New York—About 10% of U.S. statin users—making up a forth of adults over 40— discontinue the medications because they experience symptoms they assume are a drug side effect.

A new scientific statement from the American Heart Association suggests that often is not true and that, overall, statins are associated with a low risk of side effects and have benefits outweighing any risks. The position paper was published in Circulation: Arteriosclerosis, Thrombosis and Vascular Biology.

The American Heart Association Clinical Lipidology, Lipoprotein, Metabolism and Thrombosis Committee notes that the most effective statins produce a mean reduction in low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage. The authors, led by NYU Langone Medical Center researchers, add that six of the seven marketed statins are available in generic form, which makes them affordable for most patients.

The scientific statement was based on data from randomized, controlled trials, supplemented with observational data where necessary. It discusses 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 review points out that the risk of statin-induced serious muscle injury, including rhabdomyolysis, is less than 0.1%, and the risk of serious hepatotoxicity is about 0.001%.
At the same time, The risk of statin-induced newly diagnosed diabetes mellitus is about 0.2% per year of treatment, depending on the underlying risk of diabetes mellitus in the population studied.

The authors write that while statins possibly increase the risk of hemorrhagic stroke in patients with cerebrovascular disease, the drugs definitively are linked to a greater reduction in the risk of atherothrombotic stroke and, as a result, 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,” the document states.

The committee discusses how, in about 10% of patients, statins are discontinued 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,” the authors explain. “This suggests that muscle symptoms are usually not caused by pharmacological effects of the statin.”

The AHA recommends restarting statin therapy in those patients, despite the challenges, adding, “It is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority.”

“In most cases, you should not stop taking your statin medication if you think you are having side effects from the drug—instead, talk to your healthcare provider about your concerns. Stopping a statin can significantly increase the risk of a heart attack or stroke caused by a blocked artery,” said Mark Creager, M.D., former president of the American Heart Association and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

The AHA recommends statin therapy for the following groups:
• Adults aged 40-75 years with LDL cholesterol of 70-189 mg/dL and a 7.5% or higher risk for having a heart attack or stroke within 10 years
• People with a history of a cardiovascular event (heart attack, stroke, stable or unstable angina, peripheral artery disease, transient ischemic attack, or coronary or other arterial revascularization)
• People age 21 years and older who have a very high level of LDL cholesterol (i.e., 190 mg/dL or higher)
• People with diabetes and an LDL cholesterol level of 70-189 mg/dL who are aged 40 to 75 years.

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