Evidence map›Paper›PMID 34101308›Full record

Trial reportEuropean journal of heart failure2021

Effect of sacubitril/valsartan vs. enalapril on changes in heart failure therapies over time: the PARADIGM-HF trial.

Ankeet S Bhatt, Muthiah Vaduganathan, Brian L Claggett, Jiankang Liu, Milton Packer, Akshay S Desai, Martin P Lefkowitz, Jean L Rouleau, Victor C Shi, Michael R Zile and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 6% 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, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 4 countries.

Ankeet S Bhatt *Division of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Muthiah Vaduganathan *Division of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Brian L ClaggettDivision of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Jiankang LiuDivision of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Milton PackerBaylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.
Akshay S DesaiDivision of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Martin P LefkowitzNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jean L RouleauMontreal Heart Institute, Université de Montréal, Montréal, QC, Canada.
Victor C ShiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Michael R ZileMedical University of South Carolina, Charleston and Ralph H. Johnston Veterans Administration Medical Center, Charleston, SC, USA.
Karl SwedbergDepartment of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.
Orly VardenyCenter for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, and University of Minnesota, Minneapolis, MN, USA.
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Scott D SolomonDivision of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
Brigham and Women's Hospital · USBaylor University Medical Center · USBritish Heart Foundation · GBMedical University of South Carolina · USMontreal Heart Institute · CANovartis (United States) · USTris Pharma (United States) · USUniversity of Gothenburg · SEUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSacubitril/valsartan improves morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Whether initiation of sacubitril/valsartan limits the use and dosing of other elements of guideline-directed medical therapy for HFrEF is unknown. We examined the effects of sacubitril/valsartan, compared with enalapril, on β-blocker and mineralocorticoid receptor antagonist (MRA) use and dosing in a large randomized clinical trial. METHODS AND

resultsPatients with full data on medication use were included. We examined β-blocker and MRA use in patients randomized to sacubitril/valsartan vs. enalapril through 12-month follow-up. New initiations and discontinuations of β-blocker and MRA were compared between treatment groups. Overall, 8398 (99.9%) had full medication and dose data at baseline. Baseline use of β-blocker and MRA at any dose was 87% and 56%, respectively. Mean doses of β-blocker and MRA were similar between treatment groups at baseline and at 6-month and 12-month follow-up. New initiations through 12-month follow-up were infrequent and similar in the sacubitril/valsartan and enalapril groups for β-blockers [37 (9.0%) vs. 42 (10.2%), P = 0.56] and MRA [127 (7.6%) vs. 143 (9.2%), P = 0.10]. Among patients on MRA therapy at baseline, there were fewer MRA discontinuations in patients on sacubitril/valsartan as compared with enalapril at 12 months [125 (6.2%) vs. 187 (9.0%), P = 0.001]. Discontinuations of β-blockers were not significantly different between groups in follow-up (2.2% vs. 2.6%, P = 0.26).

conclusionsInitiation of sacubitril/valsartan, even when titrated to target dose, did not appear to lead to greater discontinuation or dose down-titration of other key guideline-directed medical therapies, and was associated with fewer discontinuations of MRA. Use of sacubitril/valsartan (when compared with enalapril) may promote sustained MRA use in follow-up.

Indexed as

EnalaprilHeart FailureAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsHumansStroke VolumeTetrazolesTreatment OutcomeValsartanAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsEnalaprilsacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanGuideline-directed medical therapyHeart failure with reduced ejection fractionMineralocorticoid receptor antagonistsSacubitril/valsartanβ-blockers

Identifiers

PMID34101308
PMCPMC9291580
OpenAlexW3168936597

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.