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Patients with Erectile Dysfunction Prefer Treatment with Levitra (Vardenafil HCl): Presented at ESSM

COLOGNE, GERMANY -- November 17, 2003 -- Results of a new clinical study indicate that most men with erectile dysfunction (ED) prefer the new PDE5-inhibitor drugs to sildenafil (Viagra) and of these, nearly one-half of men prefer vardenafil (Levitra)(1), the product most recently approved in Europe and the United States. The direct comparison study is being presented for the first time today at the 6th Congress of the European Society for Sexual Medicine (ESSM) in Istanbul.

In terms of overall preference, most men rated vardenafil as the preferred option (47%) compared with tadalafil (19%) or sildenafil (34%) at the recommended starting dose. Vardenafil was also the preferred option at the maximum dose (43% compared to 40% taldalafil, 17% sildenafil).

"These findings highlight the benefit of having new alternatives to treat ED. This is one of the first studies to compare all three PDE5-inhibitors, and our initial results show that the majority of men who have tried all three drugs preferred the newer agents to sildenafil, and of these, more men preferred vardenafil," said Frank Sommer, MD, lead study investigator. Dr Sommer is consultant at the Department of Urology, University Medical Centre, Cologne.

In the prospective, placebo-controlled, crossover multicentre study, men in a stable heterosexual relationship who had ED for 6 months received sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra) and placebo in a randomised sequence, with a one week wash-out period between treatments. The study consisted of two separate trials of maximum dose (100mg sildenafil, 20mg tadalafil, 20mg vardenafil; 86 men) and recommended starting dose (50mg sildenafil, 10mg tadalafil, 10mg vardenafil; 47 men). Efficacy was measured using benchmark International Index of Erectile Function (IIEF) and Global Assessment Questionnaire (GAQ) endpoints. Patient satisfaction and preference were also assessed. Men were also asked cite the reasons for their preference of different treatment options:

* Of those who preferred vardenafil, the two reasons most commonly cited by patients were hardness of erection (89% at maximum dose, 90% at starting dose) and ease of getting an erection (84% at maximum dose, 86% at starting dose).
* Among those who preferred tadalafil, duration of erection was most commonly quoted (88% at maximum dose, 89% at starting dose).
* Those who preferred sildenafil, did so because of its lesser side effects (60% at maximum dose, 56% at starting dose).

All three PDE5-inhibitors were significantly more effective than placebo in achieving an erection with vaginal penetration and maintaining an erection to completion of intercourse, but vardenafil performed better than the two other PDE5-inhibitors at both doses.

"These results show that vardenafil is preferred on the key variables necessary for success and satisfaction -- ease of getting an erection and hardness of erection," said Dr Sommer. "Physicians should consider all the available options to ensure that patients receive the treatment that best meets their needs."

References:

(1) Sommer F, Mathers M, Klotz T et al. Which PDE5-inhibitor do patients prefer? A comparative randomised multicenter study of sildenafil, taldalafil and vardenafil. Presented at the 6th Congress of the European Society of Sexual Medicine, Istanbul, Turkey, November 2003.

(2) 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.

(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) Southgate J. New rivals to Viagra expand the market. Scrip World
Pharmaceutical News, 2002.


SOURCE: University of Cologne, Germany

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