Diabetologie und Stoffwechsel 2014; 9 - P141
DOI: 10.1055/s-0034-1374998

Severe hypoglycaemia under therapy with sulfonylurea in patients with type 2 diabetes (T2D) in Germany/Austria: Event rate and identification of patients at risk

N Schloot 1, 2, A Haupt 3, M Schütt 4, C Nicolay 3, M Reaney 5, K Fink 6 RW Holl 6, for the German BMBF Competence Net Diabetes Mellitus
  • 1Lilly Deutschland GmbH, Diabetes Business Unit, Bad Homburg, Germany
  • 2German Diabetes Center at Heinrich Heine University Düsseldorf, Institute for Clinical Diabetology, Düsseldorf, Germany
  • 3Lilly Deutschland GmbH, Bad Homburg, Germany
  • 4University of Lübeck, Department of Internal Medicine I, Lübeck, Germany
  • 5Lilly Research Centre, Windlesham, United Kingdom
  • 6Ulm University, Institute for Epidemiology and Medical Biometry, Ulm, Germany

Background: We investigated the rate of severe hypoglycemia and confounding factors in T2D patients treated with sulfonylurea (SU) in the German/Austrian DPV-Wiss-database cohort.

Methods: Data from 29,485 SU-treated patients were analyzed (mean (SD) age 69.5 (11.5)yrs, diabetes duration 9.7 (7.6)yrs, with/without antidiabetic co-medication). Primary objective was to estimate the event rate of severe hypoglycemia (defined as requirement for help +/-coma or emergency hospitalization due to hypoglycemia). Secondary objective was the identification of confounding risk factors for hypoglycemia through group comparison and hierarchical negative binomial regression.

Result: Severe hypoglycemic events were reported in 826 (2.8%) of all SU-treated patients; n = 531 (1.8%) suffered from coma, n = 501 (1.7%) were hospitalized at least once. Event rates/year [95% CI] were 0.039 [0.037; 0.042], 0.019 [0.018; 0.021] and 0.016 [0.015; 0.018]. Unadjusted severe hypoglycemia rates for different treatment groups were 0.074 (SU+insulin), 0.038 (SU+insulin+other OAD), 0.027 (SU+other OAD), 0.042 (SU only). Patients with severe hypoglycemia were older (p < 0.0001) and had longer diabetes duration (p = 0.0195). In regression analysis, severe hypoglycemia was associated with lower HbA1c and mild hypoglycemic events (all p < 0.0001). Lower eGFR was associated with an increased rate of severe hypoglycemia (> 60 ml/min: 3.9% of all patients with SU; 30 – 60 ml/min: 4.8%; ≤30 ml/min: 7.7%). Indirect measures of insulin resistance such as increased BMI, plasma triglycerides and participation in educational diabetes program were associated with less frequent severe hypoglycemia (all p ≤0.0002).

Conclusions: Our analysis of real-life data showed higher risk associated with severe hypoglycemia for patients with older age, non-severe hypoglycemia and decreased eGFR, suggesting that treatment with SU in those patients should be considered with caution.