New Drug Bempedoic Acid Could Reduce Cardiovascular Risk Despite Statin Intolerance
Statins, drugs used to lower cholesterol, are commonly prescribed to reduce the risk of cardiovascular events, but up to a third of patients are unable to tolerate them due to side effects. Now, recent research suggests that a newer drug, bempedoic acid, may be able to reduce the risk of heart attack and stroke even when taken alone.
Bempedoic acid, which is available under the trade name Nexletol, was approved by the US Food and Drug Administration (FDA) in 2020 as an additional treatment for patients with certain conditions who have high cholesterol despite maximally tolerated statin therapy. The trial, known as CLEAR Outcomes, is the first to explore whether bempedoic acid could reduce cardiovascular outcomes.
The study found that, compared to participants in the placebo group, those who took bempedoic acid had a combined 13% lower risk of death from cardiovascular disease, nonfatal strokes, and nonfatal heart attacks. On average, participants receiving bempedoic acid saw their LDL-C (low-density lipoprotein cholesterol) levels drop by between 20% to 25% over the course of the study.
The study, published in the New England Journal of Medicine, also showed that bempedoic acid significantly reduced the risk of major adverse cardiovascular events (MACE-4) and (MACE-3) by 13% (P=0.004) and 15% (P=0.006), respectively, and significantly reduced the risk of myocardial infarction by 23% (P=0.002) and coronary revascularization by 19% (P=0.001).
The study authors caution that, while bempedoic acid is a promising treatment option, it is not a replacement for statins. “Given the overwhelming evidence of the vascular benefits of statins, clinicians should continue their efforts to prescribe them at the maximum tolerated doses for appropriate patients, including those who may have discontinued statins because of presumed side effects,” said lead author John Alexander, MD.
In addition, bempedoic acid may come with certain side effects, such as an increased risk of gout, gallstones, and elevated levels of uric acid and creatinine in the blood. Patients should discuss these potential side effects with their doctor before taking the drug.
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