27
5. Statin Safety and Statin-Associated Side Effects
COR LOE
Recommendations
III: No
Benefit
B-R 9. Coenzyme Q10 is NOT recommended for routine use in
patients treated with statins or for the treatment of SAMS.
III: No
Benefit
C-LD 10. In patients treated with statins, routine measurements of
creatine kinase and transaminase levels are NOT useful.
Table 9. 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 auto-
immune myopathy
(HMGCR antibodies,
incomplete resolution)
Rare Case reports
New-onset diabetes
mellitus
Depends on
population; more
frequent if diabetes
mellitus risk
Diabetes mellitus risk
factors/metabolic
syndrome
RCTs/meta-
analyses
Liver
Transaminase
elevation 3× ULN
Infrequent RCTs/
cohorts/
observational
Case reports
Hepatic failure Rare
