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Improved Satisfaction Seen in Overall Sexual Performance with Levitra: Presented at CUA

MONTREAL, QC -- June 24, 2003 -- New clinical findings about Levitra(tm) (vardenafil HCI) presented at the Canadian Urological Association (CUA) meeting in Montreal, June 22 to 25, show that men with erectile dysfunction (ED) taking the medication reported significantly improved satisfaction with erection hardness, orgasmic function and overall sexual performance.

Additional data demonstrate the long-term safety (including cardiovascular safety) and efficacy of Levitra, show sexual response as early as 16 minutes, and indicate that the medication remains largely unaffected by food and alcohol.

In total, 11 Levitra data podium and poster presentations will be announced. In Canada, the Therapeutic Products Directorate of Health Canada is currently reviewing Levitra for efficacy and safety and market authorization has not yet been obtained.

CUA Data Demonstrated a Favourable Safety and Efficacy Profile
Several studies presented by leading Canadian investigators demonstrated the long-term efficacy and safety of Levitra, including cardiovascular (CV) safety among men with ED. Additional studies showed that Levitra consistently improved all efficacy parameters of erectile function (EF) in a broad population of men, restoring normal EF in a large majority of men with mild ED and in a substantial proportion of men with severe ED.

Dr. Serge Carrier, Urologist, CUSM-Hop Royal Victoria, Assistant Professor, Division of Urology, Department of Surgery, McGill University, Montreal, Quebec, reported in a key podium presentation that Levitra exhibited a favourable CV-safety profile in men with ED and one or more cardiovascular co-morbidities (including high blood pressure, high blood cholesterol, smoking, diabetes and cardiovascular disease). The incidence of CV-related adverse events with Levitra was similar to that of placebo.

"The study findings that Levitra does not adversely impact cardiovascular health are significant for men suffering from ED," said Dr. Carrier. "Many men with cardiovascular diseases also suffer from ED. As such, as a future treatment option, Levitra will give those men who are appropriate patients the choice and confidence to treat their condition."

In other clinical data results announced at the CUA:
-- A presentation by Dr. Alvaro Morales, Urologist, Kingston General Hospital, Professor, Department of Urology, Queen's University, Kingston, Ontario, showed Levitra provided a significant, long-term improvement; at 52 weeks, the average success rate of maintaining erections was 82 per cent for 10 mg and 86 per cent for 20 mg Levitra. Both doses were well tolerated.
-- A presentation by Dr. Luc Valiquette, Urologist, Hospital Saint-Luc du CHUM, Montreal, Quebec, showed that 89 per cent of patients with mild ED and up to
40 per cent of patients with severe ED achieved erectile function (EF) scores consistent with normal EF after receiving Levitra.
-- A presentation by Dr. Gerald Brock, Associate Professor, Department of Surgery, Division of Urology, St. Joseph's Health Care, London, Ontario, showed Levitra 10 mg and 20 mg significantly improved all efficacy variables in men with ED after undergoing nerve-sparing radical prostatectomy. In a subgroup of patients who had depressive symptoms at baseline, 20 mg Levitra significantly improved their overall symptoms of depression.
-- In the studies presented, adverse events were generally mild to moderate in intensity; the most frequent adverse events were headache, flushing, nasal congestion, upset stomach and nausea.

Findings from several other Levitra studies were also highlighted at the CUA.

CUA Data Demonstrated Improved Sexual Experience with Levitra
In one study, participants taking Levitra significantly improved patient satisfaction with erection hardness, orgasmic function, and overall sexual experience relative to placebo over six months. In this phase III, multicentre, double-blind clinical trial, 805 men with ED were randomized to Levitra 5 mg, 10 mg or 20 mg or placebo. Results showed that after 26 weeks:
-- Men taking Levitra 20 mg on average reported a satisfaction rate three times higher than men taking placebo for erection hardness (59 per cent versus 18 per cent). Men taking Levitra 10 mg on average reported a satisfaction rate nearly three times higher than men taking placebo for erection hardness (52 per cent versus 18 per cent).
-- Significant improvements also were noted in intercourse satisfaction, orgasmic function and overall sexual experience in men taking 10 mg or 20 mg of Levitra compared with men taking placebo.

"For men, erectile function isn't only about penetration, it's also about the quality of their erection - their ability to get an erection that is sufficiently hard and lasts long enough for sexual intercourse," said Dr. Valiquette. "Ultimately, it's the quality of the erection that can lead to a satisfying sexual experience. These findings showed that Levitra improved the quality of erection and improved a man's overall satisfaction with his sexual experience compared with placebo," added Dr. Valiquette.

CUA Data Demonstrated Levitra Improved Satisfaction By Working Quickly
In a separate randomized, double-blind study, men with mild to severe ED received a four-week supply of Levitra 20 mg or placebo and were asked to start sexual activity immediately after dosing. Results showed that significantly more men taking Levitra 20 mg experienced an erection adequate for successful completion of intercourse as early as 16 minutes after dosing compared with men taking placebo (34 per cent versus 24 per cent, respectively).

"An important consideration for many patients is the time to onset for an ED treatment. For this reason, results showing a quick onset of Levitra in some men experiencing ED are very positive," said Dr. Jay Lee, Urologist at the University of Calgary. "Levitra provides a reliable and fast treatment option for men suffering from ED."

CUA Data Demonstrated that the Impact on Levitra was Minimal When Food and Alcohol were Consumed
Two studies examined the effects of alcohol, a high-fat breakfast and a moderate-fat evening meal on the pharmacokinetics (PK) and tolerability of Levitra in healthy male subjects.

In a randomized, double-blind, three-fold crossover study, 20 mg Levitra or placebo was administered orally together with alcohol (0.5 g/kg in 200 ml of orange juice) or placebo. In another randomized, crossover study, 20 mg Levitra was administered at 8:00 a.m. after an overnight fast or immediately after consuming a high-fat breakfast (57 per cent fat), or at 6:00 p.m. on an empty stomach or after consuming a moderate-fat meal (30 per cent fat).

Results showed that Levitra PK parameters were largely unaffected by alcohol and food, except when taken with a meal with high-fat content (more than 55 per cent). In this situation, absorption was delayed by one hour.


SOURCE: Bayer HealthCare

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