In the setting of rapidly increasing trend of hypertension, a post-hoc subgroup analysis of the Felodipine Event Reduction (FEVER) Study was conducted to determine the effects of early blood pressure control on cardiovascular (CV) outcomes.Design and method:
The FEVER Study was a double-blind randomized trial conducted in 9711 Chinese hypertensive patients in which the CV outcomes were significantly reduced by felodipine compared with placebo. In this analysis, patients were regrouped to either the uncontrolled BP group (SBP/DBP, > = 140/90 mmHg) or the controlled BP group (<140/90 mmHg) at 1 and 6 months. A landmarking approach was used in the analysis of the outcome of the data.The analysis was restricted to those patients who had not experienced an outcome before 6 months from randomization and who were still in the trial at 6 months. All the patients (independently of randomization) with controlled BP at 6 months were enrolled into the analysis. They were divided into two groups according to the time of their BP became controlled, i.e., at 1 month and between 1 and 6 months. The primary outcome measure was time to first stroke (fatal or nonfatal). Secondary outcomes included all cardiovascular events. For comparisons of outcome incidence Cox proportional hazard models were used, and hazard ratios with 95% confidence intervals (CIs) calculated with curves starting from month 6 for earlier controlled vs. later controlled. Adjustments for baseline risk were performed by entering baseline characteristics [sex, age, smoking habit, serum cholesterol, serum creatinine, BMI, SBP and DBP at the landmark 6-month visit, LVH, diabetes, current or previous cardiovascular disease, and randomized treatment (placebo or felodipine)]Results:
The number of patients (mean age, 61.7 ± 7.2 years; BMI, 26.1 ± 3.3 kg/m2) in the controlled/uncontrolled BP groups were 2968/6743 at 1 month, 4128/5583 at 3 months, and 4615/5096 at 6 months.Conclusions:
The final results of the outcomes will be presented during the ESH meeting.