Real-world evidence for beneficial effects of essential phospholipids in patients with non-alcoholic fatty liver disease
Non-alcoholic fatty liver disease: a life-style disease
High treatment satisfaction with EPL treatment
Significant improvements in ultrasound and in the blood parameters
The ultrasound results of NAFLD also improved significantly, especially in terms of the echogenicity and structure of the liver – and to a comparable extent in all comorbidity groups (see Tab. 1). At the start of the study, hyperechogenicity of the liver was present in 84.0% of the patients and a heterogeneous liver structure in 62.9%. After 24 weeks, a significant improvement in liver hyperechogenicity was found in 68.3% of the patients (95% confidence interval [CI] 66.6% to 70.1%) and in liver structure in 42.7% (95% CI 40.9% to 44.5%) (p < 0.05 compared to baseline). Considering only patients with ultrasound abnormalities detected at baseline, EPL therapy was accompanied with a significant and consistent ultrasound improvement with statistically significant (p < 0.05) improvement of liver echogenicity in 69.6% of patients at 12 weeks and maximal improvement of liver hyperechogenicity in 81.4% of patients at 24 weeks (p < 0.05) .
Tab. 1. Proportion (%) of patients with improved or unchanged ultrasonographic findings after 24 weeks of EPL treatment, according to comorbidity nature
|Features [%]||Hypertension (n=1635)||Overweight/obesity (n=2285)||Type 2 diabetes mellitus (n=475)||High cholesterol (n=2119)|
|Improved||No change||Improved||No change||Improved||No change||Improved||No change|
|Diffuse liver hyperechogenicity||67.7||32.3||68.8||31.2||68.2||31.8||67.8||32.2|
|Heterogeneous structure of the liver*||43.6||56.4||43.3||56.6||40.6||59.3||43.7||56.2|
|Indistinctness and/or underlined vascular pattern||24.8||75.2||23.1||76.9||24.8||75.2||24.4||75.6|
|Distal echo signal attenuation||21.7||78.3||22.5||77.5||22.7||77.3||21.5||78.5|
|*Worsening of “heterogeneous structure of the liver” occurred in 0.1% of patients in each comorbidity subgroup|
Levels of the liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) are useful parameters in the diagnosis of NAFLD; at the same time, liver enzyme levels do not correlate with the histological severity of NAFLD. There was a consistent and significant reduction in serum levels of ALT, AST and GGT during the 24-week study period (see Fig. 1). Compared to the baseline levels, mean ALT decreased by 20.0 U/L, mean AST by 16.5 U/L and mean GGT by 15.9 U/L. The changes were already statistically significant after 12 weeks (all p < 0.001 in the paired t-test for the two timepoints). At the end of the study, the ALT, AST and GGT levels were normal in 75.8%, 89.2% and 62.5% of the patients respectively (all p < 0.001 compared to the baseline value) .
Fig. 1. Mean +/– SD liver function tests (U/L) at baseline and weeks 12 and 24 in the overall study population. ALT: alanine aminotransferase; AST: aspartate aminotransferase; GGT: gamma-glutamyl transferase
- Lazebnik LB, Golovanova EV, et al. Non-alcoholic fatty liver disease in adults: clinic, diagnostics, treatment. Guidelines for therapists, third version. Experimental and Clinical Gastroenterology. 2021;185(1):4–52. (In Russ.) DOI: 10.31146/1682-8658-ecg-185-1-4-52
- Derovs A, Pokrotnieks J, Derova J, Laivacuma S, Zeltiņa I, Vīksna L. Society of Digestive Diseases (Latvia). [Clinical practical guidelines for diagnostics, treatment and monitoring of non-alcoholic fatty liver disease]. Nealkohola taukainās aknu slimības diagnostikas, ārstēšanas un novērošanas klīniskās praktiskās rekomendācijas. Rīga: SIA Medicīna un Prese, 2020. 44 p.
- Hartleb M, Wunsch E, Milkiewicz P, et al. Postępowanie z chorymi na niealkoholową stłuszczeniową chorobę wątroby: Zalecenia Polskiej Grupy Ekspertów NAFLD 2019. Med Prakt. 2019;10:47–74.
- Fan JG, Wei L, Zhuang H, et al. Guidelines of prevention and treatment of nonalcoholic fatty liver disease (2018, China). J Dig Dis. 2019;20(4):163–73.
- Maev IV, Samsonov AA, et al. Real-world comorbidities and treatment patterns among patients with non-alcoholic fatty liver disease receiving phosphatidylcholine as adjunctive therapy in Russia. BMJ Open Gastroenterol. 2019;6(1):e000307. https://doi: 10.1136/bmjgast-2019-000307. eCollection 2019.
- Maev IV, Samsonov AA, et al. Effectiveness of phosphatidylcholine in alleviating steatosis in patients with non-alcoholic fatty liver disease and cardiometabolic comorbidities (MANPOWER study). BMJ Open Gastro 2020;7:e000341. doi:10.1136/bmjgast-2019-000341
- Maev IV, Samsonov AA, et al. Effectiveness of phosphatidylcholine as adjunctive therapy in improving liver function tests in patients with non-alcoholic fatty liver disease and metabolic comorbidities: real-life observational study from Russia. BMJ Open Gastro 2020;7:e000368. doi:10.1136/bmjgast-2019-000368
Conflict of interest: K. Starostin and B. Popovic are employees of Sanofi. I. Maev and C. Pavlov declare no conflict of interest.
Disclosures: Medical writing and publication funded by Sanofi.