Lipoprotein and apolipoprotein ratios in the VYTAL trial of ezetimibe/simvastatin compared with atorvastatin in type 2 diabetes

John R. Guyton, Ronald B Goldberg, Theodore Mazzone, Ruth S. Weinstock, Adam Polis, Elizabeth Rosenberg, Andrew M. Tershakovec

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk. Objective: To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM. Methods: Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance. Results: Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, -30.2%; ATORVA 20 mg -34.9%; EZE/SIMVA 10/20 mg, -41.6%; ATORVA 40 mg, -37.9%; and EZE/SIMVA 10/40 mg, -43.5%. Tolerability of the two treatments was similar. Conclusion: For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.

Original languageEnglish
Pages (from-to)19-24
Number of pages6
JournalJournal of Clinical Lipidology
Volume2
Issue number1
DOIs
StatePublished - Feb 1 2008

Fingerprint

Simvastatin
Apolipoproteins
Type 2 Diabetes Mellitus
Lipoproteins
HDL Cholesterol
Cholesterol
LDL Cholesterol
Coronary Disease
Apolipoprotein A-I
Apolipoproteins B
Therapeutics
Ezetimibe
Atorvastatin Calcium
Analysis of Variance

Keywords

  • Apolipoprotein B/A-I ratio
  • Atorvastatin
  • Diabetes mellitus
  • Ezetimibe
  • Lipoprotein ratios
  • Simvastatin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine
  • Nutrition and Dietetics

Cite this

Lipoprotein and apolipoprotein ratios in the VYTAL trial of ezetimibe/simvastatin compared with atorvastatin in type 2 diabetes. / Guyton, John R.; Goldberg, Ronald B; Mazzone, Theodore; Weinstock, Ruth S.; Polis, Adam; Rosenberg, Elizabeth; Tershakovec, Andrew M.

In: Journal of Clinical Lipidology, Vol. 2, No. 1, 01.02.2008, p. 19-24.

Research output: Contribution to journalArticle

Guyton, John R. ; Goldberg, Ronald B ; Mazzone, Theodore ; Weinstock, Ruth S. ; Polis, Adam ; Rosenberg, Elizabeth ; Tershakovec, Andrew M. / Lipoprotein and apolipoprotein ratios in the VYTAL trial of ezetimibe/simvastatin compared with atorvastatin in type 2 diabetes. In: Journal of Clinical Lipidology. 2008 ; Vol. 2, No. 1. pp. 19-24.
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abstract = "Background: Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk. Objective: To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM. Methods: Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance. Results: Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, -30.2{\%}; ATORVA 20 mg -34.9{\%}; EZE/SIMVA 10/20 mg, -41.6{\%}; ATORVA 40 mg, -37.9{\%}; and EZE/SIMVA 10/40 mg, -43.5{\%}. Tolerability of the two treatments was similar. Conclusion: For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.",
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AU - Guyton, John R.

AU - Goldberg, Ronald B

AU - Mazzone, Theodore

AU - Weinstock, Ruth S.

AU - Polis, Adam

AU - Rosenberg, Elizabeth

AU - Tershakovec, Andrew M.

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N2 - Background: Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk. Objective: To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM. Methods: Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance. Results: Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, -30.2%; ATORVA 20 mg -34.9%; EZE/SIMVA 10/20 mg, -41.6%; ATORVA 40 mg, -37.9%; and EZE/SIMVA 10/40 mg, -43.5%. Tolerability of the two treatments was similar. Conclusion: For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.

AB - Background: Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk. Objective: To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM. Methods: Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance. Results: Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, -30.2%; ATORVA 20 mg -34.9%; EZE/SIMVA 10/20 mg, -41.6%; ATORVA 40 mg, -37.9%; and EZE/SIMVA 10/40 mg, -43.5%. Tolerability of the two treatments was similar. Conclusion: For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.

KW - Apolipoprotein B/A-I ratio

KW - Atorvastatin

KW - Diabetes mellitus

KW - Ezetimibe

KW - Lipoprotein ratios

KW - Simvastatin

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