The BIGuanides and Prevention of Risks in Obesity (BIGPRO1) results suggest that metformin would be a suitable candidate for long-term intervention for the prevention of diabetes but that its use in a trial of primary prevention of cardiovascular diseases requires either a reevaluation of its properties toward the most potentially atherogenic anomalies of the IRS or a better definition of the target population.

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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 ≥1.7 and ≤6.5 mmol/l, high blood pressure (systolic ≥140 and ≤180 and/or diastolic ≥90 and ≤105 mmHg, or treatment for hypertension) and a waist‐to‐hip ratio ≥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. Copyright © 2000 John Wiley & Sons, Ltd.

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