An international study published Friday, 23 March 2001 in The Lancet shows that a well established drug -- fenofibrate -- significantly reduces the risk of atherosclerosis -- the leading cause of potentially fatal events in millions of people with type 2 diabetes.
The Diabetes Atherosclerosis Intervention Study (DAIS) was undertaken at
the request of, and in collaboration with, the World Health Organisation. It
showed that fenofibrate reduces progression of atherosclerosis -- the
narrowing of the arteries -- by up to 42 per cent. This is achieved by
correcting the blood lipid abnormalities which commonly occur in patients with
diabetes, i.e. by increasing levels of high density lipoprotein cholesterol
(HDL-C, the "good" cholesterol) and decreasing the levels of two "bad"
cholesterols -- triglycerides and low density lipoprotein cholesterol (LDL-C).
DAIS was designed as an angiographic study in order to provide its
information more quickly and with fewer patients than needed in a clinical
event study. Hence, although it showed a 23% reduction in clinical coronary
events in those receiving the active form of fenofibrate, the study was too
short and had too few participants to make this statistically significant.
DAIS, undertaken in 418 men and women in Canada, France and Scandinavia,
is the first study to specifically evaluate the benefits of correcting lipid
abnormalities in type 2 diabetes.
The Project Director, Professor George Steiner, Toronto General Hospital,
Canada, said: "DAIS has major implications for public health worldwide. There
is an epidemic of diabetes. By the year 2010, there will be 239 million people
with diabetes in the world. Approximately 80% of these people will have type 2
diabetes, a form which is generally seen in men and women above the age of 50
years. They have a 75-80% risk of dying of heart disease, a figure that is 2-4
times greater than that of the population without diabetes.
"For the first time, we now have a study entirely carried out in this
patient population that shows that by effectively treating the lipid
abnormalities which often occur in these patients, we can significantly reduce
the risk of the primary cause of death and disability.
"There is a strong message from this study. Every person with type 2
diabetes should have their lipids measured when their diabetes is diagnosed
and annually afterwards. Where their lipids are found to be abnormal, they
should be treated with diet and optimum blood sugar control. If this is
insufficient to normalise the lipids, a "lipid lowering" drug should be added.
Fenofibrate has been very effective in improving the reduced HDL and increased
triglycerides that are typically seen in type 2 diabetes."
The study also showed that fenofibrate, which has been widely used in non-
diabetic patients, was as well tolerated and had as few side effects as did a
placebo -- an inactive tablet.