The Felodopine Event Reduction (FEVER) study showed that the addition of felodopine significantly reduced events and further reduced blood pressure, in patients already treated with low-dose hydrochlorothiazide. The results of FEVER were presented by Drs.°Lisheng Liu°and°Yuqing Zhang°rom Beijing, China, at the 15th European Meeting on Hypertension in Milan.
The primary endpoint -fatal and nonfatal stroke -was reduced by 26.8% (p=.0019) with felodipine. The secondary endpoints were also significantly reduced with felodipine: CV events by 27.4%, all cardiac events by 34.6%, coronary events by 32.5%, all-cause mortality by 33.2%, and cancer by 36.4%.
Men and women aged 50-79 years (patients ≤60 years old with at least 1 prior CVE or 2 CV risk factors; patients > 60 with at least 1 prior CVE or 1 CV risk factor were initially treated for 6 weeks with hydrochlorothiazide 12.5 mg daily and then patients with a SBP 140-180 mmHg or DBP 90-100 mmHg were randomized to felodipine 5 mg daily or placebo. For blood pressure that remained above 160/90 mm Hg, other non-calcium antagonist antihypertensive agents could be added. At screening, treated patients with blood pressures < 210/115 mmHg or untreated patients with SBP 160-210 mmHg or DBP 95-115 mmHg
A total of 4841 patients in the felodopine group and 4870 patients in the placebo group were in the intention-to-treat analysis.
At 3 years, the blood pressures were 137.8/82.2 mmHg in the felodopine group and 141.4/83.9 mmHg in the placebo group; the blood pressure difference was -3.54/-1.73 mmHg. More patients in the felodopine than in the placebo group had a SBP below 140 mmHg (80.4% vs 74.8%, respectively; p<0.001) at 36 months.
Flush occurred more frequently in the felodipine group (1.4% vs 0.2% placebo) as well as ankle edema (1.0% vs 0.37% with placebo), and fatigue was reported more often in the placebo group (1.05% vs 0.64% with felodopine).
The mean age of the FEVER study patients was 61.8 years in the felodopine group and 60.5 years in the placebo group, and 39% were women. BMI was 61.5 kg/m2, the screening SBP 158 mm Hg, screening DBP 92 mmHg, screening heart rate 76 bpm, randomization SBP 154 mmHg, randomization DBP 91 mm Hg, randomization heart rate 76 bpm, and 89% were receiving antihypertensive treatment at the time of the screening. A total of 29% were smokers, 24% had elevated serum cholesterol, 11% LVH, 2% proteinuria, 41% BMI >27 hg/m2, 14% history of stroke, 2% history of MI, 13% history of angina, 6% history of heart failure, 10% history of TIA.