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Title: Levitra (Vardenafil HCl) Starts To Work In As Early As Ten Minutes In Men With Erectile Dysfunction

"Levitra (Vardenafil HCl) Starts To Work In As Early As Ten Minutes In Men With Erectile Dysfunction"

No Other Oral ED Treatment Has Been Proven to Work as Fast as Levitra WEST HAVEN, CT and PHILADELPHIA, PA -- May 10, 2004 -- According to the results of a new study, some men with erectile dysfunction (ED) can now achieve an erection in as few as 10 minutes with Levitra® (vardenafil HCl).1 These findings were presented at the 7th Congress of the European Federation of Sexology (EFS) this week. In a separate retrospective analysis of two studies, Levitra was shown to provide a favorable window of opportunity of up to 12 hours. 2 "I treat many men with ED, and for some, rapid onset is an important consideration in an oral ED treatment," said Marc Gittelman, M.D., founder and director of the Miami Center for Sexual Health and voluntary assistant professor at the University of Miami School of Medicine. "These new Levitra data are important because it is the first time any oral ED treatment has been shown to work in as early as 10 minutes. I think this is exciting news for men with ED who are looking for a treatment that is reliable, fast and provides a quality response." In a U.S. nationwide omnibus survey conducted by Harris Interactive® in April 2004, 41 percent of 206 respondents who experience ED, or have a partner who experiences ED, said they would want an ED treatment to start working in "15 minutes or less."3 The online survey, sponsored by Bayer Pharmaceuticals Corporation and GlaxoSmithKline, was conducted among a nationwide sample of 2,016 U.S. adults (1,013 men and 1,003 women). "Waiting for an ED treatment to kick in can be stressful," said Levitra patient Frank Marcoulides "With Levitra, I know I have a treatment I can rely on to work fast and improve my erection quality. Levitra is the right choice for my wife and me." About the ONTIME Study In this double-blind, at-home study, men with ED (n=732) were randomized to receive Levitra (10mg or 20 mg) or placebo and asked to start sexual activity immediately after dosing and to assess their erections using a stopwatch for the first four attempts. Time-points from 25 to five minutes were tested comparing Levitra with placebo to determine the earliest onset of action. Results showed that: · Within 25 minutes, significantly more men taking Levitra experienced an erection adequate for completion of successful intercourse compared with men taking placebo (50 percent of men taking Levitra 10 mg and 53 percent of men taking Levitra 20 mg vs 26 percent of men taking placebo).1a · At all time periods >10 minutes, a statistically superior response was seen with Levitra (10 mg and 20 mg) compared with placebo (49 out of 232 for Levitra 10 mg vs 32 out of 235 for placebo 10 mg; 56 out of 241 for Levitra 20 mg vs 35 out of 235 for placebo 20 mg).1b · The most commonly reported adverse events were generally mild to moderate and included headache and flushing.1c Window of Opportunity Analysis In a retrospective, pooled analysis of two pivotal, randomized, double-blind, placebo-controlled Phase III studies involving 1385 patients with ED, patients were instructed to take Levitra 60 minutes prior to sexual activity. Results showed that: · Of the number of patients (34 out of 347) who initiated sexual activity eight to 12 hours after taking Levitra 10 mg (23 out of 326 for placebo), improved success rates of intercourse completion (SEP3) with Levitra 10 mg were 79 percent vs 54 percent for placebo (Nominal P=0.02 vs placebo). 2a · 95 percent of patients treated with Levitra 10mg initiated sexual activity 45 to 75 minutes after dosing, where improved success rates of intercourse completion (SEP3) with Levitra 10 mg was 67 percent vs 35 percent for placebo. 2b 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 83 countries. Levitra was approved by the U.S. Food and Drug Administration for the treatment of ED on August 19, 2003, providing American men with their first new ED treatment choice in five years. Levitra is a prescription medicine that is used to treat erectile dysfunction (ED). 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 problems, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. You should not take Levitra if your doctor determines that sexual activity poses a health risk for you. Men who experience an erection for more than four hours should seek immediate medical attention. Levitra does not protect against sexually transmitted diseases. The starting dose of Levitra is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking certain medications such as ritonavir, indinavir, ketoconazole, itraconazole, and erythromycin, lower doses of Levitra are recommended, and time between doses of Levitra may need to be extended. In clinical trials, the most commonly reported side effects were headache, flushing, and stuffy or runny nose. Levitra is available in 2.5 mg, 5 mg, 10 mg, and 20 mg tablets. Individual patient results may vary. REFERENCES 1. Montorsi F, Padma-Nathan H, Buvat J, et al. Time to Onset of Action Leading To Successful Sexual Intercourse by Vardenafil (Levitra®) in Men with Erectile Dysfunction. To be presented at the 7th Congress of the European Federation of Sexology (EFS), May 12-16, 2004, Brighton, UK. 2. Stief C, Valiquette L, Montorsi F et al. Vardenafil (Levitra®) improves maintenance success rates from 15 minutes to up to 12 hours from time of dosing to start of sexual activity. Presented at the 4th World Congress on the Aging Male. 26-29 February 2004, Prague, Czech Republic. 3. Harris Interactive®, "A Study About ED." Submitted April 21, 2004. p.12 and 14. Harris Interactive conducted a study for Levitra. This report presents the findings of the online omnibus survey conducted among a nationally representative sample of 2,016 U.S. adults comprising 1,013 men and 1,003 women 18 years of age or older. Interviewing was completed during the period April 15 through April 19, 2004. The 1,848 respondents who have had sexual intercourse were the main focus of the study. The margin of error is plus or minus 2.2 percentage points. Data were propensity weighted. 4. 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. 5. 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. 6. 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. 7. 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). 8. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544. SOURCE: Ogilvy Public Relations Worldwide

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