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Title: Combination of Simvastatin/Ezetimibe Reduces C-Reactive Protein Better Than Simvastatin Alone: Presented at ACC

"Combination of Simvastatin/Ezetimibe Reduces C-Reactive Protein Better Than Simvastatin Alone: Presented at ACC"

By Ed Susman ATLANTA, G.A. -- March 15, 2006 -- A combination of the anticholesterol drugs simvastatin (Zocor) and ezetimibe (Zetia) work together to reduce C-reactive protein, a marker of inflammation in the vascular system, better than either drug alone. "The combined therapy was significantly better in lowering LDL-cholesterol compared to monotherapy, and it was significantly better in lowering C-reactive protein markers compared to monotherapy," said Christie M. Ballantyne, MD, associate chief and professor of medicine, section of atherosclerosis and lipoprotein research, Baylor College of Medicine, Houston, Texas. In his oral presentation on March 13[^th at the 55^th Annual Scientific Session of the American College of Cardiology (ACC), Dr. Ballantyne said, "Ezetimibe/simvastatin provided enhanced lipid regulation and anti-inflammatory effects compared to simvastatin alone."

He and colleagues prepared a post hoc analysis of 3 similar, randomized, placebo-controlled, double-blind studies that included 3083 people with hypercholesterolemia. In the studies, patients were taken off medicines for 4 to 6 weeks and were then equally randomized to placebo, ezetimibe 10 mg, ezetimibe/simvastatin 10 mg/10 mg, ezetimibe/simvastatin 10 mg/20 mg, ezetimibe/simvastatin 10 mg/40 mg, ezetimibe/simvastatin 10 mg/80 mg, simvastatin 10 mg, simvastatin 20 mg, simvastatin 40 mg, or simvastatin 80 mg. Subjects in the studies were on treatment for 12 weeks.

Pooled data shows that simvastatin was successful in lowering C-reactive protein values 14.3% from baseline. While ezetimibe, by itself, did not significantly reduce levels of C-reactive protein, the combination of simvastatin and ezetimibe -- the same combination that forms the cholesterol-lowering drug Vytorin -- reduced C-reactive protein levels by 31%. The difference between the 2 drugs and simvastatin alone was statistically significant at the P <.001 level, Dr. Ballantyne said.

When it came to decreasing cholesterol levels, the same pattern was seen, he said. By itself, simvastatin lowered cholesterol 38%, while together the 2 drugs reduced cholesterol 52.5% in the pooled data, Dr. Ballantyne said.

[Presentation title: Effects of Ezetimibe/Simvastatin Compared to Simvastatin Monotherapy in Reducing C-Reactive Protein and Low-Density Lipoprotein Cholesterol. Abstract 808-5]

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