Evidence Hub

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

Comaschi M, Corsi A, Di Pietro C, Bellatreccia A, Mariz S, COM06 Study Investigators

Nutrition, metabolism, and cardiovascular diseases : NMCD, 2008

250 participants

Abstract

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 =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.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

Related studies

Go deeper in Evidence Hub

Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.

Open this study Sign up free