Long-Term Safety and Efficacy of Triple Combination Ezetimibe/Simvastatin Plus Extended-Release Niacin in Patients With Hyperlipidemia

Sergio Fazio, John R. Guyton, Adam B. Polis, Adeniyi J. Adewale, Joanne E. Tomassini, Nicholas W. Ryan, Andrew M. Tershakovec

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

The safety and efficacy of combination ezetimibe/simvastatin (E/S) plus extended-release niacin was assessed in 942 patients with type IIa/IIb hyperlipidemia for 64 weeks in a randomized, double-blind study. Patients received E/S (10/20 mg) plus niacin (to 2 g) or E/S (10/20 mg) for 64 weeks, or niacin (to 2 g) for 24 weeks and then E/S (10/20 mg) plus niacin (2 g) or E/S (10/20 mg) for an additional 40 weeks. The primary end point, the safety of E/S plus niacin, included prespecified adverse events (ie, liver, muscle, discontinuations due to flushing, gallbladder-related, cholecystectomy, fasting glucose changes, new-onset diabetes). The secondary end points included the percentage of change from baseline in high-density lipoprotein (HDL) cholesterol, triglycerides, non-HDL cholesterol, and low-density lipoprotein cholesterol, other lipids, lipoprotein ratios and high-sensitivity C-reactive protein. The anticipated niacin-associated flushing led to a greater rate of study discontinuations with the E/S plus niacin regimen than with E/S alone (0.7%, p

Original languageEnglish (US)
Pages (from-to)487-494
Number of pages8
JournalAmerican Journal of Cardiology
Volume105
Issue number4
DOIs
StatePublished - Feb 15 2010
Externally publishedYes

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Niacin
Hyperlipidemias
Safety
Cholecystectomy
Simvastatin Drug Combination Ezetimibe
Gallbladder
Double-Blind Method
C-Reactive Protein
LDL Cholesterol
HDL Cholesterol
Lipoproteins
Fasting
Triglycerides
Lipids
Glucose
Muscles
Liver

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Long-Term Safety and Efficacy of Triple Combination Ezetimibe/Simvastatin Plus Extended-Release Niacin in Patients With Hyperlipidemia. / Fazio, Sergio; Guyton, John R.; Polis, Adam B.; Adewale, Adeniyi J.; Tomassini, Joanne E.; Ryan, Nicholas W.; Tershakovec, Andrew M.

In: American Journal of Cardiology, Vol. 105, No. 4, 15.02.2010, p. 487-494.

Research output: Contribution to journalArticle

Fazio, Sergio ; Guyton, John R. ; Polis, Adam B. ; Adewale, Adeniyi J. ; Tomassini, Joanne E. ; Ryan, Nicholas W. ; Tershakovec, Andrew M. / Long-Term Safety and Efficacy of Triple Combination Ezetimibe/Simvastatin Plus Extended-Release Niacin in Patients With Hyperlipidemia. In: American Journal of Cardiology. 2010 ; Vol. 105, No. 4. pp. 487-494.
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