Identical LDL-cholesterol lowering but non-identical effects on NF-κB activity: High dose simvastatin vs combination therapy with ezetimibe

Atherosclerosis. 2012 Jul;223(1):190-6. doi: 10.1016/j.atherosclerosis.2012.04.003. Epub 2012 May 7.

Abstract

Objective: Lowering LDL-cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-κB. To our knowledge, anti-inflammatory potential of newer cholesterol lowering agents such as ezetimibe is less intensively studied. Therefore we analyzed the effects of equipotent LDL-lowering therapy with simvastatin alone compared to a combination with ezetimibe on NF-κB activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Methods: Thirty-one patients with type 2 diabetes were included in a double-blind, randomized trial receiving either 80 mg simvastatin (sim80; n = 10) or a combination of 10 mg simvastatin and 10 mg ezetimibe (sim10eze10; n = 11) or placebo (n = 9) for eight weeks. NF-κB binding activity and inflammatory markers (IL-6, hsCRP) were analyzed at baseline and after eight weeks of treatment. NF-κB binding activity was analyzed by electrophoretic mobility shift assay. IL-6 and hsCRP were measured by ELISA.

Results: After eight weeks of treatment LDL-cholesterol was lowered to the same extent in both treatment groups (p = 0.40) but not in placebo. However, patients taking sim80 showed a significant reduction of mononuclear NF-κB binding activity compared to baseline (p = 0.009) while no effect was observed in the sim10eze10 group (p = 0.79). Similar differences in anti-inflammatory effects were also observed when analyzing hsCRP (sim80: p = 0.03; sim10eze10: p = 0.40) and IL-6 levels (sim80: p = 0.15; sim10eze10: p = 0.95).

Conclusion: High dose simvastatin therapy reduces proinflammatory transcription factor NF-κB binding activity and hsCRP levels, while combination of low dose simvastatin with ezetimibe resulting in a similar LDL-reduction does not affect these inflammatory markers.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Azetidines / administration & dosage*
  • Biomarkers / blood
  • C-Reactive Protein / metabolism
  • Cholesterol, LDL / blood*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / immunology
  • Double-Blind Method
  • Down-Regulation
  • Drug Combinations
  • Electrophoretic Mobility Shift Assay
  • Enzyme-Linked Immunosorbent Assay
  • Ezetimibe, Simvastatin Drug Combination
  • Female
  • Germany
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hypercholesterolemia / blood
  • Hypercholesterolemia / drug therapy*
  • Hypercholesterolemia / immunology
  • Inflammation / blood
  • Inflammation / drug therapy*
  • Inflammation / immunology
  • Inflammation Mediators / blood
  • Interleukin-6 / blood
  • Male
  • Middle Aged
  • NF-kappa B / blood*
  • Simvastatin / administration & dosage*
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Azetidines
  • Biomarkers
  • Cholesterol, LDL
  • Drug Combinations
  • Ezetimibe, Simvastatin Drug Combination
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • IL6 protein, human
  • Inflammation Mediators
  • Interleukin-6
  • NF-kappa B
  • C-Reactive Protein
  • Simvastatin