Rationale and design for the antihypertensive and lipid lowering treatment to prevent heart attack trial (ALLHAT)

American Journal of Hypertension

Volumn 9, Issue 4 I, 1996, Pages 342-360

  Davis, Barry R ^a   Cutler, Jeffrey A ^b   Gordon, David J ^b   Furberg, Curt D ^c   Wright Jr , Jackson T ^d   Cushman, William C ^e   Grimm, Richard H ^f   LaRosa, John ^g   Whelton, Paul K ^g   Perry, H Mitchell ^g   Alderman, Michael H ^g   Ford, Charles E ^a   Oparil, Suzanne ^g   Francis, Charles ^g   Proschan, Michael ^b   Pressel, Sara ^a   Black, Henry R ^g   Hawkins, C Morton ^a  

^a UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

^b NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^c WAKE FOREST SCHOOL OF MEDICINE   (United States)

^d CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

^f UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^g NONE

Author keywords

ALLHAT trial; amlodipine; chlorthalidone; clinical trial; doxazosin; economics; hypercholesterolemia; hypertension; lisinopril; pharmacologic therapy

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; AMLODIPINE; ANTILIPEMIC AGENT; CALCIUM ANTAGONIST; CHLORTALIDONE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; DOXAZOSIN; LISINOPRIL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PRAVASTATIN;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ECONOMICS; FEMALE; HEART INFARCTION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW;

EID: 0029918188     PISSN: 08957061     EISSN: None     Source Type: Journal    
DOI: 10.1016/0895-7061(96)00037-4     Document Type: Article

References (52)

1. The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med 1993;153:154-183.
2. Burt VL, Whelton P, Rocella EJ, et al: Prevalence of hypertension in the U.S. adult population: results from the Third National Health and Nutrition Examination survey, 1988-1991. Hypertension 1995;25:305-313.
3. Manolio TA, Cutler JA, Furberg CD, et al: Trends in the pharmacologic management of hypertension in the United States. Arch Intern Med 1995;15:829-837.
4. MacMahon SW, Cutler JA, Furberg CD, et al: The effects of drug treatment for hypertension on morbidity and mortality from cardiovascular disease: a review of randomized controlled trials. Prog Cardiovasc Dis 1986;29(3, suppl 1):99-119.
5. Collins R, Peto R, MacMahon S, et al: Blood pressure, stroke, and coronary heart disease. Part 2. Short-term reductions in blood pressure: overview of randomized drug trials in their epidemiological context. Lancet 1990;335:827-838.
6. MacMahon S, Peto R, Cutler J, et al: Blood pressure, stroke, and coronary heart disease. Part 1. Prolonged differences in blood pressure: prospective, observational studies corrected for the regression dilution bias. Lancet 1990;335:765-774.
7. SHEP Cooperative Research Group: Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA 1991;265:3255-3264.
8. Dahlof B, Lindholm LH, Hansson L, et al: Morbidity and mortality in the Swedish Trial in Old Patients with Hypertension (STOP-Hypertension). Lancet 1991; 338:1281-1285.
9. MRC Working Party: Medical Research Council of treatment of hypertension in older adults: principal results. Br Med J 1992;304:405-412.
10. Cohen JD, Neaton JD, Prineas RJ, Daniels KA, for the MRFIT Research Group: Diuretics, serum potassium, and ventricular arrhythmias in the Multiple Risk Factor Intervention Trial. Am J Cardiol 1987;60:548-554.
11. Ferrari P, Rosman J, Weidman P: Antihypertensive agents, serum lipoproteins, and glucose metabolism. Am J Cardiol 1991;67:26B-35B.
12. Materson BJ, Reda DJ, Cushman WC, et al, for the DVA Cooperative Study Group on Antihypertensive Agents: Single-drug therapy for hypertension in men: a comparison of six antihypertensive agents with placebo. N Engl J Med 1993;328:914-921.
13. Neaton JD, Grimm RH Jr, Prineas RJ, et al, for the Treatment of Mild Hypertension Study Research Group: Treatment of Mild Hypertension Study: final results. JAMA 1993;270:713-724.
14. Held PH, Yusuf S, Furberg CD: Calcium channel blockers in acute myocardial infarction and unstable angina: an overview. Br Med J 1989;299:1187-1192.
15. Yusuf S, Held P, Furberg C: Update of effects of calcium antagonists in myocardial infarction or angina in light of the second Danish Verapamil Infarction Trial (DAVIT-II) and other recent studies. Am J Cardiol 1991;67:1295-1297.
16. The SOLVD Investigators: Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293-302.
17. Pfeffer MA, Braunwald E, Moye LA, et al: The effect of captopril on morbidity and mortality in patients with left ventricular dysfunction following myocardial infarction. N Engl J Med 327:678-684, 1992.
18. The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators: Effects of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet 1993;342:821-828.
19. The SOLVD Investigators: Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med 1992;327:685-691.
20. Pollare T, Lithell H, Berne C: A comparison of the effects of hydrochlorothiazide and captopril on glucose and lipid metabolism in patients with hypertension. N Engl J Med 1989;321:868-873.
21. Paolisso G, Gambardella A, Verza M, et al: ACE inhibition improves insulin-sensitivity in aged insulin-resistant hypertensive patients. J Hum Hypertens 1992; 6:175-179.
22. Chobanian AV, Haudenschild CC, Nickerson C, et al: Anti-atherogenic effect of captopril in the Watanabe heritable hyperlipidemic rabbit. Hypertension 1990; 15:327-331.
23. Pool JL: Effects of doxazosin on serum lipids: A review of the clinical data and molecular basis for altered lipid metabolism. Am Heart J 1991;121:251-259.
24. Lithell H: Effects of antihypertensive drugs on insulin, glucose and lipid metabolism. Diabetes Care 1991; 14:203-209.
25. Hernandez RH, Carvajal AR, Guerrero PJ, et al: Evidence of an antiplatelet aggregation in normotensive subjects and patients with hypertension: an in-vitro study. Am Heart J 1991;121:389-394.
26. Hernandez RH, Guerrero PJ, Carvajal AR, et al: Evidence of an antiplatelet aggregation action of doxazosin in patients with hypertension: an ex-vivo study. Am Heart J 1991;121:395-401.
27. Jansson JH: Effects of doxazosin and atenolol on the fibrinolytic system in patients with hypertension and elevated serum cholesterol. Eur J Clin Pharmacol 1991;40:321-326.
28. Gordon DJ, Rifkind BM: 3-Hydroxy-3-methyglutaryl coenzyme A (HMG CoA) reductase inhibitors: a new class of cholesterol-lowering agents. Ann Intern Med 1987;107:759-761.
29. Jacobs D, Blackburn H, Higgins M, et al: Report of the conference on low blood cholesterol: mortality associations. Circulation 1992;86:1046-1060.
30. Holme I: An analysis of randomized trials evaluating the effect of cholesterol reduction on total mortality and coronary heart disease incidence. Circulation 1990;82:1916-1924.
31. Muldoon MF, Manuck SB, Mathews KA: Lowering cholesterol concentrations and mortality: a quantitative review of primary prevention trials. Br Med J 1990; 301:309-314.
32. Roussow JE, Lewis B, Rifkind BM: The value of lowering cholesterol after myocardial infarction. N Engl J Med 1990;323:1112-1119.
33. Ravnskov U: Cholesterol lowering trials in coronary heart disease: frequency of citation and outcome. Br Med J 1992;306:1367-1373.
34. Davey Smith G, Song F, Sheldon TA: Cholesterol lowering and mortality: the importance of considering initial level of risk. Br Med J 1993;306:1367-1373.
35. Holme I: Relation of coronary heart disease incidence and total mortality to plasma cholesterol reduction in randomised trials: use of meta-analysis. Br Heart J 1993;69(suppl):S42-S47.
36. Thompson SG. Controversies in meta-analysis: the case of the trials of cholesterol reduction. Stat Meth Med Res 1993;2:173-192.
37. Law MR, Wald NJ, Thompson SG: By how much and how quickly does reduction in serum cholesterol lower risk of ischemic heart disease? Br Med J 1994;308:367-373.
38. Law MR, Thompson SG, Wald NJ. Assessing possible hazards of reducing serum cholesterol. BMJ 1994;308: 373-379.
39. Gould AL, Roussow JE, Santanello NC, et al: Cholesterol reduction yields clinical benefit; a new look at old data. Circulation (in press).
40. Gordon DJ: Cholesterol lowering and total mortality, in Rifkind BM (ed): Contemporary Issues in Cholesterol Lowering : Clinical and Population Aspects. Marcel Dekker, New York, 1994.
41. Scandanavian Simvastatin Survival Study Group: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandanavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-1389.
42. LaRosa J, Applegate W, Crouse J, et al: Cholesterol lowering in the elderly - Results of the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study. Arch Intern Med 1994:154;529-539.
43. Dunnett CW. A multiple comparisons procedure for comparing several treatments with a control. J Am Stat Assoc 1955;60:573-583.
44. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Summary of the second report of the Nation Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269:3015-3023.
45. Friedewald WT, Levy RI, Fredrickson DS: Estimation of the concentration of low-density lipoprotein cholesterol in plasma without use of the preparative ultracentrifuge. Clin Chem 1972;18:499-502.
46. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-170.
47. Laird NM, Ware JH: Random effects models for longitudinal data. Biometrics 1982;38:963-974.
48. Lan KKG, Wittes J: The B-value: a tool for monitoring data. Biometrics 1988;44:579-585.
49. Davis BR, Hardy RJ: Data monitoring in clinical trials: the case for stochastic curtailment. J Clin Epidemiol 1994;47:1033-1042.
50. Sleight P: Trials and tribulations: the ISIS experience. Aust NZ J Med 1992;22(5, suppl):583-586.
51. Williford WO, Collins JF, Garg R, et al: Design and implementation of the NHLBI and the VA Cooperative Studies Program Collaborative Study trial to evaluate the effect of digitalis on mortality in heart failure. Controlled Clin Trials 1992;13:386.
52. Vital and Health Statistics. Serum Lipids of Adults 20-74 Years: United States, 1976-80. Series II: Data from the National Health Survey, No. 242, DHHS Publication No. (PHS) 93-1692. US Public Health Service, Hyattsville, Maryland, 1993.