IMPROVE-IT: Modest Clinical Benefit from Ezetimibe

By Larry Husten

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

Adding ezetimibe to statin therapy in patients with an acute coronary event is associated with a small reduction in adverse cardiovascular outcomes, according to results of the IMPROVE-IT study presented Monday at the American Heart Association meeting.

Roughly 18,000 high-risk patients were randomized after an acute coronary event to either ezetimibe or placebo on top of a statin. Patients had LDL levels of 50-125 mg/dL, or 50-100 mg/dL if on a prior cholesterol drug.

After an average of 6 years' follow-up, primary endpoint events — CV death, MI, hospitalization for unstable angina, coronary revascularization >1 month after randomization, or stroke — occurred in 35% of the placebo group versus 33% of the ezetimibe group, a 6.4% reduction in risk. Researchers calculated that 50 patients would need to be treated for 7 years to prevent one event. There were no differences between the groups in overall deaths, coronary deaths, or cardiovascular deaths, but there were significant risk reductions in MI (13%), stroke (14%), and ischemic stroke (21%). Diabetics had a larger benefit than nondiabetics.

At the AHA press conference, Neil Stone, the chairman of the AHA/ACC cardiovascular guidelines committee, said that ezetimibe should now be viewed as a proven therapy. The results, he said, expand the options for additional proven lipid-lowering therapies that have been shown to add incremental benefit.