Results were presented 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 per cent 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.
"We are encouraged by the overall safety reported in the ACCORD Lipid study for fenofibrate," added Sun. "The results are consistent with the safety shown in other studies and support how fibrates are used in treatment today based on guideline recommendations."
The National Cholesterol Education Program (NCEP) treatment guidelines recommend using fibrates with statins in patients with triglycerides above 200 mg/dL when the LDL goal has been met.
The primary endpoint for ACCORD Lipid (n = 5,518) compared fenofibrate plus simvastatin to simvastatin alone on cardiovascular outcomes of heart attacks, strokes and cardiovascular death. There was no statistical difference in the primary outcome between the two treatment groups (p = 0.32). In a pre-specified sub-group of patients with both high triglycerides (at or above 204 mg/dL) and low HDL (at or below 34 mg/dL), there was a 31 percent lower rate of cardiovascular events in the fibrate-plus-statin arm compared to the statin-only arm (p = 0.057 for interaction).