Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE)-rationale and design of atorvastatin versus usual care in hypercholesterolemic patients with coronary artery disease.

摘要: G of the National Cholesterol Education Program (NCEP) and other national international organizations are now placing increased emphasis on importance effective reduction cholesterol, in particular low-density lipoprotein (LDL) patients with coronary artery disease (CAD).1,2 These recommendations based overwhelming evidence from epidemiologic studies clinical trials.3–9 More recent have led to suggestion that additional benefit may be gained by lowering LDL cholesterol beyond currently recommended levels. The Post-Coronary Artery Bypass Graft trial demonstrated who had undergone bypass grafts, there was significantly less progression atherosclerosis an aggressive approach (to a mean 93 97 mg/dl [2.4 2.5 mmol/L]) compared moderate treatment strategy (mean level 132 136 [3.4 3.5 mmol/L]).10 In Atorvastatin Versus Revascularization Treatments study, stable CAD were randomized receive atorvastatin 80 mg/day or angioplasty and/or usual medical care.11 36% relative risk ischemic events showed trend toward significance associated 77 (1.99 mmol/L) 119 (2.08 angioplasty/usual-care group. • Aggressive Lipid Lowering Initiation Abates New Cardiac Events (ALLIANCE) is ongoing 4-year, population-based, randomized, open-label study lipid care regimen managed healthcare setting. has been shown reduce 41% 61% over 10to 80-mg/day dose range.12 Furthermore, head-to-head evaluations, 10 40 greater reductions than milligramequivalent doses simvastatin, pravastatin, fluvastatin, lovastatin.13 primary objective ALLIANCE test hypothesis levels NCEP guidelines can provide incremental terms reducing incidence major existing CAD. Men women aged 18 75 years history identified relevant organization (MHCO) databases. defined as 1 following: acute myocardial infarction (.3 months before screening), percutaneous transluminal (.6 graft surgery unstable angina screening). Patients chronic awaiting revascularization procedures not enrolled study. Major exclusion criteria were: breastfeeding pregnancy; childbearing age planned become pregnant during study; did practice method birth control considered acceptable investigator; any significant abnormalities investigator believed compromise patient’s safety successful completion process likely limit life duration all cancers (excluding basal cell squamous skin cancers); York Heart Association class III IV congestive heart failure; known hypersensitivities hydroxymethylglutaryl coenzyme A reductase inhibitors. Informed consent obtained From Metabolic Atherosclerosis Research Center, Cincinnati, Ohio; Chicago Center for Clinical Research, Chicago, Illinois; Departments Medicine Pharmacology, University Minnesota, Minneapolis, Minnesota; Parke-Davis Pharmaceutical Ann Arbor, Michigan. This being sponsored Division Warner Lambert Company, Michigan; Pfizer Inc., York, York. Mr. Singer’s address is: 2800 Plymouth Road, Michigan 48105. Manuscript received August 16, 1999; revised manuscript accepted February 2, 2000. TABLE I Cardiovascular Outcomes