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June 18/25, 2019 Circulation. 2019;139:e1082–e1143. DOI: 10.1161/CIR.0000000000000625 e1118 CLINICAL STATEMENTS AND GUIDELINES Recommendation-Specific Supportive Text 1. A clinician–patient risk discussion focused on indications, benefits, risks of statin-associated side effects, and patient concerns and preferences should precede initiation of statin treatment.S5-2 This dialogue is the foundation of a longitudinal care partnership that is based on informed decision-making. Future encounters should address statin response, emphasize adherence, and reaffirm benefit. Statin-associated symptoms should be comprehensively assessed, and because most can be well managed,S5-3–S5-7 the goal should be to optimize patient-centered strategies for ASCVD prevention. 2. The majority of SAMS are subjective myalgia (pain, aches) in the absence of other findings.S5-13,S5-25,S5-30 Myalgia is more likely to be statin associated if it is bilateral, involves proximal muscles, has its onset within weeks to months after initiation of statins, and resolves after discontinuation of statins.S5-13,S5-14 A thorough assessment of symptoms is recommended, in addition to evaluation for nonstatin etiologies, assessment of predisposing factors, and a physical exam. Objective muscle weakness Table 11. Statin-Associated Side Effects (SASE) Statin-Associated Side Effects Frequency Predisposing Factors Quality of Evidence Statin-associated muscle symptoms (SAMS) Myalgias (CK normal) Infrequent (1% to 5%) in RCTs; frequent (5% to 10%) in observational studies and clinical setting Age, female sex, low body mass index, high-risk medications (CYP3A4 inhibitors, OATP1B1 inhibitors), comorbidities (HIV, renal, liver, thyroid, preexisting myopathy), Asian ancestry, excess alcohol, high levels of physical activity, and trauma RCTs cohorts/ observational Myositis/myopathy (CK > ULN) with concerning symptoms or objective weakness Rare RCTs cohorts/ observational Rhabdomyolysis (CK >10× ULN + renal injury) Rare RCTs cohorts/ observational Statin-associated autoimmune myopathy (HMGCR antibodies, incomplete resolution) Rare Case reports New-onset diabetes mellitus Depends on population; more frequent if diabetes mellitus risk factors are present, such as body mass index ≥30, fasting blood glucose ≥100 mg/dL; metabolic syndrome, or A1c ≥6%. Diabetes mellitus risk factors/metabolic syndrome RCTs/meta-analyses High-intensity statin therapy Liver Transaminase elevation 3× ULN Infrequent RCTs/cohorts/ observational Case reports Hepatic failure Rare Central nervous system Memory/cognition Rare Case reports; no increase in memory/ cognition problems in 3 large-scale RCTs Cancer No definite association RCTs/meta-analyses Other Renal function Unfounded Cataracts Unfounded Tendon rupture Unfounded Hemorrhagic stroke Unfounded Interstitial lung disease Unfounded Low testosterone Unfounded CK indicates creatine kinase; HIV, human immunodeficiency virus; HMGCR, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase; SAMS, statin-associated muscle symptoms; SAAM, statin-associated autoimmune myopathy; SASE, statin associated side effects; and ULN, upper limit of normal. Downloaded from http://ahajournals.org by on October 7, 2026