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Clinical Outcomes in Antihypertensive Treatment of Type 2 Diabetes, Impaired Fasting Glucose Concentration, and Normoglycemia
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
Paul K. Whelton, MD, MSc;
Joshua Barzilay, MD;
William C. Cushman, MD;
Barry R. Davis, MD, PhD;
Ekambaram IIamathi, MD;
John B. Kostis, MD;
Frans H. H. Leenen, MD, PhD;
Gail T. Louis, RN;
Karen L. Margolis, MD;
David E. Mathis, MD;
Jamal Moloo, MD;
Chuke Nwachuku, MA, MPH, DrPH;
Deborah Panebianco, MD;
David C. Parish, MD;
Sara Pressel, MS;
Debra L. Simmons, MD;
Udho Thadani, MD; for the ALLHAT Collaborative Research Group
Arch Intern Med. 2005;165:1401-1409.
Background Optimal first-step antihypertensive drug therapy in type 2 diabetes mellitus (DM) or impaired fasting glucose levels (IFG) is uncertain. We wished to determine whether treatment with a calcium channel blocker or an angiotensin-converting enzyme inhibitor decreases clinical complications compared with treatment with a thiazide-type diuretic in DM, IFG, and normoglycemia (NG).
Methods Active-controlled trial in 31 512 adults, 55 years or older, with hypertension and at least 1 other risk factor for coronary heart disease, stratified into DM (n = 13 101), IFG (n = 1399), and NG (n = 17 012) groups on the basis of national guidelines. Participants were randomly assigned to double-blind first-step treatment with chlorthalidone, 12.5 to 25 mg/d, amlodipine besylate, 2.5 to 10 mg/d, or lisinopril, 10 to 40 mg/d. We conducted an intention-to-treat analysis of fatal coronary heart disease or nonfatal myocardial infarction (primary outcome), total mortality, and other clinical complications.
Results There was no significant difference in relative risk (RR) for the primary outcome in DM or NG participants assigned to amlodipine or lisinopril vs chlorthalidone or in IFG participants assigned to lisinopril vs chlorthalidone. A significantly higher RR (95% confidence interval) was noted for the primary outcome in IFG participants assigned to amlodipine vs chlorthalidone (1.73 [1.10-2.72]). Stroke was more common in NG participants assigned to lisinopril vs chlorthalidone (1.31 [1.10-1.57]). Heart failure was more common in DM and NG participants assigned to amlodipine (1.39 [1.22-1.59] and 1.30 [1.12-1.51], respectively) or lisinopril (1.15 [1.00-1.32] and 1.19 [1.02-1.39], respectively) vs chlorthalidone.
Conclusion Our results provide no evidence of superiority for treatment with calcium channel blockers or angiotensin-converting enzyme inhibitors compared with a thiazide-type diuretic during first-step antihypertensive therapy in DM, IFG, or NG.
Author Affiliations: Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine (Dr Whelton and Ms Louis), and Department of Medicine, Tulane University School of Medicine (Dr Whelton), New Orleans, La; Kaiser Permanente of Georgia and Division of Endocrinology, Emory University School of Medicine, Atlanta, Ga (Dr Barzilay); Medical Research Service, Veterans Affairs Medical Center, Memphis, Tenn (Dr Cushman); Coordinating Center for Clinical Trials, University of Texas–Houston School of Public Health (Dr Davis and Ms Pressel); Renal Services, Section of Nephrology, St Catherine of Siena Medical Center, and Division of Nephrology and Hypertension, Department of Medicine, Winthrop-University Hospital, Stony Brook, NY (Dr Ilamathi); Department of Medicine, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick (Dr Kostis); Hypertension Unit, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario (Dr Leenen); Division of Clinical Epidemiology, Hennepin County Medical Center, Minneapolis, Minn (Dr Margolis); Department of Internal Medicine, Medical Center of Central Georgia, Mercer University School of Medicine, Macon (Drs Mathis and Parish); Department of Internal Medicine, University of South Carolina School of Medicine, Columbia (Dr Moloo); Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (Dr Nwachuku); Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Va (Dr Panebianco); Department of Internal Medicine, University of Arkansas for Medical Sciences, Central Arkansas Veterans Healthcare System, Little Rock (Dr Simmons); and Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Veterans Affairs Medical Center, Oklahoma City (Dr Thadani).
Group Information: A complete list of the participants in the ALLHAT Collaborative Research Group was published in JAMA. 2002;288:2994-2996.
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