New studies demonstrate reliable efficacy using Levitra

New findings on the long-term benefits of Levitra showed that men with erectile dysfunction (ED) taking Levitra reported clinically significant, sustained improvement in erectile function (EF) over a two-year period.¹

Levitra was also shown to be a reliable and fast-acting agent for the treatment of ED in patients participating in clinical trials.^2,3 Results from the new studies were presented today at the Second International Consultation on Erectile and Sexual Dysfunctions, Paris, France, a meeting supported by the World Health Organisation.'It is impressive to find that Levitra's excellent efficacy is sustained for an extended period of time. If an ED drug loses its effect over time, the full benefits of treatment are lost and, as a result, men may lose confidence in their therapy and their sexual function,' said Dr Christopher Stief, a professor in the department of urology at Medizinische Hochschule in Hannover, Germany. Study participants reported improved erectile function throughout two years. A total of 755 men with ED completed a one-year treatment period with Levitra. Of those, 566 men agreed to continue to receive Levitra 10 mg or 20 mg in a double-blind study for an additional year. Of the 479 men who completed the study, two-year results showed:¹

• 9 in 10 men taking Levitra reported improved erections throughout the study period (92% of men taking Levitra 20 mg and 90% of men taking Levitra 10 mg).⁴

• Not only did Levitra significantly improve men's erectile function, but study participants were reportedly five times more likely, on average, to maintain their erections through completion of sexual intercourse (89% vs. 17% at baseline for men taking Levitra 20 mg and 87% vs. 16% at baseline for men taking Levitra 10 mg).⁵

Additional studies show rapid onset of erections and high success rates using Levitra 20 mg. New data from other studies reinforced Levitra's excellent efficacy and reliability, specifically with respect to how quickly and consistently it works in study participants. In one of these studies, significantly more men taking Levitra 20 mg experienced an erection adequate for successful completion of intercourse as early as 16 minutes after dosing than men taking placebo in an at-home setting. Results from this multi-centre, double-blind study were based on 498 patients randomised to either Levitra 20 mg or placebo.²

In a second study, 76 percent of men reported successful penetration on their first attempt at intercourse after taking Levitra 20 mg (versus 44% placebo) and the men who were successful the first time also reported successful penetration 91 percent of the time on subsequent attempts (versus 74% placebo). Findings were based on a retrospective data analysis of two double-blind, Phase III trials involving 1385 men for a 12-week study period.³

'Bayer and GSK are very pleased with these results as they reinforce the body of evidence showing Levitra not only improves erectile function the first time and reliably time after time but that this improvement is sustained over the long term,' said Dr Wolfgang Plischke, president, Bayer Pharmaceuticals division of Bayer HealthCare. 'Men want to be confident that the ED drug they take works at the moment when they need it to and we believe that Levitra provides such confidence.' In all studies, the most common adverse events were generally mild to moderate and included headache, flushing and rhinitis (nasal congestion).

Reference

1. Stief C, Porst H, Saenz de Tejada I et al. 'Sustained efficacy and tolerability of vardenafil over two years in men with erectile dysfunction.' To be presented at the 2nd International Consultation on Erectile and Sexual Dysfunctions. Co-sponsored by the World Health Organization (WHO), International Consultation on Urological Diseases (ICUD) and Societe Internationale d"Urologie (SIU), 28 June-1 July 2003, Paris. 2. Padma-Nathan H, Kaufman, J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. To be presented at the 2nd International Consultation on Erectile and Sexual Dysfunctions. Co-sponsored by WHO, ICUD and SIU, 28 June-1 July 2003, Paris. 3. Montorsi F, Hellstrom W, Valiquette L et al. Reliable efficacy over time of vardenafil, a potent, highly selective PDE-5 inhibitor in men with erectile dysfunction: a retrospective analysis of two pivotal phase lll studies. To be presented at the 2nd International Consultation on Erectile and Sexual Dysfunctions. Co-sponsored by WHO, ICUD and SIU, 28 June-1 July 2003, Paris. 4. Based on the global assessment question (GAQ), a widely accepted measure to evaluate ED treatment efficacy. 5. Based on a diary question in the Sexual Encounter Profile (SEP-3) related to completing sexual intercourse.