Nanette C Schloot1,2, Axel Haupt1, Morten Schütt3, Klaus Badenhoop4, Markus Laimer5,6, Claudia Nicolay7, Matthew Reaney8, Katharina Fink9, Reinhard W Holl9. 1. Medical BU Diabetes, Lilly Deutschland GmbH, Bad Homburg, Bad Homburg, Germany. 2. Institute for Clinical Diabetology, German Diabetes Center, Heinrich Heine University, Düsseldorf, Germany. 3. Department of Internal Medicine I, University of Lübeck, Lübeck, Germany. 4. Department of Internal Medicine I, Division of Endocrinology and Metabolism, Goethe University Hospital, Frankfurt am Main, Germany. 5. Department of Internal Medicine I, Medical University of Innsbruck, Innsbruck, Austria. 6. Division of Endocrinology, Diabetes & Clinical Nutrition, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland. 7. European Statistics, Diabetes (HTA/Medical Affairs), Lilly Deutschland GmbH, Bad Homburg, Bad Homburg, Germany. 8. eResearchTechnology Limited (ERT), Peterborough, United Kingdom. 9. Institute for Epidemiology and Medical Biometry (ZIBMT), German Center for Diabetes Research (DZD), University Ulm, Ulm, Germany.
Abstract
BACKGROUND: We investigated the rate of severe hypoglycemic events and confounding factors in patients with type 2 diabetes treated with sulfonylurea at specialized diabetes centers, documented in the German/Austrian DPV-Wiss database. METHODS: Data from 29 485 sulfonylurea-treated patients were analyzed (median[IQR] age 70.8[62.2-77.8] years, diabetes duration 8.2[4.3-12.8] years). The primary objective was to estimate the event rate of severe hypoglycemia (requiring external help, causing unconsciousness/coma/convulsion and/or emergency hospitalization). Secondary objectives included exploration of confounding risk factors through group comparison and Poisson regression. RESULTS: Severe hypoglycemic events were reported in 826(2.8%) of all patients during their most recent year of sulfonylurea treatment. Of these, n = 531(1.8%) had coma, n = 501(1.7%) were hospitalized at least once. The adjusted event rate of severe hypoglycemia [95%CI] was 3.9[3.7-4.2] events/100 patient-years (coma: 1.9[1.8-2.1]; hospitalization: 1.6[1.5-1.8]). Adjusted event rates by diabetes treatment were 6.7 (sulfonylurea + insulin), 4.9 (sulfonylurea + insulin + other OAD), 3.1 (sulfonylurea + other OAD) and 3.8 (sulfonylurea only). Patients with ≥1 severe event were older (p < 0.001) and had longer diabetes duration (p = 0.020) than patients without severe events. Participation in educational diabetes-programs and indirect measures of insulin-resistance (increased BMI, plasma-triglycerides) were associated with fewer events (all p < 0.001). Impaired renal function was common (n = 3113 eGFR; ≤30 mL/min) and associated with an increased rate of severe events (≤30 mL/min: 7.7; 30-60 mL/min: 4.8; >60 mL/min: 3.9). CONCLUSIONS: These real-life data showed a rate of severe hypoglycemia of 3.9/100 patient-years in sulfonylurea-treated patients from specialized diabetes centers. Higher risk was associated with known risk factors including lack of diabetes education, older age and decreased eGFR but also with lower BMI and lower triglyceride levels, suggesting that sulfonylurea treatment in those patients should be considered with caution.
BACKGROUND: We investigated the rate of severe hypoglycemic events and confounding factors in patients with type 2 diabetes treated with sulfonylurea at specialized diabetes centers, documented in the German/Austrian DPV-Wiss database. METHODS: Data from 29 485 sulfonylurea-treated patients were analyzed (median[IQR] age 70.8[62.2-77.8] years, diabetes duration 8.2[4.3-12.8] years). The primary objective was to estimate the event rate of severe hypoglycemia (requiring external help, causing unconsciousness/coma/convulsion and/or emergency hospitalization). Secondary objectives included exploration of confounding risk factors through group comparison and Poisson regression. RESULTS: Severe hypoglycemic events were reported in 826(2.8%) of all patients during their most recent year of sulfonylurea treatment. Of these, n = 531(1.8%) had coma, n = 501(1.7%) were hospitalized at least once. The adjusted event rate of severe hypoglycemia [95%CI] was 3.9[3.7-4.2] events/100 patient-years (coma: 1.9[1.8-2.1]; hospitalization: 1.6[1.5-1.8]). Adjusted event rates by diabetes treatment were 6.7 (sulfonylurea + insulin), 4.9 (sulfonylurea + insulin + other OAD), 3.1 (sulfonylurea + other OAD) and 3.8 (sulfonylurea only). Patients with ≥1 severe event were older (p < 0.001) and had longer diabetes duration (p = 0.020) than patients without severe events. Participation in educational diabetes-programs and indirect measures of insulin-resistance (increased BMI, plasma-triglycerides) were associated with fewer events (all p < 0.001). Impaired renal function was common (n = 3113 eGFR; ≤30 mL/min) and associated with an increased rate of severe events (≤30 mL/min: 7.7; 30-60 mL/min: 4.8; >60 mL/min: 3.9). CONCLUSIONS: These real-life data showed a rate of severe hypoglycemia of 3.9/100 patient-years in sulfonylurea-treated patients from specialized diabetes centers. Higher risk was associated with known risk factors including lack of diabetes education, older age and decreased eGFR but also with lower BMI and lower triglyceride levels, suggesting that sulfonylurea treatment in those patients should be considered with caution.
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Authors: Lukas Lunger; Andreas Melmer; Willi Oberaigner; Marco Leo; Martin Juchum; Karin Pölzl; Johannes Gänzer; Martha Innerebner; Egon Eisendle; Gertrud Beck; Hermann Kathrein; Bernhard Heindl; Hans Robert Schönherr; Monika Lechleitner; Herbert Tilg; Christoph Ebenbichler Journal: Wien Klin Wochenschr Date: 2016-12-01 Impact factor: 1.704
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