The Real-life Safety and Efficacy of Vardenafil: An International Post-marketing Surveillance Study - Results from 29 358 German Patients

Abstract

We assessed the safety, efficacy and patient acceptability of vardenafil (Levitra, Bayer HealthCare, Leverkusen, Germany) under real-life conditions in patients with erectile dysfunction (ED) in a multinational post-marketing surveillance study. An initial and up to two follow-up visits were documented for 29 358 German ED patients receiving vardenafil. Patients were interviewed about overall treatment success, and individual sexual attempts were evaluated in a patient questionnaire. Overall erectile improvement was reported by 93.9% of physicians, and similar improvement rates were reported for both 10 mg and 20 mg vardenafil dosages. Most patients experienced improved erections after the first (73.6%) or second (88.5%) tablet. Sexual attempts were successful with respect to partner penetration in 94.9% of patients and with respect to maintenance of erection during intercourse in 87.7% of patients. Adverse drug reactions were very rare (1.3% of patients). Vardenafil was highly effective, reliable and well tolerated in ED patients treated under real-life conditions.

Cardiovascular Effects of Phosphodiesterase 5 Inhibitors

“…was not increased in comparison to an estimated incidence in a patient population of similar age and risk profile [2,3,27]. The overall spectrum of side effects and events appears to be comparable for vardenafil [28,96,97] and tadalafil [57,98,99]. There is a recently published analysis of 35 controlled trials and 8 open-label trials on tadalafil treatment for erectile dysfunction: In the placebogroup the rate of myocardial infarction was calculated to be 0.41/100 patients years, and for the tadalafil groups the risk was 0.33/100 patients years in tadalafil treatment [98].…”

ACceptance of Therapy In Vardenafil-treated patients with Erectile dysfunction (ACTIVE): a noninterventional study in Germany

“…Although uncontrolled, the data from this study complement results from clinical trials, and also build on findings from previous noninterventional observational studies, such as the REALISE study. 18,19 In contrast to clinical trials, the results from this study are based on a sample from everyday clinical practice and thus may be more representative of real-life treatment. The study sample included patients over a wide age range, with ED of differing etiology and severity.…”

“…More than half of patients (B63%) experienced an improvement in erectile function after just one dose of vardenafil, and approximately half engaged in sexual intercourse within 30 min of taking vardenafil. Such success rates are important for patient confidence and compliance with treatment, 23 and 19 whereas in the ReliabilityVardenafil for Erectile Dysfunction I (RELY-I) study, first-dose penetration success rates ranged from 75 to 84% for patients with diabetes, dyslipidemia and hypertension. 23 Further placebo-controlled studies have shown the rapid onset of action of vardenafil, with more than 50% of participants achieving erections within 25 min, 24 and as rapidly as 15 min.…”

“…This is consistent with the findings from clinical trials of men with ED and diabetes, hypertension and dyslipidemia, and from noninterventional studies. [13][14][15][16][17][18][19]21 Conditions such as diabetes and severe vascular disease can adversely affect the treatment outcomes in ED, 22 but the beneficial outcome with PDE5 inhibitors is likely to be unaffected, except in patients with advanced vascular impairment. A further consideration is the possibility of adverse drug interactions, as long-term medication is usual among patients with underlying conditions.…”

“…Previously, vardenafil was shown to be efficacious and well tolerated in clinical trials of patients with diabetes, 13,14 hypertension 15,16 and dyslipidemia, 17 as well as in the Real-Life Safety and Efficacy of vardenafil (REALISE) study, a worldwide noninterventional study that included large numbers of men with ED and cardiovascular and metabolic conditions. 18,19 This paper presents the data collected in Germany between July 2005 and January 2007. The aim of this study was to assess the safety and effectiveness of, and notably patient satisfaction with, vardenafil treatment in men with ED, including those with underlying cardiovascular and metabolic conditions, under daily life conditions over a period of 3-12 months.…”