerability of the drug.
All primary endpoints showed statistically and clinically significant improvements compared with placebo. Results showed that after 12 weeks, men were three times more likely to complete sexual intercourse successfully on Levitra than on placebo (46.1 percent vs. 16.1 percent, respectively).1 When compared with baseline, men were four times more likely to complete sexual intercourse successfully on Levitra (46.1 percent vs. 10.1 percent, respectively).1 Among those taking placebo, there were no clinically or statistically significant differences in success in maintaining erections to completion of successful intercourse after taking the sugar pill as compared with baseline (16.1 percent vs. 11.6 percent, respectively).1
In the clinical trial, the most commonly reported adverse events were generally mild to moderate and included headache, flushing, nasal congestion and upset stomach.1
Studies have shown that 1 is effective the first time most men take it and provides reliable improvement of erection quality for many men with ED.2,3 Levitra is the first product in five years to receive U.S. Food and Drug Administration (FDA) approval for the treatment of ED, offering a new choice to physicians and patients.
ED and Levitra
ED - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance4 - 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 405 - 152 million men worldwide6 and 30 million men in the United States alone.7
Despite the high prevalence of sexual problems, nine out of 10 men in the U.S. have not yet sought treatment from a physician.8
Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for Levitra in November 2001. To date, Levitra has received regulatory approval for the treatment of ED in more than 50 countries. Levitra was approved by the U.S. Food and Drug Administration for the treatment of ED on August 19, 2003, providing men with their first new ED treatment choice in five years.
Levitra is a medicine that may be used up to once a day to treat ED. Levitra is for use by prescription only. Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take Levitra. Men who use alpha blockers, sometimes prescribed for high blood pressure or prostate symptoms, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. The most commonly reported side effects are headache, flushing and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention. Men should not take Levitra if their doctor determines that sexual activity poses a health risk.
For more information about Levitra, please visit www.Levitra.com
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 healthcare 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.
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 U.S. 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:
- Carson C, Hatzichristou D, Carrier S, et al. Vardenafil exhibits efficacy in men with erectile dysfunction unresponsive to prior sildenafil therapy: results of a phase III clinical trial - Patient Response with Vardenafil in Sildenafil Nonresponders (PROVEN). To be presented at the 5th Annual Fall Research Meeting of the Sexual Medicine Society of North America, October 11, 2003, Denver.
- Valiquette L, Hellstrom W, Gittelman M, et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 24, 2002, Montreal, Quebec, Canada.
- Saenz de Tejada I, Glina S, Becher E, Ulbrich E, Vardenafil Study Group. Vardenafil exhibits long-term efficacy and safety for up to 52 weeks. Presented at the V Congress of the European Society for Sexual and Impotence Research (ESSIR), December 3, 2002, in Hamburg, Germany.
- 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.
- 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.
- 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.
- 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).
- Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544.
+ViagraTM (sildenafil citrate) is a registered trademark of Pfizer Inc.
*All study participants had a documented history of non-response to Viagra and met all six of the following rigorous criteria:
(1) Must have previously made at least six attempts at intercourse with Viagra, administering each dose in accordance with the dosing recommendations outlined in the Viagra package insert, AND
(2) Must have reported unsuccessful intercourse in at least four of their last six attempts at intercourse with Viagra, in that the patient was not able to achieve at least a partial erection (some enlargement of the penis); or was not able to insert his penis into his partner's vagina; or did not have an erection that lasted long enough for successful intercourse, AND
(3) Must have reported unsuccessful intercourse at their most recent attempt at intercourse with Viagra, AND
(4) Must have attempted Viagra on the highest available dose (100 mg) at least once and reported unsuccessful intercourse on 100 mg at least once, according to dosing recommendations outlined in the Viagra package insert, AND
(5) Must have discontinued Viagra due to a lack of efficacy, AND
(6) In the medical opinion of the study physician, the study participant was considered to be unresponsive to Viagra
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