Rosuvastatin/Ezetimibe Bests Simvastatin/Ezetimibe for Lipid, Cholesterol Control: Presented at ACC
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Rosuvastatin/Ezetimibe Bests Simvastatin/Ezetimibe for Lipid, Cholesterol Control: Presented at ACC

By Walter Alexander

ATLANTA -- March 19, 2010 -- The combination of ezetimibe 10 mg with rosuvastatin 20 mg as compared with ezetimibe 10 mg and either 40 or 80 mg of simvastatin produced greater lipid improvements and a higher percentage of patients achieving low-density lipoprotein cholesterol (LDL-C) goals, researchers said here at the 59th Annual Scientific Sessions of the American College of Cardiology (ACC).

According to Christie M. Ballantyne, MD, Center for Prevention of Cardiovascular Disease, Baylor College of Medicine, Houston, Texas, rosuvastatin has been shown in several studies to be more effective than other statins in allowing patients to achieve their lipid goals.

Reaching more stringent guideline targets for patients at high risk for cardiovascular disease, however, may require combination therapy, Dr. Ballantyne said here during a presentation on March 14. “If you look at a patient who’s hard to get to target, ‘how do you do this?’ is the bottom line issue for doctors.”

Research has shown the combination of a statin with ezetimibe, an inhibitor of cholesterol absorption, to facilitate more substantial reductions in LDL-C, he added.

The open-label, multicentre, phase 3b Gauging the Lipid Effects of Rosuvastatin Plus Ezetimibe Versus Simvastatin Plus Ezetimibe Therapy (GRAVITY) study included 814 patients (mean age ~62 years; ~56% male) with hypercholesterolaemia and coronary heart disease history or its risk equivalent, fasting LDL-C >=130 mg/dL but <220 mg/dL, and fasting triglycerides <400 mg/dL.

The primary endpoint was mean percent change in LDL-C from baseline to week 12.

Rosuvastatin 10 mg plus ezetimibe 10 mg achieved significantly (P < .001) greater reductions in LDL-C (-59.7%), and greater improvements in most other lipid parameters compared with simvastatin 40 mg plus ezetimibe 10 mg (LDL-C, -55.2%) or simvastatin 80 mg plus ezetimibe 10 mg (LDL-C, -57.4%).

Rosuvastatin 10 mg plus ezetimibe resulted in significantly (P < .05) greater reductions in LDL-C, total cholesterol (-43.0% vs -39.6%), triglycerides (-28.9% vs -23.0%), non- high-density lipoprotein cholesterol (-54.7% vs -49.9%), and apolipoprotein B (-46.1% vs -42.0%), compared with simvastatin 40 mg plus ezetimibe.

Furthermore, at the end of the study significantly more patients achieved LDL-C goals of <100 mg/dL (P < .05) and <70 mg/dL (P < .001) with rosuvastatin 20 mg plus ezetimibe (95.6%/77.0% for <100 mg/dL/<70 mg/dL) than with simvastatin 40 mg plus ezetimibe (87.4%/55.3%) or simvastatin 80 mg plus ezetimibe 10 mg (88.6%/67.7%).

Patients receiving rosuvastatin 10 mg with ezetimibe 10 mg were more likely (P < .05) to achieve the LDL-C goal of <100 mg/dL (93.3% vs 87.4%) than those receiving simvastatin 40 mg plus ezetimibe 10 mg.

All treatments were generally well tolerated; myalgia, the most frequently reported adverse event, affected about 2% of patients during combination therapy.

“Basically, this a very good option for people who are hard to get to targets, with good effects on all the lipids,” said Dr. Ballantyne. He did note that the ezetimibe plus simvastatin combinations are available in a single pill, unlike the rosuvastatin plus ezetimibe combinations.

[Presentation title: Randomized Comparison of Rosuvastatin Plus Ezetimibe Versus Simvastatin Plus Ezetimibe: Results of the GRAVITY Study. Abstract 1019-98]

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