Predictors of one year blood pressure control and treatment resistance in the value trial

Abstract

The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial is testing the hypothesis that for the same level of BP control, the AT1-receptor blocker valsartan reduces serious cardiac events by 15% compared to the CCB amlodipine. VALUE is a double-blind, randomized, in 31 countries, prospective trial of 15314 previously treated (92%) or untreated hypertensives, 42.4% women, mean age 67.2 yrs, BMI 28.6 kg/m2, coronary heart disease (CHD) in 45.8%, high cholesterol in 32.9%, type-2 diabetes mellitus (DM) in 31.7% and 24.0% smokers. The primary endpoint is expected in 1450 pts. in 2-3 yrs. The aim of this analysis is to identify predictors of 1-year BP control and resistance to treatment in the VALUE population. BP decreased from 154.7/87.6 at randomization to 141.3/80.9 mmHg at 12 months and control rate <140/90 mmHg improved from 21.4 to 54.6%. Responsive (n=4328) achieved goal BP on monotherapy and resistant (n=1091) remained >160 and/or >100 mmHg at the highest drug titration step (step 5). Characteristics are shown in the accompanying table. The odds of being controlled were up 23% in pts. with controlled SBP at baseline, decreased by 3% per mmHg rise in baseline pulse pressure (PP) and 2% per year of age, were 23% less in DM, 25% higher in USA, 85% higher in Asians, 25% higher in CHD and 34% higher in smokers. In the “best” model, pts. not in USA (RR 1.58, p<0.0001), Oriental (RR 0.49, p<0.0004) and PP (3% per mmHg rise, RR 1.03, p<0.0001) predicted resistance. Thus, overall the 1-year blood pressure control in VALUE is comparable to the best previously reported in large hypertension outcome trials. Geographical origin and pulse pressure at baseline most strongly predicted resistance to drug therapy.