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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  &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.    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 &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  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.

international journal of clinical practice

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