Document Detail


Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial.
MedLine Citation:
PMID:  11277825     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome, but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events.
OBJECTIVE: To determine whether treatment with atorvastatin, 80 mg/d, initiated 24 to 96 hours after an acute coronary syndrome, reduces death and nonfatal ischemic events.
DESIGN AND SETTING: A randomized, double-blind trial conducted from May 1997 to September 1999, with follow-up through 16 weeks at 122 clinical centers in Europe, North America, South Africa, and Australasia.
PATIENTS: A total of 3086 adults aged 18 years or older with unstable angina or non-Q-wave acute myocardial infarction.
INTERVENTIONS: Patients were stratified by center and randomly assigned to receive treatment with atorvastatin (80 mg/d) or matching placebo between 24 and 96 hours after hospital admission.
MAIN OUTCOME MEASURES: Primary end point event defined as death, nonfatal acute myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization.
RESULTS: A primary end point event occurred in 228 patients (14.8%) in the atorvastatin group and 269 patients (17.4%) in the placebo group (relative risk [RR], 0.84; 95% confidence interval [CI], 0.70-1.00; P =.048). There were no significant differences in risk of death, nonfatal myocardial infarction, or cardiac arrest between the atorvastatin group and the placebo group, although the atorvastatin group had a lower risk of symptomatic ischemia with objective evidence and requiring emergency rehospitalization (6.2% vs 8.4%; RR, 0.74; 95% CI, 0.57-0.95; P =.02). Likewise, there were no significant differences between the atorvastatin group and the placebo group in the incidence of secondary outcomes of coronary revascularization procedures, worsening heart failure, or worsening angina, although there were fewer strokes in the atorvastatin group than in the placebo group (12 vs 24 events; P =.045). In the atorvastatin group, mean low-density lipoprotein cholesterol level declined from 124 mg/dL (3.2 mmol/L) to 72 mg/dL (1.9 mmol/L). Abnormal liver transaminases (>3 times upper limit of normal) were more common in the atorvastatin group than in the placebo group (2.5% vs 0.6%; P<.001).
CONCLUSION: For patients with acute coronary syndrome, lipid-lowering therapy with atorvastatin, 80 mg/d, reduces recurrent ischemic events in the first 16 weeks, mostly recurrent symptomatic ischemia requiring rehospitalization.
Authors:
G G Schwartz; A G Olsson; M D Ezekowitz; P Ganz; M F Oliver; D Waters; A Zeiher; B R Chaitman; S Leslie; T Stern;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  285     ISSN:  0098-7484     ISO Abbreviation:  JAMA     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-03-30     Completed Date:  2001-04-19     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1711-8     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Angina, Unstable / blood,  drug therapy*
Anticholesteremic Agents / therapeutic use*
Double-Blind Method
Female
Heptanoic Acids / therapeutic use*
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
Lipids / blood
Male
Middle Aged
Myocardial Infarction / blood,  drug therapy*
Proportional Hazards Models
Pyrroles / therapeutic use*
Recurrence
Survival Analysis
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Heptanoic Acids; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Lipids; 0/Pyrroles; A0JWA85V8F/atorvastatin
Comments/Corrections
Comment In:
JAMA. 2001 Aug 1;286(5):532-3; author reply 533-5   [PMID:  11476649 ]
JAMA. 2001 Apr 4;285(13):1758-60   [PMID:  11277832 ]
Curr Atheroscler Rep. 2002 Jan;4(1):11-3   [PMID:  11772416 ]
JAMA. 2001 Aug 1;286(5):533-5   [PMID:  11476650 ]
Summary for patients in:
Curr Cardiol Rep. 2002 Nov;4(6):485   [PMID:  12379168 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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