November 19, 2014

Ezetimibe Can Help Improve LDL-C Levels, Reduce Cardiovascular Events in High-Risk Patients

By Walter Alexander

CHICAGO -- November 19, 2014 -- Adding ezetimibe to statin therapy among high-risk patients with acute coronary syndromes not only improved cholesterol levels, but also led to greater reductions in cardiovascular events, researchers said here at the 2014 Annual Meeting of the American Heart Association (AHA).

The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) included 144 patients stabilised following acute coronary syndromes (ACS) with low-density lipoprotein cholesterol (LDL-C) levels <125 mg/dL (statin-naïve) or 50 to 100 mg/dL (prior lipid-lowering therapy).

Patients were randomised to receive simvastatin 40 g with or without ezetimibe 10 mg. Simvastatin doses were increased to 80 mg when LDL-C was >79 in both treatment groups.

The primary endpoint was first occurrence of cardiovascular death, nonfatal myocardial infarction, re-hospitalisation for unstable angina, coronary revascularisation (30 days or more following randomisation) or stroke.

Patients were followed for a minimum of 2.5 years or until 5,250 patients experienced a primary endpoint.

Ninety-six months after randomisation, the median average LDL-C level was 69.5 mg/dL in the simvastatin only group and 53.7 mg/dL in the ezetimibe plus simvastatin group.

Reductions in the combination group were also seen for total cholesterol (-19.3 mg/dL), triglycerides (-16.7 mg/dL), and high sensitivity C-reactive protein (-0.5 mg/dL). High density lipoprotein (HDL) increased in the ezetimibe/simvastatin group (+0.6 mg/dL).

The combined primary endpoint was reported at a rate of 34.7% for the simvastatin group and at 32.7% for the ezetimibe/simvastatin group (P = .016), with the number needed to treat being 50.

No significant increases in cancer, muscle- or gallbladder-related events were observed.

“IMPROVE-IT reaffirms the LDL hypothesis that reducing LDL-C prevents cardiovascular events,” said Christopher Cannon, MD, Brigham and Women’s Hospital, Boston, Massachusetts.

The results should be taken into account for future guidelines, he added.

[Presentation title: Anti-Lipid Therapy and Prevention of CAD. Abstract LBCT.02]
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