Evidence map›Paper›PMID 31579904›Full record

Trial reportAge and ageing2019

Efficacy and safety of empagliflozin in older patients in the EMPA-REG OUTCOME® trial.

Pedro Monteiro, Richard M Bergenstal, Elvira Toural, Silvio E Inzucchi, Bernard Zinman, Stefan Hantel, Sanja Giljanovic Kiš, Stefan Kaspers, Jyothis T George, David Fitchett

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Age and ageing, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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

67 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  17. Risk management of cardiovascular disease in older patients with diabetes.Hypertension research : official journal of the Japanese Society of Hypertension · 2025
    Review
  18. Novel Cardiometabolic Medications in the Cardiovascular-Kidney-Metabolic Syndrome Era.The Journal of clinical endocrinology and metabolism · 2025 · on this map
    Review
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  20. Review

7 more citing papers are in PubMed but not listed here.

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

10 authors.

Pedro MonteiroHospitais da Universidade de Coimbra, Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal.
Richard M BergenstalInternational Diabetes Center at Park Nicollet, Minneapolis, MN, USA.
Elvira TouralCentro de Salud Lavapies, Madrid, Spain.
Silvio E InzucchiSection of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.
Bernard ZinmanLuenefeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Stefan HantelBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Sanja Giljanovic KišEli Lilly (Suisse) S.A., Representative Office, Zagreb, Croatia.
Stefan KaspersBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Jyothis T GeorgeBoehringer Ingelheim International GmbH, Ingelheim, Germany.
David FitchettSt. Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, ON, Canada.

Funding

Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

objectiveThe risks of cardio-renal complications of diabetes increase with age. In the EMPA-REG OUTCOME® trial, empagliflozin reduced cardiovascular (CV) mortality by 38% in patients with type 2 diabetes (T2D) and CV disease. Here we compare outcomes with empagliflozin in older patients in EMPA-REG OUTCOME.

methodsPatients with T2D and CV disease were randomised to empagliflozin 10 or 25 mg, or placebo plus standard of care. In post hoc analyses, risks of 3-point major adverse CV events (3P-MACE: composite of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke), CV death, hospitalisation for heart failure, all-cause mortality, all-cause hospitalisation and incident/worsening nephropathy were evaluated for empagliflozin versus placebo by baseline age (<65, 65 to <75, ≥75 years). Adverse events (AEs) were analysed descriptively.

resultsEffect of empagliflozin on all outcomes was consistent across age categories (P ≥ 0.05 for interactions) except 3P-MACE. The 3P-MACE hazard ratios (HRs) were 1.04 (95% confidence interval [CI] 0.84, 1.29), 0.74 (0.58, 0.93) and 0.68 (0.46, 1.00) in patients aged <65, 65 to <75, and ≥75 years, respectively (P = 0.047 for treatment-by-age group interaction). Corresponding CV death HRs were 0.72 (95% CI 0.52, 1.01), 0.54 (0.37, 0.79) and 0.55 (0.32, 0.94), respectively (P = 0.484 for treatment-by-age group interaction). Across age categories, empagliflozin AEs reflected its known safety profile. Rates of bone fractures, renal AEs and diabetic ketoacidosis were similar between empagliflozin and placebo across age categories.

conclusionsIn the EMPA-REG OUTCOME trial, empagliflozin reduced risks of CV mortality, heart failure and renal outcomes, supporting its cardio-renal benefits in older patients.

Indexed as

AgedBenzhydryl CompoundsCardiovascular DiseasesDiabetes Mellitus, Type 2FemaleGlucosidesHumansHypoglycemic AgentsMaleMiddle AgedMyocardial InfarctionStrokeBenzhydryl CompoundsempagliflozinGlucosidesHypoglycemic Agentsagedcardiovascular diseaseclinical trialkidney diseasestype 2 diabetes

Identifiers

PMID31579904
PMCPMC7963112

What OpenQuestion holds

Textmetadata
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.