The New England Journal of Medicine has published the results (PDF) of the JUPITER study. This study has been reported in the general media (BBC) with an indication that treatment recommendations may need to be revised based on the findings.
The study was a primary prevention study in patients at high risk of cardiovascular events with risk defined by age and blood levels of high-sensitivity C-reactive protein (CRP) but low-density lipoprotein levels (LDL-C) below 3.4mmol/L.
The study recruited 17,802 patients and randomly assigned them to treatment with rosuvastatin 20mg or placebo. The primary endpoint of the study was a combination of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for unstable angina and death from cardiovascular causes.
The study found a statistically significant relative risk reduction of 44% in the primary outcome (Hazard Ratio = 0.56; 95% CI, 0.46 to 0.69; P<0.00001). There were similar risk reductions for stroke and MI when analysed as secondary outcomes. Treatment reduced LDL-C by 50% and CRP by 37%.
The study was originally designed to be event driven, reaching adequate statistical power when 520 primary events had occurred. The study was stopped early when the benefits became clear however only 393 primary events had occurred. This may impact on the overall validity of the results.
An accompanying editorial (PDF) points out that absolute risk reductions are an important consideration before implementing changes to practice. Absolute benefits must be weighed against the associated risks and costs of the treatment in deciding if the intervention is clinically appropriate.
The editorial also notes that evidence already exists that statins reduce the risk of cardiovascular events in those at high risk. Guidelines that recommend a threshold level of cardiovascular risk before starting treatment are based on economic evaluations; this new evidence will almost certainly initiate a review of the current guidelines to balance the benefits of treatment and its long-term safety and cost.
Action: The results of this study need careful analysis before changes are made to national guidelines and current practice. Clinicians should continue to implement existing guidance.