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Levitra shows fastest response of any PDE5 for erectile dysfunction
London | Wednesday, May 12, 2004, 08:00 Hrs  [IST]

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.

"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.

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