To Give or Not to Give? Statins for Primary Prevention
Cardiovascular diseases are the leading cause of death worldwide. The role of statin therapy in reducing the recurrence of Myocardial Infarction (MI) after an episode (secondary prevention) and in reducing the risk in patients with risk factors of Coronary Artery Disease (CAD) is well documented by several large Randomized Controlled Trials (RCT’s). However, whether statins should be used for reducing the incidence for MI in people with low risk factors at baseline (primary prevention) remains a gray area. Recently, several leading medical journals such as Journal of American Medical Association (JAMA) published debates both in favor and against the use of statins in primary prevention, re-igniting the interest in the field.
Despite the relatively low risk profile of statins, these agents like any other drugs are not free from adverse effects. While myopathy and elevated liver function tests are well known side effects, long term studies have shown more serious consequences such as an increased risk to develop diabetes. This has ranged from an increased risk of 48% in post-menopausal women (Arch Intern Med. 2012), 25% in the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) Trial (NEJM: 2008), and to 13% in a meta-analysis of 57,593 patients (Diabetes Care: 2009).
On the other hand, the role of statins in reducing both cardiovascular and all cause mortality is almost unequivocal even for primary prevention. Kostis et al (J Am Coll Cardiol. 2012) in a meta-analysis of 18 trials on 141,235 patients showed the beneficial effect in both men and women whether for primary or secondary prevention. Similarly the JUPITER trial showed that the aggressive lowering of Low Density Lipid (LDL-C) in the rovustatin group (20 mg per day) lead to a 44% reduction in the risk of myocardial infarction, stroke, and revascularization.
With on-going debate on the role of statins in primary prevention and its mediation of insulin resistance, it is imperative to highlight the imperative role of dietary modifications and exercise on favorable lipid profile. Statins continue to act as useful adjuncts despite elusive role in primary prevention. Clinicians should make their decisions on risk based individualized treatment decisions. Food and Drug Administration (FDA) has inculcated more information in the statin labels about increased glycosylated hemoglobin levels in those with statin therapy and that “FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”