Levitra shows fastest ever response time demonstrated of any PDE5 treatment tor erectile dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 10 May 2004 - 0:00 PDT

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Treatment with Levitra can result in an erection in just 10 minutes in some men and in most men within 25 minutes. A new clinical study that measured the speed with which men with ED can achieve an erection demonstrated that Levitra has the most rapid onset to date of any PDE-5 inhibitor on the market. The study will be presented at the 7th European Federation of Sexology (EFS) congress in Brighton this week.

The study (called ONTIME - ONseT of Vardenafil In Men with Erectile Dysfunction), presented in the UK, showed that Levitra had a statistically significant response superior to placebo at 10 and 11 minutes with 10 mg and 20 mg doses, respectively. The ONTIME study assessed the earliest time elapsed from dosing to attainment of an erection adequate for penetration leading to completion of successful intercourse (as measured by SEP3 ).

"The results of the ONTIME study show Levitra demonstrated the fastest onset of action to date, meaning men can be confident and engage in a satisfying sexual experience when they want to," says Professor Francesco Montorsi, study investigator and Associate Professor of Urology at the Universita' Vita Salute San Raffaele in Milan.

In another study presented at the congress, speed of action was an essential attribute of ED treatment, more so than duration, according to the largest published survey of male sexuality (Men's Attitudes to Life Events and Sexuality [MALES]). This study found that in men with ED, rapid onset was considered important irrespective of age, while long duration of action became less important as men aged. 1

"The combined results of these studies demonstrate that men value a rapid onset of action and that Levitra offers patients what they want," concluded Professor Montorsi.

The MALES study included interviews with 2912 men, aged 20-75, from 8 countries (UK, US, Germany, France, Italy, Spain, Mexico and Brazil).

The ONTIME study was conducted in 724 patients in 80 centres in Europe and North America (8 countries). It was a randomised, double blind, parallel group, multicentre trial, which studied men with ED (baseline IIEF-EF score of 13.0 [moderate severity], ITT population ). The study design included a four-week unmedicated run-in period, followed by a four-week treatment with Levitra 10 mg, 20 mg or placebo, taken on demand. The first four doses were used to determine the earliest time of onset.

In the ONTIME study, the most common drug-related adverse events were generally mild to moderate and included headache, flushing, rhinitis and dyspepsia.

Notes to Editors

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. 2

It is estimated that some degree of ED affects more than one half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED. The number of men with ED is expected to more than double to 322 million by 2025. 3,4 , Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated. 5

Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human penile erectile tissue and is associated with erections. PDE-5 inhibitors typically work by blocking this enzyme to enhance or prolong the erectile response.

Levitra was specifically selected for development as an ED therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme.

Levitra 5, 10 and 20 mg doses are contraindicated in men taking nitrates and nitric oxide donors (a group of medications used to treat angina pectoris, or chest pain), in men concomitantly using HIV protease inhibitors (such as indinavir and ritonavir), and in patients with a known hypersensitivity to any component of the tablet. Please refer to individual country labels for other important prescriber information.

Levitra, researched and discovered by Bayer AG, is marketed by Bayer and GlaxoSmithKline plc (GSK) through a worldwide co-promotion and co-development agreement. Levitra was approved on 6 March 2003 by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The US Food and Drug Administration (FDA) approved Levitra for the treatment of ED on 19 August 2003.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry.

Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.

Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

About GSK

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Vivanza is the vardenafil brand marketed by GSK in Italy.

For further information about ED, please visit: www.AllAboutED.com.

*Sexual Encounter Profile (SEP): A questionnaire containing seven patient diary questions that allow patients to record sexual events. The most pertinent and widely used SEP questions to diagnose and evaluate ED treatments are:

SEP2 Patient Diary: Were you able to insert your penis into your partner's vagina?

SEP3 Patient Diary: Did your erection last long enough to satisfactorily complete sexual intercourse?

International Index of Erectile Function (IIEF): One of five areas of the International Index of Erectile Function (IIEF) used to measure quantity and quality of erections. It includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse.

The intent to treat (ITT) population included those patients who met the following criteria:

Valid for safety

Received at least one dose of study medication

Answered one valid diary after randomisation

REFERENCES

1 Eardley I, Rosen R, Fisher W, Niederberger C, Sand M.Rapid Onset vs. Long Duration of Action: Effect of Age and Comorbidity on Attribute Ranking in The Men's Attitudes to Life Events and Sexuality (MALES) Study. To be presented at the 7th Congress of the European Federation of Sexology 12-16 May 2004, Brighton, UK.

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 Magazine, 2002.

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