Effects of 1-year treatment with metformin on metabolic and cardiovascular risk factors in non-diabetic upper-body obese subjects with mild glucose anomalies: A post-hoc analysis of the BIGPRO1 trial

• Published in: Diabetes & metabolism 2009-11, Vol.35 (5), p.385-391
• Main Authors: Fontbonne, A, Diouf, I, Baccara-Dinet, M, Eschwege, E, Charles, M.-A
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Blood Glucose - analysis; Blood Pressure - drug effects; Cardiometabolic risk factors; Cardiovascular Diseases - complications; Cardiovascular Diseases - epidemiology; Cholesterol - blood; Cholesterol, LDL - blood; Clinical trial; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - prevention & control; Diabetes. Impaired glucose tolerance; Double-Blind Method; Endocrine pancreas. Apud cells (diseases); Endocrinology & Metabolism; Endocrinopathies; Essai clinique; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Facteurs de risque cardiométaboliques; Female; Glucose Intolerance - complications; Glucose Intolerance - drug therapy; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Internal Medicine; Male; Medical sciences; Metabolic diseases; Metabolic Syndrome - complications; Metabolic Syndrome - epidemiology; Metformin; Metformin - adverse effects; Metformin - therapeutic use; Metformine; Middle Aged; Obesity; Obesity, Abdominal - complications; Prediabetes; Prédiabète; Risk Factors
• ISSN: 1262-3636; 1878-1780
• DOI: 10.1016/j.diabet.2009.03.005

Abstract Aim Metformin has recently been considered as a possible pharmacological complement to lifestyle measures for preventing type 2 diabetes in high-risk subjects. However, little is known of its effects on metabolic and cardiovascular risk factors in non-diabetic subjects. Methods The BIGPRO1 trial was a 1-year multicentre, randomized, double-blind, controlled clinical trial of metformin versus placebo, carried out in the early 1990s, in 457 upper-body obese non-diabetic subjects with no cardiovascular diseases or contraindications to metformin. We compared the changes (1-year minus baseline) in cardiometabolic risk factors between treatment groups in two subsets of trial subjects: those with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) ( n = 101); and those who fulfilled the inclusion criteria of the Diabetes Prevention Program (DPP) ( n = 51). Comparisons were adjusted for age and gender. Results In the IFG/IGT subset, significant differences in 1-year changes were observed for systolic blood pressure, which decreased markedly more in the metformin group than in the placebo group ( P < 0.003), and for fasting plasma glucose, and total and LDL cholesterol, which decreased slightly in the metformin group, but increased in the placebo group ( P < 0.04). Similar results were observed in the subset with DPP criteria. Also, there were no significant differences in 1-year changes for weight, waist-to-hip ratio, 2-h post-load blood glucose, fasting and 2-h post-load insulin, HDL cholesterol, triglycerides and fibrinolytic markers between the two treatment groups. Conclusion In subjects at high risk of developing diabetes, the use of metformin showed beneficial and no untoward effects on cardiometabolic risk factors.