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IDEAL: The I ncremental D ecrease in E nd Points Through A ggressive L ipid Lowering Study

IDEAL: The I ncremental D ecrease in E nd Points Through A ggressive L ipid Lowering Study. IDEAL: Study design. I ncremental D ecrease in E nd Points Through A ggressive L ipid Lowering. Objective: To compare intensive vs less-intensive lipid-lowering therapies

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IDEAL: The I ncremental D ecrease in E nd Points Through A ggressive L ipid Lowering Study

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  1. IDEAL: The Incremental Decrease in End Points Through Aggressive Lipid Lowering Study

  2. IDEAL: Study design Incremental Decrease in End Points Through Aggressive Lipid Lowering Objective: To compare intensive vs less-intensive lipid-lowering therapies Design: Prospective, randomized, open-label, blinded end-point evaluation ( PROBE) Population: N = 8888 with previous MI Treatment: Atorvastatin 80 mg, simvastatin 20-40 mg/d Primary outcome:Coronary death, nonfatal MI, resuscitated cardiac arrest Secondary outcomes: Major CVD (primary event, stroke), CHD (primary event, coronary revascularization, hospitalization for UA), any CVD (any of the above, PAD, hospitalization for CHF), all-cause mortality Follow-up: Median 4.8 years Pedersen TR et al. JAMA. 2005;294:2437-45.

  3. IDEAL: Reduction in primary endpoint Incremental Decrease in End Points Through Aggressive Lipid Lowering Major coronary event* 16 Simvastatin 12 11% RRRHR = 0.89 (95% CI, 0.78–1.01) P = 0.07 Cumulativehazard (%) 8 Atorvastatin 4 0 0 1 2 3 4 5 Time from randomization (years) No. at risk Simvastatin 4449 4293 4165 4037 3917 1200 Atorvastatin 4439 4285 4170 4053 3940 1182 *Death from CAD, nonfatal MI, cardiac arrest with resuscitation Pedersen TR et al. JAMA. 2005;294:2437-45.

  4. IDEAL: Reduction in secondary endpoints Incremental Decrease in End Points Through Aggressive Lipid Lowering Any coronary heart disease* Any cardiovascular disease† 16% RRRHR = 0.84 (95% CI, 0.78–0.91) P < 0.001 40 40 16% RRRHR = 0.84 (95% CI, 0.76–0.91) P < 0.001 30 30 Simvastatin Cumulativehazard (%) Simvastatin 20 20 Atorvastatin Atorvastatin 10 10 0 0 0 1 2 3 4 5 0 1 2 3 4 5 Time from randomization (years) Time from randomization (years) No. at risk Simvastatin 4449 3937 3920 3527 3370 1002 Atorvastatin 4439 3984 3799 3632 3496 1032 4449 3841 3580 3338 3127 908 4439 3902 3671 3469 3299 963 *Major coronary event, hospitalization for UA, coronary revascularizations †CHD endpoints, peripheral vascular disease, hospitalization for nonfatal CHF Pedersen TR et al. JAMA. 2005;294:2437-45.

  5. IDEAL: Summary Incremental Decrease in End Points Through Aggressive Lipid Lowering • High-dose atorvastatin vs usual-dose simvastatin in post-MI patients: • Trend to benefit in primary outcome (11% RRR) • Significant reductions in composite secondary outcomes (13% to 16%) • No difference between groups in all-cause or CV mortality • No difference between groups in serious adverse events • Incidence of liver enzyme elevation with atorvastatin was <1% and comparable with results of other trials 4 studies now support aggressive lipid lowering to reduce CV events in high-risk patients: IDEAL, PROVE IT-TIMI 22, A to Z, TNT Pedersen TR et al. JAMA. 2005;294:2437-45.Cannon CP. JAMA. 2005;294:2492-4.

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