title: Design and baseline characteristics of the Incremental Decrease in End Points through Aggressive Lipid Lowering study.
abstract: The Incremental Decrease in End Points through Aggressive Lipid Lowering (IDEAL) study is an investigator-initiated trial designed to determine whether additional clinical benefit might be gained through a strategy that decreases levels of low-density lipoprotein cholesterol levels better than those currently achieved with established statin therapy in patients who have coronary heart disease. IDEAL is a multicenter prospective, randomized, open-label, blinded, end point classification study. Patients who had myocardial infarction were randomized to prescription treatment with 80 mg/day of atorvastatin or 20 mg/day of simvastatin (the dose was increased to 40 mg/day at week 24 in those patients whose plasma total cholesterol remained >5.0 mmol/L, or 190 mg/dl, or whose low-density lipoprotein cholesterol remained >3.0 mmol/L, or 115 mg/dl). The primary clinical outcome variable is the time to initial occurrence of a major coronary event, which is defined as nonfatal acute myocardial infarction, coronary death, or resuscitated cardiac arrest. The study is designed to have a power of 90% to detect a relative decrease of 20% in the atorvastatin-group compared with the simvastatin-group in the number of major events caused by coronary heart disease over approximately 5.5 years. The 8,888 randomized patients had the following characteristics: mean age 61.7 +/- 9.5 years, 19.1% women (mean age 64.0 +/- 9.5 years), baseline total cholesterol 5.1 +/- 1.0 mmol/L (197 mg/dl), low-density lipoprotein cholesterol 3.2 +/- 0.9 mmol/L (124 mg/dl), and high-density lipoprotein cholesterol 1.2 +/- 0.3 mmol/L (46 mg/dl). Drug treatment before randomization consisted of statins in 77% of patients, aspirin in 78.9%, beta blockers in 75.1%, and angiotensin-converting enzyme inhibitors in 30%.
authors.affiliation: Center for Preventive Medicine, Ullevål University Hospital, N-0407 Oslo, Norway. t.r.pedersen@ioks.uio.no
authors.forename: Terje R
authors.initials: TR
authors.lastname: Pedersen
authors.forename: Ole
authors.initials: O
authors.lastname: Faergeman
authors.forename: John J P
authors.initials: JJ
authors.lastname: Kastelein
authors.forename: Anders G
authors.initials: AG
authors.lastname: Olsson
authors.forename: Matti J
authors.initials: MJ
authors.lastname: Tikkanen
authors.forename: Ingar
authors.initials: I
authors.lastname: Holme
authors.forename: Mogens Lytken
authors.initials: ML
authors.lastname: Larsen
authors.forename: Fredrik S
authors.initials: FS
authors.lastname: Bendiksen
authors.forename: Christina
authors.initials: C
authors.lastname: Lindahl
authors.forename: Gary
authors.initials: G
authors.lastname: Palmer
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects*; D003327:Coronary Disease / Q000517:prevention & control*; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011758:Pyrroles / Q000627:therapeutic use*; D012107:Research Design; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin; D019821:Simvastatin