Glycemic control with Glyburide/Metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial - 25/08/11
Abstract |
Purpose |
To assess the efficacy and safety of adding rosiglitazone to an established regimen of glyburide/metformin in patients with type 2 diabetes who had not achieved adequate glycemic control (glycosylated hemoglobin [HbA1C] levels >7.0% and ≤10.0%).
Methods |
Following an open-label, lead-in phase to optimize the dosing of glyburide/metformin tablets, 365 patients randomly received additive therapy comprising rosiglitazone (4 mg once daily) or placebo for 24 weeks. Based on glycemic response, rosiglitazone dose was maintained or increased to 4 mg twice daily. Glyburide/metformin dose was maintained or reduced by 2.5/500 mg for symptomatic hypoglycemia. The primary endpoint was the change in HbA1C level from baseline to week 24. The proportions of patients achieving HbA1C levels <7% and a fasting plasma glucose level <126 mg/dL were also assessed.
Results |
After 24 weeks, therapy with glyburide/metformin plus rosiglitazone resulted in a greater reduction in HbA1C levels (–1.0%, P <0.001) compared with combination therapy that included placebo, and in a larger proportion of patients (42% vs. 14%) who attained levels <7%. The difference in fasting plasma glucose levels between groups was –48 mg/dL (P <0.001), favoring glyburide/metformin plus rosiglitazone. The adverse event profile in the rosiglitazone-treated group included mild-to-moderate edema (8%), hypoglycemia (22%), and weight gain of 3 kg. No patient experienced hypoglycemia requiring third-party assistance.
Conclusion |
In patients with inadequate glycemic control despite established glyburide/metformin therapy, the addition of rosiglitazone improves glycemic control, allowing more patients to achieve an HbA1C level <7% and perhaps delaying the need for insulin treatment.
Le texte complet de cet article est disponible en PDF.Keywords : additive therapy, combination therapy, glyburide, metformin, rosiglitazone, type 2 diabetes
Plan
This study was supported by a grant from the Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey. Dr. Dailey has received grant support from Bristol-Myers Squibb and has served on its Speakers Bureau and as an occasional consultant. |
Vol 116 - N° 4
P. 223-229 - février 2004 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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