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Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?

INTRODUCTION: In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased h...

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Autores principales: Ahrén, Bo, Foley, James Edward, Dejager, Sylvie, Akacha, Mouna, Shao, Qing, Heimann, Guenter, Dworak, Markus, Schweizer, Anja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269641/
https://www.ncbi.nlm.nih.gov/pubmed/25230877
http://dx.doi.org/10.1007/s13300-014-0082-y
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author Ahrén, Bo
Foley, James Edward
Dejager, Sylvie
Akacha, Mouna
Shao, Qing
Heimann, Guenter
Dworak, Markus
Schweizer, Anja
author_facet Ahrén, Bo
Foley, James Edward
Dejager, Sylvie
Akacha, Mouna
Shao, Qing
Heimann, Guenter
Dworak, Markus
Schweizer, Anja
author_sort Ahrén, Bo
collection PubMed
description INTRODUCTION: In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased hypoglycemia with glimepiride was driven by the 6 mg/day dose; it was therefore of interest to assess whether the risk of hypoglycemia is also different between vildagliptin and a low (2 mg/day) dose of glimepiride. METHODS: Data (n = 3,059) were from the aforementioned randomized, double-blind study. Comparisons between vildagliptin (50 mg twice daily) and glimepiride (subgroups of patients on 2 mg/day, 6 mg/day, and ‘other’, and overall glimepiride group) were done by modeling hypoglycemia risk as a function of time and last-measured glycated hemoglobin (HbA(1c)) using discrete event time modeling, with treatment, age, gender as additional covariates. RESULTS: The hypoglycemia risk was significantly lower in patients receiving vildagliptin versus patients remaining on glimepiride 2 mg/day throughout the study, with similar results unadjusted or adjusted for last HbA(1c) [adjusted hazard ratio (HR) = 0.06 (95% CI 0.03, 0.11)]. The risk of hypoglycemia was very low with vildagliptin over the full HbA(1c) range, while the risk with glimepiride 2 mg/day increased with lower HbA(1c). The increase for lower levels of HbA(1c) was more pronounced in the glimepiride 2 mg/day than 6 mg/day subgroup, with the 6 mg/day subgroup showing the lowest hypoglycemia risk among the glimepiride groups [adjusted HR vildagliptin vs. 6 mg/day glimepiride = 0.21 (95% CI 0.11, 0.40)]. CONCLUSION: The data show a substantially lower risk of confirmed hypoglycemia with vildagliptin compared to low-dose (2 mg/day) glimepiride. The analysis indicates that the previously reported results are not driven by high doses of glimepiride and points to interesting differences among patients regarding the susceptibility to hypoglycemia with sulfonylureas. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-014-0082-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-42696412014-12-19 Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities? Ahrén, Bo Foley, James Edward Dejager, Sylvie Akacha, Mouna Shao, Qing Heimann, Guenter Dworak, Markus Schweizer, Anja Diabetes Ther Original Research INTRODUCTION: In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased hypoglycemia with glimepiride was driven by the 6 mg/day dose; it was therefore of interest to assess whether the risk of hypoglycemia is also different between vildagliptin and a low (2 mg/day) dose of glimepiride. METHODS: Data (n = 3,059) were from the aforementioned randomized, double-blind study. Comparisons between vildagliptin (50 mg twice daily) and glimepiride (subgroups of patients on 2 mg/day, 6 mg/day, and ‘other’, and overall glimepiride group) were done by modeling hypoglycemia risk as a function of time and last-measured glycated hemoglobin (HbA(1c)) using discrete event time modeling, with treatment, age, gender as additional covariates. RESULTS: The hypoglycemia risk was significantly lower in patients receiving vildagliptin versus patients remaining on glimepiride 2 mg/day throughout the study, with similar results unadjusted or adjusted for last HbA(1c) [adjusted hazard ratio (HR) = 0.06 (95% CI 0.03, 0.11)]. The risk of hypoglycemia was very low with vildagliptin over the full HbA(1c) range, while the risk with glimepiride 2 mg/day increased with lower HbA(1c). The increase for lower levels of HbA(1c) was more pronounced in the glimepiride 2 mg/day than 6 mg/day subgroup, with the 6 mg/day subgroup showing the lowest hypoglycemia risk among the glimepiride groups [adjusted HR vildagliptin vs. 6 mg/day glimepiride = 0.21 (95% CI 0.11, 0.40)]. CONCLUSION: The data show a substantially lower risk of confirmed hypoglycemia with vildagliptin compared to low-dose (2 mg/day) glimepiride. The analysis indicates that the previously reported results are not driven by high doses of glimepiride and points to interesting differences among patients regarding the susceptibility to hypoglycemia with sulfonylureas. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-014-0082-y) contains supplementary material, which is available to authorized users. Springer Healthcare 2014-09-18 2014-12 /pmc/articles/PMC4269641/ /pubmed/25230877 http://dx.doi.org/10.1007/s13300-014-0082-y Text en © The Author(s) 2014 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Ahrén, Bo
Foley, James Edward
Dejager, Sylvie
Akacha, Mouna
Shao, Qing
Heimann, Guenter
Dworak, Markus
Schweizer, Anja
Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title_full Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title_fullStr Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title_full_unstemmed Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title_short Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
title_sort higher risk of hypoglycemia with glimepiride versus vildagliptin in patients with type 2 diabetes is not driven by high doses of glimepiride: divergent patient susceptibilities?
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269641/
https://www.ncbi.nlm.nih.gov/pubmed/25230877
http://dx.doi.org/10.1007/s13300-014-0082-y
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