2005•PubMedRequires access
[Efficacy and safety of vardenafil in patients with erectile dysfunction. Results of the Mexican Multicentric Study].
Mariano Sotomayor-de-Zavaleta, Eusebio Rubio‐Aurioles, Guillermo Feria-Bernal, Arturo Mendoza-Valdés, Luis Fernando Quinzaños-Sordo, Fernando Ugarte-y-Romano, Antonio Hurtado‐Coll, Martín Telich-Vidal, Miguel Angel Barreto-Fernández, María del Rosario Tapia-Serrano, Sergio Ermen Ureta-Sánchez, Jorge A. Jaspersen-Gastelum, Carlos Pacheco-Gahbler, Ignacio R Sentíes-Hernández, Jorge Luis Rodríguez Olguín, Javier Pérez-García
Open publisher page 0 citations
Abstract
UNLABELLED: The objective of the present study was to determine the efficacy and safety of a fixed dose of vardenafil in the treatment of patients with erectile dysfunction (ED). MATERIAL AND METHODS: This was an open label, prospective and multicentric trial. After a 4-week wash out period, all patients received 20 mg of vardenafil given on demand for 12 weeks. Primary efficacy variables were the erectile function domain of the International Index of Erectile Function (IIEF), answers to questions 2 and 3 of the Sexual Encounter Profile (SEP) and the Global Assessment Question (GAQ). All adverse events were recorded and reported. RESULTS: 229 patients were screened. 177 received at least one dose of vardenafil and were included in the safety analysis. Mean age was 54.4 years old. Etiology of ED was organic or mixed in 77% of the patients. Erectile function domain of the IIEF changed from a basal mean score of 14.8 to 25.5 at the end of the study. 80.5% of the patients reported erections of rigidity and duration enough for satisfactory sexual intercourse and 93.3% improved their erections at the end of the study. Adverse events were mild to moderate and the most common were headache, dyspepsia, rhinitis and facial flushing. The drop out rate due to adverse events was 1.7%. CONCLUSIONS: This multicenter study confirms the high efficacy of this new phosphodiesterase type 5 inhibitor, vardenafil. There was a low rate of discontinuations due to adverse events and a favorable safety profile. The results of this study are similar to the results of other studies conducted in other parts of the world.