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The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

ALLHAT. U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung, and Blood Institute. Major Outcomes in High Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic.

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The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

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  1. ALLHAT U.S. Department of Health and Human Services National Institutes of Health National Heart, Lung, and Blood Institute Major Outcomes in High Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) The ALLHAT Collaborative Research Group Sponsored by the National Heart, Lung, and Blood Institute (NHLBI) www.allhat.org JAMA 2002;288:2981-2997

  2. ALLHAT AntihypertensiveTrial Design • Randomized, double-blind, multi-center clinical trial • Determine whether occurrence of fatal CHD or nonfatal MI is lower for high-risk hypertensive patients treated with newer agents (CCB, ACEI, alpha-blocker) compared with a diuretic • 42,418 high-risk hypertensive patients ≥ 55 years

  3. ALLHAT Background • In addition to their BP lowering potential all antihypertensive agents have other important mechanisms of action and indications. • These actions may convey benefits or risks independent of BP lowering • By having a common BP goal for all treatment arms, ALLHAT aimed to evaluate the health effects of these non-BP actions

  4. ALLHAT Secondary Outcomes • All-cause mortality • Stroke • Combined CHD – nonfatal MI, CHD death, coronary revascularization, hospitalized angina • Combined CVD – (CHD, stroke, coronary revascularizations, heart failure [treated non-hospitalized, hospitalized, fatal], angina (treated non-hospitalized, hospitalized), peripheral arterial disease (revascularization procedure)

  5. ALLHAT Secondary Outcomes(Continued) • HQOL (Health-related quality of life) • GI Bleeding • Costs

  6. ALLHAT Step 1Treatment Protocol

  7. ALLHAT Step UpTreatment Protocol

  8. ALLHAT Baseline Characteristics

  9. ALLHAT On Step 1 or Equivalent Treatment by Antihypertensive Treatment Group

  10. ALLHAT BP Results by Treatment Group Compared to chlorthalidone: SBP significantly higher in the amlodipine group (~1 mm Hg) and the lisinopril group (~2 mm Hg). Compared to chlorthalidone: DBP significantly lower in the amlodipine group (~1 mm Hg).

  11. ALLHAT 1.6 = mean number of drugs Blood Pressure Control 2.0 1.8 1.7 1.6 1.4 @ 5 years: 62% were on >2 drugs 30% were on 1 drug and controlled Cushman, et al. J Clin Hypertens 2002;4:393-404

  12. ALLHAT Biochemical Results * p<.05 compared to chlorthalidone † Ann Intern Med. 1999;130:461-470

  13. ALLHATUSE OF POTASSIUM SUPPLEMENTATION % on potassium suppl.

  14. ALLHAT Biochemical Results – Fasting Glucose – mg/dL *p<.05 compared to chlorthalidone

  15. ALLHAT Renal Outcomes C = Chlorthalidone; A = Amlodipine; L = Lisinopril

  16. ALLHAT .2 .16 .12 Cumulative CHD Event Rate .08 .04 0 0 1 2 3 4 5 6 7 Years to CHD Event Cumulative Event Rates for the Primary Outcome (Fatal CHD or Nonfatal MI) by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril Number at Risk: Chlorthalidone 15,255 14,477 13,820 13,102 11,362 6,340 2,956 209 Amlodipine 9,048 8,576 8,218 7,843 6,824 3,870 1,878 215 Lisinopril 9,054 8,535 8,123 7,711 6,662 3,832 1,770 195

  17. ALLHAT .1 .08 .06 Cumulative Stroke Rate .04 .02 0 0 1 2 3 4 5 6 7 Years to Stroke Cumulative Event Rates for Stroke by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril Number at risk: Chlor 15,255 14,515 13,934 13,309 11,570 6,385 3,217 567 Amlo 9,048 8,617 8,271 7,949 6,937 3,845 1,813 506 Lisin 9,054 8,543 8,172 7,784 6,765 3,891 1,828 949

  18. ALLHAT Total 0.93 (0.82, 1.06) Total 1.15 (1.02, 1.30) Age < 65 0.93 (0.73, 1.19) Age < 65 1.21 (0.97, 1.52) Age >= 65 0.93 (0.81, 1.08) Age >= 65 1.13 (0.98, 1.30) Men 1.00 (0.85, 1.18) Men 1.10 (0.94, 1.29) Women 0.84 (0.69, 1.03) Women 1.22 (1.01, 1.46) Black 0.93 (0.76, 1.14) Black 1.40 (1.17, 1.68) Non-Black 0.93 (0.79, 1.10) Non-Black 1.00 (0.85, 1.17) Diabetic 0.90 (0.75, 1.08) Diabetic 1.07 (0.90, 1.28) Non-Diabetic 0.96 (0.81, 1.14) Non-Diabetic 1.23 (1.05, 1.44) 0.50 1 2 0.50 1 2 Amlodipine Better Chlorthalidone Better Lisinopril Better Chlorthalidone Better P = .01 for interaction Stroke – Subgroup Comparisons – RR (95% CI)

  19. ALLHAT .3 .25 .2 .15 Cumulative Mortality Rate .1 .05 0 0 1 2 3 4 5 6 7 Years to Death Cumulative Event Rates for All-Cause Mortality by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril Number at risk: Chlor 15,255 14,933 14,564 14,077 12,480 7.185 3,523 428 Amlo 9,048 8,847 8,654 8,391 7,442 4,312 2,101 217 Lisin 9,054 8,853 8,612 8,318 7,382 4,304 2,121 144

  20. ALLHAT .5 .4 .3 Cumulative Combined CVD Event Rate .2 .1 0 0 1 2 3 4 5 6 7 Years to Combined CVD Event Cumulative Event Rates for Combined CVD by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril Number at risk: Chlor 15,255 13,752 12,594 11,517 9,643 5,167 2,362 288 Amlo 9,048 8,118 7,451 6,837 5,724 3,049 1,411 153 Lisin 9,054 7,962 7,259 6,631 5,560 3,011 1,375 139

  21. ALLHAT Total 1.04 (0.99, 1.09) Total 1.10 (1.05, 1.16) Age < 65 1.03 (0.94, 1.12) Age < 65 1.05 (0.97, 1.15) Age >= 65 1.05 (0.99, 1.12) Age >= 65 1.13 (1.06, 1.20) Men 1.04 (0.98, 1.11) Men 1.08 (1.02, 1.15) Women 1.04 (0.96, 1.13) Women 1.12 (1.03, 1.21) Black 1.06 (0.96, 1.16) Black 1.19 (1.09, 1.30) Non-Black 1.04 (0.97, 1.10) Non-Black 1.06 (1.00, 1.13) Diabetic 1.06 (0.98, 1.15) Diabetic 1.08 (1.00, 1.17) Non-Diabetic 1.02 (0.96, 1.09) Non-Diabetic 1.12 (1.05, 1.19) 0.50 1 2 0.50 1 2 Amlodipine Better Chlorthalidone Better Lisinopril Better Chlorthalidone Better P = .04 for interaction Combined CVD – Subgroup Comparisons – RR (95% CI)

  22. ALLHAT .15 .12 .09 Cumulative CHF Rate .06 .03 0 0 1 2 3 4 5 6 7 Years to HF Cumulative Event Rates for Heart Failure by ALLHAT Treatment Group Chlorthalidone Amlodipine Lisinopril Number at risk: Chlor 15,255 14,528 13,898 13,224 11,511 6,369 3,016 384 Amlo 9,048 8,535 8,185 7,801 6,785 3,775 1,780 210 Lisin 9,054 8,496 8,096 7,689 6,698 3,789 1,837 313

  23. ALLHAT Overall Conclusions Because of the superiority of thiazide-type diuretics in preventing one or more major forms of CVD and their lower cost, they should be the drugs of choice for first-step antihypertensive drug therapy.

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