Cardiovascular Safety of Vardenafil and Alpha-Blockers Combined: Subgroup Analysis of a Post-Marketing Study

Journal of Sex Research, Feb, 2006

Cardiovascular Safety of Vardenafil and Alpha-Blockers Combined: Subgroup Analysis of a Post-Marketing Study, Gerald Faich, Pharmaceutical Safety Assessments; Joel Morganroth, University of Pennsylvania; Kuno Sprenger, Ernst Weidmann, Akos F. Pap, and Harald Landen, Bayer Vital GmbH, Germany

We investigated the cardiovascular safety profile of vardenafil in patients receiving concomitant alpha-blockers. The impact of concomitant use of vardenafil and alpha-blockers on cardiovascular safety was assessed by a descriptive subgroup analysis, with particular attention paid to cardiac safety parameters, particularly to incidence rates of dizziness, hypotension, syncope, stroke, and myocardial infarction. We analyzed data from a total of 29,358 subjects, a high percentage (23%) over 65 years of age. Concomitant alpha-blocker treatment was reported for 4% of subjects. The most frequently-used alpha-blockers were tamsulosin (n = 725), alfuzosin (n = 223), doxazosin (n = 189), and terazosin (n = 103). Relevant comorbidities of patients on alpha-blockers included presence of cardiac disease (28%), vascular disease (50%), hypertension (42%), and benign prostatic hyperplasia (82%). Adverse events (AEs) were reported by 2% of subjects receiving alpha-blockers and vardenafil concomitantly. These AEs were typical for these classes of compounds. There was no clinically relevant difference in incidences of AEs between patients using and not using alpha-blockers. Serious AEs were reported in two subjects receiving tamsulosin; one subject reported severe fatigue, and one patient reported syncope within 5-24 hours of taking the first vardenafil dose. There were no reports of stroke, myocardial infarction, ventricular tachycardia, torsades de pointes, or death. Overall, data from subjects treated with alpha-blockers concomitantly with vardenafil showed a favorable cardiovascular safety profile.