[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]

Author(s): Marin-Iranzo R, de la Sierra-Iserte A, Roca-Cusachs A, Olivan-Martinez J, Redon-Mas J, Luque-Otero M, de la Figuera-von Wichman M, Pontes-Garcia C, Delgadillo-Duarte J, grupo del estudio ENVIDA

Affiliation(s): Unidad de Nefrologia, Hospital de Covadonga, Oviedo. rmarini@senefro.org

Publication date & source: 2005-09, Rev Clin Esp., 205(9):418-24.

Publication type: Multicenter Study; Randomized Controlled Trial

INTRODUCTION: Combined therapy or dose-tiration are acceptable second-line therapeutic options after a first treatment failure. MATERIAL AND 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). CONCLUSION: 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.