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Erectile Dysfunction Medications Levitra (Vardenafil) Can Work in as Few as Ten Minutes

TORONTO, ON -- October 7, 2004 -- According to the results of the ONTIME study (ONseT of Vardenafil In Men with ED) published in the most recent issue of the Journal of Sexual Medicine, men with erectile dysfunction (ED) can achieve an erection in as fast as
10 minutes with Levitra® (vardenafil HCl), which is the fastest onset time published for Levitra to date.¹ It is the first study to demonstrate an oral ED treatment working as early as 10 minutes after intake.

"I treat many men with ED and rapid onset of action is an important consideration when choosing an ED treatment," said Dr. Luc Valiquette, Urologist, Centre Hospitalier de l'Univeristé de Montréal. "This new Levitra study is good news for men with ED who are looking for a treatment that is fast."

Patients And Physicians Looking for Fast Action
The Canadian Sexual Satisfaction Survey, published in the Journal of Sexual & Reproductive Medicine, showed that 49 per cent of men and 67 per cent of physicians were interested in a medication that provides fast onset of action.² Conducted by Leger Marketing, the survey was designed and endorsed by the CMSHC and funded by an unrestricted educational grant from Bayer HealthCare and GlaxoSmithKline Inc.

"As a prescribing physician, I continue to hear patient feedback that men want a product that works fast, and I also see data that confirms the importance of a rapid onset for patients and their partners," said Dr. Valiquette. "Levitra continues to be another great treatment option for Canadian men with ED and I encourage men who have ED to make the first move and speak with their doctors."

About the ONTIME Study
The ONTIME study, which involved patients across Europe and North America, including Canada, assessed the earliest time elapsed from dosing to an erection adequate for completion of successful intercourse. In the 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. A stopwatch was used to assess erections for the first four attempts, in time-points from five to 25 minutes.

Results showed that in as early as 10 minutes, a statistically superior response was seen with Levitra (10 mg and 20 mg) compared with placebo (at 10 minutes, 21 per cent for Levitra 10 mg versus 14 per cent for placebo, P<0.025; at 11 minutes, 23 per cent for Levitra 20 mg versus
15 per cent for placebo, P<0.025).¹ By 25 minutes, this difference further increased with more men being able to achieve an erection with Levitra adequate for completion of intercourse
(50 per cent of men taking Levitra 10 mg and 53 per cent of men taking Levitra 20 mg versus
26 per cent of men taking placebo) (P<0.0001).¹

About Levitra
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. Concomitant use of Levitra with ritonavir, indinavir, ketoconazole, or itraconazole is contraindicated (should not be used together).³
The most commonly reported side effects in clinical trials were headache, flushing, and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention.³

Erectile Dysfunction
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 three to four million men in Canada alone.⁷ Despite the high prevalence of sexual problems, only 12 per cent of men worldwide have received treatment.⁸




® LEVITRA is a registered trademark of Bayer AG used under license.


References
1. Montorsi F, Padma-Nathan H, Buvat J, et al. Earliest Time to Onset of Action Leading to Successful Intercourse with Vardenafil Determined in an At-Home Setting: A Randomized, Double-Blind, Placebo-Controlled Trial. J Sex Med 2004;1:168-178.
2. Brock G, Carrier S, Gajewski J, Barkin J. Erectile dysfunction and the primary care physician's perspective: A comparison with the patient's perceptions. J Sex Reprod Med 2003; 3:19B-22B.
3. Levitra® (vardenafil hydrochloride tablets) Product Monograph.
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. Barkin J, Carrier S, Gajewski J, Brock G. Erectile function and male sexual satisfaction: A national survey.
J Sex Reprod Med 2003; 3:10B-14B.
8. Chew KK, et al. Erectile dysfunction in general medicine practice: prevalence and clinical correlates. Int J Impot Res 2000; 12:41-45.


SOURCE: GlaxoSmithKline Inc.

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