High-Dose Atorvastatin vs Usual-Dose Simvastatin for Secondary Prevention After Myocardial Infarction: The IDEAL Study: A Randomized Controlled Trial

• Published in: JAMA : the journal of the American Medical Association 2005-11, Vol.294 (19), p.2437-2445
• Main Authors: Pedersen, Terje R, Faergeman, Ole, Kastelein, John J. P, Olsson, Anders G, Tikkanen, Matti J, Holme, Ingar, Larsen, Mogens Lytken, Bendiksen, Fredrik S, Lindahl, Christina, Szarek, Michael, Tsai, John, Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group, for the
• Format: Article
• Language: English
• Subjects: Aged; Atorvastatin Calcium; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Cholesterol, LDL - blood; Coronary heart disease; Coronary vessels; Drug dosages; Female; General aspects; Heart; Heart attacks; Heptanoic Acids - administration & dosage; Heptanoic Acids - therapeutic use; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Low density lipoprotein; Male; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Myocardial Infarction - prevention & control; Myocarditis. Cardiomyopathies; Prevention; Proportional Hazards Models; Prospective Studies; Pyrroles - administration & dosage; Pyrroles - therapeutic use; Risk; Simvastatin - administration & dosage; Simvastatin - therapeutic use
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.294.19.2437

CONTEXT Evidence suggests that more intensive lowering of low-density lipoprotein cholesterol (LDL-C) than is commonly applied clinically will provide further benefit in stable coronary artery disease. OBJECTIVE To compare the effects of 2 strategies of lipid lowering on the risk of cardiovascular disease among patients with a previous myocardial infarction (MI). DESIGN, SETTING, AND PARTICIPANTS The IDEAL study, a prospective, randomized, open-label, blinded end-point evaluation trial conducted at 190 ambulatory cardiology care and specialist practices in northern Europe between March 1999 and March 2005 with a median follow-up of 4.8 years, which enrolled 8888 patients aged 80 years or younger with a history of acute MI. INTERVENTIONS Patients were randomly assigned to receive a high dose of atorvastatin (80 mg/d; n = 4439), or usual-dose simvastatin (20 mg/d; n = 4449). MAIN OUTCOME MEASURE Occurrence of a major coronary event, defined as coronary death, confirmed nonfatal acute MI, or cardiac arrest with resuscitation. RESULTS During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group. A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07). Nonfatal acute MI occurred in 321 (7.2%) and 267 (6.0%) in the 2 groups (HR, 0.83; 95% CI, 0.71-0.98; P = .02), but no differences were seen in the 2 other components of the primary end point. Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% CI, 0.77-0.98; P = .02). Occurrence of any coronary event was reported in 1059 simvastatin and 898 atorvastatin patients (HR, 0.84; 95% CI, 0.76-0.91; P