Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: The VYTAL study

Ronald B Goldberg, John R. Guyton, Theodore Mazzone, Ruth S. Weinstock, Adam Polis, Patricia Edwards, Joanne E. Tomassini, Andrew M. Tershakovec

Research output: Contribution to journalArticle

106 Citations (Scopus)

Abstract

OBJECTIVE: To compare the efficacy and safety of the recommended usual starting and next highest doses of ezetimibe/ simvastatin and atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia. PATIENTS AND METHODS: This double-blind, multicenter study (June 22 to December 7, 2005) consisted of adult patients randomized to the recommended usual starting (ezetimibe/simvastatin, 10/20 mg/d, vs atorvastatin, 10 or 20 mg/d) or next highest (ezetimibe/simvastatin, 10/40 mg/d, vs atorvastatin, 40 mg/d) doses. Efficacy end points included percent changes from baseline in low-density lipoprotein cholesterol (LDL-C) levels (primary) and proportion of patients attaining LDL-C levels less than 70 mg/dL (secondary). RESULTS: A total of 1229 patients participated in the study. Significantly greater mean reductions were found in LDL-C levels with ezetimibe/simvastatin, 10/20 mg/d (-53.6%; 95% confidence interval [CI], -55.4% to -51.8%), than with atorvastatin, 10 mg/d (-38.3%; 95% CI, -40.1% to -36.5%; P<.001) or 20 mg/d (-44.6%; 95% CI, -46.4% to -42.8%; P<.001), and with ezetimibe/simvastatin, 10/40 mg/d (-57.6%; 95% CI, -59.4% to -55.8%), vs atorvastatin, 40 mg/d (-50.9%; 95% CI, -52.7% to -49.1%; P<.001). Ezetimibe/simvastatin was also superior to atorvastatin in attainment of LDL-C levels less than 70 mg/dL (P<.001 for all dose comparisons). Significantly better improvements with ezetimibe/simvastatin than with atorvastatin (P≤.001) were observed for total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoproteln cholesterol. Ezetimibe/ simvastatin, 10/20 mg/d, reduced high-sensitivity C-reactive protein and triglyceride levels significantly more than atorvastatin, 10 mg/d (P=.02), with comparable reductions at other doses. Incidences of clinical adverse events, including serious drug-related and prespecified gastrointestinal-, gallbladder-, and hepatitis-related allergic reactions or rash events, and laboratory adverse events, including repeated elevation of hepatic transaminases or creatine kinase levels, were similar for both treatments. CONCLUSION: Ezetimibe/simvastatin provided additional lipid-modifying benefits over atorvastatin monotherapy at the recommended usual starting and next highest doses in patients with type 2 diabetes. Both treatments were generally well tolerated.

Original languageEnglish
Pages (from-to)1579-1588
Number of pages10
JournalMayo Clinic Proceedings
Volume81
Issue number12
StatePublished - Jan 1 2006

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Simvastatin
Hypercholesterolemia
Type 2 Diabetes Mellitus
LDL Cholesterol
Confidence Intervals
Cholesterol
Ezetimibe
Atorvastatin Calcium
Creatine Kinase
Transaminases
Exanthema
Gallbladder
Double-Blind Method
C-Reactive Protein
HDL Cholesterol
Hepatitis
Multicenter Studies
Hypersensitivity
Triglycerides
Lipids

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Goldberg, R. B., Guyton, J. R., Mazzone, T., Weinstock, R. S., Polis, A., Edwards, P., ... Tershakovec, A. M. (2006). Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: The VYTAL study. Mayo Clinic Proceedings, 81(12), 1579-1588.

Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia : The VYTAL study. / Goldberg, Ronald B; Guyton, John R.; Mazzone, Theodore; Weinstock, Ruth S.; Polis, Adam; Edwards, Patricia; Tomassini, Joanne E.; Tershakovec, Andrew M.

In: Mayo Clinic Proceedings, Vol. 81, No. 12, 01.01.2006, p. 1579-1588.

Research output: Contribution to journalArticle

Goldberg, RB, Guyton, JR, Mazzone, T, Weinstock, RS, Polis, A, Edwards, P, Tomassini, JE & Tershakovec, AM 2006, 'Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: The VYTAL study', Mayo Clinic Proceedings, vol. 81, no. 12, pp. 1579-1588.
Goldberg, Ronald B ; Guyton, John R. ; Mazzone, Theodore ; Weinstock, Ruth S. ; Polis, Adam ; Edwards, Patricia ; Tomassini, Joanne E. ; Tershakovec, Andrew M. / Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia : The VYTAL study. In: Mayo Clinic Proceedings. 2006 ; Vol. 81, No. 12. pp. 1579-1588.
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abstract = "OBJECTIVE: To compare the efficacy and safety of the recommended usual starting and next highest doses of ezetimibe/ simvastatin and atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia. PATIENTS AND METHODS: This double-blind, multicenter study (June 22 to December 7, 2005) consisted of adult patients randomized to the recommended usual starting (ezetimibe/simvastatin, 10/20 mg/d, vs atorvastatin, 10 or 20 mg/d) or next highest (ezetimibe/simvastatin, 10/40 mg/d, vs atorvastatin, 40 mg/d) doses. Efficacy end points included percent changes from baseline in low-density lipoprotein cholesterol (LDL-C) levels (primary) and proportion of patients attaining LDL-C levels less than 70 mg/dL (secondary). RESULTS: A total of 1229 patients participated in the study. Significantly greater mean reductions were found in LDL-C levels with ezetimibe/simvastatin, 10/20 mg/d (-53.6{\%}; 95{\%} confidence interval [CI], -55.4{\%} to -51.8{\%}), than with atorvastatin, 10 mg/d (-38.3{\%}; 95{\%} CI, -40.1{\%} to -36.5{\%}; P<.001) or 20 mg/d (-44.6{\%}; 95{\%} CI, -46.4{\%} to -42.8{\%}; P<.001), and with ezetimibe/simvastatin, 10/40 mg/d (-57.6{\%}; 95{\%} CI, -59.4{\%} to -55.8{\%}), vs atorvastatin, 40 mg/d (-50.9{\%}; 95{\%} CI, -52.7{\%} to -49.1{\%}; P<.001). Ezetimibe/simvastatin was also superior to atorvastatin in attainment of LDL-C levels less than 70 mg/dL (P<.001 for all dose comparisons). Significantly better improvements with ezetimibe/simvastatin than with atorvastatin (P≤.001) were observed for total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoproteln cholesterol. Ezetimibe/ simvastatin, 10/20 mg/d, reduced high-sensitivity C-reactive protein and triglyceride levels significantly more than atorvastatin, 10 mg/d (P=.02), with comparable reductions at other doses. Incidences of clinical adverse events, including serious drug-related and prespecified gastrointestinal-, gallbladder-, and hepatitis-related allergic reactions or rash events, and laboratory adverse events, including repeated elevation of hepatic transaminases or creatine kinase levels, were similar for both treatments. CONCLUSION: Ezetimibe/simvastatin provided additional lipid-modifying benefits over atorvastatin monotherapy at the recommended usual starting and next highest doses in patients with type 2 diabetes. Both treatments were generally well tolerated.",
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T1 - Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia

T2 - The VYTAL study

AU - Goldberg, Ronald B

AU - Guyton, John R.

AU - Mazzone, Theodore

AU - Weinstock, Ruth S.

AU - Polis, Adam

AU - Edwards, Patricia

AU - Tomassini, Joanne E.

AU - Tershakovec, Andrew M.

PY - 2006/1/1

Y1 - 2006/1/1

N2 - OBJECTIVE: To compare the efficacy and safety of the recommended usual starting and next highest doses of ezetimibe/ simvastatin and atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia. PATIENTS AND METHODS: This double-blind, multicenter study (June 22 to December 7, 2005) consisted of adult patients randomized to the recommended usual starting (ezetimibe/simvastatin, 10/20 mg/d, vs atorvastatin, 10 or 20 mg/d) or next highest (ezetimibe/simvastatin, 10/40 mg/d, vs atorvastatin, 40 mg/d) doses. Efficacy end points included percent changes from baseline in low-density lipoprotein cholesterol (LDL-C) levels (primary) and proportion of patients attaining LDL-C levels less than 70 mg/dL (secondary). RESULTS: A total of 1229 patients participated in the study. Significantly greater mean reductions were found in LDL-C levels with ezetimibe/simvastatin, 10/20 mg/d (-53.6%; 95% confidence interval [CI], -55.4% to -51.8%), than with atorvastatin, 10 mg/d (-38.3%; 95% CI, -40.1% to -36.5%; P<.001) or 20 mg/d (-44.6%; 95% CI, -46.4% to -42.8%; P<.001), and with ezetimibe/simvastatin, 10/40 mg/d (-57.6%; 95% CI, -59.4% to -55.8%), vs atorvastatin, 40 mg/d (-50.9%; 95% CI, -52.7% to -49.1%; P<.001). Ezetimibe/simvastatin was also superior to atorvastatin in attainment of LDL-C levels less than 70 mg/dL (P<.001 for all dose comparisons). Significantly better improvements with ezetimibe/simvastatin than with atorvastatin (P≤.001) were observed for total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoproteln cholesterol. Ezetimibe/ simvastatin, 10/20 mg/d, reduced high-sensitivity C-reactive protein and triglyceride levels significantly more than atorvastatin, 10 mg/d (P=.02), with comparable reductions at other doses. Incidences of clinical adverse events, including serious drug-related and prespecified gastrointestinal-, gallbladder-, and hepatitis-related allergic reactions or rash events, and laboratory adverse events, including repeated elevation of hepatic transaminases or creatine kinase levels, were similar for both treatments. CONCLUSION: Ezetimibe/simvastatin provided additional lipid-modifying benefits over atorvastatin monotherapy at the recommended usual starting and next highest doses in patients with type 2 diabetes. Both treatments were generally well tolerated.

AB - OBJECTIVE: To compare the efficacy and safety of the recommended usual starting and next highest doses of ezetimibe/ simvastatin and atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia. PATIENTS AND METHODS: This double-blind, multicenter study (June 22 to December 7, 2005) consisted of adult patients randomized to the recommended usual starting (ezetimibe/simvastatin, 10/20 mg/d, vs atorvastatin, 10 or 20 mg/d) or next highest (ezetimibe/simvastatin, 10/40 mg/d, vs atorvastatin, 40 mg/d) doses. Efficacy end points included percent changes from baseline in low-density lipoprotein cholesterol (LDL-C) levels (primary) and proportion of patients attaining LDL-C levels less than 70 mg/dL (secondary). RESULTS: A total of 1229 patients participated in the study. Significantly greater mean reductions were found in LDL-C levels with ezetimibe/simvastatin, 10/20 mg/d (-53.6%; 95% confidence interval [CI], -55.4% to -51.8%), than with atorvastatin, 10 mg/d (-38.3%; 95% CI, -40.1% to -36.5%; P<.001) or 20 mg/d (-44.6%; 95% CI, -46.4% to -42.8%; P<.001), and with ezetimibe/simvastatin, 10/40 mg/d (-57.6%; 95% CI, -59.4% to -55.8%), vs atorvastatin, 40 mg/d (-50.9%; 95% CI, -52.7% to -49.1%; P<.001). Ezetimibe/simvastatin was also superior to atorvastatin in attainment of LDL-C levels less than 70 mg/dL (P<.001 for all dose comparisons). Significantly better improvements with ezetimibe/simvastatin than with atorvastatin (P≤.001) were observed for total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoproteln cholesterol. Ezetimibe/ simvastatin, 10/20 mg/d, reduced high-sensitivity C-reactive protein and triglyceride levels significantly more than atorvastatin, 10 mg/d (P=.02), with comparable reductions at other doses. Incidences of clinical adverse events, including serious drug-related and prespecified gastrointestinal-, gallbladder-, and hepatitis-related allergic reactions or rash events, and laboratory adverse events, including repeated elevation of hepatic transaminases or creatine kinase levels, were similar for both treatments. CONCLUSION: Ezetimibe/simvastatin provided additional lipid-modifying benefits over atorvastatin monotherapy at the recommended usual starting and next highest doses in patients with type 2 diabetes. Both treatments were generally well tolerated.

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