THE HEPATOPROTECTOR ROPREN FOR THE TREATMENT OF PATIENTS WITH NONALCOHOLIC STEATOHEPATITIS: A PROSPECTIVE OBSERVATIONAL STUDY.

Objectives: New and effective drugs to improve liver function and fibrosis are urgently needed for patients with nonalcoholic steatohepatitis (NASH). This study examines the effectiveness of treatment of patients with NASH with the registered heparoprotector, Ropren~ Methods. This observational study used Ropren? in a post-registration setting to treat 20 females (38-56 years) with chronic NASH unresponsive to standard treatment. Ropren? is a biopolymer made up of polyprenols (analogue of dolichol) isolated from the green verdure of spruce (Picea abies (L) Karst). Ropren? was given orally, three times a day (54 mg/day). Measurements before and after treatment included symptoms and blood biochemistry (triglycerides, high-density lipoproteins, low-density lipoproteins, alanine transaminase, aspartate transaminase, alkaline phosphatase and gamma-glutamyl-transpeptidase). Liver fibrosis was measured with indirect ultrasound elastometry.

Results: After 12 weeks of Ropren? treatment, improvements were found for blood lipids and clinical and biochemical signs, including reductions in total cholesterol and triglycerides (p <0.05). Ropren® also significantly decreased the liver fibrosis index (p <0.05). No side effects were observed.

Conclusions: Ropren® treatment increased the elasticity of the liver and might be useful to reduce the risk of cirrhosis. Although the sample size in this study was small, the results demonstrated that a randomised-controlled trial of Ropren? for NASH is warranted.