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Nine in Ten Men Report Improvement in Erections with LevitraŽ (vardenafil HCl) Over a Two-Year Period

WEST HAVEN, CT, and PHILADELPHIA, PA -- June 30, 2003 -- New clinical findings on the long-term efficacy, safety and tolerability of the oral investigational drug LevitraŽ (vardenafil HCl) showed that men with erectile dysfunction (ED) reported clinically significant, sustained improvement in erectile function (EF) over a two-year period.¹

Results from the study were presented at the 2^nd International Consultation on Erectile and Sexual Dysfunctions in Paris, France.

"It was impressive that 90% of men reported improvement in erectile function after taking Levitra over a two-year period," said Wayne Hellstrom, M.D., professor of urology and chief of infertility and sexual dysfunction at Tulane University School of Medicine in New Orleans. "These findings showed sustained efficacy with Levitra, which is an important consideration when evaluating ED treatment options."

A total of 755 men with ED completed a one-year treatment period with Levitra. Of those, 566 men continued to receive Levitra 10 mg or 20 mg in a double-blind study for an additional year. Of the 479 men who completed the study, two-year results showed:

Nine in 10 men (92% taking Levitra 20 mg and 90% taking Levitra 10 mg) reported improved erections at two years based on the global assessment question (GAQ*).¹

Men were five times more likely, on average, to report success in maintaining erections to completion of successful intercourse after taking Levitra 20 mg than before they took the drug (89.3% vs. 17.4%, respectively). Similar findings were seen in men taking Levitra 10 mg (86.5% vs. 15.9%, respectively).¹

Study participants also reported that their erectile function returned to near normal as assessed by IIEF-EF⁺-more- domain score. At baseline, the mean llEF-EF domain score was 13.8 for men taking Levitra 20 mg and 13.4 for men taking Levitra 10 mg (both considered moderate ED). By week four of the study mean IIEF-EF domain score approached normal (>25) in both groups of patients and was sustained throughout the two years of the study.¹

Men taking Levitra 10 mg or 20 mg also were twice as likely to report an improvement in successful penetration than before they took the drug.¹

In the study, Levitra was well tolerated. The most commonly reported adverse events were generally mild to moderate, including headache, flushing, rhinitis (nasal congestion) and dyspepsia.¹

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 performance² – 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 40³ – 152 million men worldwide⁴ and 30 million men in the United States alone.⁵ Despite the high prevalence of sexual dysfunction, nine out of 10 men in the U.S. have not yet sought treatment from a physician.⁶

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.

* The GAQ is a standard question utilized in ED studies to assess improvement of erectile function (EF) over a four-week period.

+ International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score. A score of >25 is considered normal erectile function.

REFERENCES:

1.Stief C, Porst H, Saenz de Tejada I, Ulbrich E. Sustained efficacy and tolerability of vardenafil over two years in men with erectile dysfunction. To be presented at the 2^nd International Consultation on Erectile and Sexual Dysfunctions. June 28-July 1, 2003. Paris, France.
2.Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1^st 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.
3.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.
4.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.
5.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).
6.Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544.


SOURCE: Bayer/GlaxoSmithKline

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