Statin therapy is warranted when patients have high lipid levels (total cholesterol, triglycerides, and LDL). People with high LDL cholesterol have an increased risk of developing cardiovascular disease. However, statin therapy may come with a multitude of side effects including muscle pain, liver damage, and many food/drug interactions.
Patients with hyperlipidemia who are unable to tolerate optimal statin therapy are at increased cardiovascular risk due to ongoing elevations in low-density lipoprotein cholesterol (LDL-C). The objective of the CLEAR Tranquility trial was to evaluate the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy in patients with a history of statin intolerance who require additional LDL-C lowering.
Bempedoic Acid inhibits cholesterol synthesis in the liver, causing decreased cholesterol synthesis, which therefore lowers LDL-C in blood via upregulation of low-density lipoprotein receptors. Ezetimibe inhibits absorption of cholesterol by the small intestine, therefore leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a subsequent reduction of hepatic cholesterol stores and an increase in LDL receptors to clear cholesterol from the blood.
After a 4-week ezetimibe 10 mg/day run-in period, patients were randomized 2:1 to treatment with bempedoic acid 180 mg or placebo once daily added to ezetimibe 10 mg/day for 12 weeks. The primary endpoint was the percent change from baseline to week 12 in LDL-C.
The study population comprised 269 patients (181 bempedoic acid, 88 placebo). Bempedoic acid added to background lipid-modifying therapy that included ezetimibe reduced LDL-C by 28.5% more than placebo.
This study is beneficial to our SNF facilities, as patients may not be able to tolerate statin therapy but we would still like to keep their lipids levels under control. While this is a new drug that was recently approved in 2020, it shows promise and is worth keeping in mind when using alternative treatments for lipid control .