title: The JUPITER trial: myth or reality?
abstract: The JUPITER trial is widely hailed as a landmark trial that has the potential to dramatically change the landscape of primary prevention of cardiovascular disease. Like most trials, however, it is not without its limitations. We address some of the common myths and misunderstandings that are underscored by the JUPITER trial. First, by its intentional and ill-advised exclusion of patients with low levels of high-sensitivity C-reactive protein (hsCRP), it is not possible to assess whether baseline hsCRP modifies treatment response to statins or whether it identifies patients most likely to benefit from statin therapy. Second, by stopping the trial early, one cannot rule out the possibility that the treatment benefit was overestimated and risk was underestimated, thereby precluding a reliable estimate of benefit/risk. Finally, as a consequence of early stopping, it is not possible to reliably assess the cost-effectiveness of primary prevention with rosuvastatin. Given these limitations, the attendant societal health policy implications remain largely unknown.
authors.affiliation: Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA. ryan.morrissey@cshs.org
authors.forename: Ryan P
authors.initials: RP
authors.lastname: Morrissey
authors.forename: George A
authors.initials: GA
authors.lastname: Diamond
authors.forename: Sanjay
authors.initials: S
authors.lastname: Kaul
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D011322:Primary Prevention; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D018570:Risk Assessment; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States
chemical_list: D015415:Biomarkers; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D002097:C-Reactive Protein