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Drug information

Ezetrol

POM
Read time: 32 mins
Last updated: 06 May 2020
Published: 01 Apr 2021

4.1 Therapeutic indications

Primary Hypercholesterolaemia

Ezetrol co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone.

Ezetrol monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated.

Prevention of Cardiovascular Events

Ezetrol is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.

Homozygous Familial Hypercholesterolaemia (HoFH)

Ezetrol co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

Homozygous Sitosterolaemia (Phytosterolaemia)

Ezetrol is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia.

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Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).