Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

Real-life effectiveness of OADs as add-on therapy after monotherapy failure in patients with substantial hyperglycaemia (HbA1c ≥10.0%): a post-hoc analysis of the EDGE study (#309)

Päivi M. Paldánius 1 , Ivona Daskalova 2 , Giovanni Bader 1 , Chantal Mathieu 3
  1. Novartis Pharma AG, Basel, Switzerland
  2. Military Medical Academy, Sofia, Bulgaria
  3. Catholic University of Leuven, Leuven, Belgium

Poor glycaemic control is often attributable to delayed stepwise addition of oral or injectable therapies in the face of increasing hyperglycaemia, ultimately prompting insulin initiation. This post-hoc analysis of the EDGE study aimed to evaluate the effectiveness of vildagliptin vs comparator oral anti-diabetic drugs (OADs) in patients in whom insulin was not started, despite HbA1c ≥10.0% at the time of intensification of failing monotherapy.

Patients became eligible for inclusion only after the add-on treatment was chosen by the physician, based on clinical judgment and patient need. Patients were assigned to either the vildagliptin or ‘other OADs’ (excluding incretin therapies) cohort. Change in HbA1c was evaluated 12 months after treatment intensification, for each cohort and between the cohorts. Response, defined as achieving HbA1c of <7.0% at 12 months without hypoglycaemia or weight gain ≥3%, was also assessed.

Of the 3853 patients with HbA1c ≥10.0% (mean 11.1%) at baseline, 2634 (68.4%) received vildagliptin and 1219 (31.6%) received other OADs. Overall, mean age was 55.3 years, BMI 29.3 kg/m2 and diabetes duration 5.6 years. After 12 months, the mean change in HbA1c was -3.4% and -3.0% in the vildagliptin and other OADs cohorts, respectively (p<0.001 for both cohorts vs baseline, and between cohorts). Response was achieved by twice as many patients in the vildagliptin than in the other OADs cohort (18.6% vs 8.4%; OR 2.5; 95% CI: 1.99, 3.14; p<0.001). Adverse events were generally comparable between the cohorts; however, the absolute number of hypoglycaemic events was lower in the vildagliptin cohort (10 vs 26 events).

Results demonstrate that, in a real-life setting, clinical inertia is real and vildagliptin provided a clinically meaningful HbA1c reduction in patients with HbA1c ≥10.0%. Although treatment with OADs may not be regarded as the optimal approach in patients with substantial hyperglycaemia, vildagliptin provides an attractive treatment option should insulin or other therapeutic strategies not be clinically suitable.