The FEVER (Felodipine EVEnt Reduction) trial; a randomised, double-blind, placebo-controlled trial in Chinese hypertensive patients
Authors:
M. Souček; M. Plachý
Authors‘ workplace:
II. interní klinika Lékařské fakulty MU a FN u sv. Anny, Brno, přednosta doc. MUDr. Miroslav Souček, CSc.
Published in:
Vnitř Lék 2007; 53(1): 63-70
Category:
Reviews
Overview
The FEVER trial observed the difference between intense and less intense treatment of hypertension by comparing combination therapy consisting of a low diuretic dose (12.5 mg of hydrochlorothiazide) and a low calcium antagonist dose (5 mg of felodipine) with monotherapy based on a low diuretic dose (12.5 mg of hydrochlorothiazide) in Chinese hypertensive patients. The trial enrolled 9,711 hypertonics (of which 4,841 on hydrochlorothiazide + felodipine combination and 4,870 on hydrochlorothiazide + placebo combination). Blood pressure decreased from 158.7/92.4 to 138.1/82.3 mmHg and from 158.0/92.7 to 141.6/83.9 mmHg in the combination therapy group and monotherapy group, respectively. The average difference throughout the trial was 4.2/2.1 mmHg. The primary endpoint – fatal and non-fatal stroke (CVA) – was reduced by 27 % in the combination therapy group. Among secondary endpoints, the success ratio of combination therapy was expressed by 27 % reduction of all cardiovascular events, 35 % reduction of all cardiac events, 32 % reduction of coronary events and 31 % reduction of deaths. The minor difference between systolic and diastolic blood pressure of approximately 4/2 mmHg was related to a decrease in the incidence of CVA and cardiovascular events in Chinese hypertonics.
Key words:
hypertension – hydrochlorothiazide – felodipine – combination therapy – monotherapy – cerebrovascular accident
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