The real-life safety and efficacy of Vardenafil (realise) study: findings from Indonesia
2008-11-01 00:00:00
Data were analyzed from 1,171 patients with a mean (SD) age of 51.9 (9.0) years. Vardenafil 10 mg was the most frequently used dose (73.2%). Overall tolerability was rated very satisfying/satisfying by 96.1% of patients. Erections improved in 96.8% of patients, and improvement occurred after the first (69.6%) or second tablet (88.2% cumulative) in the majority of cases. Among 530 pre-treated patients, 420 (79.2%) preferred vardenafil over their last ED treatment, including 302 out of 389 patients (77.6%) previously treated with sildenafil. Vardenafil was generally well tolerated. There were 32 patients (2.73%) with adverse drug reactions (ADRs). Headache (1.02%), flushing (0.94%) and rhinitis (0.51%) were the most frequently reported ADRs; all are symptoms associated with the pharmacological action of phosphodiesterase-type 5 inhibitors such as vardenafil. Vardenafil showed very good safety and efficacy in this non-interventional study of 1,171 patients from Indonesia. These findings are consistent with data reported from other open-label studies with vardenafil.