Cardiovascular Safety of Vardenafil and Alpha-Blockers Combined: Subgroup Analysis of a Post-Marketing Study.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 (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. ; 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 hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). , syncope syncope Effect of temporary impairment of blood circulation to a part of the body. It is often used as a synonym for fainting, which is loss of consciousness due to inadequate blood flow to the brain. , stroke, and myocardial infarction myocardial infarction: see under 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 benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. (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 Torsades de pointes or torsades is a French term that literally means "twisting of the points". It was first described by Dessertenne in 1966[1] and refers to a specific variety of ventricular tachycardia that exhibits distinct characteristics on the , or death. Overall, data from subjects treated with alpha-blockers concomitantly with vardenafil showed a favorable cardiovascular safety profile. |
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