STATIN SAFETY AND STATIN- ASSOCIATED SIDE EFFECTS Recommendations for Statin Safety and Statin-Associated Side Effects Referenced studies that support recommendations are summarized in Online Data Supplements 40 and 41. COR LOE Recommendations I A A clinician patient risk discussion is recommended before initiation of statin therapy to review net clinical benefit, weighing the potential for ASCVD risk reduction against the potential for statin-associated side effects, statin drug interactions, and safety, while emphasizing that side effects can be addressed I A In patients with statin-associated muscle symptoms (SAMS), a thorough assessment of symptoms is recommended, in addition to an evaluation for nonstatin causes and I B-R In patients with indication for statin therapy, identification of potential predisposing factors for statin-associated side effects, including new-onset diabetes mellitus and SAMS, is recommended before initiation of I B-R In patients with statin-associated side effects that are not severe, it is recommended to reassess and to rechallenge to achieve a maximal LDL-C lowering by modified dosing regimen, an alternate statin or in combination with nonstatin therapy.S5-3 S5-8 I B-R In patients with increased diabetes mellitus risk or new-onset diabetes mellitus, it is recommended to continue statin therapy, with added emphasis on adherence, net clinical benefit, and the core principles of regular moderate-intensity physical activity, maintaining a healthy dietary pattern, and sustaining modest weight loss.S5-8 S5-12 I C-LD In patients treated with statins, it is recommended to measure creatine kinase levels in individuals with severe statin- associated muscle symptoms, objective muscle weakness, and to measure liver transaminases (aspartate aminotransferase, alanine aminotransferase) as well as total bilirubin and alkaline phosphatase (hepatic panel) if there are symptoms suggesting I B-R In patients at increased ASCVD risk with chronic, stable liver disease (including non-alcoholic fatty liver disease) when appropriately indicated, it is reasonable to use statins after obtaining baseline measurements and determining a schedule of monitoring and safety checks.S5-16 S5-18 IIa B-R In patients at increased ASCVD risk with severe statin-associated muscle symptoms or recurrent statin-associated muscle symptoms despite appropriate statin rechallenge, it is reasonable to use RCT proven nonstatin therapy that is likely to provide net clinical III: No Benefit B-R Coenzyme Q10 is not recommended for routine use in patients treated with statins or for the treatment of SAMS.S5-20,S5-21 III: No Benefit C-LD In patients treated with statins, routine measurements of creatine kinase and transaminase levels are not useful.S5-13 S5-15 Synopsis Statin therapy is usually well tolerated and safe.S5-1,S5-14, As with other classes of medications, associ- ated side effects are seen. 