Bempedoic acid/ezetimibe
combination drug
Bempedoic acid/ezetimibe, sold under the brand name Nexlizet among others, is a fixed-dose combination medication used for the treatment of high cholesterol. It is a combination of bempedoic acid and ezetimibe.
The most common side effects are hyperuricemia (high blood levels of uric acid) and constipation.
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor and ezetimibe is a cholesterol absorption inhibitor. Bempedoic acid works by blocking an enzyme in the liver called adenosine triphosphate citrate lyase, which is involved in making cholesterol. Ezetimibe works by binding to a gut protein called 'Niemann-Pick C1 Like 1', preventing cholesterol from being absorbed into the blood from the gut.
The combination was approved for medical use in the United States in February 2020, and in the European Union in March 2020.
Medical uses
In the United States, bempedoic acid/ezetimibe is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
In the European Union, bempedoic acid/ezetimibe is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
in combination with a statin in people unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
alone in people who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
in people already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
Contraindications
In the EU it must not be used in pregnant or breast-feeding women. Use during pregnancy is not recommended in the US.
History
The European Medicines Agency recommended approval of bempedoic acid/ezetimibe (Nustendi) in the EU in January 2020.
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