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Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association.

Publication ,  Journal Article
Newman, CB; Preiss, D; Tobert, JA; Jacobson, TA; Page, RL; Goldstein, LB; Chin, C; Tannock, LR; Miller, M; Raghuveer, G; Duell, PB; Pollak, A ...
Published in: Arterioscler Thromb Vasc Biol
February 2019

One in 4 Americans >40 years of age takes a statin to reduce the risk of myocardial infarction, ischemic stroke, and other complications of atherosclerotic disease. The most effective statins produce a mean reduction in low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage, and 6 of the 7 marketed statins are available in generic form, which makes them affordable for most patients. Primarily using data from randomized controlled trials, supplemented with observational data where necessary, this scientific statement provides a comprehensive review of statin safety and tolerability. The review covers the general patient population, as well as demographic subgroups, including the elderly, children, pregnant women, East Asians, and patients with specific conditions such as chronic disease of the kidney and liver, human immunodeficiency viral infection, and organ transplants. The risk of statin-induced serious muscle injury, including rhabdomyolysis, is <0.1%, and the risk of serious hepatotoxicity is ≈0.001%. The risk of statin-induced newly diagnosed diabetes mellitus is ≈0.2% per year of treatment, depending on the underlying risk of diabetes mellitus in the population studied. In patients with cerebrovascular disease, statins possibly increase the risk of hemorrhagic stroke; however, they clearly produce a greater reduction in the risk of atherothrombotic stroke and thus total stroke, as well as other cardiovascular events. There is no convincing evidence for a causal relationship between statins and cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, or tendonitis. In US clinical practices, roughly 10% of patients stop taking a statin because of subjective complaints, most commonly muscle symptoms without raised creatine kinase. In contrast, in randomized clinical trials, the difference in the incidence of muscle symptoms without significantly raised creatinine kinase in statin-treated compared with placebo-treated participants is <1%, and it is even smaller (0.1%) for patients who discontinued treatment because of such muscle symptoms. This suggests that muscle symptoms are usually not caused by pharmacological effects of the statin. Restarting statin therapy in these patients can be challenging, but it is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority. Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.

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Published In

Arterioscler Thromb Vasc Biol

DOI

EISSN

1524-4636

Publication Date

February 2019

Volume

39

Issue

2

Start / End Page

e38 / e81

Location

United States

Related Subject Headings

  • United States
  • Rhabdomyolysis
  • Randomized Controlled Trials as Topic
  • Muscular Diseases
  • Liver
  • Kidney
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Drug Interactions
  • Diabetes Mellitus
 

Citation

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Newman, C. B., Preiss, D., Tobert, J. A., Jacobson, T. A., Page, R. L., Goldstein, L. B., … 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 Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council, . (2019). Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol, 39(2), e38–e81. https://doi.org/10.1161/ATV.0000000000000073
Newman, Connie B., David Preiss, Jonathan A. Tobert, Terry A. Jacobson, Robert L. Page, Larry B. Goldstein, Clifford Chin, et al. “Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association.Arterioscler Thromb Vasc Biol 39, no. 2 (February 2019): e38–81. https://doi.org/10.1161/ATV.0000000000000073.
Newman CB, Preiss D, Tobert JA, Jacobson TA, Page RL, Goldstein LB, et al. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol. 2019 Feb;39(2):e38–81.
Newman, Connie B., et al. “Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association.Arterioscler Thromb Vasc Biol, vol. 39, no. 2, Feb. 2019, pp. e38–81. Pubmed, doi:10.1161/ATV.0000000000000073.
Newman CB, Preiss D, Tobert JA, Jacobson TA, Page RL, Goldstein LB, Chin C, Tannock LR, Miller M, Raghuveer G, Duell PB, Brinton EA, Pollak A, Braun LT, Welty FK, 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 Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol. 2019 Feb;39(2):e38–e81.

Published In

Arterioscler Thromb Vasc Biol

DOI

EISSN

1524-4636

Publication Date

February 2019

Volume

39

Issue

2

Start / End Page

e38 / e81

Location

United States

Related Subject Headings

  • United States
  • Rhabdomyolysis
  • Randomized Controlled Trials as Topic
  • Muscular Diseases
  • Liver
  • Kidney
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Drug Interactions
  • Diabetes Mellitus