Fenofibrate appears more effective in women

Fenofibrate therapy lowers the incidence of cardiovascular disease in women moreso than in men, according to results of the Fenofibrate and Event Lowering inDiabetes (FIELD) study. "Fenofibrate reduced the cardiovascular event rate in womento a greater extent than in men, raising the possibility that it may be moreeffective in women," says Michael D’Emded, MD, Endocrine Research Unit, RoyalBrisbane Hospital, Brisbane, Australia.

These results, he says, contradict those of older epidemiologic studies,including the Framingham Heart study, which have found that lipid-lowering benefitsmen more than women.

The FIELD study included 9,795 patients with type 2 diabetes randomized tolipid-lowering with fenofibrate or placebo for five years. Overall, active treatmentreduced cardiovascular events, angina and acute coronary syndrome hospitalizations,amputations, coronary or carotid revascularizations, laser procedures for diabeticretinopathy, and progression of proteinuria compared with placebo.

Because a large number of FIELD patients were women (37.3%), Dr. D’Emded analyzedthe results to determine whether there were outcome differences between sexes. "Thecohort of women in FIELD was the largest number of women with type 2 diabetesrandomized into a prospective study of lipid-lowering," he says.

In FIELD, 3,657 women not taking a statin were randomized to receive 200 mgfenofibrate daily (n=1,824) or placebo. The primary endpoint was the incidence ofmajor cardiovascular events, including coronary events, coronary heart disease (CHD)death, nonfatal MI, stroke, and revascularization during the study.

After adjusting for starting statin therapy during the study, insulin use,hormone replacement therapy, stopping fenofibrate treatment, and the use of othercardiovascular drugs, treatment significantly lowered the risk of an endpoint eventamong women.

CHD death or nonfatal MI occurred in 4.5% of women in the placebo group and in3.5% of those taking fenofibrate (p=0.07). There was a nonsignificantreduction in CHD death or nonfatal MI among men in the treatment group. Overall,cardiovascular disease events occurred in 9.5% of women in the placebo group and7.7% in the fenofibrate group (p=0.008); the difference among men did notreach significance.

Revascularization was needed in 5.6% of women in the placebo group and in 4.2% ofthose in the treatment group (p=0.02), but in men, revascularization was morepronounced (p<0.001). There was no significant reduction in stroke in menor women.

"There was a greater reduction in LDL among women, and it is possible that thiswas the major contributor to the overall greater reduction in risk," Dr. D’Emdedsays. "Use of insulin or hormone-replacement therapy could not explain theresult."