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Levitra (vardenafil HCl) Improves Erectile Function in African-American, Hispanic and Caucasian Men: Presented at NMA

WEST HAVEN, CT and PHILADELPHIA, PA -- August 7, 2003 -- A new open-label, flexible-dose, clinical study has shown that the oral investigational drug LevitraŽ (vardenafil HCl) is effective in improving erectile function (EF) in most men of diverse ethnic origin. African-American, Hispanic and Caucasian men with erectile dysfunction (ED) who took Levitra [pronounced luh-VEE-tra] reported improvements in their EF,¹ including reliability of response over time.²

These new findings are being presented this week at the 2003 Annual Convention and Scientific Assembly of the National Medical Association (NMA), a professional scientific organization representing the collective interests of physicians and patients of African descent and a leading force for parity in medicine, elimination of health disparities and promotion of optimal health.

"These new clinical findings for Levitra show that men reported a reliable response to Levitra, not only over the treatment period, but also across ethnic origins," said James Bennett, M.D., lead study investigator and board-certified urologist in private practice at Midtown Urology in Atlanta. "In my practice, I see a diverse group of men, with varying degrees of erectile function, and it is important that the treatments I prescribe work regardless of ethnic background, age or degree of erectile difficulty. My patients want to be able to count on their treatment to work consistently," added Dr. Bennett, who is a long-time member of the NMA and was designated "Practitioner of the Year" by the organization in 1999.

Study Shows that Levitra is Reliable and Well-Tolerated in Most African-American, Hispanic and Caucasian Men

To evaluate the efficacy, reliability and tolerability of Levitra in men of diverse ethnic origin, investigators conducted a 10-week, open-label, multicenter study involving 136 African-American, 102 Hispanic and 153 Caucasian men with ED. In this flexible-dose study, participants were given a starting dose of Levitra 10 mg. At weeks two and six of the trial, investigators could adjust the starting dose to 20 mg or 5 mg based on the efficacy and tolerability of the drug.

Key results at the end of the 10-week study showed:
ˇ Nearly nine in 10 men (up to 89 percent) reported improvement in EF based on the global assessment question (GAQc) after taking Levitra.¹
ˇ African-American, Hispanic and Caucasian men reported high rates of successful penetration on their first attempt (>80 percent) and reliable results on subsequent attempts (>92 percent) after taking Levitra.²

In the study, adverse events were generally mild to moderate. The most commonly reported adverse events were headache, flushing and nasal congestion.^1,2

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 performance³ - 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 - 152 million men worldwide⁵ 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.

REFERENCES:

1. Bennett J, Shapiro J, Taylor T. Vardenafil improves erectile function in African-American, Hispanic and Caucasian men with erectile dysfunction (ED). To be presented at the 2003 Annual Convention and Scientific Assembly of the National Medical Association, August 6, 2003, Philadelphia.

2. Bennett J, Shapiro J, Taylor T. Vardenafil provides for reliable successful intercourse in African-American, Hispanic and Caucasian men with erectile dysfunction (ED). To be presented at the 2003 Annual Convention and Scientific Assembly of the National Medical Association, August 6, 2003, Philadelphia.

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.


SOURCE: Ogilvy Public Relations Worldwide

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