Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
The New England Journal of Medicine 5th March 2023
1 Expert Comment
This double-blind, randomized, placebo-controlled study investigated the effects of bempedoic acid on cardiovascular outcomes in statin-intolerant patients with or at high risk for cardiovascular disease. Treatment with bempedoic acid was associated with a significantly lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization). However, there were higher incidences of gout and cholelithiasis as well as small increases in serum creatinine, uric acid, and hepatic enzyme levels with bempedoic acid than with placebo.
The findings suggest that bempedoic acid improves cardiovascular outcomes and can be a potential alternative treatment option for statin-intolerant patients with or at high risk for cardiovascular disease.
Written by Steven E. Nissen MD, MACC
The problem of statin intolerance, typically myalgias, represents one of the most challenging and frustrating clinical problems encountered by physicians and other caregivers who treat patients with preexisting cardiovascular disease or those at high risk for a first event. Despite explaining the benefits of lowering LDL-C levels with statins, some patients will decline treatment, thereby placing themselves at a high risk for cardiovascular morbidity and mortality. Bempedoic acid is not active in peripheral tissues when administered orally, requiring conversion in the liver to an active moiety. This property results in a low incidence of statin-associated muscle symptoms. The CLEAR Outcomes trial demonstrated that administration of bempedoic acid, compared with placebo, resulted in a significant reduction in the primary four-component major adverse cardiovascular event endpoint and several key secondary endpoints, including three-component major adverse cardiovascular events, myocardial infarction, and coronary revascularization but not cardiovascular death. These findings establish bempedoic acid as a safe and effective alternative in patients unable or unwilling to take statins.
Bempedoic acid and CVS outcomes.
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