Masato Takeuchi1, Taichi Kawamura1,2, Izumi Sato1,3, Koji Kawakami1. 1. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan. 2. Senju Pharmaceutical Co., Ltd., Osaka, Japan. 3. K-CONNEX, Keihanshin Consortium for Fostering the Next Generation of Global Leaders in Research, Kyoto, Japan.
Abstract
PURPOSE: Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. METHODS: We extracted data of adult patients with T2DM from a medical claims database in Japan, which included 1 million individuals. The study period was 2005-2013, before the era of sodium-glucose cotransporter-2 inhibitors. The inclusion criteria were patients with a diagnosis of T2DM who had at least 1 prescription for a glucose-lowering drug. We further examined the number of DKA-related admissions and medication use prior to admission. Calculation of DKA incidence was on a patient-years basis, with 95% confidence interval using a Poisson distribution. RESULTS: Of 36,674 adult patients with T2DM, we identified 74 cases admitted for DKA, with an estimated DKA incidence of 0.48/1000 (95% confidence interval, 0.38-0.60/1000) patient-years. Of these 74 cases, approximately two-thirds of patients had no past or recent history of glucose-lowering drug use before admission for DKA. CONCLUSIONS: This study estimated that the incidence of DKA was 0.48/1000 patient-years in Japan, similar to previous studies. We also found that underuse of glucose-lowering medication was common among patients hospitalized for DKA. KEY POINTS The population-based incidence of DKA in T2DM is largely unknown. In Japan, the estimated DKA incidence was 0.48/1000 (95% CI, 0.38-0.60/1000) patient-years. Drug-induced DKA is an emerging research area, and our results can be applied to evaluating the risk of DKA.
PURPOSE: Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. METHODS: We extracted data of adult patients with T2DM from a medical claims database in Japan, which included 1 million individuals. The study period was 2005-2013, before the era of sodium-glucose cotransporter-2 inhibitors. The inclusion criteria were patients with a diagnosis of T2DM who had at least 1 prescription for a glucose-lowering drug. We further examined the number of DKA-related admissions and medication use prior to admission. Calculation of DKA incidence was on a patient-years basis, with 95% confidence interval using a Poisson distribution. RESULTS: Of 36,674 adult patients with T2DM, we identified 74 cases admitted for DKA, with an estimated DKA incidence of 0.48/1000 (95% confidence interval, 0.38-0.60/1000) patient-years. Of these 74 cases, approximately two-thirds of patients had no past or recent history of glucose-lowering drug use before admission for DKA. CONCLUSIONS: This study estimated that the incidence of DKA was 0.48/1000 patient-years in Japan, similar to previous studies. We also found that underuse of glucose-lowering medication was common among patients hospitalized for DKA. KEY POINTS The population-based incidence of DKA in T2DM is largely unknown. In Japan, the estimated DKA incidence was 0.48/1000 (95% CI, 0.38-0.60/1000) patient-years. Drug-induced DKA is an emerging research area, and our results can be applied to evaluating the risk of DKA.
Authors: Suetonia C Palmer; Britta Tendal; Reem A Mustafa; Per Olav Vandvik; Sheyu Li; Qiukui Hao; David Tunnicliffe; Marinella Ruospo; Patrizia Natale; Valeria Saglimbene; Antonio Nicolucci; David W Johnson; Marcello Tonelli; Maria Chiara Rossi; Sunil V Badve; Yeoungjee Cho; Annie-Claire Nadeau-Fredette; Michael Burke; Labib I Faruque; Anita Lloyd; Nasreen Ahmad; Yuanchen Liu; Sophanny Tiv; Tanya Millard; Lucia Gagliardi; Nithin Kolanu; Rahul D Barmanray; Rita McMorrow; Ana Karina Raygoza Cortez; Heath White; Xiangyang Chen; Xu Zhou; Jiali Liu; Andrea Flores Rodríguez; Alejandro Díaz González-Colmenero; Yang Wang; Ling Li; Surya Sutanto; Ricardo Cesar Solis; Fernando Díaz González-Colmenero; René Rodriguez-Gutierrez; Michael Walsh; Gordon Guyatt; Giovanni F M Strippoli Journal: BMJ Date: 2021-01-13