Evidence map›Paper›PMID 34908223›Full record

Trial reportDiabetes, obesity & metabolism2022

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.

Kohei Kaku, Christoph Wanner, Stefan D Anker, Stuart Pocock, Atsutaka Yasui, Michaela Mattheus, Søren S Lund

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

Kohei KakuDepartment of General Internal Medicine, Kawasaki Medical School General Medical Center, Okayama, Japan.ORCID 0000-0003-1574-0565
Christoph WannerWürzburg University Clinic, Würzburg, Germany.
Stefan D AnkerDepartment of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Stuart PocockDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Atsutaka YasuiMedical Division, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.ORCID 0000-0003-4903-7210
Michaela MattheusBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Søren S LundBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Boehringer Ingelheim (Germany) · DEBerlin-Brandenburger Centrum für Regenerative Therapien · DEBoehringer Ingelheim (Japan) · JPKawasaki Medical School · JPLondon School of Hygiene & Tropical Medicine · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe sodium-glucose co-transporter 2 inhibitor empagliflozin reduced the total burden of cardiovascular, mortality, and all-cause hospitalization events, including first and recurrent events, in EMPA-REG OUTCOME participants with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD). We investigated the effect of empagliflozin on the total burden of cardiovascular and hospitalization events in Asian participants. MATERIALS AND

methodsParticipants were randomized to empagliflozin 10 mg, 25 mg or placebo plus standard of care. The primary and key secondary outcomes were the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke and the primary outcome plus hospitalization for unstable angina, respectively. The effect of pooled empagliflozin versus placebo on total (first plus recurrent) cardiovascular and hospitalization events was analysed using a negative binomial model that preserves randomization and accounts for within-patient correlation of multiple events. We analysed Asian versus non-Asian EMPA-REG OUTCOME population subgroups post hoc.

resultsAmong 1517 Asian participants, empagliflozin reduced the relative risk of total events of the primary outcome by 39% versus placebo [rate ratio (95% confidence interval): 0.61 (0.43, 0.89)], the key secondary outcome by 33% [0.67 (0.48, 0.93)], the composite of cardiovascular death (excluding fatal stroke) and hospitalization for heart failure by 43% [0.57 (0.33, 0.996)], and all-cause hospitalization by 21% [0.79 (0.65, 0.97)]. The effects of empagliflozin were consistent between Asian and non-Asian populations (treatment-by-subgroup interaction p > .05).

conclusionsEmpagliflozin reduced the total burden of cardiovascular and hospitalization events in Asian and non-Asian EMPA-REG OUTCOME participants with T2D and established ASCVD, consistent with the overall trial population.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Benzhydryl CompoundsGlucosidesHospitalizationHumansHypoglycemic AgentsTreatment OutcomeBenzhydryl CompoundsempagliflozinGlucosidesHypoglycemic Agentsantidiabetic drugcardiovascular diseaseclinical trialempagliflozinSGLT2 inhibitortype 2 diabetes

Identifiers

PMID34908223
PMCPMC9305124
OpenAlexW4200429255

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.