Atherogenic lipoprotein phenotype in type 2 diabetes: reversal with micronised fenofibrate

Diabetes Metab Res Rev. Nov-Dec 1999;15(6):395-9. doi: 10.1002/(sici)1520-7560(199911/12)15:6<395::aid-dmrr65>3.0.co;2-n.

Abstract

Background: To assess the short-term effects of a micronised formulation of fenofibrate on lipids, lipoproteins and their composition, reflecting an atherogenic lipoprotein phenotype (ALP), in patients with stable Type 2 diabetes.

Methods: Thirty-two (18 male, 14 female) patients with Type 2 diabetes were randomised to a double-blind, placebo-controlled parallel group study after a 4-week diet run-in phase to a 12-week treatment period with either daily micronised fenofibrate 200 mg (Lipantil Micro((R))) or placebo.

Results: Baseline mean lipid and lipoproteins were similar in both groups: total cholesterol (TC) 7.5 mmol/l, serum triglyceride (TG) 3. 1 mmol/l, HDL-cholesterol (HDL-c) 1.2 mmol/l, LDL-cholesterol (LDL-c) 4.7 mmol/l, and a predominance (52%) of small dense LDL-III at concentration of 192 mg lipoprotein/100 ml, reflecting an ALP. Treatment with micronised fenofibrate resulted in significant changes in TC (-17%, p<0.001), serum TG (-44%, p<0.05), HDL-c (+20%, p<0.01), LDL-c (-22%, p<0.001), apo-B (-18%, p<0.05) and alterations in LDL subfraction masses (LDL-I +64%, p<0.05; LDL-II +53%, p<0.05; LDL-III -51%, p<0.001) resulting in LDL-III comprising 28% of total LDL (p<0.001). In the placebo group the only significant changes were in TG (+21%, p<0.05) and apo-B (+9%, p<0.05).

Conclusions: Micronised fenofibrate therapy in patients with Type 2 diabetes improved an establisheded ALP resulting in a more favourable lipid and LDL subfraction profile. The long-term clinical implications of these changes await the results of the major intervention trials of lipid modification in Type 2 diabetes.

Publication types

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

MeSH terms

  • Adult
  • Arteriosclerosis / blood
  • Arteriosclerosis / drug therapy*
  • Diabetes Mellitus, Type 2 / blood*
  • Diet
  • Double-Blind Method
  • Female
  • Fenofibrate / administration & dosage
  • Fenofibrate / therapeutic use*
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / therapeutic use*
  • Lipids / blood
  • Lipoproteins / blood*
  • Lipoproteins, LDL / blood
  • Male
  • Middle Aged
  • Powders

Substances

  • Glycated Hemoglobin A
  • Hypolipidemic Agents
  • Lipids
  • Lipoproteins
  • Lipoproteins, LDL
  • Powders
  • Fenofibrate