Hypercholesterolaemia and mixed dyslipidaemiaNustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statinCardiovascular diseaseNustendi is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:• in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
VYTORIN — ORGANON, approved 2024-03-28 (NDA021687).
58,467 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.