title: [Double blind study of the efficacy and safety of the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg versus the increase of amlopidine dose in essential hypertensive patients not controlled with amlodipine 5 mg].
abstract: BACKGROUND
  Combined therapy or dose-tiration are acceptable second-line therapeutic options after a first treatment failure.
  
  
  METHODS
  This double blind clinical trial compared the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg (E/N) with amlopidine 10 mg (A) in 323 hypertensive patients not previously controlled with amlodipine 5 mg.
  
  
  RESULTS
  After 6 weeks of treatment, the E/N and A groups had similar percentages of blood pressure normalization (55% versus 60.2%; p = 0.4588). The adverse events related with the treatment were significantly less frequent with E/N than with a (19.8% versus 37%; p = 0.0029), especially due to a lower incidence of malleolar edema in E/N (11.1% versus 33.6%; p < 0.0001).
  
  
  CONCLUSIONS
  Combining the efficacy and tolerability data, treatment with E/N permitted control of blood pressure of 2.8 patients per every patient with adverse events, while this rate for A was 1.6 to 1.
authors.affiliation: Unidad de Nefrología, Hospital de Covadonga, Oviedo. rmarini@senefro.org
authors.forename: R
authors.initials: R
authors.lastname: Marín-Iranzo
authors.forename: A
authors.initials: A
authors.lastname: de la Sierra-Iserte
authors.forename: A
authors.initials: A
authors.lastname: Roca-Cusachs
authors.forename: J
authors.initials: J
authors.lastname: Oliván-Martínez
authors.forename: J
authors.initials: J
authors.lastname: Redón-Mas
authors.forename: M
authors.initials: M
authors.lastname: Luque-Otero
authors.forename: M
authors.initials: M
authors.lastname: de la Figuera-von Wichman
authors.forename: C
authors.initials: C
authors.lastname: Pontes-García
authors.forename: J
authors.initials: J
authors.lastname: Delgadillo-Duarte
mesh_terms: D017311:Amlodipine / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004656:Enalapril / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009568:Nitrendipine / Q000008:administration & dosage*
chemical_list: D000959:Antihypertensive Agents; D017311:Amlodipine; D004656:Enalapril; D009568:Nitrendipine