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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
  1. Igor V Maev1,
  2. Aleksey A Samsonov1,
  3. Liudmila K Palgova2,
  4. Chavdar S Pavlov3,
  5. Elena N Shirokova3,
  6. Elena I Vovk1,
  7. Kirill M Starostin4
  1. 1AI Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russian Federation
  2. 2Clinical Research and Educational Center in Gastroenterology and Hepatology, Saint Petersburg State University, Saint-Petersburg, Russian Federation
  3. 3IM Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russian Federation
  4. 4Medical Affairs, Sanofi-Aventis SA, Moscow, Russian Federation
  1. Correspondence to Dr Kirill M Starostin; Kirill.Starostin{at}sanofi.com

Abstract

Objective Non-alcoholic fatty liver disease (NAFLD) is the most common cause of abnormal results of liver function tests. Earlier research showed that polyenylphosphatidylcholine (PPC) has hepatoprotective effects and thus can be used for the treatment of NAFLD and the prevention of its progression. Accordingly, the aim of this observational study was to evaluate if PPC administered as adjunctive therapy in routine clinical practice can effectively improve liver function tests of NAFLD in Russian patients with associated metabolic comorbidities.

Design A total of 2843 adult patients with newly diagnosed NAFLD, who had a least one of four comorbidities, namely, overweight/obesity, hypertension, type 2 diabetes mellitus, and hypercholesterolaemia, and who were prescribed 1.8 g/day of PPC as an adjunctive treatment to standard care, were enrolled during 2015–2016. Laboratory data were collected at baseline and 12 and 24 weeks of the study, and included liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT)), fasting plasma glucose, and lipid profile.

Results Overall, 2263 patients (79.6%) had at least two metabolic comorbidities associated with NAFLD, and overweight/obesity was the most common comorbidity reported in 2298 (80.8%) patients. At 24 weeks, there was a significant decrease in liver enzyme levels (all p<0.001 compared with baseline). Across the four comorbidity subgroups, there was a mean drop of ALT levels ranging from 19.7 to 22.0 U/L, AST from 16.9 to 18.4 U/L, and GGT from 17.2 to 18.7 U/L. Similar findings were reported in subgroups with either one, two, three, or four comorbidities, with a significant decrease in liver enzyme levels ranging from 18.4 to 22.4 U/L for ALT, 14.8 to 18.7 U/L for AST, and 15.5 to 19.5 U/L for GGT.

Conclusions Adjuvant treatment with PPC resulted in consistent improvements in liver enzymes in patients with newly diagnosed NAFLD and associated metabolic comorbidities.

Trial registration number NCT00063622.

  • liver function test
  • fatty liver
  • nutritional supplementation
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Footnotes

  • Contributors IVM was the study’s national coordinator who contributed to the design and supervision of the study. All authors participated in the acquisition, analysis, and interpretation of the data. CSP, ENS, LKP, AAS, EIV, and KMS contributed to the drafting of the initial manuscript and its finalisation. All authors have read and approved the final version of the manuscript.

  • Funding This study was funded by Sanofi, France.

  • Competing interests KMS is a Sanofi employee. The other authors declare that they have no conflict of interest.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymised and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com.

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