A real-world study of polyenyl phosphatidylcholine in the management of patients with metabolic associated fatty liver disease in China clinical practice

Yi Pan^1,2Feng Xue^1,2Shanshan Wang³Bihui Zhong⁴Yutao Zhan⁵Qi Wang⁶Youqing Xu⁷Huiying Rao⁸Yuqiang Mi^10,9Yuemin Nan¹¹Xiaoyuan Xu¹²Branko Popovic¹³Xiaoqing Li¹⁴Bruno Scarpellini¹⁵Sabine Tong¹⁶Lai Wei^17,2*

• ¹Beijing Tsinghua Changgeng Hospital, Tsinghua University, Beijing, China
• ²School of Clinical Medicine, Tsinghua University, Beijing, Beijing, China
• ³Beijing North Medical Health Economic Research Center, Beijing, China
• ⁴Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China, Guangzhou, Guangdong, China
• ⁵Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing, China
• ⁶Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China., Beijing, China
• ⁷Department of Gastroenterology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
• ⁸Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China, Beijing, China
• ⁹Clinical School of the Second People's Hospital, Tianjin Medical University, Tianjin, China, Tianjin, China
• ¹⁰Department of Hepatology, Tianjin Second People's Hospital, Tianjin, China, Tianjin, China
• ¹¹Department of Traditional and Western Medical Hepatology, Hebei Medical University Third Hospital, Shijiazhuang, China, Shijiazhuang, Hebei Province, China
• ¹²Department of Gastroenterology, Peking University First Hospital, Beijing, China, Beijing, China
• ¹³Opella, a Sanofi company, Frankfurt, Germany, Frankfurt, Germany
• ¹⁴Opella, a Sanofi company, Beijing, China, Beijing, China
• ¹⁵Opella, a Sanofi company, Sao Paulo, Brazil, Sao Paulo, Brazil
• ¹⁶Opella, a Sanofi company, Neuilly Sur Seine, France, Neuilly Sur Seine, France
• ¹⁷Beijing Tsinghua Changgung Hospital, Tsinghua University, China, Beijing, China

Background/Objectives Metabolic dysfunction-associated fatty liver disease (MAFLD) is highly prevalent in China. Clinical evidence supporting the role of polyenyl phosphatidylcholine (PPC) in delaying liver fibrosis in patients with MAFLD is limited. Hence this study evaluated the effectiveness of PPC and its association with delaying progression of liver fibrosis in patients with MAFLD in China. Methods This multicenter, retrospective observational study included patients with type 2 diabetes mellitus or ≥2 metabolic dysregulations. Patients from the MAFLD cohort were divided into two groups to receive either PPC or control (no hepatoprotective treatment). The primary endpoint was the change in baseline fibrosis (FIB)-4 index at 12 and 24 weeks. The secondary endpoint involved comparison of changes in liver enzymes and blood lipid levels. Results Among 22,705 patients with MAFLD who were treated with hepatoprotective drugs, 7,093 received PPC. Significant reduction in baseline fibrosis was observed at 24 weeks (PPC: ˗0.12±0.62 vs. control: 0.11±0.50, p=0.034). Baseline aspartate aminotransferase (AST) levels significantly improved at 12 weeks (PPC: ˗6.25±15.18 vs. control: ˗2.41±15.40; p=0.0392). In the PPC group, baseline alanine transaminase (ALT) levels decreased at 12-and 24-weeks compared to those of the control group, but results were not significant. PPC significantly reduced baseline total bilirubin at 12 weeks (p=0.0122) and 24 weeks (p=0.0010), and low-density lipoprotein cholesterol levels at 12 weeks (p=0.0442). Conclusions PPC treatment can lower the risk of liver fibrosis and improve liver function and lipid profiles. Further validation is warranted in other ethnic groups in larger cohorts.