The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia

Abstract

Objective:

To compare the effects of simvastatin alone versus simvastatin plus ezetimibe on small dense low-density lipoprotein cholesterol (sdLDL-C) concentration in subjects with primary hypercholesterolemia.

Research design and methods:

Patients with LDL-C levels above those recommended by the National Cholesterol Education Program Adult Treatment Panel III were randomized to open-label simvastatin 40 mg (n = 50) or simvastatin/ezetimibe 10/10 mg as a fixed combination (n = 50) daily. LDL particle size (estimated by electrophoresis), sdLDL-C levels, and lipid profile were blindly assessed at baseline and 3 months.

Clinical trial registration:

clinicaltrials.gov NCT00932620.

Results:

Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg decreased total cholesterol (−31% and −36%, respectively), LDL-C (−43% and −49%, respectively), triglycerides (−17% and −19%, respectively), non-high-density lipoprotein cholesterol (non-HDL-C; −40% and −46%, respectively), large LDL-C (−40 and −44%, respectively) and sdLDL-C levels (−42% and −46%, respectively, all p < 0.000 vs baseline) and increased LDL particle size (+0.5% and +0.7%, respectively, both p < 0.05 vs baseline). The changes in total cholesterol, LDL-C and non‐HDL-C were greater in the simvastatin/ezetimibe group (all p < 0.05). Changes in triglycerides, large LDL-C, sdLDL-C levels and LDL particle size were similar in the two groups. In multivariate analysis, baseline sdLDL-C and triglyceride levels, but not the choice of treatment, were significantly and independently correlated with the changes in sdLDL-C levels.

Conclusion:

The combination of simvastatin 10 mg plus ezetimibe 10 mg is similarly effective to simvastatin 40 mg in improving sdLDL-C concentration and LDL particle size in subjects with primary hypercholesterolemia.

Key words::

• Ezetimibe
• Low density lipoprotein particle size
• Simvastatin
• Small dense low density lipoprotein

Transparency

Declaration of funding

This work was supported by a research grant from Merck Sharp and Dome (MSD). The sponsors had no role in the design of the study and did not influence the interpretation of the data or writing of the manuscript.

Declaration of financial/other relationships

M.F., E.N.L., E.M., C.V.R., A.D.T. and M.S.E. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

The CMRO peer reviewers have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

Acknowledgments

None.