Evidence map›Paper›PMID 32369546›Full record

ArticleAmerican journal of hypertension2020

Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial.

João Pedro Ferreira, David Fitchett, Anne Pernille Ofstad, Bettina Johanna Kraus, Christoph Wanner, Isabella Zwiener, Bernard Zinman, Sabine Lauer, Jyothis T George, Patrick Rossignol and 1 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in American journal of hypertension, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01131676 (A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 7% 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.

NCT01131676 phase3completednot on this map

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2015Enrolled7,064ConditionsDiabetes Mellitus, Type 2ArmsBI 10773 low dose, Placebo BI 10773 high dose, BI 10773 high dose, Placebo BI 10773 low dose
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Targeted approaches to diagnose and treat resistant hypertension in Asia.Hypertension research : official journal of the Japanese Society of Hypertension · 2024
    Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Management of Hypertension in Diabetic Kidney Disease.Journal of clinical medicine · 2023
    Review
  15. Article
  16. Denervation or stimulation? Role of sympatho-vagal imbalance in HFpEF with hypertension.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Review
  17. Review
  18. Rethinking Resistant Hypertension.Journal of clinical medicine · 2022
    Review
  19. 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

11 authors at 7 institutions in 4 countries.

João Pedro FerreiraUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.
David FitchettDivision of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Anne Pernille OfstadBoehringer Ingelheim Norway KS, Asker, Norway.
Bettina Johanna KrausComprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.
Christoph WannerDepartment of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.
Isabella ZwienerBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
Sabine LauerBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Jyothis T GeorgeBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Patrick RossignolUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.
Faiez ZannadUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France.
Boehringer Ingelheim (Germany) · DEInserm · FRBoehringer Ingelheim (Norway) · NOMount Sinai Hospital · CASt. Michael's Hospital · CAUniversitätsklinikum Würzburg · DEUniversity of Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundType 2 diabetes (T2D) and resistant hypertension often coexist, greatly increasing risk of target-organ damage and death. We explored the effects of empagliflozin in patients with and without presumed resistant hypertension (prHT) in a post hoc analysis of EMPA-REG OUTCOME (NCT01131676).

methodsOverall, 7,020 patients received empagliflozin 10, 25 mg, or placebo with median follow-up of 3.1 years. We defined baseline prHT as ≥3 classes of antihypertensive drugs including a diuretic and uncontrolled blood pressure (BP; systolic blood pressure (SBP) ≥140 and/or diastolic blood pressure ≥90 mm Hg) or ≥4 classes of antihypertensive, including a diuretic, and controlled BP. We explored the effect of empagliflozin on cardiovascular (CV) death, heart failure (HF) hospitalization, 3-point major adverse cardiac events, all-cause death, and incident/worsening nephropathy by Cox regression and BP over time by a mixed-repeated-measures-model analysis.

results1,579 (22.5%) patients had prHT. The mean difference in change in SBP from baseline to week 12 vs. placebo was -4.5 (95% confidence interval, -5.9 to -3.1) mm Hg (P < 0.001) in prHT and -3.7 (-4.5, -2.9) mm Hg (P < 0.001) in patients without prHT. SBP was more frequently controlled (<130/80 mm Hg) with empagliflozin than with placebo. Patients with prHT had 1.5- to 2-fold greater risk of HF hospitalization, incident/worsening nephropathy, and CV death compared with those without prHT. Empagliflozin improved all outcomes in patients with and without prHT (interaction P > 0.1 for all outcomes).

conclusionsEmpagliflozin induced a clinically relevant reduction in SBP and consistently improved all outcomes regardless of prHT status. Due to these dual effects, empagliflozin should be considered for patients with hypertension and T2D.

Indexed as

AgedAntihypertensive AgentsBenzhydryl CompoundsBlood PressureCardiovascular DiseasesDiabetes Mellitus, Type 2Diabetic NephropathiesDrug ResistanceDrug Therapy, CombinationFemaleGlucosidesHeart FailureHospitalizationHumansHypertensionMaleAntihypertensive AgentsBenzhydryl CompoundsempagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitorsblood pressureempagliflozinhypertensionresistant hypertensiontype 2 diabetes

Identifiers

PMID32369546
PMCPMC7814223
OpenAlexW3022929430

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.