The effect of pioglitazone as add-on therapy to metformin or sulphonylurea compared to a fixed-dose combination of metformin and glibenclamide on diabetic dyslipidaemia.

Author(s): Comaschi M, Corsi A, Di Pietro C, Bellatreccia A, Mariz S, COM06 Study Investigators

Affiliation(s): Emergency Department, University Hospital St Martin, Genoa, Italy. marco.comaschi@hsanmartino.it

Publication date & source: 2008-06, Nutr Metab Cardiovasc Dis., 18(5):373-9. Epub 2007 Oct 24.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND AND AIMS: Diabetic dyslipidaemia contributes to the increased risk of cardiovascular disease in patients with Type 2 diabetes. This paper examines the effectiveness of adding pioglitazone to metformin or a sulphonylurea (SU) compared with a fixed-dose combination of metformin and glibenclamide on diabetic dyslipidaemia in patients with Type 2 diabetes. METHODS AND RESULTS: Patients (n=250) treated with metformin (< or =3g/day) or an SU as monotherapy at a stable dose for > or =3 months were randomised to receive either pioglitazone (15-30 mg/day) in addition to their metformin or SU, or a fixed-dose combination tablet containing metformin (400mg) and glibenclamide (2.5 mg) [up to 3 tablets daily] for 6 months. Addition of pioglitazone tended to increase plasma high-density lipoprotein-cholesterol (HDL-C) [0.04 mmol/L; P=0.051] at 6 months and significantly reduced plasma triglycerides (-0.25 mmol/L; P=0.013) compared with baseline. Patients treated with metformin/glibenclamide for 6 months had reduced HDL-C (-0.09 mmol/L; P<0.01) and no change in plasma triglyceride levels (0.03 mmol/L; P=0.733). Both treatment regimes resulted in a similar level of glycaemic control. CONCLUSION: The beneficial effects of pioglitazone on diabetic dyslipidaemia may help combat the increased cardiovascular morbidity and mortality observed in patients with Type 2 diabetes while providing stable glycaemic control.