Baseline characteristics of the diabetic participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Objective - Hypertension (HTN) is a major risk factor for cardiovascular di sease (CVD) in the setting of diabetes. There is no consensus on how best t o treat hypertension among those with diabetes. Here we describe the charac teristics of a cohort of hypertensive adults with diabetes who are part of a large prospective blood pressure study. This study will help clarify the treatment of HTN in the setting of diabetes. Research design and methods - The Antihypertensive and Lipid-Lowering Treat ment to Prevent Heart Attack Trial (AI.I.HAT) is a double-blind randomized trial of 42,448 high-risk hypertensive participants, ages greater than or e qual to 55 years, designed to determine whether the incidence of fatal and nonfatal coronary heart disease (CHD) and combined cardiovascular events (f atal and nonfatal CHD, revascularization surgery, angina pectoris, congesti ve heart failure, and stroke) differs between diuretic (chlorthahdone) trea tment and three alternative antihypertensive therapies: a calcium channel b locker (amlodipine), an ACE inhibitor (lisinopril), and an alpha-adrenergic blocker (doxazosin). The planned follow-up is an average of 6 years, to be completed in March 2002. Results - There are 15,297 diabetic individuals in the ALLHAT study (36.0% of the entire cohort). Of these individuals, 50.2% are male, 39.4% are Afri can-American, and 17.7% are Hispanic. Demographic and laboratory characteri stics of the cohort are similar to those of other studies of the U.S. elder ly population with HTN. The sample size has 42 and 93% confidence respectiv ely, for detecting a 16% difference between the diuretic and each of the no ndiuretic treatments for the two study outcomes. Conclusions - The diabetic cohort in ALLHAT will be able to provide valuabl e information about the treatment of hypertension in older diabetic patient s at risk for incident CVD.