Drug May Help Prevent Cardiovascular Disease In Type 2 Diabetes Patients, The Lancet
The cholesterol-lowering drug fenofibrate may reduce the risk of combined cardiovascular disease events (CVD) - heart attack, stroke, and bypass surgery - in patients with type 2 diabetes but does not reduce the combined risk of coronary heart disease death and nonfatal heart attack , concludes a randomised trial published online today (Monday November 14, 2005) by The Lancet.
Patients with type 2 diabetes have an increased risk of CVD, partly owing to the high concentrations of fatty substances (lipids) in their blood. The rates of mortality after a heart attack in this group is high and can reduce life expectancy by an average of 5-10 years.
A class of drugs called fibrates can correct abnormal concentrations of lipids in type 2 diabetes patients, however, their role in preventing cardiovascular events in this setting has been unclear until now. The FIELD study was designed to assess the effect of fenofibrate on coronary events-coronary heart disease death or non-fatal heart attack .
Anthony Keech (University of Sydney, NSW, Australia) and colleagues recruited over 14200 patients, aged 50 - 75 years, with type 2 diabetes, into the study from 63 centres in Australia, New Zealand, and Finland. 78% of patients had no prior history of CVD.
Half of the patients were randomly allocated fenofibrate and half placebo daily for five years. Patients in both groups also started other lipid treatments, mainly statins, while on the study. The investigators found that fenofibrate did not reduce the risk of the primary outcome of coronary events. However, patients given fenofibrate had a 11% relative risk reduction in total CVD events, which includes deaths from CVD, heart attack , stroke , and bypass surgery. The benefit was mainly due to a reduction in non-fatal heart attacks and bypass surgery. The drug was well tolerated by patients but associated with a slightly increased risk of pancreatitis (inflammation of the pancreas) and pulmonary embolism. The overall mortality was similar in both groups.
Dr Keech comments: “FIELD provides information to help guide clinicians on the future use of fenofibrate in patients with type 2 diabetes. The results are likely to be of particular importance among patients without previous cardiovascular disease. Fenofibrate should be considered in the context of the well established benefits statin therapy, where its main use will probably be in combination therapy.”
The online publication of the FIELD study coincides with a presentation at the American Heart Association meeting in Dallas, Texas, USA