The randomised, double-blind IMPROVE-IT trial enrolled patients who had been hospitalised for acute coronary syndrome within the preceding 10 days (n=18,144). Before hospitalisation, 34% of participants were already receiving statins.
Fewer cardiovascular events
The addition of ezetimibe to a starting dose of simvastatin 40mg provided incremental benefit in reducing the relative risk of the primary endpoint (a composite of cardiovascular death, non-fatal myocardial infarction, unstable angina requiring hospitalisation, coronary revascularisation and non-fatal stroke) by 6.4% compared with simvastatin alone.
At 7 years the primary endpoint occurred in 32.7% of patients in the ezetimibe/simvastatin group compared with 34.7% of patients in the simvastatin monotherapy group (HR 0.936; 95% CI 0.89—0.99, p=0.016).
The median time-weighted average LDL cholesterol level over the course of the trial was 1.4mmol/L in the ezetimibe/simvastatin group and 1.8mmol/L in the simvastatin monotherapy group (p<0.001).
In February, NICE reaffirmed its guidance recommending ezetimibe monotherapy as an option for treating primary hypercholesterolaemia in adults unable to take statins. Ezetimibe can also be prescribed on the NHS in combination with initial statin therapy, as an option when statins fail to control serum total or LDL cholesterol levels, and when a change to an alternative statin is being considered.
Updated 8th March 2016
Ezetimibe/simvastatin fixed-dose combination (Inegy) also indicated to reduce cardiovascular risk
Inegy (ezetimibe/simvastatin) is now also licensed to reduce the risk of cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome.
The recommended starting dose is one 10mg/40mg tablet once daily in the evening. This may be increased to 10mg/80mg only if the benefits are expected to outweigh the potential risks.