[The FEVER (Felodipine EVEnt Reduction) trial; a randomised, double-blind, placebo-controlled trial in Chinese hypertensive patients]

Abstract

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 9711 hypertonics (of which 4841 on hydrochlorothiazide + felodipine combination and 4870 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.