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London, June 30, 2003 - 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).
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. 6
- 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. 7,8 Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently being treated. 9
- 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 is formulated as an orange, round, coated tablet in doses of 5, 10 and 20 mg.
- Levitra is contraindicated in men taking nitrates and nitric oxide donors (a group of medications used to treat angina pectoris, or chest pain) and in patients with a known hypersensitivity to any component of the tablet. It is also contraindicated in men for whom sex is inadvisable and men older than 75 years who concomitantly use potent CYP 3A4 inhibitors (such as ritonavir, indinavir, ketoconazole and itraconazole). 10
- Levitra is being co-developed and marketed by Bayer AG and GlaxoSmithKline plc. Levitra was approved on 6 March 2003 by the European Commission.
References
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. 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. 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. 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.
6. 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 Societé Internationale d'Urologie (SIU) and held 1-3 July 1999, Paris. 2000, p.713.
7. 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.
8. Aytac IA, McKinlay JB and Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999;84:50-56.
9. Southgate J. New rivals to Viagra expand the market. Scrip World Pharmaceutical News, 2002.
10. Summary of Product Characteristics, March 2003.
About Bayer HealthCare
Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare has annual sales amounting to some 10 billion euro and is one of the world's leading innovators in the health care and medical products industry. Bayer HealthCare combines the global activities of the divisions of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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Under the safe harbour provisions of the US Private Securities Litigation Reform Act of 1995, GlaxoSmithKline cautions investors that any forward-looking statements or projections made by GSK, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the company's operations are discussed in the section "Cautionary factors that may affect future results" in GSK's results announcement for the year ended 31 December 2002, filed with the U.S. Securities and Exchange Commission.
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