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CHICAGO -- Elderly Japanese patients with elevated LDL cholesterol, but no history of coronary artery disease, who took ezetimibe (Zetia) saw a reduced risk of atherosclerotic cardiovascular events, researchers reported here.

After 5 years, the incidence of the primary outcome composite endpoint -- sudden cardiac death, fatal and nonfatal MI, fatal and nonfatal stroke, coronary revascularization -- occurred in about 6% of the patients on ezetimibe monotherapy versus about 10% on usual care (34.1% relative risk reduction, P=0.002), reported Yasuyoshi Ouchi, MD, PhD, of Tokyo University/Toranoman Hospital, and colleagues.

"The result obtained in this study is the first evidence suggesting that the primary prevention of cardiovascular events is possible even in patients, 75 years or older," said Ouchi in a presentation at the American Heart Association annual meeting.

But Mary Norine Walsh, MD, immediate past president of the American College of Cardiology, told 口袋女优 that she did not see these results from the EWTOPIA75 trial changing clinical practice immediately.

However, "The most important thing about EWTOPIA is that it was performed in patients over the age of 75," said Walsh, of St. Vincent Heart Center in Indianapolis. "We have a dearth of information about prevention in that age group which makes this study very important. It did show LDL lowering with the study drug and a decrease in the primary endpoint, which was driven by the cardiac event rate."

The researchers enrolled 3,796 patients and randomized 1,898 to ezetimibe and 1,898 to placebo. The final analysis reported here included 1,716 ezetimibe patients and 1,695 usual care patients, after excluding ineligible patients and those who withdrew from the study.

Patients were eligible for inclusion if they had LDL cholesterol levels of ≥140 mg/dL; if they were at least age 75 years of age (mean age 80.6); and had one other coronary disease risk factor, such as diabetes, smoking, or hypertension. All patients were given dietary counseling.

The average total cholesterol at baseline was 245 mg/dL and the average LDL at baseline was 161 mg/dL. About 85% of the patients said they had never smoked, while 5.2% were current smokers.

About 75% of the participants in the study were women, as women generally live longer than men in Japan and other developed countries, Ouchi noted.

For secondary endpoints, Ouchi reported a 20% reduction in cardiac events (P=0.041). In addition, cerebrovascular events and all-cause mortality were not statistically different between the groups.

Study limitations included the lack of a placebo group and the open-label design.

Walsh, who was not involved in the study, said she study population demographics may not make the results generalizable.

"The vast majority of the patients in this study had never smoked, which makes it much different that the United States and Western Europe," she stated. Walsh also pointed out that EWTOPIA 75 was a "women-dominated trial, and there were many patients who, throughout the trial, were excluded. This lack of retention is a weakness in the study."

Walsh called the trial "hypothesis generating. As we often say, another trial is needed. I think we need a placebo-controlled trial in a similar population that is more ethnically diverse. We cannot make any recommendations on the basis of EWTOPIA."

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