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Erschienen in:
01.08.2005 | Adis Drug Profile
Rosiglitazone/Metformin
Erschienen in: Drugs | Ausgabe 11/2005
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▴ The thiazolidinedione rosiglitazone and the biguanide metformin are effective antihyperglycaemic agents with different modes of action; rosiglitazone primarily increases insulin sensitivity, whereas metformin primarily reduces hepatic glucose output.
▴ Antihyperglycaemic combination therapy is often required to achieve effective glycaemic control. A fixed-dose formulation of rosiglitazone/metformin was recently approved in the EU and the US for the treatment of type 2 diabetes mellitus in patients inadequately controlled on metformin monotherapy.
▴ Bioequivalence between the fixed-dose combination tablet and coadministration of rosiglitazone with metformin at the same dosage has been established in a pharmacokinetic study.
▴ Fixed-dose rosiglitazone/metformin 8mg/2g per day reduced glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels to a significantly greater extent than metformin 3 g/day in patients with type 2 diabetes in a 24-week, randomised, double-blind study.
▴ Rosiglitazone plus metformin was significantly more effective than metformin alone at reducing HbA1c and FPG levels in patients with type 2 diabetes in three 26-week, randomised, double-blind, placebo-controlled studies.
▴ Rosiglitazone plus metformin was generally well tolerated in all studies and had a tolerability profile similar to that of metformin monotherapy. Mild or moderate symptomatic hypoglycaemia was reported in ≤4.4% of rosiglitazone plus metformin recipients.