Evidence map›Paper›PMID 38041517›Full record

Observational studyESC heart failure2024

Pharmacoutilization and adherence to sacubitril/valsartan in real world: the REAL.IT study in HFrEF.

Massimo Iacoviello, Gabriele Di Gesaro, Filippo Maria Sarullo, Daniela Miani, Mauro Driussi, Michele Correale, Claudio Bilato, Andrea Passantino, Erberto Carluccio, Alessandra Villani and 5 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in ESC heart failure, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 12% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Observational
  6. Article
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

15 authors at 12 institutions in 1 country.

Massimo IacovielloSurgical and Medical Sciences Department, University of Foggia, Foggia, Italy.ORCID https://orcid.org/0000-0001-9613-5062
Gabriele Di GesaroU.O. Cardiologia IRCCS ISMETT Palermo, Palermo, Italy.
Filippo Maria SarulloU.O.S. Di Riabilitazione Cardiovascolare Ospedale Buccheri La Ferla Fatebenefratelli, Palermo, Italy.
Daniela MianiSOC Cardiologia, Dipartimento Cardiotoracico, Azienda Sanitaria Universitaria Friuli Centrale, Ospedale S. Maria della Misericordia, Udine, Italy.
Mauro DriussiSOC Cardiologia, Dipartimento Cardiotoracico, Azienda Sanitaria Universitaria Friuli Centrale, Ospedale S. Maria della Misericordia, Udine, Italy.
Michele CorrealeSC Universitaria di Cardiologia AOU 'Ospedali Riuniti' Foggia, Foggia, Italy.
Claudio BilatoU.O.C. Cardiologia Azienda ULSS 8 Berica - Ospedali dell'Ovest Vicentino, Arzignano, Italy.
Andrea PassantinoDivision of Cardiology and Cardiac Rehabilitation, U.O. Cardiologia ICS Maugeri SpA SB Bari, IRCCS Istituto di Bari, Bari, Italy.
Erberto CarluccioCardiologia e Fisiopatologia Cardiovascolare, Azienda Ospedaliera Universitaria 'Santa Maria della Misericordia', Perugia, Italy.
Alessandra VillaniUO Cardiologia, Istituto AuxologicoItaliano IRCCS, Dipartimento di Scienze Cardiovascolari, Neurologiche, Metaboliche, Milan, Italy.
Luca Degli EspostiCEO of CliCon S.r.l. Società Benefit, Bologna, Italy.
Chiara d'AgostinoNovartis Farma SpA, Milan, Italy.
Elena PeruzziNovartis Farma SpA, Milan, Italy.
Simone PoliNovartis Farma SpA, Milan, Italy.
Andrea di LenardaCardiovascular Center, University Hospital and Health Services of Trieste, Trieste, Italy.
Novartis (Italy) · ITOspedale Santa Maria della Misericordia di Udine · ITAzienda Ospedaliera di Perugia · ITIRCCS Istituto Auxologico Italiano · ITIstituti Clinici Scientifici Maugeri · ITIstituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione · ITOspedale Buccheri la Ferla Fatebenefratelli · ITOspedale Sant'Anna · ITOspedali Riuniti di Foggia · ITSocietà Italiana di Fisica · ITUniversity of Foggia · ITUniversity of Trieste · IT

Funding

Novartis Farma
6 · The paper itself

Abstract

aimsThe current European Society of Cardiology (ESC) guidelines provide clear indications for the treatment of acute and chronic heart failure (HF). Nevertheless, there is a constant need for real-world evidence regarding the effectiveness, adherence, and persistence of drug therapy. We investigated the use of sacubitril/valsartan for the treatment of HF with reduced ejection fraction in real-world clinical practice in Italy. METHODS AND

resultsAn observational, retrospective, non-interventional cohort study based on electronic medical records from nine specialized hospital HF centres in Italy was carried out on patients with prescription of sacubitril/valsartan. Overall, 948 patients had a prescription of sacubitril/valsartan, with 924 characterized over 6 months and followed up for 12 months. Pharmacoutilization data at 1 year of follow-up were available for 225 patients {mean age 69.7 years [standard deviation (SD) = 10.8], 81.8% male}. Of those, 398 (45.2%) reached the target dose of sacubitril/valsartan of 97/103 mg in a mean time of 6.9 (SD = 6.2) weeks. Blood pressure and hypotension in 61 patients (65%) and worsening of chronic kidney disease in 10 patients (10.6%) were the main reasons for not reaching the target dose. Approximatively 50% of patients had a change in sacubitril/valsartan dose during follow-up, and 158 (70.2%) were persistent with the treatment during the last 3 months of follow-up. A sensitivity analysis (persistence during the last 4 months of follow-up) showed persistence for 162 patients (72.0%). Adherence data, available for 387 patients, showed full adherence for 205 (53%). Discontinuation (102/717 patients, 14.2%) was mainly due to hypotension and occurred after a mean time of 34.3 (SD = 28.7) weeks. During follow-up, out of 606 patients with available data, 434 patients (71.6%) had an HF add-on drug or drugs concomitant with sacubitril/valsartan. HF-related hospitalization during follow-up was numerically higher in non-persistent (16/67 patients, 23.9%) vs. patients persistent to sacubitril/valsartan (30/158, 19%) (P = 0.405).

conclusionsReal-world data on the use of sacubitril/valsartan in clinical practice in Italy show a rapid titration to the target dose, high therapeutic adherence enabling a good level of therapeutic management in line with ESC guidelines for patients with reduced ejection fraction.

Indexed as

AminobutyratesBiphenyl CompoundsHeart FailureHypotensionVentricular Dysfunction, LeftAgedCohort StudiesFemaleHumansMaleRetrospective StudiesStroke VolumeTetrazolesTreatment OutcomeValsartanAminobutyratesBiphenyl CompoundssacubitrilTetrazolesValsartanAdherenceHeart failure with reduced ejection fractionPersistencePharmacoutilizationReal-world practiceSacubitril/valsartan

Identifiers

PMID38041517
PMCPMC10804148
OpenAlexW4389265475

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Registered trials

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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.