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Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE)

Mathieu, C.; Barnett, A. H.; Brath, H.; Conget, I.; de Castro, J. J.; Goeke, R.; Marquez Rodriguez, E.; Nilsson, Marie P LU ; Pagkalos, E. and Penfornis, A., et al. (2013) In International Journal of Clinical Practice 67(10). p.947-956
Abstract
AimReal-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale pragmatic' trials. MethodsEDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and... (More)
AimReal-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale pragmatic' trials. MethodsEDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end-point (PEP) evaluated proportions of patients decreasing HbA(1c)>0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end-point (SEP 3) was attainment of end-point HbA(1c)<7% without hypoglycaemia or 3% increase in body weight. ResultsIn this large group of T2DM patients, a second OAD was added at mean HbA(1c) of 8.21.3%, with no baseline HbA(1c) difference between cohorts. Second-line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin-based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p<0.001). In patients with baseline HbA(1c)7%, SEP 3 was achieved by 35% of patients on a vildagliptin-based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p<0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data. ConclusionEDGE demonstrates that in a real-life' setting, vildagliptin as second OAD can lower HbA(1c) to target without well-recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large-scale, prospective, real-life studies poses challenges but yields valuable clinical information complementary to RCTs. (Less)
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International Journal of Clinical Practice
volume
67
issue
10
pages
947 - 956
publisher
Wiley-Blackwell
external identifiers
  • wos:000325007600008
  • scopus:84884988211
ISSN
1742-1241
DOI
10.1111/ijcp.12252
language
English
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yes
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d6b2ad18-cad2-4b41-a417-a1ec13063c3f (old id 4172028)
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2013-12-06 12:30:58
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2019-02-20 05:24:56
@article{d6b2ad18-cad2-4b41-a417-a1ec13063c3f,
  abstract     = {AimReal-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale pragmatic' trials. MethodsEDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end-point (PEP) evaluated proportions of patients decreasing HbA(1c)&gt;0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end-point (SEP 3) was attainment of end-point HbA(1c)&lt;7% without hypoglycaemia or 3% increase in body weight. ResultsIn this large group of T2DM patients, a second OAD was added at mean HbA(1c) of 8.21.3%, with no baseline HbA(1c) difference between cohorts. Second-line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin-based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p&lt;0.001). In patients with baseline HbA(1c)7%, SEP 3 was achieved by 35% of patients on a vildagliptin-based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p&lt;0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data. ConclusionEDGE demonstrates that in a real-life' setting, vildagliptin as second OAD can lower HbA(1c) to target without well-recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large-scale, prospective, real-life studies poses challenges but yields valuable clinical information complementary to RCTs.},
  author       = {Mathieu, C. and Barnett, A. H. and Brath, H. and Conget, I. and de Castro, J. J. and Goeke, R. and Marquez Rodriguez, E. and Nilsson, Marie P and Pagkalos, E. and Penfornis, A. and Schaper, N. C. and Wangnoo, S. K. and Kothny, W. and Bader, G.},
  issn         = {1742-1241},
  language     = {eng},
  number       = {10},
  pages        = {947--956},
  publisher    = {Wiley-Blackwell},
  series       = {International Journal of Clinical Practice},
  title        = {Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE)},
  url          = {http://dx.doi.org/10.1111/ijcp.12252},
  volume       = {67},
  year         = {2013},
}