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Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes.
Diabetes Metab Res Rev. 2002 Mar-Apr; 18(2):127-34.DM

Abstract

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.

Authors+Show Affiliations

Instituto Nacional de Ciencias Medicas y Nutricion S.Z., Mexico City, Mexico.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11994904

Citation

Gómez-Perez, Francisco J., et al. "Efficacy and Safety of Rosiglitazone Plus Metformin in Mexicans With Type 2 Diabetes." Diabetes/metabolism Research and Reviews, vol. 18, no. 2, 2002, pp. 127-34.
Gómez-Perez FJ, Fanghänel-Salmón G, Antonio Barbosa J, et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Diabetes Metab Res Rev. 2002;18(2):127-34.
Gómez-Perez, F. J., Fanghänel-Salmón, G., Antonio Barbosa, J., Montes-Villarreal, J., Berry, R. A., Warsi, G., & Gould, E. M. (2002). Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Diabetes/metabolism Research and Reviews, 18(2), 127-34.
Gómez-Perez FJ, et al. Efficacy and Safety of Rosiglitazone Plus Metformin in Mexicans With Type 2 Diabetes. Diabetes Metab Res Rev. 2002;18(2):127-34. PubMed PMID: 11994904.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. AU - Gómez-Perez,Francisco J, AU - Fanghänel-Salmón,Guillermo, AU - Antonio Barbosa,Juan, AU - Montes-Villarreal,Juan, AU - Berry,Rhona A, AU - Warsi,Ghulam, AU - Gould,Errol M, PY - 2002/5/8/pubmed PY - 2002/10/9/medline PY - 2002/5/8/entrez SP - 127 EP - 34 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab. Res. Rev. VL - 18 IS - 2 N2 - 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. SN - 1520-7552 UR - https://www.unboundmedicine.com/medline/citation/11994904/Efficacy_and_safety_of_rosiglitazone_plus_metformin_in_Mexicans_with_type_2_diabetes_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=1520-7552&amp;date=2002&amp;volume=18&amp;issue=2&amp;spage=127 DB - PRIME DP - Unbound Medicine ER -