title: [Efficacy and safety of vardenafil in patients with erectile dysfunction. Results of the Mexican Multicentric Study].
abstract: 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).
  
  
  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.
authors.affiliation: Departamento de Urología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México, DF. marsoza@quetzal.innsz.mx
authors.forename: Mariano
authors.initials: M
authors.lastname: Sotomayor-de-Zavaleta
authors.forename: Eusebio
authors.initials: E
authors.lastname: Rubio-Aurioles
authors.forename: Guillermo
authors.initials: G
authors.lastname: Feria-Bernal
authors.forename: Arturo
authors.initials: A
authors.lastname: Mendoza-Valdés
authors.forename: Luis Fernando
authors.initials: LF
authors.lastname: Quinzaños-Sordo
authors.forename: Fernando
authors.initials: F
authors.lastname: Ugarte-y-Romano
authors.forename: Antonio
authors.initials: A
authors.lastname: Hurtado-Coll
authors.forename: Martín
authors.initials: M
authors.lastname: Telich-Vidal
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Barreto-Fernández
authors.forename: María del Rosario
authors.initials: Mdel R
authors.lastname: Tapia-Serrano
authors.forename: Sergio Ermen
authors.initials: SE
authors.lastname: Ureta-Sánchez
authors.forename: Jorge
authors.initials: J
authors.lastname: Jaspersen-Gastelum
authors.forename: Carlos
authors.initials: C
authors.lastname: Pacheco-Gahbler
authors.forename: Ignacio R
authors.initials: IR
authors.lastname: Sentíes-Hernández
authors.forename: Jorge
authors.initials: J
authors.lastname: Olguin
authors.forename: Javier
authors.initials: J
authors.lastname: Pérez-García
mesh_terms: D000328:Adult; D000368:Aged; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008800:Mexico; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D013450:Sulfones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D014227:Triazines / Q000627:therapeutic use*; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride