Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: The HYPOCRAS study

Aim. - Despite half of all type 2 diabetes mellitus (T2DM) patients being over 65 and treatment being complicated by an elevated risk of iatrogenic hypoglycaemia, information about antidiabetic treatment is scarce in this age group. This prospective observational study compares DPP4-inhibitors (DPP4-i) with conventional oral antidiabetic drugs (COAD) in the real-life treatment of elderly patients with T2DM uncontrolled on metformin alone. Methods. - Two treatment cohorts (DPP4-i and COAD, constituted on the basis of the GP decision of add-on therapy at the 1st visit) were compared after 6 months. The primary objective was to assess the incidence of hypoglycaemic episodes in relationship with glycaemic control assessed by HbA(1c) level. Results. - Demographics and disease history were comparable between the two cohorts (DPP4-i, n=931 and COAD, n=257) at baseline. The incidence of hypoglycaemia/severe hypoglycaemia was significantly higher over 6 months in the COAD cohort (20.1%/2.4% vs. 6.4%/0.1%; P < 0.001) whereas similar improvements were observed in glycaenaic control with HbA(1c) down from 7.9% to 7.0% (COAD) and 6.9% (DPP4-i). The 7% target was reached without hypoglycaemia in more patients in the DPP4-i than in COAD cohort (59.7% vs. 45.5%; P < 0.001). Patients in both cohorts who experienced hypoglycaemia more frequently had a pre-existing diabetic complication. The COAD was more likely to be discontinued (6.6% vs. 1.6%; P < 0.001). Conclusion. - This large cohort study of elderly T2DM patients in France shows that the incidence of hypoglycaemia was three times higher in patients prescribed a COAD versus a DPP4-i after 6 months while both treatments induced satisfactory glycaemic control. (C) 2012 Elsevier Masson SAS. All rights reserved.