BACKGROUND: Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled withmetformin alone. METHODS: This randomized, double-blind, placebo-controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n=39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n=37), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n=40) for 26 weeks. RESULTS:Mean hemoglobin A(1c) (HbA(1c)) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (-0.7%; p=0.0052) and 4 mg bd (-1.2%; p=0.0008) groups, but increased in the placebo group (+0.3%; p=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose-ordered manner compared with placebo (p<or=0.0019 and p=0.0006, respectively). C-peptide and immunoreactive insulin levels were decreased from baseline in both rosiglitazone groups. Although mean increases in total cholesterol, low-density lipoprotein (LDL)-cholesterol, and high-density lipoprotein (HDL)-cholesterol were observed in the rosiglitazone groups, the total cholesterol:HDL-cholesterol ratio remained unchanged. The proportion of patients with one or more adverse events was similar across all three groups. There were no cases of hepatotoxicity. CONCLUSION: Addition of rosiglitazone 2 mg bd and 4 mg bd to metformin therapy improved glycemic control in Mexican patients whose type 2 diabetes was inadequately controlled by metformin alone. Furthermore, the combination of rosiglitazone plus metformin was well tolerated. Copyright 2002 John Wiley & Sons, Ltd.
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BACKGROUND:Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone. METHODS: This randomized, double-blind, placebo-controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n=39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n=37), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n=40) for 26 weeks. RESULTS: Mean hemoglobin A(1c) (HbA(1c)) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (-0.7%; p=0.0052) and 4 mg bd (-1.2%; p=0.0008) groups, but increased in the placebo group (+0.3%; p=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose-ordered manner compared with placebo (p<or=0.0019 and p=0.0006, respectively). C-peptide and immunoreactive insulin levels were decreased from baseline in both rosiglitazone groups. Although mean increases in total cholesterol, low-density lipoprotein (LDL)-cholesterol, and high-density lipoprotein (HDL)-cholesterol were observed in the rosiglitazone groups, the total cholesterol:HDL-cholesterol ratio remained unchanged. The proportion of patients with one or more adverse events was similar across all three groups. There were no cases of hepatotoxicity. CONCLUSION: Addition of rosiglitazone 2 mg bd and 4 mg bd to metformin therapy improved glycemic control in Mexican patients whose type 2 diabetes was inadequately controlled by metformin alone. Furthermore, the combination of rosiglitazone plus metformin was well tolerated. Copyright 2002 John Wiley & Sons, Ltd.
Authors: Wendy L Bennett; Nisa M Maruthur; Sonal Singh; Jodi B Segal; Lisa M Wilson; Ranee Chatterjee; Spyridon S Marinopoulos; Milo A Puhan; Padmini Ranasinghe; Lauren Block; Wanda K Nicholson; Susan Hutfless; Eric B Bass; Shari Bolen Journal: Ann Intern Med Date: 2011-03-14 Impact factor: 25.391
Authors: Elizabeth Selvin; Shari Bolen; Hsin-Chieh Yeh; Crystal Wiley; Lisa M Wilson; Spyridon S Marinopoulos; Leonard Feldman; Jason Vassy; Renee Wilson; Eric B Bass; Frederick L Brancati Journal: Arch Intern Med Date: 2008-10-27
Authors: Stijntje D Roes; Reza A Dehnavi; Jos J M Westenberg; Hildo J Lamb; Bart J A Mertens; Jouke T Tamsma; Albert de Roos Journal: J Cardiovasc Magn Reson Date: 2011-10-28 Impact factor: 5.364