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Title: Ezetimibe-Statin Combination Lowers Cholesterol Safely and Effectively in the Elderly: Presented at AGS

"Ezetimibe-Statin Combination Lowers Cholesterol Safely and Effectively in the Elderly: Presented at AGS"

By Emma Hitt BALTIMORE, MD -- May 17, 2003 -- The cholesterol-lowering drug ezetimibe (Zetia®) appears to be safe and effective when co-administered with statin drugs in elderly patients, new research suggests. Leslie Lipka, MD, PhD, and colleagues from the Schering-Plough Research Institute of Kenilworth, New Jersey, reported their findings here on May 15th at the 2003 Annual Scientific Meeting of the American Geriatrics Society. According to Dr. Lipka, ezetimibe and statins are highly complementary. Statins inhibit the synthesis of cholesterol in the liver, whereas ezetimibe inhibits the absorption of dietary and biliary cholesterol in the intestine. Researchers analysed data from four phase III, multicenter, randomised trials involving 2,382 patients with primary hypercholesterolaemia, defined as low-density lipoprotein (LDL) cholesterol levels between 145 and 250 mg/dL and triglyceride levels of 350 mg/dL or less. Statins used in the studies were atorvastatin, simvastatin, pravastatin, and lovastatin. Patients first underwent dietary stabilisation and a placebo run-in period. They were then randomised to receive one of four treatments for 12 weeks: placebo, one of the statins, 10 mg ezetimibe, or a statin plus 10 mg ezetimibe. The researchers reported on a subgroup analysis comparing statin monotherapy with statin plus ezetimibe in 1,332 patients younger than 65 years , 529 patients 65 years or older, 1,738 patients younger than 75 years of age, and 123 patients 75 years or older. Compared to statin monotherapy, combination therapy significantly reduced LDL cholesterol. The differences were reductions of -12.8, -15.5, -13.5, and -14.5, respectively, in each four age group. Overall, changes in LDL and high-density lipoprotein cholesterol and triglycerides appeared to occur independent of age. Incidence of adverse events, liver function and muscle enzymes were similar between the statin- and combination-therapy groups. Older patients in the combination group had a slightly higher incidence of adverse events than younger patients, but no clinically significant elevations of liver transaminase or creatine phosphokinase were seen in patients 65 years or older. Ezetimibe has a half-life of 22 hours, which allows for once-daily dosing, in the morning or evening, the researchers pointed out. "Co-administration of ezetimibe and a statin consistently increased the percentage of subjects reaching their LDL cholesterol target by greater than ten percentage points compared to statin alone," Dr. Lipka concluded. "[The combination] offers a highly efficacious new treatment paradigm in integrated lipid management." Zetia® (ezetimibe) is marketed by Schering-Plough Pharmaceuticals. [Study title: Efficacy and Safety of Ezetimibe Co-administered with Statins in Elderly Patients with Hypercholesterolemia. Abstract P122.]

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