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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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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Nutrition and Diabetes
volume
6
issue
7
article number
e217
publisher
Nature Publishing Group
external identifiers
  • pmid:27376699
  • 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
2024-01-04 21:22:25
@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>}},
  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}},
  doi          = {{10.1038/nutd.2016.25}},
  volume       = {{6}},
  year         = {{2016}},
}