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Real-world evidence for beneficial effects of essential phospholipids in patients with non-alcoholic fatty liver disease


EFSM: 2022;2:220080DOI: 10.52778/efsm.22.0080Gepubliceerd op: 10.04.2022
Igor Maev, Chavdar Pavlov, Kirill M Starostin en Branko Popovic

Essential phospholipids (EPLs) belong to the group of hepatoprotective agents and are recommended in the Russian guideline for the treatment of non-alcoholic fatty liver disease (NAFLD). A large-scale observational study now confirms this recommendation based on treatment satisfaction, improvement of ultrasound parameters and normalisation of liver enzyme levels.

Non-alcoholic fatty liver disease: a life-style disease

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the world and affects roughly 37% of adults in Russia. NAFLD is regarded as the hepatic manifestation of metabolic syndrome, which includes obesity, dyslipidaemia, hypertension, and type 2 diabetes. Untreated, NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis or hepatocellular carcinoma. The World Gastroenterology Organization recommends a resource-sensitive approach to NAFLD diagnosis that employs non-invasive methods such as ultrasound and measurement of liver enzymes. Presently EPL are recommended as one treatment option in several countries including Russia, Latvia, Poland, and China [1–4].

High treatment satisfaction with EPL treatment

The MANPOWER study, a Russian observational study, included 2843 NAFLD patients. These patients received EPL (1800 mg/day) for 24 weeks as an adjunct treatment to standard care and had at least one of four comorbidities: obesity, hypertension, type 2 diabetes and hypercholesterolaemia [5–7]. 80% of the patients had at least two other metabolic diseases in addition to NAFLD. The most frequent comorbidities were overweight/obesity (81%) and hypercholesterolaemia (75%). Many patients received medication to treat their comorbidities. It was alarming that 15% of patients with diabetes received no other medication apart from EPL, and 40% of the overweight/obese patients were not given appropriate treatment. In relation to the EPL therapy of these patients, the majority (82%) of physicians were either extremely satisfied (22%) or very satisfied (60%). Patient satisfaction with their EPL therapy was also very high (82%). The 6-month compliance rate of EPL treatment was estimated as 90.5% [5].

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) [6].

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)
 ImprovedNo changeImprovedNo changeImprovedNo changeImprovedNo change
Diffuse liver hyperechogenicity67.732.368.831.268.231.867.832.2
Heterogeneous structure of the liver*43.656.443.356.640.659.343.756.2
Indistinctness and/or underlined vascular pattern24.875.223.176.924.875.224.475.6
Distal echo signal attenuation21.778.322.577.522.777.321.578.5
*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) [7].

Summary

Based on the antifibrotic and antioxidative effects of EPL, the Russian Guidelines recommend EPL as an adjunct treatment for NAFLD. Real-world data confirm that EPL support the normalisation of pathological findings in NAFLD. Long-term intake of EPL can be particularly beneficial to patients with metabolic comorbidities and difficulties in maintaining changes to their lifestyle.

Literature

  1. 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
  2. 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.  
  3. 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.
  4. 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.
  5. 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.  
  6. 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
  7. 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.

Aansluiting/Correspondentie: Igor Maev, MD, PhD, Dr. Med. Sci., A. I. Evdokimov, Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia, Chavdar Pavlov, MD, PhD, Dr. Med. Sci., I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russian Federation, Kirill M Starostin, MD, Sanofi, Moscow, Russia en Branko Popovic, MD, Sanofi, Industriepark Hoechst, 65926 Frankfurt am Main, Germany
Ingediend op: 19.11.2021Aangenomen op: 01.04.2022Gepubliceerd op: 10.04.2022
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