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EZETROL® (ezetimibe) - licensed for the prevention of cardiovascular events1

Updated on 27/09/2018

CARDIOVASCULAR

The IMPROVE-IT Study2

Objective

To discover whether the addition of ezetimibe to statin therapy would reduce the rate of cardiovascular events.

Design

  • Multicentre, double-blind randomised trial of 18,144 patients
  • Patients must have been hospitalised for ACS within the preceding 10 days with a LDL-C level of 1.3 to 2.6mmol/L if receiving statin therapy or 1.3 to 3.2 mmol/L if receiving no statin therapy
  • Patients were randomised to either a combination of simvastatin 40mg and ezetimibe or simvastatin 40mg and placebo

Primary endpoint

A composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring hospitalisation, coronary revascularisation (≥ 30 days after randomisation) or nonfatal stroke.

Adding EZETROL improves CV outcomes beyond a statin alone2

Ezetimibe + simvastatin achieved an additional 6.4% relative risk reduction in major cardiovascular events compared with simvastatin alone (p=0.016).

ldlc

Mean LDL-C at 1 year was reduced from a baseline of 2.5mmol/L to 1.4 mmol/L in the ezetimibe/simvastatin group and 1.8 mmol/L in the simvastatin group (p<0.001).

ldlc

Primary endpoint* at 7 years was 32.7% in the ezetimibe/simvastatin group and 34.7% in the simvastatin group (absolute risk reduction, 2%; HR, 0.936; Cl, 0.89 to 0.99; p=0.016).

RRR, relative risk reduction

Ezetimibe + statin reduced non-fatal stroke and non-fatal MI vs. statin alone2

Ezetimibe + simvastatin significantly reduced nonfatal MI and nonfatal stroke compared with simvastatin alone

Tertiary endpoints

The absolute event rates were 12.8% in the ezetimibe/simvastatin group and 14.4% in the simvastatin group (HR 0.871; 95% Cl, 0.80 to 0.95;
p= 0.002).

Tertiary endpoints

The absolute event rates were 3.49% in the ezetimibe/simvastatin group and 4.24% in the simvastatin group (HR 0.80; 95% Cl, 0.68 to 0.95;
p= 0.010).

RRR, relative risk reduction

Related content

 

References

  1. EZETROL Summary of Product Characteristics.
  2. Cannon CP et al. Ezetimibe added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med 2015; 372: 2387-2397.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

CARD-1247022-0002 | Date of Preparation: September 2018