If mild to moderate muscle symptoms develop during statin therapy:.If unexplained severe muscle symptoms or fatigue develop during statin therapy, promptly discontinue the statin and address the possibility of rhabdomyolysis by evaluating CK, creatinine, and a urinalysis for myoglobinuria.To avoid unnecessary discontinuation of statins, obtain a history of prior or current muscle symptoms to establish a baseline before initiating statin therapy.It is reasonable to evaluate and treat muscle symptoms, including pain, tenderness, stiffness, cramping, weakness, or fatigue, in statin-treated patients according to the following management algorithm: (IIa B)
Patient characteristics or concomitant use of drugs affecting statin metabolism.Īdditional characteristics that may modify the decision to use higher statin intensities may include, but are not limited to:.Unexplained ALT elevations >3 times ULN.History of previous statin intolerance or muscle disorders.Multiple or serious comorbidities, including impaired renal or hepatic function.Moderate-intensity statin therapy should be used in individuals in whom high-intensity statin therapy would otherwise be recommended when characteristics predisposing them to statin associated adverse effects are present.Ĭharacteristics predisposing individuals to statin adverse effects include, but are not limited to: To maximize the safety of statins, selection of the appropriate statin and dose in men and nonpregnant/nonnursing women should be based on patient characteristics, level of ASCVD risk, and potential for adverse effects. ‡ Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis.† Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study (47).There might be a biological basis for a less-than-average response. * Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice.BID indicates twice daily CQ, critical question FDA, Food and Drug Administration LDL-C, low-density lipoprotein cholesterol and RCTs, randomized controlled trials
Italic type indicates statins and doses that are approved by the FDA but have not been tested in the RCTs reviewed. All of these RCTs demonstrated a reduction in major cardiovascular events. Boldface type indicates specific statins and doses that were evaluated in RCTs ( 16– 17, 18– 46, 47– 48, 49) included in CQ1, CQ2, and the Cholesterol Treatment Trialists 2010 meta-analysis included in CQ3 ( 20).
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