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
“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 Endocrine Today.
Patients were randomly assigned to one of the following regimens:
- 10 mg/20 mg of combination
ezetimibe and simvastatin plus niacin titrated to a 2-g dose for 64
- 10 mg/20 mg of combination ezetimibe and simvastatin alone for 64
- 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 ,
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
Disclosure: Dr. Tershakovec is an employee for Merck as well as a
For more information:
- Fazio S. Poster Session 1011-298. Presented at: American College of
Cardiology 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.