Patients with acute coronary syndrome who received ezetimibe in addition to statin therapy had improvements in cardiovascular outcomes and a lowering of low-density lipoprotein (LDL) cholesterol, according to a double-blind, randomized controlled trial.
After a year of treatment, adding ezetimibe to simvastatin led to a 24 percent reduction in LDL cholesterol and a lower rate of the primary composite endpoint of cardiovascular death, major coronary events or nonfatal stroke.
Lead researcher Christopher P. Cannon, MD, of Brigham and Women’s Hospital in Boston, and colleagues published their findings online June 3 in The New England Journal of Medicine.
The IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study enrolled 18,144 patients who underwent randomization at 1,147 sites in 39 countries between Oct. 26, 2005, and July 8, 2010. They received 40 mg of simvastatin plus 10 mg of ezetimibe once daily or 40 mg of simvastatin plus placebo once daily.
Merck, the manufacturer of ezetimibe and simvastatin, funded the trial. The FDA initially approved the combination medication in 2004.
Patients in the study were all at least 50 years old and had an LDL cholesterol level of 50 mg/dL or higher. They had follow-up visits at 30 days, 4 months and every 4 months afterward until the study ended or they discontinued treatment. The mean age was 64, and 24 percent of patients were women.
At baseline, each group had a mean LDL cholesterol level of 93.8 mg/dL. After a year, the mean LDL cholesterol level was 53.2 mg/dL in the ezetimibe-simvastatin group and 69.9 mg/dL in the simvastatin group.
At one year, the ezetimibe-simvastatin group also had significantly lower levels of total cholesterol, triglycerides, non-high-density lipoprotein cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein.