The Jupiter trial is a case in point, published in the prestigious NEJM. If you look at the numbers you will see less than a 1% risk reduction per 100patient years for stroke and heart attack. This could also be phrased as a 99% chance the drug does nothing. Then consider liver, muscle toxicity and diabetic risk to balance the efficacy of the drug. ‘The rates of the primary endpoint were .77 and 1.36 per 100 person years in the rosuvastatin and placebo groups respectively’. They then state this is s 56% risk reduction. In medicine where we live on the multiple normal distributions of a biological system, I would say less that a 1% absolute risk reduction means the treatment is poor to useless. Note also that diabetes went up in the statin group
Vascular risk is best modified by exercise, normal weight, treating hypertension, healthy food choices. Most patients that take statins in the United States have metabolic syndrome which includes elevated lipids but is secondary to obesity. Taking a pill for cholesterol in isolation is not going to modify risk.
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METHODS
We randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein
(LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.
RESULTS
The trial was stopped after a median follow-up of 1.9 years (maximum, 5.0). Rosuvastatin reduced LDL cholesterol levels by 50% and high-sensitivity C-reactive protein levels by 37%. The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46 to 0.69; P<0.00001), with corresponding rates of 0.17 and 0.37 for myocardial infarction (hazard ratio, 0.46; 95% CI, 0.30 to 0.70; P=0.0002), 0.18 and 0.34 for stroke (hazard ratio, 0.52; 95% CI, 0.34 to 0.79; P=0.002), 0.41 and 0.77 for revascularization or unstable angina (hazard ratio, 0.53; 95% CI, 0.40 to 0.70; P<0.00001), 0.45 and 0.85 for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes (hazard ratio, 0.53; 95% CI, 0.40 to 0.69; P<0.00001), and 1.00 and 1.25 for death from any cause (hazard ratio, 0.80; 95% CI, 0.67 to 0.97; P=0.02). Consistent effects were observed in all subgroups evaluated. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes
CONCLUSIONS
In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)
Introduction
Methods
TRIAL DESIGN
JUPITER was a randomized, double-blind, placebo-controlled, multicenter trial conducted at 1315 sites in 26 countries (see the Supplementary Appendix, available with the full text of this article at www.nejm.org). The trial protocol was designed and written by the study chair and approved by the local institutional review board at each participating center. The trial data were analyzed by the academic study statistician and the academic programmer. The academic authors vouch for the accuracy and completeness of the data and the analyses.
The trial was financially supported by AstraZeneca. The sponsor collected the trial data and
