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 as...

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Published in:Drugs - real world outcomes 2021-09, Vol.8 (3), p.369-382
Main Authors: Ivashkin, Vladimir T., Maevskaya, Marina V., Shirokova, Elena N., Maev, Igor V., Samsonov, Alexey A., Sas, Evgeniy I., Palgova, Liudmila K., Starostin, Kirill
Format: Article
Language:English
Subjects:
Abdomen
Alcohol
Clinical medicine
Clinical outcomes
Diabetes
Drug dosages
Drug therapy
Ethics
Hepatitis
Internal Medicine
Laboratories
Lipids
Liver diseases
Longitudinal studies
Medical research
Medicine
Medicine & Public Health
Obesity
Observational studies
Original
Original Research Article
Patients
Pharmacology/Toxicology
Pharmacotherapy
Ultrasonic imaging
Weight control
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Summary: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  
ISSN:2199-1154
2198-9788
DOI:10.1007/s40801-021-00250-x