The Real-Life Safety and Efficacy of vardenafil (REALISE) study: results in men from Europe and overseas with erectile dysfunction and cardiovascular or metabolic conditions

The Journal of Sexual Medicine
Hermann Van AhlenJens Ulrich Hanisch

Abstract

The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED). To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥ 18 years) and associated underlying conditions (N=73,946), in a real-life setting. Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD). CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use. Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespectiv...Continue Reading

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Citations

Apr 3, 2013·Archives of Sexual Behavior·Sabina SarinYitzchak M Binik
Jan 11, 2014·Current Cardiology Reports·Richard A Lange, Glenn N Levine
Oct 15, 2011·The Journal of Sexual Medicine·Shiu-Dong ChungHerng-Ching Lin
Aug 4, 2011·The Journal of Sexual Medicine·Shiu-Dong ChungHerng-Ching Lin
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Apr 15, 2020·Current Vascular Pharmacology·Konstantinos ImprialosMichael Doumas

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