Safety and tolerability of empagliflozin in East Asian patients with type 2 diabetes: Pooled analysis of phase I–III clinical trials
Journal
Journal of Diabetes Investigation
Journal Volume
10
Journal Issue
2
Pages
418-428
Date Issued
2019
Author(s)
Yabe D.
Yasui A.
Ji L.
Lee M.-K.
Ma R.C.W.
Okamura T.
Zeller C.
Kaspers S.
Lee J.
Kohler S.
Seino Y.
Abstract
Aims/Introduction: We investigated the safety and tolerability of empagliflozin (EMPA) in East Asian patients with type 2 diabetes. Materials and Methods: Data were pooled from participants with type 2 diabetes evenly randomized to a placebo, EMPA 10 mg or EMPA 25 mg in 15 phase I–III trials. Adverse events (AEs) were analyzed in the subgroup of trial participants from East Asian countries/regions. Results: In total, 709, 724 and 708 East Asian trial participants with type 2 diabetes received a placebo, EMPA 10 mg and EMPA 25 mg, respectively; total exposure was 953, 1,072, and 1,033 patient-years in these groups, respectively. The EMPA and placebo groups had similar incidences of severe AEs, serious AEs and AEs leading to discontinuation. Incidences of hypoglycemia differed according to anti-diabetes medication used at baseline. Higher rates of events consistent with genital infection were observed with EMPA (EMPA 1.5–1.7/100, placebo 0.2/100 patient-years). Rates of AEs consistent with volume depletion were comparable among treatment groups (0.8–1.4/100 patient-years), but in trial participants aged ?65 years, the rate was greater with EMPA 25 mg (EMPA 25 mg 3.5/100, placebo 2.0/100 patient-years). Incidences of events consistent with urinary tract infection, thromboembolic events, renal events, hepatic AEs, diabetic ketoacidosis, fractures and lower limb amputation were similar between EMPA and the placebo. Conclusions: In the present pooled analysis, EMPA was well tolerated in East Asian type 2 diabetes patients based on >2,100 patient-years’ exposure, consistent with results from the overall analysis population. ? 2018 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd
Subjects
Adverse drug event; Genital infection; Sodium–glucose cotransporter 2 inhibitor
SDGs
Other Subjects
empagliflozin; insulin; metformin; placebo; sulfonylurea; benzhydryl derivative; biological marker; empagliflozin; glucoside; glycosylated hemoglobin; hemoglobin A1c protein, human; age; Article; dehydration; diabetic ketoacidosis; disease severity; dizziness; drug dose comparison; drug safety; drug tolerability; drug withdrawal; East Asian; fracture; genital tract infection; human; hyperglycemia; hypoglycemia; kidney disease; non insulin dependent diabetes mellitus; phase 1 clinical trial (topic); phase 2 clinical trial (topic); phase 3 clinical trial (topic); priority journal; rash; rhinopharyngitis; side effect; thromboembolism; toxic hepatitis; upper respiratory tract infection; urinary tract infection; adverse drug reaction; aged; analysis; female; follow up; glucose blood level; incidence; Japan; male; maximum tolerated dose; middle aged; non insulin dependent diabetes mellitus; prognosis; randomized controlled trial (topic); safety; Aged; Benzhydryl Compounds; Biomarkers; Blood Glucose; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Glucosides; Glycated Hemoglobin A; Humans; Incidence; Japan; Male; Maximum Tolerated Dose; Middle Aged; Prognosis; Randomized Controlled Trials as Topic; Safety; Sodium-Glucose Transporter 2 Inhibitors
Publisher
Blackwell Publishing
Type
journal article