An Observational Study of Essentiale-L in the Treatment of Patients with Fatty Liver Disease.

ABSTRACT

Background: The most common forms of liver disease are alcoholic fatty liver disease and nonalcoholic fatty liver disease (NAFLD), which lead to cirrhosis, liver failure and death. Essential phospholipids play an important role in the management of these conditions. Polyenephosphatidylcholine (PPC) is a major active ingredient in essential phospholipids. It has a high bioavailability and affinity for cellular and subcellular membranes, and helps to maintain membrane fluidity and function. Essentiale-L comprises of PPC, which is a mixture of 94-96% of polyunsaturated phosphatidylcholine. It is prescribed in the management of viral hepatitis and fatty liver disease. Objective: There are only few recent clinical studies conducted in India regarding the role of Essentiale-L in the management of fatty liver disease therefore, we undertook this openlabel, nonrandomized, real clinical practice study, on adult patients diagnosed with fatty liver disease including NAFLD as well as alcoholic fatty liver disease (AFLD). Methods: All adult patients satisfying the inclusion and exclusion criteria were included in the study. Patients diagnosed with fatty liver disease including NAFLD as well as AFLD were treated for 90 days with Essentiale-L two capsules thrice-daily. Vital signs, adverse effects and laboratory evaluations (liver function tests, lipid profile and fasting blood glucose tests) were recorded at baseline (Day 0), Day 7, Day 21, Day 30, Day 60 and Day 90. Results: Essentiale-L showed a consistent improvement in both clinical as well as laboratory parameters in patients with fatty liver disease. The decrease in the liver enzyme levels from baseline was significant at Days 60 and 90 (p < 0.05). However, the decrease in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and triglyceride levels was significant only at Day 90 (p < 0.05). The change in fasting blood glucose levels from baseline were not significant. Conclusion: Essentiale-L is a safe and effective option in patients with fatty liver disease. It can be safely recommended in patients with type 2 diabetes along with fatty liver disease since it did not alter the blood glucose levels significantly.