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

C. Mathieu; A. H. Barnett; H. Brath; I. Conget; J. J. de Castro; R. Goeke; E. Marquez Rodriguez; P. M. Nilsson; E. Pagkalos; A. Penfornis; N. C. Schaper; S. K. Wangnoo; W. Kothny; G. Bader

doi:10.1111/ijcp.12252

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

C. Mathieu^*, A. H. Barnett, H. Brath, I. Conget, J. J. de Castro, R. Goeke, E. Marquez Rodriguez, P. M. Nilsson, E. Pagkalos, A. Penfornis, N. C. Schaper, S. K. Wangnoo, W. Kothny, G. Bader

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Aim Real-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)

Original language	English
Pages (from-to)	947-956
Journal	International Journal of Clinical Practice
Volume	67
Issue number	10
DOIs	https://doi.org/10.1111/ijcp.12252
Publication status	Published - Oct 2013

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Mathieu, C., Barnett, A. H., Brath, H., Conget, I., de Castro, J. J., Goeke, R., Marquez Rodriguez, E., Nilsson, P. M., Pagkalos, E., Penfornis, A., Schaper, N. C., Wangnoo, S. K., Kothny, W., & Bader, G. (2013). Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE). International Journal of Clinical Practice, 67(10), 947-956. https://doi.org/10.1111/ijcp.12252

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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)",

abstract = "Aim Real-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)",

author = "C. Mathieu and Barnett, {A. H.} and H. Brath and I. Conget and {de Castro}, {J. J.} and R. Goeke and {Marquez Rodriguez}, E. and Nilsson, {P. M.} and E. Pagkalos and A. Penfornis and Schaper, {N. C.} and Wangnoo, {S. K.} and W. Kothny and G. Bader",

year = "2013",

month = oct,

doi = "10.1111/ijcp.12252",

language = "English",

volume = "67",

pages = "947--956",

journal = "International Journal of Clinical Practice",

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Mathieu, C, Barnett, AH, Brath, H, Conget, I, de Castro, JJ, Goeke, R, Marquez Rodriguez, E, Nilsson, PM, Pagkalos, E, Penfornis, A, Schaper, NC, Wangnoo, SK, Kothny, W & Bader, G 2013, 'Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE)', International Journal of Clinical Practice, vol. 67, no. 10, pp. 947-956. https://doi.org/10.1111/ijcp.12252

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. et al.
In: International Journal of Clinical Practice, Vol. 67, No. 10, 10.2013, p. 947-956.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE)

AU - Mathieu, C.

AU - Barnett, A. H.

AU - Brath, H.

AU - Conget, I.

AU - de Castro, J. J.

AU - Goeke, R.

AU - Marquez Rodriguez, E.

AU - Nilsson, P. M.

AU - Pagkalos, E.

AU - Penfornis, A.

AU - Schaper, N. C.

AU - Wangnoo, S. K.

AU - Kothny, W.

AU - Bader, G.

PY - 2013/10

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N2 - Aim Real-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)

AB - Aim Real-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)

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DO - 10.1111/ijcp.12252

M3 - Article

C2 - 23961850

SN - 1368-5031

VL - 67

SP - 947

EP - 956

JO - International Journal of Clinical Practice

JF - International Journal of Clinical Practice

IS - 10

ER -

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

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