17
Table 6. Statin Safety Recommendations (continued)
Recommendations
ACC/AHA
COR
ACC/AHA
LOE
9. For individuals presenting with a confusional state or
memory impairment while on statin therapy, it may be
reasonable to evaluate the patient for nonstatin causes,
such as exposure to other drugs, as well as for systemic and
neuropsychiatric causes, in addition to the possibility of
adverse effects associated with statin drug therapy.
IIb C
a
Based on the presence of clinical ASCVD, diabetes mellitus, LDL-C ≥190 mg/dL, or level of
estimated 10-year ASCVD risk.
b
Individuals with elevated ALT levels (usually ≥1.5 or 2 times ULN) were excluded from RCT
participation. Unexplained ALT ≥3 times ULN is a contraindication to statin therapy as listed in
manufacturer's prescribing information.
c
Statin use is associated with a very modest excess risk of new onset diabetes in RCTs and meta-
analyses of RCTs (i.e., ~0.1 excess cases per 100 individuals treated 1 year with moderate-intensity
statin therapy and ~0.3 excess cases per 100 individuals treated for 1 year with high-intensity
statin therapy). e increased risk of new onset diabetes appears to be confined to those with risk
factors for diabetes. ese individuals are also at higher risk of ASCVD due to these risk factors.
erefore, if a statin-treated individual develops diabetes as detected by current diabetes screening
guidelines, they should be counseled to adhere to a heart healthy dietary pattern, engage in physical
activity, achieve and maintain a healthy body weight, cease tobacco use, and continue statin therapy
to reduce their risk of ASCVD events.
Table 7. Nonstatin Safety Recommendations
Recommendations
ACC/AHA
COR
ACC/AHA
LOE
Safety of Niacin
1. Baseline hepatic transaminases, fasting blood glucose
or hemoglobin A1c, and uric acid should be obtained
before initiating niacin, and again during up-titration to a
maintenance dose and every 6 months thereaer.
I B
2. Niacin should NOT be used if:
• Hepatic transaminase elevations are higher than 2 to 3
times ULN.
• Persistent severe cutaneous symptoms, persistent
hyperglycemia, acute gout or unexplained abdominal
pain or gastrointestinal symptoms occur.
• New-onset atrial fibrillation or weight
loss occurs.
III: Harm B
III: Harm B
III: Harm B
3. In individuals with adverse effects from niacin, the
potential for ASCVD benefits and the potential for adverse
effects should be reconsidered before reinitiating niacin
therapy.
I B
