Treating heart attack patients with the lipid-lowering drug ezetimibe as well as a statin lowered their risk of another cardiovascular event, research published in NEJM shows.
The study – providing the first long-term outcomes data on ezetimibe – found the combination was associated with a two percentage point reduction in the rate of a composite outcome that included cardiovascular death, MI and stroke, when compared with treatment with a statin alone.
Over 18,000 patients were involved, all of whom had recently had an acute coronary syndrome and had ‘normal’ LDL cholesterol levels – above 50 mg/dL (1.3 mmol/L), but no higher than 100 mg/dL (2.6 mmol/L) if they were already on lipid-lowering therapy or 125 mg/dL (3.2 mmol/L) if not. The participants were randomly assigned to a combination of simvastatin (40mg) and ezetimibe (20mg) daily, or simvastatin (40mg) and placebo.
Over the six-year study period, the patients who took ezetimibe achieved lower cholesterol levels, with a median LDL cholesterol of 53.7 mg/dL (1.4 mmol/L) compared with 69.5 mg/dL (1.8 mmol/L) in the statin-only group.
The rate of the primary endpoint (cardiovascular death, nonfatal MI, unstable angina requiring rehospitalisation, coronary revascularisation or nonfatal stroke) at seven years of follow-up was 32.7% in the ezetimibe group compared with 34.7% in the simvastatin only group – equating to a significant 6% relative reduction in risk.
The researchers concluded: ‘The addition of ezetimibe to statin therapy in stable patients who had had an acute coronary syndrome and who had LDL cholesterol levels within guideline recommendations further lowered the risk of cardiovascular events.
‘The event reduction was consistent with the predicted effects seen with statins, even in the range of low LDL cholesterol levels in this trial, and no offsetting adverse events or toxic effects were observed.’
The research provides long-awaited evidence to support NICE recommendations on ezetimibe – its use was first recommended in 2007 lipid modification guidelines, a decision that was questioned at the time and came under further scrutiny when an interim study found that the addition of the drug did not reduce progression of atherosclerosis any further than with statin monotherapy.