Published Online
on July 24, 2006

A more recent version of this article appeared on September 1, 2006

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Submitted on February 20, 2006
Revised on March 13, 2006

Clinical Events in High-Risk Hypertensive Patients Randomly Assigned to Calcium Channel Blocker Versus Angiotensin-Converting Enzyme Inhibitor in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

Frans H.H. Leenen^*; Chuke E. Nwachuku; Henry R. Black; William C. Cushman; Barry R. Davis; Lara M. Simpson; Michael H. Alderman; Steven A. Atlas; Jan N. Basile; Aloysius B. Cuyjet; Richard Dart; James V. Felicetta; Richard H. Grimm; L. Julian Haywood; Syed Z.A. Jafri; Michael A. Proschan; Udho Thadani; Paul K. Whelton; Jackson T. Wright;; for the Antihypertensive Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Collaborative Research Group

From the University of Ottawa Heart Institute (F.H.H.L.), Ottawa, Ontario, Canada; National Heart, Lung, and Blood Institute (M.A.P., C.E.N.), Bethesda, Md; Rush-Presbyterian-St. Luke’s Medical Center (H.R.B.), Chicago, Ill; Memphis Veterans Affairs Medical Center (W.C.C.), Tenn; University of Texas Health Science Center School of Public Health (B.R.D., L.M.S.), Houston; Albert Einstein College of Medicine (M.H.A.), Bronx, NY; Bronx Veterans Affairs Medical Center (S.A.A.), NY; Charleston Veterans Affairs Medical Center (J.N.B.), SC; New Jersey Medical School (A.B.C.), Newark; Marshfield Clinic (R.D.), Marshfield, Wis; Carl T. Hayden Veterans Affairs Medical Center (J.V.F.), Phoenix, Ariz; Berman Center for Outcomes and Clinical Research (R.H.G.), Minneapolis, Minn; Los Angeles County-University of Southern California Medical Center (L.J.H.); Fargo Veterans Affairs Medical Center (S.Z.A.J.), ND; University of Oklahoma Health Sciences Center and Veterans Affairs Medical Center (U.T.), Oklahoma City; Tulane University Health Sciences Center (P.K.W.), New Orleans, La; University Hospitals of Cleveland (J.T.W.), Ohio.

^* To whom correspondence should be addressed. E-mail: fleenen{at}ottawaheart.ca.

Abstract--The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT) provides a unique opportunity to compare the long-term relative safety and efficacy of angiotensin-converting enzyme inhibitor and calcium channel blocker-initiated therapy in older hypertensive individuals. Patients were randomized to amlodipine (n=9048) or lisinopril (n=9054). The primary outcome was combined fatal coronary heart disease or nonfatal myocardial infarction, analyzed by intention-to-treat. Secondary outcomes included all-cause mortality, stroke, combined cardiovascular disease (CVD), end-stage renal disease (ESRD), cancer, and gastrointestinal bleeding. Mean follow-up was 4.9 years. Blood pressure control was similar in nonblacks, but not in blacks. No significant differences were found between treatment groups for the primary outcome, all-cause mortality, ESRD, or cancer. Stroke rates were higher on lisinopril in blacks (RR=1.51, 95% CI 1.22 to 1.86) but not in nonblacks (RR=1.07, 95% CI 0.89 to 1.28), and in women (RR=1.45, 95% CI 1.17 to 1.79), but not in men (RR=1.10, 95% CI 0.92 to 1.31). Rates of combined CVD were higher (RR=1.06, 95% CI 1.00 to 1.12) because of higher rates for strokes, peripheral arterial disease, and angina, which were partly offset by lower rates for heart failure (RR=0.87, 95% CI 0.78 to 0.96) on lisinopril compared with amlodipine. Gastrointestinal bleeds and angioedema were higher on lisinopril. Patients with and without baseline coronary heart disease showed similar outcome patterns. We conclude that in hypertensive patients, the risks for coronary events are similar, but for stroke, combined CVD, gastrointestinal bleeding, and angioedema are higher and for heart failure are lower for lisinopril-based compared with amlodipine-based therapy. Some, but not all, of these differences may be explained by less effective blood pressure control in the lisinopril arm.

Key words: antihypertensive therapy • hypertension, detection and control • calcium channel blockers • angiotensin-converting enzyme • cardiovascular diseases • stroke • heart failure

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