26
Diagnosis
5. Statin Safety and Statin-Associated Side Effects
5. Statin Safety and Statin-Associated Side Effects
COR LOE
Recommendations
I A 1. 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 successfully.
I A 2. In patients with statin-associated muscle symptoms (SAMS),
a thorough assessment of symptoms is recommended,
in addition to an evaluation for nonstatin causes and
predisposing factors.
I B-R 3. 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 treatment.
I B-R 4. 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.
I B-R 5. 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.
I C-LD 6. 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 hepatotoxicity.
I B-R 7. 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.
IIa B-R 8. 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 benefit.
