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Differences in glycemic control across world regions : A post-hoc analysis in patients with type 2 diabetes mellitus on dual antidiabetes drug therapy

Brath, H.; Paldanius, P. M.; Bader, G.; Kolaczynski, W. M. and Nilsson, P. M. LU (2016) In Nutrition and Diabetes 6(7).
Abstract

Objective:This post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM).Methods:Patients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy. The primary effectiveness end point (PEP) was achieving glycated hemoglobin (HbA1c) reduction >0.3% without hypoglycemia, peripheral edema, discontinuation owing to gastrointestinal events or weight gain ≥5% at... (More)

Objective:This post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM).Methods:Patients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy. The primary effectiveness end point (PEP) was achieving glycated hemoglobin (HbA1c) reduction >0.3% without hypoglycemia, peripheral edema, discontinuation owing to gastrointestinal events or weight gain ≥5% at 12 months. The secondary effectiveness end point (SEP) was achieving HbA1c of <7% without hypoglycemia or weight gain ≥3% at 12 months.Results:Baseline characteristics of patients (N=43 791), including mean HbA1c (8.2%), varied across regions. Baseline age (62.3 years) and T2DM duration (6.3 years) were greater in patients from Europe than those from India and the Middle East (age: 51.8 and 52.1 years; T2DM duration: 4.3 and 4.2 years, respectively). The probability of achieving PEP with dual therapy was higher in India (odds ratio (OR): 1.5), Latin America (OR: 1.2) and Middle East (OR: 2.0) than in Europe (OR: 0.8) and East Asia (OR: 0.3). Achievement of SEP in patients receiving dual therapy was greater in Latin America (OR: 1.7) and Middle East (OR: 1.7). Vildagliptin add-on therapy allowed more patients to achieve SEP across regions. Women aged ≥45 years less often attained glycemic target (HbA1c<7%) without significant weight gain ≥5% compared with women aged <45 years (OR: 0.876, 95% confidence interval: 0.774, 0.992; P=0.037).Conclusions:Baseline HbA1c and T2DM duration differed considerably across all regions. Treatment intensification with second OAD, particularly with a DPP-4 inhibitor vildagliptin, resulted in good treatment response without tolerability issues despite delayed intensification of failing monotherapy across regions.

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author
publishing date
type
Contribution to journal
publication status
published
subject
in
Nutrition and Diabetes
volume
6
issue
7
publisher
Nature Publishing Group
external identifiers
  • scopus:84977570570
ISSN
2044-4052
DOI
10.1038/nutd.2016.25
language
English
LU publication?
no
id
7f235a8a-afea-415f-837c-99d8c9229858
date added to LUP
2017-01-23 14:17:54
date last changed
2017-10-01 05:29:16
@article{7f235a8a-afea-415f-837c-99d8c9229858,
  abstract     = {<p>Objective:This post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM).Methods:Patients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy. The primary effectiveness end point (PEP) was achieving glycated hemoglobin (HbA1c) reduction &gt;0.3% without hypoglycemia, peripheral edema, discontinuation owing to gastrointestinal events or weight gain ≥5% at 12 months. The secondary effectiveness end point (SEP) was achieving HbA1c of &lt;7% without hypoglycemia or weight gain ≥3% at 12 months.Results:Baseline characteristics of patients (N=43 791), including mean HbA1c (8.2%), varied across regions. Baseline age (62.3 years) and T2DM duration (6.3 years) were greater in patients from Europe than those from India and the Middle East (age: 51.8 and 52.1 years; T2DM duration: 4.3 and 4.2 years, respectively). The probability of achieving PEP with dual therapy was higher in India (odds ratio (OR): 1.5), Latin America (OR: 1.2) and Middle East (OR: 2.0) than in Europe (OR: 0.8) and East Asia (OR: 0.3). Achievement of SEP in patients receiving dual therapy was greater in Latin America (OR: 1.7) and Middle East (OR: 1.7). Vildagliptin add-on therapy allowed more patients to achieve SEP across regions. Women aged ≥45 years less often attained glycemic target (HbA1c&lt;7%) without significant weight gain ≥5% compared with women aged &lt;45 years (OR: 0.876, 95% confidence interval: 0.774, 0.992; P=0.037).Conclusions:Baseline HbA1c and T2DM duration differed considerably across all regions. Treatment intensification with second OAD, particularly with a DPP-4 inhibitor vildagliptin, resulted in good treatment response without tolerability issues despite delayed intensification of failing monotherapy across regions.</p>},
  articleno    = {e217},
  author       = {Brath, H. and Paldanius, P. M. and Bader, G. and Kolaczynski, W. M. and Nilsson, P. M.},
  issn         = {2044-4052},
  language     = {eng},
  month        = {07},
  number       = {7},
  publisher    = {Nature Publishing Group},
  series       = {Nutrition and Diabetes},
  title        = {Differences in glycemic control across world regions : A post-hoc analysis in patients with type 2 diabetes mellitus on dual antidiabetes drug therapy},
  url          = {http://dx.doi.org/10.1038/nutd.2016.25},
  volume       = {6},
  year         = {2016},
}