Study: Levitra works fast, lasts up to 12 hours from time of dosing

Study: Levitra works fast, lasts up to 12 hours from time of dosing

LEVERKUSEN, GERMANY and LONDON, ENGLAND, February 26, 2004 -- New findings about the onset and duration of Levitra showed that improved success rates of intercourse completion (SEP3) were observed as early as 15 minutes and as late as 12 hours from time of dosing in patients with erectile dysfunction (ED) who took the drug and who attempted intercourse.

Additionally, a two-year long clinical study showed that Levitra significantly and consistently improved erectile function (EF) in men with ED who completed the study. Results of the studies will be presented at the 4th World Congress on the Aging Male in Prague, Czech Republic.

"Levitra's rapid onset of action combined with its ability to last for up to 12 hours provides an appropriate window of efficacy that can meet most men's needs," said Dr Francesco Montorsi, study investigator. Dr Montorsi is Associate Professor of Urology and Chief of Center for Sexual Medicine, Universita Vita Salute San Raffaele, in Milan, Italy.

Study analysis reveals improved intercourse completion success rates at every measured time interval ranging from 15 minutes to up to 12 hours from time of dosing In a pooled analysis of two pivotal randomised, double-blind Phase III studies involving 1,479 participants, men with more than six months of ED were randomised to receive Levitra 5, 10 or 20 mg or placebo for 12 or 26 weeks. Results showed that Levitra statistically improved SEP3 success rates at every measured time interval compared with placebo, from the <15-minute interval (success rate of 52-64% for all three doses in those who made attempts) through the >8<12-hour interval (success rate of 64-86% for all three doses in those who made attempts) from time of dosage. Further, nearly nine in 10 attempts (88-93%) occurred in the first 120 minutes after dosing (success rate of 59-70% for all 3 doses at 120 minutes), indicating that the large majority of these patients initiated sexual activity within two hours of taking the PDE-5 inhibitor.

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

Further data presented at the 4th World Congress on the Aging Male confirm the long-term, reliable efficacy of Levitra. In a one-year extension of a 52-week, double-blind study, 566 men agreed to continue receiving Levitra 10 mg or 20 mg for an additional 52 weeks. Of the 479 patients who concluded the overall two-year study, results showed: 9 in 10 study participants who took Levitra reported improved erectile function throughout the study period (92% of men taking Levitra 20 mg and 90% of men taking Levitra 10 mg). Study participants were reportedly five times more likely, on average, to maintain their erection through completion of sexual intercourse (SEP3*) compared to baseline (89% vs 17% for men taking Levitra 20 mg and 87% vs 16% for men taking Levitra 10mg).

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

"These study data confirm that Levitra is a rapid and reliable treatment for ED. Based on this, I would feel very confident prescribing Levitra to the majority of my patients with ED," concluded Dr Montorsi.

Source: Bayer

Posted: February 2004


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