A Comparison Of Vardenafil And Sildenafil: Diary-Recorded Outcomes In Men With Erectile Dysfunction And Cardiovascular Risk Factors
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Dr. Eusebio Rubio-Aurioles, Hartmut Porst, Ian Eardley, Dr Irwin Goldstein |
To compare diary-recorded outcomes with vardenafil versus sildenafil, in men with erectile dysfunction. Design and Methods: This was a prospective pooled analysis of two randomised, double-blind, crossover studies, one performed in the USA and one in Europe and Mexico. Both studies comprised two 4-week periods of treatment with either vardenafil 20 mg or sildenafil 100 mg, separated by a 1-week washout period.
Study participants were men aged ?18 years with ED for >6 months according to NIH criteria and risk factors for cardiovascular disease (diabetes mellitus, hypertension and/or hyperlipidaemia). All participants also had to be in a stable, heterosexual relationship (>6 months). The primary endpoint of the study was treatment preference. Twelve diary questions were also answered during the study, including the Sexual Encounter Profile (SEP) questions 2 and 3. Results: A total of 1,057 men were randomised to treatment. Of 12 diary questions, 9 indicated a better response to vardenafil treatment versus sildenafil (nominal significance, p<0.05). These were: SEP2 (LS mean positive response with vardenafil: 83.9%, compared with 82.3% for sildenafil); SEP3 (74.4% vs 71.6%); ‘satisfied with hardness’ (55.7% vs 52.7%); ‘satisfied with sexual experience (64.9% vs 61.0%); ‘how hard was erection’ (LS mean score with vardenafil: 2.18, compared with 2.13 for sildenafil); ‘maintain erection’ (3.11 vs 3.02); ‘erection stayed hard’ (3.33 vs 3.24); ‘satisfied with length’ (3.37 vs 3.27); and ‘satisfied with girth’ (3.36 vs 3.27). The remaining 3 questions showed a trend in favour of vardenafil (‘some erection’, ‘ejaculate’, and ‘satisfied with sensitivity’). Conclusion: Diary-recorded outcomes demonstrated that vardenafil was superior to sildenafil (nominal significance) in 9/12 questions, including SEP2 and SEP3, satisfaction with sexual experience, erection hardness and maintenance of erection.
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Eusebio Rubio-Aurioles
other talks by the speaker
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Dr. Eusebio Rubio-Aurioles
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EUSEBIO RUBIO-AURIOLES, M.D., Ph.D. obtained his M.D. at Universidad La Salle in Mexico City (1978) México D.F., and his Ph.D. in the Program of Human Sexuality at New York University. (1988) He completed the post-doctoral training course in sex therapy at the Department of Psychiatry of the Mount Sinai Hospital of New York City (1983).Since 1984 he is professor at the Departamento de Psiquiatría y Salud Mental de la Facultad de Medicina de la Universidad Nacional Autónoma de México.In 1987 he founded the Asociación Mexicana para la Salud Sexual, A.C. where he is the director. Since 1993 has completed 22 clinical trials for the development of drugs for the treatment of sexual dysfunction in males and females. He has published several articles in national and international journals and books, he was the Editor of the Antología de la Sexualidad Humana published by the Consejo Nacional de Población. From 1995 to 1998 he served as the first president of the Federación Mexicana de Educación Sexual y Sexología, A.C. He is currently the President of the World Association for Sexual Health (formerly World Association for Sexology)
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Dr Irwin Goldstein
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Dr Irwin Goldstein is Director of San Diego Sexual Medicine at Alvarado Hospital, the Secretary of the International Society for the Study of Women’s Sexual Health, a former President of the Sexual Medicine Society of North America and a Clinical Professor of Surgery at University of California at San Diego.
Dr Goldstein has been involved with sexual dysfunction research since the late 1970s. His specialties include penile microvascular bypass surgery, surgery for dyspareunia, physiologic investigation of sexual function in men and women, and diagnosis and treatment of sexual dysfunction in men and women.
Dr Goldstein is currently President of The Institute for Sexual Medicine, Inc., a charitable corporation for education and research in the field. He is a board member of the International Society for Sexual Medicine and a member of the International Academy of Sex Research, the American Urological Association, the American Association of Sex Educators, Counselors and Therapists, and the International Society for the Study of Vulvovaginal Disease.
Dr Goldstein is a 2009 winner of the Gold Medal awarded by the World Association for Sexual Health in recognition of his lifetime contributions to the field.
For more information visit: http://www.sandiegosexualmedicine.com
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