title: Treatment with metformin of non-diabetic men with hypertension, hypertriglyceridaemia and central fat distribution: the BIGPRO 1.2 trial.
abstract: BACKGROUND
  In the BIGPRO 1 trial, one year of treatment with metformin in non-diabetic obese subjects with a central fat distribution had no significant effect on fasting plasma triglyceride concentration or on blood pressure despite a decrease in weight, fasting plasma insulin and glucose concentrations. To re-evaluate the effect of metformin on fasting triglyceride concentration and on blood pressure, the BIGPRO 1.2 trial included non-diabetic men (n=168) with a fasting plasma triglyceride concentration > or =1.7 and < or =6.5 mmol/l, high blood pressure (systolic > or =140 and < or =180 and/or diastolic > or =90 and < or =105 mmHg, or treatment for hypertension) and a waist-to-hip ratio > or =0.95.
  
  
  METHODS
  A randomised double-blind trial comparing metformin treatment (850 mg bid) with placebo.
  
  
  RESULTS
  Metformin had no significant effect either on blood pressure or plasma triglyceride concentration. In comparison with the placebo group, fasting plasma insulin (p<0.04), total cholesterol (p<0.05) and Apo B (p<0.008) concentrations decreased more in the metformin group in the BIGPRO 1. 2 trial, confirming most of the previous results of the BIGPRO 1 trial. Tissue plasminogen activator antigen concentration decreased significantly (p<0.01) only in the metformin group, but this was not significantly different from the placebo group (p<0.12); further, there were no significant differences in the change in plasminogen activator inhibitor 1.
  
  
  CONCLUSIONS
  The consistency of the two BIGPRO trials supports the conclusion that metformin affects several cardiovascular risk factors favourably in non-diabetic subjects with a central fat distribution.
authors.affiliation: National Institute of Health and Medical Research (INSERM), unit 258, Villejuif, France. charles@vjf.inserm.fr
authors.forename: M A
authors.initials: MA
authors.lastname: Charles
authors.forename: E
authors.initials: E
authors.lastname: Eschwège
authors.forename: P
authors.initials: P
authors.lastname: Grandmottet
authors.forename: F
authors.initials: F
authors.lastname: Isnard
authors.forename: J M
authors.initials: JM
authors.lastname: Cohen
authors.forename: J L
authors.initials: JL
authors.lastname: Bensoussan
authors.forename: H
authors.initials: H
authors.lastname: Berche
authors.forename: O
authors.initials: O
authors.lastname: Chapiro
authors.forename: P
authors.initials: P
authors.lastname: André
authors.forename: P
authors.initials: P
authors.lastname: Vague
authors.forename: I
authors.initials: I
authors.lastname: Juhan-Vague
authors.forename: J M
authors.initials: JM
authors.lastname: Bard
authors.forename: M
authors.initials: M
authors.lastname: Safar
mesh_terms: D000273:Adipose Tissue / Q000033:anatomy & histology*; D000328:Adult; D001053:Apolipoproteins / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D005602:France; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D015228:Hypertriglyceridemia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D014280:Triglycerides / Q000097:blood
chemical_list: D001053:Apolipoproteins; D007004:Hypoglycemic Agents; D014280:Triglycerides; D008687:Metformin