Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics

A multicenter, randomized trial (the LEAD study)

Gianluca Bardini, Carlo B. Giorda, Antonio E. Pontiroli, Cristina Le Grazie, Carlo M. Rotella

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Background: The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM).Methods: Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides was assessed.Results: EZ + simva 10/20 mg produced a significantly greater change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2% vs -20.8%; p <0.01) and total cholesterol (-20.6% vs -13.2%; p <0.01). A greater proportion of patients achieved LDL-C <2.6 mmol/L with EZ + simva 10/20 mg than with simvastatin 40 mg, but this was not statistically significant (78.4% vs 60%; odds ratio = 2.81; p = 0.052). Changes in high-density lipoprotein cholesterol and triglycerides were similar between treatments. Both treatments were generally well-tolerated.Conclusions: These results demonstrate that EZ + simva 10/20 mg may provide a superior alternative for LDL-C lowering vs doubling the dose of simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, the combination therapy may provide an alternative treatment for patients who require further LDL-C reduction than they can achieve with simvastatin 20 mg alone.

Original languageEnglish
Article number20
JournalCardiovascular Diabetology
Volume9
DOIs
Publication statusPublished - May 21 2010

Fingerprint

Simvastatin
LDL Cholesterol
Multicenter Studies
Type 2 Diabetes Mellitus
Coronary Disease
HDL Cholesterol
Therapeutics
Ezetimibe
Hypercholesterolemia
Double-Blind Method
Odds Ratio
Cholesterol

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics : A multicenter, randomized trial (the LEAD study). / Bardini, Gianluca; Giorda, Carlo B.; Pontiroli, Antonio E.; Le Grazie, Cristina; Rotella, Carlo M.

In: Cardiovascular Diabetology, Vol. 9, 20, 21.05.2010.

Research output: Contribution to journalArticle

@article{0ef17440a40b45bdb8d73f24c958c697,
title = "Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics: A multicenter, randomized trial (the LEAD study)",
abstract = "Background: The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM).Methods: Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides was assessed.Results: EZ + simva 10/20 mg produced a significantly greater change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2{\%} vs -20.8{\%}; p <0.01) and total cholesterol (-20.6{\%} vs -13.2{\%}; p <0.01). A greater proportion of patients achieved LDL-C <2.6 mmol/L with EZ + simva 10/20 mg than with simvastatin 40 mg, but this was not statistically significant (78.4{\%} vs 60{\%}; odds ratio = 2.81; p = 0.052). Changes in high-density lipoprotein cholesterol and triglycerides were similar between treatments. Both treatments were generally well-tolerated.Conclusions: These results demonstrate that EZ + simva 10/20 mg may provide a superior alternative for LDL-C lowering vs doubling the dose of simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, the combination therapy may provide an alternative treatment for patients who require further LDL-C reduction than they can achieve with simvastatin 20 mg alone.",
author = "Gianluca Bardini and Giorda, {Carlo B.} and Pontiroli, {Antonio E.} and {Le Grazie}, Cristina and Rotella, {Carlo M.}",
year = "2010",
month = "5",
day = "21",
doi = "10.1186/1475-2840-9-20",
language = "English",
volume = "9",
journal = "Cardiovascular Diabetology",
issn = "1475-2840",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics

T2 - A multicenter, randomized trial (the LEAD study)

AU - Bardini, Gianluca

AU - Giorda, Carlo B.

AU - Pontiroli, Antonio E.

AU - Le Grazie, Cristina

AU - Rotella, Carlo M.

PY - 2010/5/21

Y1 - 2010/5/21

N2 - Background: The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM).Methods: Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides was assessed.Results: EZ + simva 10/20 mg produced a significantly greater change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2% vs -20.8%; p <0.01) and total cholesterol (-20.6% vs -13.2%; p <0.01). A greater proportion of patients achieved LDL-C <2.6 mmol/L with EZ + simva 10/20 mg than with simvastatin 40 mg, but this was not statistically significant (78.4% vs 60%; odds ratio = 2.81; p = 0.052). Changes in high-density lipoprotein cholesterol and triglycerides were similar between treatments. Both treatments were generally well-tolerated.Conclusions: These results demonstrate that EZ + simva 10/20 mg may provide a superior alternative for LDL-C lowering vs doubling the dose of simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, the combination therapy may provide an alternative treatment for patients who require further LDL-C reduction than they can achieve with simvastatin 20 mg alone.

AB - Background: The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM).Methods: Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus simvastatin 20 mg (EZ + simva 10/20 mg) or simvastatin 40 mg for 6 weeks. Percent change in LDL-C, high-density lipoprotein cholesterol, and triglycerides was assessed.Results: EZ + simva 10/20 mg produced a significantly greater change from treated baseline compared with simvastatin 40 mg in LDL-C (-32.2% vs -20.8%; p <0.01) and total cholesterol (-20.6% vs -13.2%; p <0.01). A greater proportion of patients achieved LDL-C <2.6 mmol/L with EZ + simva 10/20 mg than with simvastatin 40 mg, but this was not statistically significant (78.4% vs 60%; odds ratio = 2.81; p = 0.052). Changes in high-density lipoprotein cholesterol and triglycerides were similar between treatments. Both treatments were generally well-tolerated.Conclusions: These results demonstrate that EZ + simva 10/20 mg may provide a superior alternative for LDL-C lowering vs doubling the dose of simvastatin to 40 mg in hyperlipidemic patients with T2DM and CHD. In addition, the combination therapy may provide an alternative treatment for patients who require further LDL-C reduction than they can achieve with simvastatin 20 mg alone.

UR - http://www.scopus.com/inward/record.url?scp=77952466162&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77952466162&partnerID=8YFLogxK

U2 - 10.1186/1475-2840-9-20

DO - 10.1186/1475-2840-9-20

M3 - Article

VL - 9

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

SN - 1475-2840

M1 - 20

ER -