Press Release
Abbott Statement: ACCORD Lipid Results Support Treatment Guidelines for Fibrate Use
ATLANTA, March 14, 2010 — 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.
"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).
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics.The company employs
approximately 83,000 people and markets its products in more than 130
countries.
Media:
Elizabeth Hoff
Marylou McNally |
(847) 772-3946
(847) 274-4972 |
Financial:
Larry Peepo |
(847) 935-6722 |
