Astronomical Science or Astronomical Marketing?

Impartial questions should always be asked when a pharmaceutical company sponsors a major clinical trial. This statement especially applies when a clinical trial purports to offer significant new targeted information on a proprietary medication that appears to change the relevance of that medication to medical practice. It is appropriate to ask such questions regarding the much publicized study Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER).¹ Is this astronomical science or astronomical marketing? JUPITER reported on 17,802 apparently healthy men and women with low-density lipoprotein cholesterol (LDL-C) lower than 130 mg/dL and high-sensitivity C-reactive protein (hsCRP) 2.0 mg/L or greater. The patients were randomized to take rosuvastatin 20 mg/day or placebo over a median follow-up of 1.9 years. It was reported that the men and women who received rosuvastatin had fewer coronary heart disease (CHD) events as compared to placebo.

The study was clearly another large and extensive outcomes study confirming the value of a statin in CHD prevention. The study also supported a causative hsCRP role in CHD and backed up the concept of “lower is better” for LDL-C.² However, this information is well-established, and major new science in JUPITER is lacking. All statins have been shown to lower LDL-C³ and hsCRP⁴ related to potency. Furthermore, neither statins in a high dose nor the most potent statins are necessary to attain a significant decrease in the hsCRP. This is frequently important because the dose of a statin can be kept low to reduce myopathy risk⁵ and still achieve significant LDL-C and hsCRP reduction by adding ezetimibe,⁴ including the attainment of an LDL-C lower than 70 mg/dL in the patient at high risk for CHD. Every time the dose of a statin is doubled, the LDL-C only decreases by an average of 6%.³ On the other hand, data initially submitted to the Food and Drug Administration (FDA) for each statin have shown that higher statin doses cause more problems, especially myopathy, and a review of various studies has shown a possible incidence of statin-related myopathy of up to 9%.⁵ Findings reported in JUPITER may result in a push to switch to rosuvastatin, a 20-mg dose of which is appropriate for difficult hypercholesterolemia; however, this high dose carries more risk of myopathy than comparably lower doses of rosuvastatin or other statins.⁵ In no case should a patient’s statin be selected or switched based on marketing or insurance reasons. Hopefully, JUPITER, which is a valuable outcomes study with additional data supporting the value of hsCRP as a CHD risk factor and which offers further support for the value of statins in the prevention of CHD, will be kept in context.

The author reports no relevant financial relationships.

Dr. Whayne is Professor of Medicine (Cardiology), Gill Heart Institute, University of Kentucky, Lexington.