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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

BACKGROUND: While 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. OBJECTIVE: This analysis evaluated adherence and satisfaction with EPL treatment...

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Autores principales: Ivashkin, Vladimir T., Maevskaya, Marina V., Shirokova, Elena N., Maev, Igor V., Samsonov, Alexey A., Sas, Evgeniy I., Palgova, Liudmila K., Starostin, Kirill
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123926/
https://www.ncbi.nlm.nih.gov/pubmed/33993460
http://dx.doi.org/10.1007/s40801-021-00250-x
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author Ivashkin, Vladimir T.
Maevskaya, Marina V.
Shirokova, Elena N.
Maev, Igor V.
Samsonov, Alexey A.
Sas, Evgeniy I.
Palgova, Liudmila K.
Starostin, Kirill
author_facet Ivashkin, Vladimir T.
Maevskaya, Marina V.
Shirokova, Elena N.
Maev, Igor V.
Samsonov, Alexey A.
Sas, Evgeniy I.
Palgova, Liudmila K.
Starostin, Kirill
author_sort Ivashkin, Vladimir T.
collection PubMed
description BACKGROUND: While 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. OBJECTIVE: This 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. METHODS: Data 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. RESULTS: Overall, 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. CONCLUSIONS: Patients 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00250-x.
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spelling pubmed-81239262021-05-17 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 Ivashkin, Vladimir T. Maevskaya, Marina V. Shirokova, Elena N. Maev, Igor V. Samsonov, Alexey A. Sas, Evgeniy I. Palgova, Liudmila K. Starostin, Kirill Drugs Real World Outcomes Original Research Article BACKGROUND: While 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. OBJECTIVE: This 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. METHODS: Data 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. RESULTS: Overall, 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. CONCLUSIONS: Patients 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00250-x. Springer International Publishing 2021-05-15 /pmc/articles/PMC8123926/ /pubmed/33993460 http://dx.doi.org/10.1007/s40801-021-00250-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Ivashkin, Vladimir T.
Maevskaya, Marina V.
Shirokova, Elena N.
Maev, Igor V.
Samsonov, Alexey A.
Sas, Evgeniy I.
Palgova, Liudmila K.
Starostin, Kirill
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123926/
https://www.ncbi.nlm.nih.gov/pubmed/33993460
http://dx.doi.org/10.1007/s40801-021-00250-x
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