Open AccessEffectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study ( EDGE )
Author(s) -
Mathieu C.,
Barnett A. H.,
Brath H.,
Conget I.,
Castro J. J.,
Göke R.,
Márquez Rodriguez E.,
Nilsson P. M.,
Pagkalos E.,
Penfornis A.,
Schaper N.C.,
Wangnoo S. K.,
Kothny W.,
Bader G.
Publication year - 2013
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/ijcp.12252
Subject(s) - medicine , vildagliptin , tolerability , diabetology , observational study , diabetes mellitus , type 2 diabetes , general hospital , pediatrics , family medicine , gerontology , endocrinology , adverse effect
Summary Aim Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials ( RCT s). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs ( OAD s) added to OAD monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials. Methods EDGE was a prospective, 1‐year, worldwide, real‐life observational study in which 2957 physicians reported on the effects of second‐line OAD s in 45,868 patients with T2 DM 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. Results In this large group of T2 DM patients, a second OAD was added at mean HbA 1c of 8.2 ± 1.3%, 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 OAD s were consistent with previous data. Conclusion EDGE 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 OAD s. In addition, EDGE illustrates that conducting large‐scale, prospective, real‐life studies poses challenges but yields valuable clinical information complementary to RCT s.