Document Detail


Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal.
MedLine Citation:
PMID:  20585068     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Among the recently reported cholesterol-lowering drug trials, the JUPITER (Justification for the Use of Statins in Primary Prevention) trial is unique: it reports a substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels.
METHODS: Careful review of both results and methods used in the trial and comparison with expected data.
RESULTS: The trial was flawed. It was discontinued (according to prespecified rules) after fewer than 2 years of follow-up, with no differences between the 2 groups on the most objective criteria. Clinical data showed a major discrepancy between significant reduction of nonfatal stroke and myocardial infarction but no effect on mortality from stroke and myocardial infarction. Cardiovascular mortality was surprisingly low compared with total mortality-between 5% and 18%-whereas the expected rate would have been close to 40%. Finally, there was a very low case-fatality rate of myocardial infarction, far from the expected number of close to 50%. The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study.
CONCLUSION: The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.
Authors:
Michel de Lorgeril; Patricia Salen; John Abramson; Sylvie Dodin; Tomohito Hamazaki; Willy Kostucki; Harumi Okuyama; Bruno Pavy; Mikael Rabaeus
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Archives of internal medicine     Volume:  170     ISSN:  1538-3679     ISO Abbreviation:  Arch. Intern. Med.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-29     Completed Date:  2010-07-29     Revised Date:  2010-12-27    
Medline Journal Info:
Nlm Unique ID:  0372440     Medline TA:  Arch Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1032-6     Citation Subset:  AIM; IM    
Affiliation:
Laboratoire Coeur and Nutrition, Faculty of Medicine, Université Joseph Fourier and Centre National de Recherche Scientifique, Grenoble, France. michel.delorgeril@ujf-grenoble.fr
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MeSH Terms
Descriptor/Qualifier:
Anticholesteremic Agents / therapeutic use*
Cardiovascular Diseases* / blood,  epidemiology,  prevention & control
Cholesterol / blood*
Drug Therapy, Combination
Fluorobenzenes / therapeutic use*
France / epidemiology
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
Incidence
Pyrimidines / therapeutic use*
Randomized Controlled Trials as Topic
Risk Factors
Sulfonamides / therapeutic use*
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Fluorobenzenes; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Pyrimidines; 0/Sulfonamides; 287714-41-4/rosuvastatin; 57-88-5/Cholesterol
Comments/Corrections
Comment In:
Arch Intern Med. 2010 Nov 8;170(20):1860-1; author reply 1861   [PMID:  21059984 ]
Arch Intern Med. 2010 Dec 13;170(22):2042; author reply 2043-4   [PMID:  21149770 ]
Arch Intern Med. 2010 Jun 28;170(12):1007-8   [PMID:  20585062 ]

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