ArticleJournal of diabetes investigation2019
Safety and tolerability of empagliflozin in East Asian patients with type 2 diabetes: Pooled analysis of phase I-III clinical trials.
Article in Journal of diabetes investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- A systematic literature review on the burden of diabetic ketoacidosis in type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2025Pooled it
- Healthcare resource utilization in patients treated with empagliflozin in East Asia.Journal of diabetes investigation · 2022Pooled it
- Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2020Pooled it
- Pooled it
- A multicenter, open-label, single-arm trial of the long-term safety of empagliflozin treatment for refractory diabetes mellitus with insulin resistance (EMPIRE-02).Journal of diabetes investigation · 2024Trial
- Long-term safety and efficacy of SGLT2 inhibitor use in older east Asians with type 2 diabetes.Journal of diabetes investigation · 2024Trial
- The effect of empagliflozin on the total burden of cardiovascular and hospitalization events in the Asian and non-Asian populations of the EMPA-REG OUTCOME trial of patients with type 2 diabetes and cardiovascular disease.Diabetes, obesity & metabolism · 2022Trial
- Kidney outcomes with SGLT2 inhibitor versus DPP4 inhibitor use in older adults with diabetes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Article
- Dapagliflozin vs. Empagliflozin for cardiorenal risk reduction: Real-world paired data and comparative study in Indonesia .F1000Research · 2025Article
- Empagliflozin Use among Patients with Heart Failure in the Outpatient Department of Medicine in a Tertiary Care Centre.JNMA; journal of the Nepal Medical Association · 2023Article
- Safety of sodium-glucose cotransporter 2 inhibitors in Asian type 2 diabetes populations.Journal of diabetes investigation · 2023Review
- Clinical Benefits of Sodium-Glucose Cotransporter 2 Inhibitors and the Mechanisms Underlying Their Cardiovascular Effects.JACC. Asia · 2022Review
- Sodium-Glucose Cotransporter-2 Inhibitors Improve Cardiovascular Dysfunction in Type 2 Diabetic East Asians.Metabolites · 2021Review
- Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations.Clinical pharmacology in drug development · 2021Article
- Article
- Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.Endocrinology, diabetes & metabolism · 2021Article
- Real-world risk of hypoglycemia-related hospitalization in Japanese patients with type 2 diabetes using SGLT2 inhibitors: a nationwide cohort study.BMJ open diabetes research & care · 2020Article
- SGLT2 Inhibitors as Add-On Therapy to Metformin for People with Type 2 Diabetes: A Review of Placebo-Controlled Trials in Asian versus Non-Asian Patients.Diabetes, metabolic syndrome and obesity : targets and therapy · 2020Review
- Update on the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in Asians and non-Asians.Journal of diabetes investigation · 2019Article
- Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Article
Corrections and comments
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Authors and funding
12 authors at 8 institutions in 6 countries.
Funding
Abstract
AIMS/
introductionWe investigated the safety and tolerability of empagliflozin (EMPA) in East Asian patients with type 2 diabetes. MATERIALS AND
methodsData 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.
resultsIn 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.
conclusionsIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.