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EZETROL® (ezetimibe) – with Atorvastatin

Updated on 27/09/2018

CARDIOVASCULAR

With Atorvastatin 20 mg

When A40 can't be tolerated, add EZETROL to A20 for greater LDL-C reduction.1

Mean percentage change in LDL-C from baseline treatment with Atorvastatin 20mg

Adapted from Bays et al. 20131
*Hypothetical patient
p<0.001
A20, atorvastatin 20 mg daily; A40, atorvastatin 40 mg daily;
LDL-C, low-density lipoprotein cholesterol

Study design1

A multicentre, randomised, double-blind, active-controlled study conducted in patients with primary hypercholesterolaemia and high cardiovascular risk who were not adequately controlled with atorvastatin 10 mg daily. Patients with high CVD risk (both previously treated and treatment naïve) were administered open-label atorvastatin 10 mg/day for 5 weeks. Patients were then required to meet a set of randomisation entry criteria, which included LDL-C levels ≥100 and ≤160 mg/dL and triglyceride levels ≤400 mg/dL. 1,547 patients were then randomised to 1 of 6 blinded treatment sequences in a 3:1:8:8:16:16 ratio based on sample size assumptions, which determined treatment in Period I (first 6 weeks) and Period II (second 6 weeks).

Treatment during Period I included (1) adding EZETROL 10 mg/day to stable therapy with atorvastatin 10 mg/day, (2) doubling atorvastatin dose to 20 mg, or (3) switching to rosuvastatin 10 mg. Patients in the latter 2 groups who persisted with LDL-C levels ≥100 and ≤160 mg/dL at the end of Period I entered Period II; patients on A20 received A20 plus EZETROL 10 mg/day or atorvastatin uptitrated to 40 mg; those on rosuvastatin 10 mg were switched to A20 plus EZETROL 10 mg/day or uptitrated to rosuvastatin 20 mg/day.

The primary endpoint was percentage change in LDL-C from baseline at the end of Period 1 (6 weeks).

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With Atorvastatin 40 mg

When A80 can't be tolerated, add EZETROL to A40 for greater LDL-C reduction.2

Mean percentage change in LDL-C from baseline treatment with Atorvastatin 40mg

Adapted from Leiter et al. 20132
*Hypothetical patient
p<0.001
A40, atorvastatin 40 mg daily; A80, atorvastatin 80 mg daily;
LDL-C, low-density lipoprotein cholesterol

Study design1

A multicentre, randomised, double-blind, parallel-group titration study conducted at 96 sites in the US and Canada. All patients defined as being high risk by the National Cholesterol Education Program Adult Treatment Panel Ill (ATP Ill).

Patients already using A40 continued using that dose for a 4-week run-in period. Switch and naїve patients received A40 for a 5-week run-in period. After the run-in period, 579 patients were randomly assigned on day 1 to 6 weeks of active treatment with either A40 plus EZETROL 10 mg daily or A80.

The primary endpoint was percentage change in LDL-C from baseline after 6 weeks of treatment.

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References

  1. Bays et al. Efficacy and safety of Ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol 2013; 112: 1885-1895.
  2. Leiter LA et al. Am J Cardiol 2008; 102: 1495-1501

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

CARD-1247021-0002 | Date of Preparation: September 2018