Statin Safety: What Every Health Care Provider Needs to Know

Purpose of Review: A key target for quality improvement in preventive cardiology is statin therapy, which is underutilized in appropriate high-risk patients for LDL-lowering to prevent atherosclerotic cardiovascular disease events. Translation of statin evidence to practice may be impeded by exaggerated concerns about adverse effects. We aim to cut through an immense amount of controversy in the scientific and mainstream discourse of statin safety by clearly demarcating the reported adverse events based on the reliability of the supporting evidence. Recent Findings: In large-scale randomized controlled trials, statin therapy achieving 80 mg/dl (2 mmol/L) reduction in serum LDL-C for 5 years in 10,000 patients would prevent major vascular events in ~ 1000 secondary prevention and ~ 500 primary prevention patients with cardiovascular risk factors. Compared to these benefits, the incidence of adverse events is remarkably low. Based on the same high-quality trial evidence, treatment of 10,000 patients with a standard statin therapy for 5 years would be expected to lead to 5 new cases of myopathy, 50–100 cases of diabetes, and possibly 5–10 cases of hemorrhagic stroke. These adverse effects have already been accounted for in estimates of benefits. Various other adverse events have been misattributed to statins mainly as a result of the large biases inherent in observational studies, which are not designed to assess drug treatment effects. Summary: Large-scale randomized evidence indicates that a small increase in myopathy, diabetes, and hemorrhagic stroke may occur with statin therapy, but these adverse effects are greatly outweighed by the cardiovascular benefit of statin therapy. When evaluating statin safety, the reliability of underlying evidence warrants close consideration.