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Clinical adverse events of high-dose versus low-dose sodium-glucose co-transporter 2 inhibitors in type 2 diabetes: a meta-analysis of 51 randomized clinical trials.

Authors
  • Shi, Fang-Hong1
  • Li, Hao2, 3
  • Yue, Jiang4
  • Jiang, Yi-Hong4
  • Gu, Zhi-Chun1
  • Ma, Jing4
  • Lin, Hou-Wen1
  • 1 Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. , (China)
  • 2 Department of Pharmacy, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. , (China)
  • 3 Clinical Research Center, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. , (China)
  • 4 Department of Endocrinology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. , (China)
Type
Published Article
Journal
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Publication Date
Aug 25, 2020
Identifiers
DOI: 10.1210/clinem/dgaa586
PMID: 32841351
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

To assess the clinical adverse events (AEs) of high-dose versus low-dose sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) in patients with type 2 diabetes mellitus (T2DM). We searched MEDLINE, EMBASE, and Cochrane Library from January 1, 2006 to March 10, 2020 for identifying eligible randomized clinical trials (RCTs) that reported AEs by high-dose and low-dose SGLT2 inhibitors in T2DM patients. Random-effects models was used to obtain summary relative risks (RRs) with associated 95% confidence intervals (CIs). Prespecified subgroup analyses according to individual SGLT2 inhibitors and follow-up duration, and Leave-one-out sensitivity analysis were conducted. A total of 51 RCTs involving 24,371 patients (12,208 received high-dose and 12,163 received low-dose SGLT2 inhibitors) were included. Overall, the heterogeneity among included studies was relatively low (I2&50% for each outcome). No significant differences between high-dose and low-dose SGLT2 inhibitors were observed for overall safety (including any AEs, serious AEs, and AEs leading to discontinuation and death) and specified safety (including infections and infestations, musculoskeletal disorders, gastrointestinal disorders, osmotic diuresis-related AEs, volume-related AEs, renal-related AEs, and metabolism and nutrition), except for a mild increase in risk for AEs related to studies drugs (RR: 1.08, 95%CI: 1.01-1.16) that mainly derived from canagliflozin (RR: 1.17, 95%CI: 1.05-1.30). Subgroups analysis were consistent with the primary outcomes. This study provided a substantial evidence that AEs of SGLT2 inhibitors were not dose-related. © Endocrine Society 2020. All rights reserved. For permissions, please e-mail: [email protected]

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