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

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 HbA1c > 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 HbA1c < 7% without hypoglycaemia or ≥ 3% increase in body weight.ResultsIn this large group of T2DM patients, a second OAD was added at mean HbA1c of 8.2 ± 1.3%, with no baseline HbA1c 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 HbA1c ≥ 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 HbA1c 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.

Evaluación del perfil de eficacia y seguridad de vildagliptina en vida real de pacientes chilenos con diabetes mellitus tipo 2

“…Ello, en contraposición con el bajo número de eventos hipoglicémicos encontrados con iDPP4, en estudios comparativos con SU 11,12 . La falta de cambio significativo de peso desde la basal, también confirma lo descrito en la literatura con iDPP4 14 , que aparecen como hipoglicemiantes con efecto neutro sobre el peso, a diferencia de lo que ocurre con SU e insulina que producen aumento de peso en el tiempo [9][10][11][12][13][14] . En una enfermedad de prevalencia creciente como lo es la DMT2 en nuestro país y en el mundo 15 , de carácter progresivo y crónico, se requiere de una terapia efectiva, con la menor cantidad de eventos adversos posibles para lograr mejor adherencia y control a largo plazo, de manera de minimizar las complicaciones micro y macrovasculares 16,17 .…”

“…Sin embargo, su consistencia con los grandes estudios realizados con vildagliptina permiten afirmar la tendencia de los resultados 10 . El análisis de subpoblaciones tiene un carácter más bien descriptivo, debido al bajo número de pacientes en cada subgrupo.…”

Management of type 2 diabetes mellitus: insights into prescribing trends

“…4 Previous EDGE study has shown that in a 'real-life' setting, vildagliptin can lower HbA1c to target more frequently than comparator oral hypoglycemic agents (OHA) with better safety profile. 5 However, there is no clarity on which particular class of OHA to be preferred in patients uncontrolled on metformin and which particular drug be selected amongst the class for varying groups of patient population. Therefore, this survey was planned to explore current prescribing trends of physicians in 'real world' for the management of diabetes mellitus considering newer treatment options.…”

Role of teneligliptin in rural India as add-on third drug in patients with type 2 diabetes mellitus

“…Mean baseline HbA1c level of 8.54% confirms the high prevalence of uncontrolled glycemic status in patients with T2DM patients in developing countries like India. 13 Long-term data from major studies like UK Prospective Diabetes Study has already established the importance of tight and early glucose control to prevent complications of diabetes. 14 In the teneligliptin monotherapy and combination therapy with other OADs, HbA1c was reduced significantly at 3 months.…”