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Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes.
Diabetes Obes Metab. 2008 Sep; 10(10):862-73.DO

Abstract

AIM

To assess the efficacy and tolerability of early combination therapy with rosiglitazone (RSG) and glimepiride (GLIM) vs. GLIM monotherapy in patients with type 2 diabetes mellitus (T2DM).

METHODS

Strategies for the addition of RSG in combination with GLIM were evaluated with data from two randomized, double-blind, placebo (PBO)-controlled studies. Study A - addition of RSG (4 or 8 mg) or PBO to continued GLIM 3 mg once daily; study B - addition of low-dose RSG (4 mg) prior to uptitration of GLIM (from 2 to 4 mg) vs. continued uptitration of GLIM (from 2 to 8 mg).

RESULTS

Study A reported significant reductions in fasting plasma glucose (FPG) from baseline to week 26 with the addition of both 4 and 8 mg RSG to GLIM 3 mg [-21 mg/dl (-1.2 mmol/l), p = 0.0019 and -43 mg/dl (-2.4 mmol/l), p < 0.0001, respectively] and in haemoglobin A(1c) (HbA(1c)) (-0.63%, p = 0.00015 and -1.17%, p < 0.0001, respectively) from a baseline of 8.2 and 8.1%, respectively. At the end of the study, target HbA(1c) <7.0% was achieved in 43 and 68% of patients in the RSG 4 mg + GLIM and RSG 8 mg + GLIM groups, respectively, compared with 32% in the PBO + GLIM (GLIM alone) group. In study B, addition of RSG to GLIM reduced mean FPG and HbA(1c) levels at week 24 from baseline [-28 mg/dl (-1.5 mmol/l), p < 0.0001, and -0.68%, p < 0.0001, respectively]. There were no significant changes with GLIM monotherapy in either study. Favourable effects of RSG + GLIM on insulin sensitivity, beta-cell function and cardiovascular disease biomarkers were also observed. All treatments were similarly well tolerated.

CONCLUSIONS

Early addition of RSG to GLIM is an effective and well-tolerated treatment option to improve glycaemic control in sulphonylurea-treated patients with T2DM.

Authors+Show Affiliations

Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA. juliorosenstock@dallasdiabetes.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18201206

Citation

Rosenstock, J, et al. "Potential Benefits of Early Addition of Rosiglitazone in Combination With Glimepiride in the Treatment of Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 10, no. 10, 2008, pp. 862-73.
Rosenstock J, Chou HS, Matthaei S, et al. Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes. Diabetes Obes Metab. 2008;10(10):862-73.
Rosenstock, J., Chou, H. S., Matthaei, S., Seidel, D. K., & Hamann, A. (2008). Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes. Diabetes, Obesity & Metabolism, 10(10), 862-73. https://doi.org/10.1111/j.1463-1326.2007.00815.x
Rosenstock J, et al. Potential Benefits of Early Addition of Rosiglitazone in Combination With Glimepiride in the Treatment of Type 2 Diabetes. Diabetes Obes Metab. 2008;10(10):862-73. PubMed PMID: 18201206.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes. AU - Rosenstock,J, AU - Chou,H S, AU - Matthaei,S, AU - Seidel,D K, AU - Hamann,A, Y1 - 2008/01/14/ PY - 2008/1/19/pubmed PY - 2009/5/5/medline PY - 2008/1/19/entrez SP - 862 EP - 73 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 10 IS - 10 N2 - AIM: To assess the efficacy and tolerability of early combination therapy with rosiglitazone (RSG) and glimepiride (GLIM) vs. GLIM monotherapy in patients with type 2 diabetes mellitus (T2DM). METHODS: Strategies for the addition of RSG in combination with GLIM were evaluated with data from two randomized, double-blind, placebo (PBO)-controlled studies. Study A - addition of RSG (4 or 8 mg) or PBO to continued GLIM 3 mg once daily; study B - addition of low-dose RSG (4 mg) prior to uptitration of GLIM (from 2 to 4 mg) vs. continued uptitration of GLIM (from 2 to 8 mg). RESULTS: Study A reported significant reductions in fasting plasma glucose (FPG) from baseline to week 26 with the addition of both 4 and 8 mg RSG to GLIM 3 mg [-21 mg/dl (-1.2 mmol/l), p = 0.0019 and -43 mg/dl (-2.4 mmol/l), p < 0.0001, respectively] and in haemoglobin A(1c) (HbA(1c)) (-0.63%, p = 0.00015 and -1.17%, p < 0.0001, respectively) from a baseline of 8.2 and 8.1%, respectively. At the end of the study, target HbA(1c) <7.0% was achieved in 43 and 68% of patients in the RSG 4 mg + GLIM and RSG 8 mg + GLIM groups, respectively, compared with 32% in the PBO + GLIM (GLIM alone) group. In study B, addition of RSG to GLIM reduced mean FPG and HbA(1c) levels at week 24 from baseline [-28 mg/dl (-1.5 mmol/l), p < 0.0001, and -0.68%, p < 0.0001, respectively]. There were no significant changes with GLIM monotherapy in either study. Favourable effects of RSG + GLIM on insulin sensitivity, beta-cell function and cardiovascular disease biomarkers were also observed. All treatments were similarly well tolerated. CONCLUSIONS: Early addition of RSG to GLIM is an effective and well-tolerated treatment option to improve glycaemic control in sulphonylurea-treated patients with T2DM. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/18201206/Potential_benefits_of_early_addition_of_rosiglitazone_in_combination_with_glimepiride_in_the_treatment_of_type_2_diabetes_ L2 - https://doi.org/10.1111/j.1463-1326.2007.00815.x DB - PRIME DP - Unbound Medicine ER -