Evidence map›Paper›PMID 33993460›Full record

ArticleDrugs - real world outcomes2021

Correlation of Objective Endpoints and Subjective Patient-Reported Outcomes in NAFLD Treatment with Essential Phospholipids: Real-World Data Based on Pooled Analysis of Observational Studies.

Vladimir T Ivashkin, Marina V Maevskaya, Elena N Shirokova, Igor V Maev, Alexey A Samsonov, Evgeniy I Sas, Liudmila K Palgova, Kirill Starostin

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.3field-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

1 citing paper in PubMed, 15 citations in OpenAlex.

  1. 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

8 authors at 5 institutions in 2 countries.

Vladimir T IvashkinI.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
Marina V MaevskayaI.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
Elena N ShirokovaI.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
Igor V MaevA.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia.
Alexey A SamsonovA.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia.
Evgeniy I SasClinical Research and Educational Center in Gastroenterology and Hepatology, Institute of High Medical Technologies of St Petersburg University, Saint Petersburg, Russia.
Liudmila K PalgovaSaint Petersburg State Pediatric Medical Academy, Saint Petersburg, Russia.
Kirill StarostinDepartment of Medical Affairs, Sanofi, 125009 Business Center "Summit", Tverskaya 22, Moscow, Russia. Kirill.Starostin@sanofi.com.ORCID http://orcid.org/0000-0001-6488-7980
Sechenov University · RUMoscow State University of Medicine and Dentistry · RUSaint Petersburg State Pediatric Medical University · RUSanofi (France) · FRSt Petersburg University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile no "gold-standard" pharmacotherapy for nonalcoholic fatty liver disease (NAFLD) is yet established, essential phospholipids (EPLs) are reported to decrease steatosis and improve laboratory parameters.

objectiveThis analysis evaluated adherence and satisfaction with EPL treatment as patient-reported outcomes and their relationship with changes in laboratory and ultrasound parameters among Russian patients with NAFLD.

methodsData were pooled from three observational Russian studies-MANPOWER (2015-2016), LIDER 1 (2012-2013), and LIDER 2 (2013)-in which EPLs were used for at least 12 weeks in the treatment of liver diseases and which measured both subjective and objective endpoints. Only patients who had NAFLD were included in this analysis. The main endpoints were to determine treatment adherence and satisfaction with 12 weeks of EPL therapy, relationship between adherence/satisfaction and changes in the laboratory and ultrasound parameters. A secondary subgroup analysis was performed to identify patients with NAFLD who responded better (or worse) to 24 weeks of adjunctive EPL treatment.

resultsOverall, 3384 patients were included. A total of 82.2% of patients were adherent to 12 weeks of EPL treatment; high/very high satisfaction was reported by 15.3%/65.9% of clinicians and 15.9%/64.4% of patients. There was positive correlation between patients' adherence and satisfaction and significant improvement in laboratory (transaminases, lipid profile; p < 0.001) and ultrasound (steatosis, p < 0.001) parameters, and improvement in symptoms (p < 0.001) after 24 weeks of EPL. Male patients, patients with unhealthy lifestyles, and those with more comorbidities showed a better response in laboratory and ultrasound parameters.

conclusionsPatients with NAFLD treated with adjunctive EPL therapy in real-world clinical practice in Russia showed good treatment adherence and treatment satisfaction. Improvements in laboratory and ultrasound parameters, as well as dynamics of patient symptoms, were positively correlated with adherence and satisfaction.

Identifiers

PMID33993460
PMCPMC8123926
OpenAlexW3162480705

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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.