In February, the U.S. Food and Drug Administration approved the labeling of rosuvastatin (Crestor) for the primary prevention of heart disease in patients with an elevated C-reactive protein level and at least one other risk factor, based on a controversial study known as JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). In a previous editorial, AFP medical editors Colin Kopes-Kerr, MD and Mark Ebell, MD, MS estimated that implementing JUPITER's approach to screening and treatment in clinical practice would cost more than $800,000 in testing, physician visits, and medications to prevent a single premature cardiovascular death over two years. They argued that this approach would be far more costly, but less beneficial, than counseling patients about healthy lifestyle changes:
The biggest problem with the JUPITER study is that it suggests that physicians continue to test and treat. First, though, we need to take time to think. One of the things to ponder is this: Couldn’t we do something better for patients than measuring everyone’s CRP levels and treating those with elevated values? Instead, we should wait for a study comparing CRP measurement to routine coronary risk factor assessment, including studies on cost-benefit analysis. We already know that lifestyle changes are effective and, therefore, we should focus on innovative ways to assist patients in making these changes.
In an exchange of Letters in the September 15th issue of AFP, one of the JUPITER's principal investigators defends the conduct of the study (which ended earlier than planned due to a "dramatic" statistical difference in cardiovascular outcomes between the rosuvastatin and placebo groups) and challenges the editorial's portrayal of this intervention as not worth pursuing in primary care. Dr. Kopes-Kerr's and Dr. Ebell's rebuttal highlights some important concepts in evidence-based medicine, including interpretation of P values and numbers needed to treat. (See this short article by AFP editor Allen Shaughnessy, PharmD for more information on evaluating and understanding articles about treatment.)
Since coronary heart disease risk assessment, prevention, and management can be complex, we have organized all of AFP's relevant articles and other resources in a convenient collection that will be updated whenever new information is published. We hope that this and other AFP By Topic collections will help you make confident clinical decisions. Please let us know if there is anything we can do to make them more useful in your practice.