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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 >or= 2.6 mmol/L (100 mg/dL) and ResultsEZ + 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.

SUBMITTER: Bardini G 

PROVIDER: S-EPMC2887787 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Ezetimibe + simvastatin versus doubling the dose of simvastatin in high cardiovascular risk diabetics: a multicenter, randomized trial (the LEAD study).

Bardini Gianluca G   Giorda Carlo B CB   Pontiroli Antonio E AE   Le Grazie Cristina C   Rotella Carlo M CM  

Cardiovascular diabetology 20100521


<h4>Background</h4>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).<h4>Methods</h4>Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C >or= 2.6 mmol/L (100 mg/dL) and <or= 4.1 mmol/L (160 mg/dL) were randomized to ezetimibe 10 mg plus  ...[more]

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