Document Detail

Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal.
MedLine Citation:
PMID:  20585068     Owner:  NLM     Status:  MEDLINE    
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.
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    
Laboratoire Coeur and Nutrition, Faculty of Medicine, Université Joseph Fourier and Centre National de Recherche Scientifique, Grenoble, France.
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MeSH Terms
Anticholesteremic Agents / therapeutic use*
Cardiovascular Diseases* / blood,  epidemiology,  prevention & control
Cholesterol / blood*
Drug Therapy, Combination
Fluorobenzenes / therapeutic use*
France / epidemiology
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
Pyrimidines / therapeutic use*
Randomized Controlled Trials as Topic
Risk Factors
Sulfonamides / therapeutic use*
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
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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