Evidence mapPaperPMID 38771475Full record

SynthesisAdvances in therapy2024

Safety of Empagliflozin: An Individual Participant-Level Data Meta-Analysis from Four Large Trials.

Christoph Wanner, Hristo Iliev, Nathalia Duarte, Elke Schueler, Ana Rita Soares, Vikram Thanam, Egon Pfarr

Abstract readMeta-Analysis
In one paragraph

Synthesis in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
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

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Gliflozins in hypertension: basic mechanisms and clinical insights.American journal of physiology. Renal physiology · 2025
    Review
  11. 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.

Christoph WannerUniversity Hospital Würzburg, Würzburg, Germany. Wanner_C@ukw.de.ORCID 0000-0001-9507-5301
Hristo IlievBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Nathalia DuarteBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Elke SchuelerMainanalytics GmbH, Sulzbach, Germany.ORCID 0000-0002-5955-8303
Ana Rita SoaresEli Lilly and Company, Lisbon, Portugal.
Vikram ThanamBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Egon PfarrBoehringer Ingelheim International GmbH, Ingelheim, Germany.ORCID 0000-0002-7799-1733

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEmpagliflozin is a sodium-glucose co-transporter-2 inhibitor used to treat type 2 diabetes (T2D) to improve glycemic control, reduce risk of cardiovascular death in patients with T2D, and treat patients with symptomatic chronic heart failure (HF) and chronic kidney disease (CKD). The safety profile of empagliflozin is well documented, although adverse events (AEs) remain of interest to clinicians. This study provides an up-to-date safety evaluation of empagliflozin.

methodsData were pooled from four long-term trials which included: patients with T2D and established cardiovascular disease (EMPA-REG OUTCOME), patients with HF, with/without diabetes (EMPEROR-Reduced and EMPEROR-Preserved), and patients with CKD, with/without diabetes (EMPA-KIDNEY). Since three of the four trials evaluated empagliflozin 10 mg, the meta-analysis was restricted to this dose.

resultsTotal trial medication exposure was 19,727 patient-years for patients who received empagliflozin (n = 10,472) and 19,447 patient-years for placebo (n = 10,461). The percentages of patients with serious AEs, fatal AEs, and AEs leading to discontinuation were similar for both groups. The incidences of serious urinary tract infection and serious pyelonephritis or urosepsis were similar for both groups but higher for women taking empagliflozin versus placebo. Serious genital infections were not increased with empagliflozin versus placebo. There was a slight increase in ketoacidosis and serious volume depletion in patients who received empagliflozin versus placebo. The occurrence of serious acute kidney injury was lower with empagliflozin versus placebo. Empagliflozin was not associated with an increased incidence of severe hypoglycemia, bone fractures, or lower limb amputations. Empagliflozin is therefore considered safe in people without diabetes, the elderly, patients with very low estimated glomerular filtration rate, low body mass index, and HF. Safety is unaltered by blood pressure, concomitant medication for hypertension, HF, and immunosuppression.

conclusionThis meta-analysis of long-term safety data extends current knowledge and confirms the safety and tolerability of empagliflozin.

Indexed as

Benzhydryl CompoundsCardiovascular DiseasesDiabetes Mellitus, Type 2GlucosidesSodium-Glucose Transporter 2 InhibitorsAgedFemaleHeart FailureHumansHypoglycemic AgentsMaleMiddle AgedRandomized Controlled Trials as TopicRenal Insufficiency, ChronicBenzhydryl CompoundsempagliflozinGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsAdverse drug eventAdverse drug reactionDrug safetyEmpagliflozinSGLT2 inhibitors

Identifiers

PMID38771475
PMCPMC11213770

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.