NLA Statement on the IMPROVE-IT Study Findings: Results Support the NLA Recommendations that Lower Is Better

Last Updated: Friday, 05-Jun-2015 16:00:00 EDT

On June 3, 2015, the anticipated final results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) was published online in the New England Journal of Medicine (NEJM 2015;372:2387-97).

In the editorial “Proof that lower is better – LDL cholesterol and IMPROVE IT” by John A. Jarcho, MD, and John F. Keany, Jr., MD, that accompanied the article, the results of IMPROVE-IT were summarized: “In IMPROVE-IT, 18,144 patients who had had an acute coronary syndrome were randomly assigned to either simvastatin (40 mg) plus ezetimibe (10 mg) or to simvastatin (40 mg) plus placebo. At 1 year, the mean LDL cholesterol level was 53.2 mg per deciliter (1.4 mmol per liter) in the simvastatin-plus-ezetimibe group, and 69.9 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group. The primary end point was a composite of cardiovascular death, major coronary event (nonfatal myocardial infarction, unstable angina, or coronary revascularization), or nonfatal stroke. At 7 years, the rate of the primary end point was significantly lower, by 2.0 percentage points, in the simvastatin-plus-ezetimibe group than in the simvastatin-monotherapy group (32.7% vs. 34.7%) [HR 0.936; CI 0.89 to 0.99; P=0.016]. No significant differences in rates of adverse events were seen between the two study groups.”

The National Lipid Association (NLA) is very excited about these results. The findings are consistent with the NLA’s Part 1 Recommendations that treatments associated with lower concentrations of atherogenic lipoproteins are associated with lower ASCVD risk. The data suggest a benefit from additional non-statin therapy to treat to goals for LDL and non-HDL cholesterol, as recently advocated in NLA Recommendations for Patient-Centered Management of Dyslipidemia: Part 1—Full Report published in the Journal of Clinical Lipidology (JCL) on March 26, 2015.

As always, the NLA urges clinicians to customize clinical decisions to individual patient clinical needs and circumstances, and to use the best available evidence.