The efficacy of Ezetimibe added to ongoing Fibrate-Statin therapy on postprandial lipid profile in the patients with type 2 Diabetes mellitus

BACKGROUND: Postprandial hypertriglyceridemia in diabetes mellitus can be followed by endothelial dysfunction, impaired vascular compliance and increased cardiovascular complications. So focus on better control of postprandial hypertriglyceridemia is as important as controlling fasting triglyceride level in type 2 DM. OBJECTIVE: We evaluated the effect of ezetimibe adding to fibrate or statin on postprandial hypertriglyceridemia. METHODS: In a randomized controlled clinical trial, 47 subjects with type 2 diabetes and hypertiglyceridemia were enrolled and divided in three treatment groups including Gemfibrozil 1200(mg/d) + placebo(group A), Ezetimibe10(mg/d) + Gemfibrozile 1200(mg/d)(group B) or Ezetimibe10(mg/d) + Atorvastatin10(mg/d) (group C) for a 6- week period. Oral fat loading test were performed in the initiation and also at the end of the study and lipid profile and APO(B) were measured. RESULTS: Fasting and postprandial serum triglyceride (TG) decreased significantly with all the three treatment groups with no difference between them in the percent of TG reduction. Although serum total cholesterol decreased significantly in all the three groups of treatment its reduction was more prominent in group C(−38.1% ± 11.2%in group C vs. -16.5% ± 19.6% and −7.2% ± 10.7% in groups B & A respectively, p < 0.0001 ). Fasting serum HDL increased significantly only by Gemfibrozil (23.4% ± 28.4% vs. 6.4% ± 18.9% and 1.8% ± 17.7%, p < 0.05 ). Fasting serum APO(B) was reduced only in ezetimibe containing groups (B &C). CONCLUSION: Adding ezetimibe to gemfibrozil has no additional effect on reducing postprandial TG but ezetimibe can potentiate the effect of low-dose atorvastatin on lowering TG and LDL-c.