[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].
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.
Marín-Iranzo
R
R
Unidad de Nefrología, Hospital de Covadonga, Oviedo. rmarini@senefro.org
de la Sierra-Iserte
A
A
Roca-Cusachs
A
A
Oliván-Martínez
J
J
Redón-Mas
J
J
Luque-Otero
M
M
de la Figuera-von Wichman
M
M
Pontes-García
C
C
Delgadillo-Duarte
J
J
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*
D000959:Antihypertensive Agents; D017311:Amlodipine; D004656:Enalapril; D009568:Nitrendipine