62% of men report improved erections with Levitra

New study shows 62% of men report improved erections with Levitra having not responded to sildenafil
New Zealand part of global trial in erection problems

Auckland, 10 October 2003 – 62% of men reported improved erections in the first clinical study to evaluate Levitra™ (vardenafil) for men who were unresponsive to treatment with sildenafil by history (identified by a rigorous set of six criteria for inclusion in this trial). These men were also nearly three times more likely to maintain their erections to completion of sexual intercourse after taking Levitra than on placebo1.

The study, referred to as the PROVEN (Patient RespOnse with VardENafil in sildenafil Non-Responders) trial, involved 14 New Zealand men from Christchurch and Tauranga as part of a global trial involving 463 men from 10 different countries. Full trial results will be presented on 11 October at the Meeting of the Sexual Medicine Society of North America (SMSNA) in Denver, USA.

“Men with erection problems want confidence their treatment is reliable and responsive. This research shows that many men including those with a history of being unresponsive to sildenafil can rely on Levitra to improve their erectile function” said Dr Ian Griffiths, Medical Director for GlaxoSmithKline.

In the August issue of The Journal of Urology, published data indicated nearly half of men (47%) who tried sildenafil discontinued taking the drug during the course of a two-and-a-half-year period. Lack of effectiveness was given as the major reason (by 74% of men) for discontinuing sildenafil treatment2.
Levitra PROVEN study demonstrated dramatic increase in success rates

A total of 463 men with erection problems who had documented a history of non-response to sildenafil were studied. Unresponsiveness to sildenafil was defined by patient history. All study participants met a rigorous set of six criteria, including failing at least four of the last six attempts at successful intercourse with sildenafil and having at least one unsuccessful attempt with the highest available dose of sildenafil (100mg). Additionally, these men were considered to be unresponsive to sildenafil in the opinion of the treating doctor. Men participated in the double-blind study for a total of 12 weeks. Initially, the men were randomised to Levitra 10mg or placebo for four weeks. Then, at weeks four and eight of the trial, doctors could adjust the starting dose of Levitra to 20mg or 5mg based on the efficacy and tolerability of the drug, or remain on 10mg.

Results showed that after 12 weeks, men were nearly three times more likely to report success in maintaining erections to completion of successful intercourse after taking Levitra than on placebo (46% vs 16%, respectively). In addition, men taking Levitra were four times more likely to report an improved erection (GAQ) than men taking placebo (62% vs 15%, respectively)1.

In the clinical trial, the most commonly reported adverse events were consistent with the PDE-5 inhibitor class and previous Levitra experience, and were generally mild to moderate and included headache, flushing, nasal congestion and dyspepsia1.

Studies have shown that Levitra works as quickly as 15 minutes3 in some men, is effective from the first time that most men take it, and provides a reliable improvement in erection quality for many men with erection problems4,5. Levitra is effective in a broad population of men including the difficult to treat10

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Notes
- Erection problems are defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance6.
- It is estimated that some degree of erection problems affect more than one half of all men over the age of 40 and that worldwide an estimated 152 million men have erection problems. The number of men with erection problems is expected to more than double to 322 million by 20257,8. Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men are currently being treated9.
- 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 erectile function therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme.

What you should know about Levitra:
Levitra (vardenafil) is an unfunded, Prescription Medicine, available in 5,10 and 20mg tablets. For the treatment of Erectile Dysfunction. You will need to pay for this medicine. A charge applies. Normal doctor's office visit fees apply. Recommended starting dose is 10 mg. Maximum of 20 mg in 24 hours. Use strictly as directed. Take no more than one dose per day. Do not take Levitra if: you are taking medicines called nitrates. Tell your doctor if you have: a heart or blood condition, kidney or liver disease, a disease or deformity of the penis, blood or bone cancer, a peptic ulcer; you are taking any other medicines or herbal remedies, including those for erectile dysfunction. Side Effects (common): Headache, flushing, heartburn, nausea, dizziness, stuffy / runny nose. Be careful driving/operating machinery. Please speak to your doctor, pharmacist or health professional if you have any concerns, feel unwell or have any of these side effects. Prices may vary depending on the pharmacy. For further information on Levitra see www.levitra.co.nz or www.medsafe.govt.nz. Ask your doctor if Levitra is right for you.

About Bayer New Zealand Ltd
Bayer New Zealand Ltd 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.

About GlaxoSmithKline New Zealand

GlaxoSmithKline New Zealand is part of one of the world’s leading research-based pharmaceutical and healthcare companies, providing innovative medicines in several therapeutic areas including asthma, mental health, diabetes and immunisation.

GSK NZ also supports the community in New Zealand through its sponsorship of Youthline, support for medical events, and a number of educational and research sponsorships in Maori and Pacific Health, and Nursing.

References

1. Carson C, Hatzichristou D, Carrier S et al. Vardenafil exhibits efficacy in men with erectile dysfunction unresponsive to prior sildenafil therapy: results of a phase III clinical trial – Patient Response with Vardenafil in Sildenafil Nonresponders (PROVEN). To be presented at the 5th Annual Fall Research Meeting of the Sexual Medicine Society of North America, October 11, 2003, Denver.

2. Gonzalgo M, Brotzman M, Trock B et al. Clinical efficacy of sildenafil citrate and predictors of long-term response. J Urol 2003;170:503-506.

3. Summary of Product Characteristics, March 2003.

4. Valiquette L, Hellstrom W, Gittelman M et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 24, 2002, Montreal, Quebec, Canada.

5. Saenz de Tejada I, Glina S, Becher E, Ulbrich E, Vardenafil Study Group. Vardenafil exhibits long-term efficacy and safety for up to 52 weeks. Presented at the V Congress of the European Society for Sexual and Impotence Research (ESSIR), December 3, 2002, in Hamburg, Germany.

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 Societe Internationale d’Urologie (SIU) and held July 1-3, 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, 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. Levitra Data Sheet. March 2003.

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