Results were presented today on behalf of the National Heart, Lung and Blood Institute from ACCORD, a study in patients with diabetes that evaluated cardiovascular outcomes in three distinct studies – glycemic control, blood pressure control and lipid control. In response to data from the ACCORD Lipid study, Abbott issued the following statement:
"The results of ACCORD Lipid were widely expected and not surprising given that two-thirds of patients in the trial would not be treated with fibrates under current guidelines," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "While the primary endpoint of the study was not met, the pre-specified subgroup of patients with high triglycerides and low HDL showed potential benefit. In these patients, fenofibrate plus simvastatin was associated with a 31 percent lower rate of heart attack, stroke and cardiovascular death than simvastatin alone."
The average triglyceride level of a patient that starts fenofibrate in the United States is 302 mg/dL, according to medical claims data. The median triglyceride level in ACCORD Lipid was 162 mg/dL. The subgroup of patients in this study with triglycerides at or above 204 mg/dL reflects real-world fibrate usage.