A large clinical trial (JUPITER) demonstrated efficacy of a statin in primary prevention of cardiovascular events in menopausal women. Understand the appropriate circumstances by which ob/gyns should prescribe statins for women.
Q. A large recent clinical trial (JUPITER) demonstrated the efficacy of a statin in primary prevention of cardiovascular events in menopausal women.1 Under what circumstances should ob/gyns prescribe statins for women? What are the goals and risks, and when should a patient be referred to a cardiologist?
A. The evidence supporting the use of statins in primary prevention of cardiovascular events in women has been scant until recently, largely because women have been traditionally underrepresented in most statin trials.2 What evidence there is has been consistent with the evidence in men, but with a higher number needed to treat, and women in secondary prevention trials have consistently had a cardiovascular event reduction on statins comparable to men. The JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) trial added dramatically to the database of primary prevention data in women.1 In this trial, 17,802 multiethnic, apparently healthy men and women (38%) with low-density lipoprotein cholesterol (LDL-C) levels of less than 130 mg/dL and high-sensitivity C-reactive protein (hs-CRP, a marker of vascular inflammation and insulin resistance) levels of 2.0 mg/L or higher were assigned to rosuvastatin (20 mg daily or placebo) and followed for occurrence of the combined primary endpoints of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. The trial was stopped after a median follow-up of 1.9 years because of significant benefit in the rosuvastatin arm of the trial. Rosuvastatin is the most potent statin; it reduced LDL-C by 50% and hs-CRP levels by 37%. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a slightly higher incidence of physician-reported diabetes.
The intensity and goals of cardiovascular risk reduction strategies are proportionate to the individual patient's cardiovascular risk evaluation. The National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III guidelines remain the cornerstone of risk assessment and treatment.3 Assessment of the 5 major risk factors-family history of premature cardiovascular disease, low high-density lipoprotein cholesterol (HDL-C <50 mg/dL), older than age 55, smoking, and hypertension-plus calculation of the Framingham Risk Score-help determine 10-year cardiovascular risk. "Low-risk" women also have cardiac events, which led to the concept of "lifetime risk evaluation": women more than 50 years old with 1 risk factor are considered to be at increased lifetime risk.4 High-risk women are those with established coronary heart disease (CHD), cerebrovascular disease, peripheral arterial disease, abdominal aortic aneurysm, end-stage or chronic renal disease, diabetes mellitus, or 10-year Framingham Risk Score greater than 20%.