Atherogenic lipoprotein phenotype in type 2 diabetes: reversal with micronised fenofibrate.
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.
Feher
M D
MD
Clinical Pharmacology (Imperial College School of Medicine), Chelsea and Westminster Hospital, London, UK. m.feher@ic.ac.uk
Caslake
M
M
Foxton
J
J
Cox
A
A
Packard
C J
CJ
D000328:Adult; D001161:Arteriosclerosis / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D011208:Powders
D011345:Fenofibrate; D006442:Glycated Hemoglobin; D000960:Hypolipidemic Agents; D008055:Lipids; D008074:Lipoproteins; D008077:Lipoproteins, LDL; D011208:Powders