Table 2.

Summary of National Lipid Association Statin Safety Recommendations

Muscle effects
	Pretreatment measurement of CK levels is generally not necessary unless an individual is at high risk.a Routine measurements of CK levels are unnecessary in asymptomatic patients. Counsel patients on the possiblity of muscle discomfort while on statin therapy and the importance of reporting symptoms. In symptomatic patients, CK levels should be measured. If CK levels < 10 times the ULN then statin therapy may be continued or doses reduced with close monitoring of symptoms. If CK levels > 10,000 IU/L or above 10 times the ULN, then admit for IV hydration therapy, monitoring of renal function, and treatment of rhabdomyolysis. Irrespective of CK levels, if muscle symptoms are intolerable, statin therapy should be discontinued with possible reinstitution of a different agent or lower dose once asymptomatic. If symptoms recur, alternative therapies should be considered.
Hepatic effects
	Measure transaminase levels before initiating therapy, 12 weeks after starting therapy, after a dose adjustment, and periodically thereafter. Monitor for signs of potential hepatotoxicity such as jaundice, malaise, fatigue, and lethargy. If present, measure transaminase levels, fractionated bilirubin levels, and liver function tests. If asymptomatic transaminase levels are between 1 to 3 times the ULN, then consider continuing statin therapy with close follow up testing. If transaminase levels increase > 3 times the ULN, then reduce the statin dose or discontinue treatment while ruling out other possible etiologies. If objective evidence of liver injury is documented, then discontinue the statin and refer the patient to a gastroenterologist.
Renal effects
	Routine measurements of serum creatinine and proetinuria are not necessary for patients on statins. Pre-treatment baseline creatinine levels may be helpful in identifying patients with underlying renal disease who may be at risk for higher muscle toxicity. If creatinine levels increase while on statin therapy, an adjustment in statin dosing may be required. If proteinuria is detected, consider adjusting the statin dose. Any perturbation of renal indices should warrant further investigation of other non-statin related causes. In patients with chronic kidney disease, statin therapy may be intiated with close attention to dose adjustments in moderate to severe renal disease.

^aNotes: Risk factors for muscle toxicity include: concomitant therapy with fibric acid derivatives, erythromycin, or azole antifungals, advanced age, small body habitus, worsening renal function, ongoing infection, trauma such as recent surgery, alcohol abuse, and untreated hypothyroidism.

Abbreviation: CK, creatine kinase; ULN, upper limit of normal.