Safety and Effectiveness of Essential Phospholipids Paste in Patients with Non-alcoholic Fatty Liver Disease or Viral Hepatitis
Main Article Content
Abstract
Background: Essential phospholipids (EPL) are used as adjuvant treatment in people with fatty liver disease and other chronic liver
diseases. A new formulation of EPL paste was developed to improve patient compliance. The study was aimed to assess the safety,
patient-reported outcomes, and impact on compliance of the new EPL paste formulation in patients with non-alcoholic fatty liver disease
(NAFLD) or viral hepatitis.
Methods: The study enrolled 147 patients (48.3% male; mean ± standard deviation (SD) age 44.8 ± 10.5 years) in the intention-to-treat
population; 72.8% had NAFLD and 27.9% had viral hepatitis B (HBV) or hepatitis C (HCV). Patients received EPL paste (one 600 mg
sachet 3 times daily) for 12 weeks, with 4-, 8-, and 12-week scheduled visits and a 13-week follow-up visit. Patient-reported outcomes
were evaluated at 4, 8, and 12 weeks compared with baseline using dedicated Likert scales. Compliance was assessed by comparing
actual versus prescribed dosing of the EPL.
Results: After 12-week treatment with EPL paste, statistically significant improvements were observed in mean ± SD Global Overall
Symptom scores (from 4.21 ± 1.09 to 1.87 ± 0.91; P < .01) and overall Gastrointestinal Symptom scores (from 19.91 ± 5.74 to 11.17 ± 3.57;
P < .01), compared to baseline scores. Compliance with prescribed essential phospholipid treatment was 99% throughout the 12-week
treatment period.
Conclusion: Essential phospholipids paste had a favorable safety profile associated with improved gastrointestinal symptoms and with
high levels of compliance in patients with NAFLD and viral hepatitis.
diseases. A new formulation of EPL paste was developed to improve patient compliance. The study was aimed to assess the safety,
patient-reported outcomes, and impact on compliance of the new EPL paste formulation in patients with non-alcoholic fatty liver disease
(NAFLD) or viral hepatitis.
Methods: The study enrolled 147 patients (48.3% male; mean ± standard deviation (SD) age 44.8 ± 10.5 years) in the intention-to-treat
population; 72.8% had NAFLD and 27.9% had viral hepatitis B (HBV) or hepatitis C (HCV). Patients received EPL paste (one 600 mg
sachet 3 times daily) for 12 weeks, with 4-, 8-, and 12-week scheduled visits and a 13-week follow-up visit. Patient-reported outcomes
were evaluated at 4, 8, and 12 weeks compared with baseline using dedicated Likert scales. Compliance was assessed by comparing
actual versus prescribed dosing of the EPL.
Results: After 12-week treatment with EPL paste, statistically significant improvements were observed in mean ± SD Global Overall
Symptom scores (from 4.21 ± 1.09 to 1.87 ± 0.91; P < .01) and overall Gastrointestinal Symptom scores (from 19.91 ± 5.74 to 11.17 ± 3.57;
P < .01), compared to baseline scores. Compliance with prescribed essential phospholipid treatment was 99% throughout the 12-week
treatment period.
Conclusion: Essential phospholipids paste had a favorable safety profile associated with improved gastrointestinal symptoms and with
high levels of compliance in patients with NAFLD and viral hepatitis.