Department of Family Medicine (Dr. Wójcik) and Center for Preventive Cardiology, Knight Cardiovascular Institute (Dr. Shapiro), Oregon Health & Science University, Portland cezarywojcik2000@ gmail.com
Dr. Wójcik reported no potential conflict of interest relevant to this article.
Dr. Shapiro serves as a consultant to Amarin Corporation, is on the advisory board of Esperion Therapeutics, Inc., and has contracted research with Akcea Therapeutics, Inc. and The FH Foundation. His work is supported by NIH K12HD043488.
Statins are one of the safest classes of medication, with an excellent risk-benefit ratio. However, there are myriad confusing media reports regarding potential adverse effects and safety of the statin class—reports that often lead patients to discontinue or refuse statins.
Statin-associated adverse effects include the common statin-associated muscle symptoms (SAMS), new-onset DM, cognitive effects, and hepatic injury. The frequency of new-onset DM depends on the population exposed to statins, with a higher incidence of new-onset DM found in patients who are already predisposed, such as those with obesity, prediabetes, and metabolic syndrome. Cognitive effects are rare and difficult to interpret; they were not reported in the large statin mega-trials but have been described in case reports. Significant transaminase elevations > 3 times the upper limit of normal are infrequent; hepatic failure with statins is extremely rare and found at the same incidence in the general population.1
SAMS include (in order of decreasing prevalence)24:
myalgias with a normal creatine kinase (CK) level
conditions such as myositis or myopathy (elevated CK level)
rhabdomyolysis (CK level > 10 times the upper limit of normal, plus renal injury)
extremely rare statin-associated autoimmune myopathy, with detectable 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase antibodies.
In patients with SAMS, thorough assessment of symptoms is recommended, in addition to evaluation for nonstatin causes and predisposing factors. Identification of potential SAMS-predisposing factors is recommended before initiation of treatment, including demographics (eg, East-Asian ancestry), comorbid conditions (eg, hypothyroidism and vitamin D deficiency), and use of medications adversely affecting statin metabolism (eg, cyclosporine).
In patients with statin-associated adverse effects that are not severe, it is recommended to reassess and rechallenge to achieve a maximal lowering of the LDL-C level by a modified dosing regimen or an alternate statin or by combining a statin with nonstatin therapy. In patients with increased risk for DM or new-onset DM, it is recommended to continue statin therapy.
Continue to: Routine CK and liver function testing...
