Objectives: To determine the safety, efficacy and patient acceptance of vardenafil 5, 10 and 20 mg in real-life use. Design and Methods: A prospective, international post-marketing surveillance study evaluating the use of Levitra® (vardenafil) for erectile dysfunction (ED) in routine clinical practice is ongoing. Patients prescribed vardenafil are followed for a period of 2 months. Safety and efficacy are measured under daily life conditions, with data acquired by interviews. A separate evaluation of data collected by 669 physicians in Indonesia between October 2003 and April 2005 was performed. Results: 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. Conclusions: 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.
Conflict of Interest: None disclosed
Financial Support/Funding: Bayer Healthcare
Sydney, Australia, April 2007
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