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.

NEW HEPATIC AND NEUROLOGICAL CLINICAL IMPLICATIONS OF LONG-CHAIN PLANT POLYPRENOLS ACTING ON THE MAMMALIAN ISOPRENOID PATHWAY.

The mammalian isoprenoid synthesis pathway (also known as the mevalonate pathway) is fundamental to the metabolism and health of organisms, with products such as cholesterol (sterol isoprenoid), ubiquinone (coenzyme Q) and dolichol (non-sterol isoprenoids) having great importance to mammalian biology and physiology. Targeting the isoprenoid pathway results in novel therapeutic options for a diverse range of conditions. Plant polyprenols are biologically active molecules that affect the isoprenoid pathway - toxic side effects have never been observed during treatment with our pharmaceuti- cal-grade polyprenols (Ropren*). Statins and bisphosphonates also act on this pathway but have the disadvantage of causing numerous side effects. Our unique ability to produce Ropren' containing not less than 95% pure polyprenols has enabled their clinical use in Russia for around eight years and has also enabled researchers to conduct trials into other therapeutic uses. Although polyprenols can treat conditions such as viral, bacterial and fungal infections, inflammation and other immune conditions, this paper focuses on the new pre-clinical and clinical effects of polyprenols in hepatic and neurological conditions. Recent pre-clinical studies have shown treatment with polyprenols from conifers had a range of neurological and cognitive effects, including improved cognitive performance in a rat model relevant to Alzheimer's disease and healthy levels of myelination in mice with an experimental model of multiple sclerosis. Early clinical data has shown Ropren' treatment improved antioxidant levels in people with diabetes and improved liver function in patients on chemotherapy treatment. Ropren' also had positive effects on electroencephalograms of people with alcohol-induced cirrhosis and Alzheimer's disease and significantly decreased symptoms in people with depression. These results pave the way for larger clinical trials and show how Ropren' is a valuable clinical tool to treat a wide range of liver and neurological conditions.