Top Things to Know: Statin Safety & Associated Adverse Events
- More than 25% of U.S. adults over the age of 40 take a statin to reduce the risk of myocardial infarction, ischemic stroke, and other complications of atherosclerotic disease, though long-term adherence is not optimal with roughly 10% of patients stopping statins because of subjective complaints, most commonly muscle symptoms without raised creatine kinase.
- This scientific statement provides a rigorous examination of statin safety and tolerability, and reviews adverse effects of statins, adverse events associated with, but not necessarily caused by statins, and drug interactions. In addition, the safety of statins in patient groups potentially vulnerable to adverse events is evaluated.
- Results of randomized controlled trials and subsequent meta-analyses largely drive the conclusions of this statement and with support from observational data for a minority of potential adverse events.
- Myopathy, including rhabdomyolysis, attributable to statin therapy occurs in <0.1% of patients at maximal recommended doses. Myopathy and rhabdomyolysis risk are related to circulating active drug concentrations and are therefore higher in the presence of drugs that interfere with statin metabolism.
- Nonserious muscle symptoms are commonly reported during statin therapy and interfere with treatment compliance, but overall less than 1% of statin-treated patients have muscle symptoms of pharmacological origin. There is increasing appreciation of the role of patient expectations of harm as the cause of muscle and other symptoms in statin-treated patients.
- There is no convincing evidence for a causal relationship between statins and cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, or tendonitis.
- Statin therapy modestly increases the risk of developing diabetes, via mechanisms not yet understood. The risk of statin-induced newly diagnosed diabetes is about 0.2% per year of treatment, depending on the underlying risk of diabetes mellitus in the population studied. The increased risk of diabetes should not deter statin use in patients considered to be at sufficiently high CVD risk to warrant statin treatment.
- Although the evidence is not conclusive, statins possibly increase the risk of hemorrhagic stroke in patients with a history of cerebrovascular disease. However, they clearly produce a greater reduction in the risk of atherothrombotic stroke and thus total stroke, as well as other cardiovascular events.
- With the exception of hemorrhagic stroke and the possible exception of newly diagnosed diabetes and some cases of autoimmune necrotizing myositis, statin adverse effects can almost always be reversed by stopping treatment.
- Overall, in patients for whom statin treatment is recommended by current guidelines, the benefit of reducing cardiovascular risk with statin therapy greatly outweighs any safety concerns.
Citation
Newman CB, Preiss D, Tobert JA, Jacobson TA, Page RL 2nd, Goldstein LB, Chin C, Tannock LR, Miller M, Raghuveer G, Duell PB, Brinton EA, Pollak A, Braun LT, Welty FK, on behalf of the American Heart Association Clinical Lipidology, Lipoprotein, Metabolism and Thrombosis Committee, a Joint Committee of the Council on Atherosclerosis, Thrombosis and Vascular Biology and Council on Lifestyle and Cardiometabolic Health, Council on Lifelong Congenital Heart Disease and Heart Health in the Young, Council on Clinical Cardiology, and Stroke Council. Statin safety and associated adverse events: a scientific statement from the American Heart Association [published online ahead of print December 10, 2018]. Arterioscler Thromb Vasc Biol. DOI: 10.1161/ATV.0000000000000073