Evidence map›Paper›PMID 29713728›Full record

Trial reportDiabetologia2018

Empagliflozin in women with type 2 diabetes and cardiovascular disease - an analysis of EMPA-REG OUTCOME®.

Bernard Zinman, Silvio E Inzucchi, Christoph Wanner, Uwe Hehnke, Jyothis T George, Odd Erik Johansen, David Fitchett, EMPA-REG OUTCOME® investigators

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 6 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

31 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Pooled it
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  10. Article
  11. 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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  13. Doxorubicin-induced cardiotoxicity and risk factors.International journal of cardiology. Heart & vasculature · 2024
    Article
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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

8 authors.

Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Silvio E InzucchiSection of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.
Christoph WannerDepartment of Medicine, Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.
Uwe HehnkeBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Jyothis T GeorgeBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Odd Erik JohansenBoehringer Ingelheim Norway KS, Drengsrudbekken 8, PO Box 405, N-1373, Asker, Norway. odd_erik.johansen@boehringer-ingelheim.com.
David FitchettDivision of Cardiology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
EMPA-REG OUTCOME® investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe global epidemic of type 2 diabetes affects women and men equally; however, the relative impact on the cardiovascular (CV) system appears greater for women than men when compared with peers without diabetes. Furthermore, women are often under-represented in CV outcome trials, resulting in less certainty about the impact of CV prevention therapies across the sexes. The EMPA-REG OUTCOME® trial, which included 28.5% women, found that empagliflozin, given in addition to standard of care, reduced the risk of CV death by 38%, heart failure (HF) hospitalisation by 35% and a composite endpoint for incident or worsening nephropathy by 39%. Here we report a secondary analysis of the trial to determine the relative effects of empagliflozin in women vs men.

methodsThe population studied were individuals with type 2 diabetes (HbA

resultsAt baseline, the demographic profile of the 2004 women (age ± standard deviation 63.6 ± 8.8 years) compared with the 5016 men (age 63.0 ± 8.6 years) in the trial was largely similar, with the exception that LDL-cholesterol was numerically higher in women (2.5 ± 1.0 vs 2.1 ± 0.9 mmol/l), consistent with lower rates of lipid-lowering therapies (75.4% vs 83.2%). Women were also less likely to have smoked (31.5% vs 69.9%). The annualised incidence rate for women in the placebo group was numerically lower than in men for CV death (1.58% vs 2.19%), numerically higher for HF hospitalisation (1.75% vs 1.33%) and similar for renal events (7.22% vs 7.75%). We did not detect any effect modification by sex within the statistical power restrictions of the analysis for CV death, HF hospitalisation and incident or worsening nephropathy (interaction p values 0.32, 0.20 and 0.85, respectively). Compared with placebo, empagliflozin increased the rates of genital infections in both women (2.5% vs 10.0%) and men (1.5% vs 2.6%). CONCLUSIONS/

interpretationCV death, HF hospitalisation and incident or worsening nephropathy rate reductions induced by empagliflozin were not different between women and men.

Indexed as

AgedBenzhydryl CompoundsBiomarkersBlood GlucoseCardiovascular DiseasesComorbidityDiabetes Mellitus, Type 2FemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsIncidenceMaleMiddle AgedRisk FactorsBenzhydryl CompoundsBiomarkersBlood GlucoseempagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsCardiovascular diseaseHeart failureMortalitySGLT2 inhibitionType 2 diabetesWomen

Identifiers

PMID29713728

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.