A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE)

BMC Medicine

Research Article

Lin Qi¹  Lixin Guo²  Hong Yang³  Tonghuan Li⁴  Li Li⁵  Sheng Chen⁶  Jing Wang⁷  Hui Wang⁸  Lin Yuan⁹ 

[1] Beijing Yanhua Hospital, Beijing, People’s Republic of China;Department of Endocrinology, Beijing Hospital, National Centre of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1, Dongdan Dahua Road, Dongcheng District, 100730, Beijing, People’s Republic of China;Rui’an People’s Hospital, Rui’an, People’s Republic of China;The 81st Hospital of People’s Liberation Army, Nanjing, People’s Republic of China;Present Address: The Second Hospital of Nanjing, Nanjing, People’s Republic of China;The First Affiliated Hospital of Ningbo University, Ningbo, People’s Republic of China;The People’s Hospital of Liuyang, Liuyang, People’s Republic of China;Weifang Municipal Hospital, Weifang, People’s Republic of China;Yancheng Tinghu District People’s Hospital, Yancheng, People’s Republic of China;Zhuhai People’s Hospital, Zhuhai, People’s Republic of China;

关键词: Chinese;    Dapagliflozin;    Genital tract infection;    Hypoglycaemia;    Non-interventional study;    Real world;    Safety;    Sodium-glucose cotransporter-2 inhibitors;    Type 2 diabetes;    Urinary tract infection;   

DOI  :  10.1186/s12916-023-02906-7

 received in 2022-10-19, accepted in 2023-05-24,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThere are few large-scale studies evaluating the safety of the sodium-glucose cotransporter-2 inhibitor, dapagliflozin, in Chinese patients with type 2 diabetes. DONATE, a multicentre, single-arm, prospective, non-interventional study, is the first real-world study evaluating the safety of dapagliflozin in Chinese patients with type 2 diabetes in routine clinical practice.MethodsBetween August 2017 and July 2020, patients with type 2 diabetes who had initiated dapagliflozin therapy and received ≥1 dose were prospectively recruited from 88 hospitals in China. Patients were subsequently followed up for 24 weeks; if patients discontinued dapagliflozin they were followed up for an additional 7 days after treatment discontinuation. The primary outcome was the proportion of patients with adverse events and serious adverse events, particularly key adverse events of special interest (AESI) including urinary tract infection, genital tract infection (typical symptoms with or without microbiological diagnosis) and hypoglycaemia (typical symptoms with or without blood glucose ≤3.9 mmol/L, or blood glucose ≤3.9 mmol/L without symptoms). Exploratory outcomes included the absolute change in metabolic parameters and the proportion of patients with other AESI including volume depletion, abnormal blood electrolytes, polyuria, renal impairment, diabetic ketoacidosis, hepatic impairment and haematuria.ResultsA total of 3000 patients were enrolled, of whom 2990 (99.7%) were included in the safety analysis set. Mean (SD) age was 52.6 (12.0) years, and 65.8% of patients were male. Mean (SD) duration of type 2 diabetes at enrolment was 8.4 (7.1) years. Mean (SD) treatment duration of dapagliflozin was 209.1 (157.6) days. Adverse events were reported in 35.4% (n = 1059) of patients during the 24-week follow-up period. Overall, 9.0% (n = 268) were related to treatment and 6.2% (n = 186) were serious. Urinary tract infection, genital tract infection and hypoglycaemia were reported in 2.3% (n = 70), 1.3% (n = 39) and 1.1% (n = 32) of patients, respectively. The proportion of patients with other AESI was also low: polyuria (0.7%; n = 21), volume depletion (0.3%; n = 9), renal impairment (0.3%; n = 8), hepatic impairment (0.2%; n = 7), haematuria (0.2%; n = 6) and diabetic ketoacidosis (0.1%; n = 2).ConclusionsThis study demonstrated that once-daily dapagliflozin was well tolerated in Chinese patients with type 2 diabetes and the overall safety profile of dapagliflozin in clinical practice in China was consistent with that reported in clinical trials.Trial registrationClinicalTrials.gov, NCT03156985. Registered on 16 May, 2017.

【 授权许可】

CC BY   
© The Author(s) 2023

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