Merck and Schering-Plough have announced the FDA’s approval of ezetimibe (Zetia drug), along with diet and in combination with fenofibrate, for lowering elevated total cholesterol and low-density lipoprotein-cholesterol (LDL-C) in patients with mixed hyperlipidemia when diet alone is not enough. Mixed hyper-lipidemia is characterized by elevations of LDL-C and triglycerides and reduced high-density lipoprotein-cholesterol (HDL-C) levels.

Fenofibrate is commonly used along with diet to treat hyperlipidemia and has proven efficacy in lowering triglyceride levels and increasing HDL-C. The use of generic ezetimibe with fibrates other than fenofibrate is not yet recommended.

Few trials have assessed the efficacy of statins for the primary or secondary prevention of cardiovascular disease in type-2 diabetic patients, let alone older patients, according to researchers from the Collaborative Atorvastatin Diabetes Study (CARDS). Some trials have found a statistically significant benefit, but others have not, perhaps because the numbers of enrolled patients were too small.

In view of these findings, a post hoc analysis of data from CARDS was con­ducted to compare statin therapy in 1,129 patients 65 to 75 years of age and in 1,709 younger patients. Treatment with atorvastatin 10 mg/ day reduced the relative risk of a first major cardiovascular event by 38% in older patients and by 37% in younger patients. The risk of a stroke was nearly halved. Two of 572 (0.3%) older patients who were taking atorvastatin had fatal heart attacks, compared with 12 of 557 (2.2%) receiving placebo.

One patient in the over-65 age group taking atorvastatin had a fatal stroke, and 12 patients had nonfatal strokes, compared with four patients who died and 17 placebo patients with nonfatal strokes. Treatment was well tolerated in both groups, even with the high use of concomitant drugs in the older patients.

More elderly patients at risk for congestive heart failure are getting aggressive statin therapy when they need it. Researchers from Kaiser Permanente Center for Health Research in Portland, Oregon, say that the 2004 update to the National Cholesterol Education Program Adult Treatment Panel III guidelines and the corresponding revision of internal guidelines in the large health maintenance organization they studied resulted in more patients receiving minimal-guideline statin therapy.

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Rosuvastatin calcium (Crestor, Astra-Zeneca) has been approved as an adjunct to diet to delay the progression of atherosclerosis in patients with elevated cholesterol levels.

In the Measuring Effects on intima media Thickness: an Evaluation Of Rosu-vastatin (METEOR) study, researchers evaluated the effects of this drug on plaque build-up in the arteries. The new label conforms to the FDA’s revised format designed to draw physicians’ attention to important drug information in an effort to reduce errors.

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The FDA has approved the 4-mg maximum dose of pitavastatin (Livalo, Kowa), which is designed to improve blood cholesterol levels. Like other statins, this agent is indicated when diet and exercise fail to lower cholesterol levels.

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