NIH presents ACCORD data

NIH's National Heart, Lung and Blood Institute reported data from the Phase III ACCORD Lipid and Blood Pressure trials to prevent major cardiovascular events in Type II diabetics who were at high risk for cardiovascular disease events. In the ACCORD Lipid study, Zocor simvastatin plus fenofibrate missed the primary endpoint of significantly reducing the rate of cardiovascular events vs. Zocor alone (2.2% vs. 2.4%, p=0.32). In a subgroup of patients with both high triglycerides (at least 204 mg/dL) and low HDL (no more than 34 mg/dL), rates of cardiovascular events were 12.4% for Zocor plus fenofibrate vs. 17.3% for Zocor alone (p=0.057). The open-label trial enrolled 5,518 patients with Type II diabetes. Merck & Co. Inc. (NYSE:MRK) markets Zocor.

Abbott Laboratories (NYSE:ABT), which markets cholesterol drugs TriCor fenofibrate and Trilipix fenofibric acid, said in a statement that the results were "widely expected and not surprising" given that two thirds of the patients in the trial would not be treated with fibrates under current guidelines. Treatment guidelines established by the National Cholesterol Education Program recommend using fibrates with statins in patients with triglycerides greater than 200 mg/dL when the LDL goal has been met. FDA said it will review the data from the trial, but at this time has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate. ...