Statins: Is It Really Time to Reassess Benefits and Risks?

Allison B. Goldfine, M.D.

N Engl J Med 2012; 366:1752-1755May 10, 2012

Article

References

Audio Interview

Interview with Dr. Allison Goldfine on statins, the associated risk of diabetes, and the FDA's response. (9:56)

No drug provides health benefits without some degree of risk, and risk–benefit assessments require ongoing review as new data become available. This is certainly the case for the use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors — statins — and the risk of new-onset diabetes.

Cardiovascular disease is the leading cause of illness and death in patients with type 2 diabetes. There is no doubt that for persons who have had an acute coronary syndrome or who have other risk factors for atherosclerotic coronary artery disease, statins effectively reduce the risks of death from any cause, death due to cardiovascular disease, fatal myocardial infarction, the need for revascularization, and stroke (see figure

Effect of Statins on Cardiovascular Event Rates, According to Reduction in LDL Cholesterol of 1 Millimole per Liter.). Over a period of 4 years of statin use, a reduction of 1 mmol per liter (39 mg per deciliter) in the level of low-density lipoprotein (LDL) cholesterol translates into a 9% reduction in the risk of death from any cause among patients with diabetes and a 13% reduction among those without diabetes.1 Benefits are realized within the first year of use but increase over time. Few drugs have had such a dramatic effect on health outcomes.