title: Comparison of bezafibrate and simvastatin in the treatment of dyslipidaemia in patients with NIDDM.
abstract: Fibrates and HMG CoA reductase inhibitors are commonly used in the treatment of diabetic dyslipidaemia. However, these two groups of drugs have not been compared in diabetic patients in a randomized controlled trial. Therefore, a multicentre study was performed in 73 subjects with non-insulin-dependent (Type 2) diabetes mellitus (NIDDM) and combined hyperlipidaemia (serum cholesterol 6.2-10.0 mmol l(-1), serum triglycerides 2.3-10.0 mmol l(-1)), comparing the efficacy of 400 mg bezafibrate with 10 mg simvastatin in a double-blind fashion. Treatment with bezafibrate during 12 weeks reduced serum triglycerides significantly more than simvastatin (-41% vs -22%, p < 0.001) and increased HDL cholesterol more (bezafibrate: + 17% vs simvastatin: + 9%, p < 0.05). LDL cholesterol levels decreased by 14% (p < 0.001) during simvastatin and increased by 21% (p < 0.01) during bezafibrate. This increase in LDL cholesterol was positively correlated with fasting serum triglycerides (p < 0.001) and was associated with a reduction of the serum apolipoprotein B concentration, suggesting an increase in LDL particle size. Metabolic control of diabetes (fasting glycaemia; HbA1c) and insulin secretion (C-peptide levels) were unaffected by both treatments. The incidence of side-effects during treatment was similar for both drugs. Thus, 400 mg bezafibrate mainly increases HDL cholesterol and lowers serum triglycerides but at the expense of an increase in LDL cholesterol; 10 mg simvastatin lowers LDL cholesterin more effectively but has a smaller effect on HDL cholesterol and triglycerides.
authors.affiliation: Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital, Basel, Switzerland.
authors.forename: T
authors.initials: T
authors.lastname: Jeck
authors.forename: W F
authors.initials: WF
authors.lastname: Riesen
authors.forename: U
authors.initials: U
authors.lastname: Keller
mesh_terms: D000368:Aged; D001053:Apolipoproteins / Q000097:blood / Q000187:drug effects; D001629:Bezafibrate / Q000009:adverse effects / Q000627:therapeutic use*; D003402:Creatine Kinase / Q000097:blood / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000187:drug effects; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood / Q000187:drug effects; D008148:Lovastatin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D019821:Simvastatin
chemical_list: D001053:Apolipoproteins; D001629:Bezafibrate; D003402:Creatine Kinase; D005340:Fibrinogen; D006442:Glycated Hemoglobin; D000960:Hypolipidemic Agents; D008055:Lipids; D008074:Lipoproteins; D008148:Lovastatin; D019821:Simvastatin