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- Title
Clinical Adverse Events of High-Dose vs Low-Dose Sodium-Glucose Cotransporter 2 Inhibitors in Type 2 Diabetes: A Meta-Analysis of 51 Randomized Clinical Trials.
- Authors
Fang-Hong Shi; Hao Li; Jiang Yue; Yi-Hong Jiang; Zhi-Chun Gu; Jing Ma; Hou-Wen Lin; Shi, Fang-Hong; Li, Hao; Yue, Jiang; Jiang, Yi-Hong; Gu, Zhi-Chun; Ma, Jing; Lin, Hou-Wen
- Abstract
<bold>Aims: </bold>The aims of this work are to assess the clinical adverse events (AEs) of high-dose vs low-dose sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) in patients with type 2 diabetes mellitus (T2DM).<bold>Methods: </bold>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% CIs. Prespecified subgroup analyses according to individual SGLT2 inhibitors and follow-up duration, and leave-one-out sensitivity analysis were conducted.<bold>Results: </bold>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, 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 study drugs (RR: 1.08; 95% CI, 1.01-1.16) that mainly derived from canagliflozin (RR: 1.17; 95% CI, 1.05-1.30). Subgroup analyses were consistent with the primary outcomes.<bold>Conclusions: </bold>This study provided substantial evidence that AEs of SGLT2 inhibitors were not dose related.
- Subjects
SODIUM-glucose cotransporter 2 inhibitors; TYPE 2 diabetes; CLINICAL trials; ARTIFICIAL pancreases; RESEARCH; META-analysis; RESEARCH methodology; ARTHRITIS Impact Measurement Scales; HYPOGLYCEMIC agents; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; DOSE-effect relationship in pharmacology
- Publication
Journal of Clinical Endocrinology & Metabolism, 2020, Vol 105, Issue 11, p1
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/clinem/dgaa586