Effectiveness of phosphatidylcholine in alleviating steatosis in patients with non-alcoholic fatty liver disease and cardiometabolic comorbidities (MANPOWER study)

Abstract

ObjectiveThe 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.DesignThis 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.ResultsOverall, 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.ConclusionThis 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.

Healthcare practitioners’ diagnostic and treatment practice patterns of nonalcoholic fatty liver disease in Poland: a cross-sectional survey

“…A real-world evidence study in Russia demonstrated improved sonographic features of NAFLD with essential phospholipids treatment of patients with at least one of four comorbidities (overweight/obesity, hypertension, diabetes, hypercholesterolemia) [ 20 ]. There are no published evidence on ornithine/choline hepatoprotective effects.…”

“…Whilst there are no FDA-approved drugs for NAFLD/NASH treatment, several types of medication are being evaluated – including insulin sensitizers, antioxidants, cholesterol-lowering drugs, modulators of nuclear transcription factors and gastrointestinal hormones [ 16 ]. Other areas of interest are gut microbiota [ 17 ], herbal preparations [ 18 ] and essential phospholipids [ 19 , 20 ].…”

Correlation of Objective Endpoints and Subjective Patient-Reported Outcomes in NAFLD Treatment with Essential Phospholipids: Real-World Data Based on Pooled Analysis of Observational Studies

“…MANPOWER was a 24-week prospective longitudinal drug registry study assessing the real-world management of patients with NAFLD with EPLs (phosphatidylcholine, Essentiale ® forte N) as an add-on therapy to standard care [27,28], with visits at baseline and 12 and 24 weeks of treatment. LIDER 1 [26] and LIDER 2 (unpublished) were 12-week studies determining the epidemiology (crosssectional parts of the studies-with one visit) and patient characteristics of real-world patients with liver pathologies who were treated with EPLs (Essentiale ® forte N) as an adjunctive treatment to standard care, with two study visits for the cohort included in the longitudinal parts of the studies (at baseline and at 12 weeks).…”

The Emerging Role of Nanomedicine in the Management of Nonalcoholic Fatty Liver Disease: A State-of-the-Art Review

“…ere is no available effective pharmacotherapy to prevent the progression of NAFLD to NASH and advanced stages of hepatic fibrosis and cirrhosis [12]. Because of the complexity of NAFLD pathophysiology, different severity levels of disease, and the heterogeneity of the patient population, developing a drug for the treatment of NAFLD is challenging [13]. Some anticipated efficient drugs have been failed in the last stages of clinical trials [14].…”