Combination ezetimibe, simvastatin plus niacin may benefit patients with hyperlipidemia

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Treatment with combination ezetimibe and simvastatin plus extended-release niacin may aid patients with hyperlipidemia in achieving target LDL cholesterol, non-HDL cholesterol and apolipoprotein B levels, according to data presented here.

To compare the efficacy of combination ezetimibe and simvastatin plus extended-release niacin with either treatment alone, researchers conducted a randomized, double blind study involving patients with type IIA and IIB hyperlipidemia.

“What we looked at in this combination with ezetimibe and the statin along with extended-release niacin how that supports the attainment of recommended LDL, non-HDL and apolipoprotein B goals and showing that the combination allows you in this patient population to get to significantly more patients to get to those goals,” Andrew M. Tershakovec, MD, MPH, researcher for Merck Research Laboratories, told Cardiology Today.

Patients were randomly assigned to one of the following regimens:

10 mg/20 mg of combination ezetimibe and simvastatin plus niacin titrated toa 2-g dose for 64 weeks.
10 mg/20 mg of combination ezetimibe and simvastatin alone for 64 weeks.
Niacin titrated to a 2-g dose for 24 weeks then 10 mg/20 mg of combination ezetimibe with or without 2 g of niacin for 40 weeks or more. .

Tershakovec and colleagues also assessed lipid outcomes in subgroups of patients with high risk for coronary heart disease, diabetes, metabolic syndrome and those without diabetes or metabolic syndrome.

Results revealed that considerably more patients receiving combination ezetimibe and simvastatin plus niacin reached concomitant LDL, non-HDL and ApoB levels when compared with those receiving niacin and combination ezetimibe and simvastatin at 24 weeks and combination ezetimibe and simvastatin at 64 weeks. In all subgroups, attainment rates remained higher for patients receiving the combination treatment plus niacin vs. niacin alone at 24 and 64 weeks. In addition, rates were generally greater with combination ezetimibe and simvastatin plus niacin vs. the combination treatment alone. Concomitant attainment of all three target lipid levels was most consistent with the single level attainment of non-HDL cholesterol.

“What this shows is that the combination of ezetimibe/statin and niacin is very potent,” Tershakovec said. “I think niacin-based therapy has been around a long time, but the outcomes data are relatively limited. However, the data that do exist are positive.”

He noted that two large outcome studies examining the use of extended-release niacin will also provide physicians with more insight into how to implement these treatments into clinical practice.

“Seeing those outcomes data would be very informative on what the utility of therapies like this really is,” Tershakovec said. – by Melissa Foster

Disclosure: Dr. Tershakovec is an employee for Merck as well as a company stockholder.

For more information:

Fazio S. Poster Session 1011-298. Presented at: ACC 60^th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

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