Clinical Outcomes in Non-Diabetic Participants with Cardiovascular r Metabolic Syndrome in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

Introduction: This randomized, double-blind, active-controlled clinical trial assessed efficacy of first-step drug therapy with calcium channel blocker or ACE-inhibitor compared with thiazide-type diuretic in persons with/without cardiovascular metabolic syndrome (CVMS). Methods: ALLHAT was a practice-based study of 33,357 hypertensive participants age 55+ years with at least one other risk factor for coronary heart disease (CHD). Interventions were chlorthalidone (C), amlodipine (A) or lisinopril (L), plus open-label step-up drugs to reach blood pressure goal. The primary outcome (PO) was combined fatal CHD or non-fatal MI. CVMS was defined as 2 or more of the following: fasting glucose 100-125 mg/dl, BMI=30, fasting triglycerides=150 mg/dl, HDL cholesterol 40 mg/dl (men)/ 50 mg/dl (women). Non-diabetic participants (N=17,515) were classified as having CVMS (N=8,013) or not (N=9,502). Results: The relative risk (95% confidence interval) in CVMS assigned to A or L compared with C was 0.96 (0.79–1.16) and 1.05 (0.88–1.27), respectively; in non-CVMS, 1.09 (0.91–1.30) and 1.06 (0.89–1.27). Conclusions: There was no evidence of superiority for prevention of CHD events during first-step therapy of hypertension with amlodipine or lisinopril compared with chlorthalidone in non-diabetic persons with CVMS. Diuretics are more efficacious in preventing other clinical outcomes, especially HF, regardless of presence/absence of CVMS