Objective The concept of using naturally occurring compounds such as polyenylphosphatidylcholine (PPC) as an adjunctive therapy to treat non-alcoholic fatty liver disease (NAFLD) and alleviate or reverse hepatic steatosis appears a very attractive option for liver protection. We aim to evaluate if PPC adjunctive therapy can effectively improve the ultrasonographic features of NAFLD in routine clinical practice in Russian patients with cardiometabolic comorbidities.
Design This 24-week, observational, prospective study was carried out in 174 medical sites across 6 federal districts of Russia. 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 received PPC as an adjunctive treatment to standard care, were enrolled. The assessment of liver ultrasonography was qualitative.
Results Overall, 2263 (79.6%) patients had at least two metabolic comorbidities associated with NAFLD, and overweight/obesity was the most common comorbidity reported in 2298 (80.8%) patients. Almost all study participants (2837/2843; 99.8%) were prescribed 1.8 g of PPC administered three times daily. At baseline, the most frequently identified abnormalities on ultrasound were liver hyperechogenicity (84.0% of patients) and heterogeneous liver structure (62.9%). At 24 weeks, a significant (p<0.05) improvement in liver echogenicity and in liver structure was observed in 1932/2827 (68.3%) patients (95% CI 66.6% to 70.1%) and in 1207/2827 (42.7%) patients (95% CI 40.9% to 44.5%), respectively. The analysis of ultrasonographic signs by number of comorbidities revealed similar findings—liver echogenicity improved in 67.2%–69.3% and liver structure in 35.6%–45.3% of patients depending on the number of comorbidities.
Conclusion This study showed that PPC adjunctive therapy may be useful in improving the ultrasonographic features of NAFLD in patients with associated cardiometabolic comorbidities. It also supports evidence regarding the role of PPC in the complex management of NAFLD.
- fatty liver
- nutritional supplementation
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Contributors IVM was the study’s national coordinator, who contributed to the design of the study and its supervision. All authors participated in the acquisition, analysis and interpretation of the data. CSP, ENS, LKP, AAS, EIV and KMS contributed to the initial manuscript drafting and finalisation. All authors have read and approved the final version of the manuscript.
Funding This study was funded by Sanofi-Aventis. Medical writing support was provided by Thomas Rohban and Magalie El Hajj (Partner 4 Health, France) and was funded by Sanofi-Aventis.
Competing interests KMS is a Sanofi employee. The other authors declare that they have no conflict of interest.
Patient consent for publication Not required.
Ethics approval The study was approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies (Protocol #13 dated 28 August 2015).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement 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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