Results from the largest, community-based clinical trial of Zetia (ezetimibe) conducted to date, involving more than 3,000 patients, showed that adding Zetia to ongoing stable statin therapy reduced LDL ("bad") cholesterol (LDL-C) by an additional 26 per cent compared to a 3 per cent additional reduction seen with continuation of a stable dose of statin monotherapy.
Adding Zetia to a statin provided significant LDL-C lowering efficacy that was consistent across a number of pre-specified treatment groups such as age, gender, race (including Caucasian, African-American and Hispanic patients), diabetes and metabolic syndrome. Zetia administered with a statin was well tolerated in the study and had an overall safety profile comparable to statin monotherapy.
In a six-week, randomized, multi-center clinical trial of 3,030 patients with LDL-C levels exceeding NCEP ATP III guidelines (baseline LDL-C levels ranging from 123 mg/dL to 167 mg/dL), patients taking marketed statins (atorvastatin, 40 per cent; simvastatin, 29 per cent; pravastatin, 22 per cent; other, 10 per cent) were randomized 2:1 to treatment with ezetimibe 10 mg (n=2020) or placebo (n=1010). Sixty-two per cent of patients in the study were on a usual starting dose of a statin. The study population was comprised of men (52 per cent) and women (48 per cent) of multiple races (Caucasian, n=2471; African-American, n=279; Hispanic, n=162; other, n=118), many with diabetes (38 per cent) and metabolic syndrome (60 per cent) from 299 U.S. sites. The mean patient age was 62; more than 15 per cent of patients studied were 75 or older. Fifty per cent of the physicians participating in the trial were community-based.
Study results showed that adding ezetimibe 10 mg to a stable dose of any statin studied significantly reduced LDL-C by an additional 26 per cent compared to a 3 per cent additional reduction seen when placebo was added to ongoing stable statin therapy, the study's primary endpoint (p<0.001). Significant reductions in LDL-C were consistently observed in patients irrespective of their NCEP ATP III coronary heart disease (CHD) risk category, age, gender, race (Caucasian, African-American or Hispanic), statin brand, statin dose, or whether or not patients in the study suffered from diabetes or metabolic syndrome.
"Adding zetia to a statin provided significant reductions in LDL cholesterol for patients in this study, including patients at increased risk for coronary heart disease such as those with diabetes and metabolic syndrome," Dr. Pearson said.