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Outcomes in High Risk Hypertensives Randomized to CCB vs. ACE Inhibitor in ALLHAT

ALLHAT. U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung, and Blood Institute. Outcomes in High Risk Hypertensives Randomized to CCB vs. ACE Inhibitor in ALLHAT.

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Outcomes in High Risk Hypertensives Randomized to CCB vs. ACE Inhibitor in 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 Outcomes in High Risk Hypertensives Randomized to CCB vs. ACE Inhibitorin ALLHAT Frans Leenen MD, PhD, Chuke Nwachuku MA, MPH, Dr PH, William Cushman MD, Henry Black MD, Lara Simpson MS, Barry Davis MD, PhD. For the ALLHAT Collaborative Research Group Sponsored by the National Heart, Lung and Blood Institute (NHLBI) www.allhat.org

  2. ALLHAT Primary Objective Determine whether treatment with the newer agents (CCB, ACEI, alpha-blocker) results in less fatal CHD and nonfatal MI compared with a diuretic POST-HOC ANALYSIS - Comparison of cardiovascular and other outcomes among 18,102 patients randomized to ACEI or dihydropyridine CCB - For sub-groups, emphasis on outcomes in Blacks vs non-Blacks considering the previously reported interaction for several major outcomes with lisinopril.

  3. ALLHAT Hypertension Trial 42,418 high-risk hypertensive patients 90% previously treated 10% untreated STEP 1 AGENTS Chlorthalidone 12.5-25 mg Amlodipine 2.5-10 mg Lisinopril 10-40 mg Doxazosin 1-8 mg N=9,061 N=9,054 N=9,048 N=15,255 STEP 2 AND 3 AGENTS (5 years) Hydralazine 10.9% Clonidine 10.6% Atenolol 28.0% Reserpine 4.3%

  4. ALLHAT Baseline Characteristics

  5. ALLHAT 86 86 84 84 82 82 80 80 78 78 76 76 74 74 Baseline and Follow-up Blood Pressures 148 148 148 146 146 146 144 144 144 142 142 142 mm Hg BP mm Hg BP 140 140 140 138 138 138 136 136 136 Amlodipine 134 134 134 Lisinopril 86 86 84 84 82 82 mm Hg BP mm Hg BP mm Hg BP 80 80 78 78 76 76 74 74 BL BL BL 3m 3m 3m 6m 6m 6m Y1 Y1 Y1 Y2 Y2 Y2 Y3 Y3 Y3 Y4 Y4 Y4 Number at Risk: Amlodipine 9048 7609 6883 6381 5637 Lisinopril 9054 7521 6700 5325 6076

  6. ALLHAT Amlodipine - Blacks Amlodipine - Non-Blacks Lisinopril - Blacks Lisinopril - Non-Blacks Baseline and Follow-up BPs by Race 148 146 Δ=3.4 144 142 Δ=1.6 mmHg SBP 140 138 136 134 132 86 84 Δ=1.8 82 mmHg DBP 80 Δ=1.1 78 76 Δ=0.5 Δ=0.8 74 BL 3m 6m Y1 Y2 Y3 Y4 Mean # of Meds: Amlodipine Blacks 1.4 1.5 1.6 1.7 - Non-Blacks 1.4 1.5 1.7 1.8 Lisinopril Blacks 1.6 1.8 1.9 2.0 - Non-Blacks 1.4 1.6 1.7 1.8

  7. 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 Treatment Group Amlodipine Lisinopril Number at Risk: 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

  8. ALLHAT Secondary Endpoints:No Differences Between Treatment Groups For

  9. ALLHAT .1 .08 .06 Amlodipine Lisinopril Cumulative Stroke Rate .04 .02 0 0 1 2 3 4 5 6 7 Years to Stroke Number at risk: Cumulative Event Rates for Stroke by Treatment Group Amlodipine 9,048 8,617 8,271 7,949 6,937 3,845 1,813 506 Lisinopril 9,054 8,543 8,172 7,784 6,765 3,891 1,828 949

  10. ALLHAT Non-Blacks 0.10 Blacks 0.10 Amlodipine 0.05 Lisinopril Amlodipine Lisinopril 0.05 0.00 0 1 2 3 4 5 6 7 Years to Stroke 0.00 0 1 2 4 5 6 7 3 Years to Stroke Cumulative Event Rates for Stroke by Race and Treatment Group Cumulative Stroke Rate

  11. ALLHAT Stroke Interaction by Gender and Race Lisinopril versus Amlodipine + favors amlodipine - favors lisinopril p=0.02 for interaction of gender within non-blacks

  12. 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 Number at risk: Cumulative Event Rates for Combined CVD by Treatment Group Amlodipine Lisinopril Amlodipine 9,048 8,118 7,451 6,837 5,724 3,049 1,411 153 Lisinopril 9,054 7,962 7,259 6,631 5,560 3,011 1,375 139

  13. ALLHAT Other Components of Combined CVD * 2X2 table RR rather than Cox PH

  14. ALLHAT .15 .12 .09 Cumulative HF Rate .06 .03 0 0 1 2 3 4 5 6 7 Years to HF Cumulative Event Rates for Heart Failure by Treatment Group Amlodipine Lisinopril Number at risk: Amlodipine 9,048 8,535 8,185 7,801 6,785 3,775 1,780 210 9,054 8,496 8,096 7,689 6,698 3,789 1,837 313 Lisinopril

  15. ALLHAT Safety Parameters

  16. ALLHAT SummaryLisinopril vs. Amlodipine +favors amlodipine - favors lisinopril

  17. ALLHAT Conclusions Non-Black Older Hypertensives At apparently equivalent BP control, most outcomes are similar on lisinopril vs. amlodipine-initiated treatment except for • less HF on lisinopril • more strokes (in women), GI bleed, and angioedema on lisinopril Black Older Hypertensives Several outcomes are similar on lisinopril vs. amlodipine-initiated treatment, but • Less HF on lisinopril • Less BP control and more cardiovascular events, including stroke, on lisinopril • more GI bleeds and angioedema on lisinopril Clinical Implications ALLHAT was not designed to identify the best step-one drug alternative if a thiazide-type diuretic cannot be used. However, considering the totality of the outcome measures, amlodipine would appear to have an advantage over lisinopril, particularly in Blacks and Women, but this depends on how clinicians weigh outcomes that favor the respective arms.

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