Obeticholic Acid: A New Era in the Treatment of Nonalcoholic Fatty Liver Disease

Abenavoli, Ludovico; Falalyeyeva, Tetyana; Boccuto, Luigi; Tsyryuk, Olena; Kobyliak, Nazarii

doi:10.3390/ph11040104

Cited by 69 publications

(57 citation statements)

References 52 publications

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“…The balance of effects of oxidative stress generated in chronic disease and with IV iron may have an impact although we did not see any additional impact of IV iron on clinical measures of endothelial dysfunction. Animal models suggest that in experimental CKD, in which iron de ciency may also be present, the impact of increased pro-oxidative factors is negated by antioxidant factors (21,22). Although the heart failure trials testing iv iron dosing included patients with renal impairment, the average eGFR in our population was 30 ml/min/1.73 m 2 and thus consistent with more advanced CKD.…”

Section: Discussionmentioning

confidence: 84%

A Multicenter Prospective Double Blinded Randomized Controlled Pilot Trial of Intravenous Iron (Ferric Derisomaltose (FDI)) in Iron Deficient but not Anemic Patients with Chronic Kidney Disease on Functional Status.

Bhandari

Allgar

Lamplugh

et al. 2020

Preprint

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Background Iron deficiency (ID) is common in patients with chronic kidney disease (CKD). Intravenous (IV) iron in heart failure leads to improvement in exercise capacity and improvement in quality of life measurements; however, data in patients with CKD are lacking.Methods The Iron and the Heart Study was a prospective double blinded randomized study in non-anemic CKD stages 3b-5 patients with ID which investigated whether 1000 mg of IV iron (ferric derisomaltose (FDI) ) could improve exercise capacity in comparison to placebo measured at 1 and 3 months post infusion. Secondary objectives included effects on hematinic profiles and hemoglobin, safety analysis and quality of life questionnaires (QoL).Results We randomly assigned 54 patients mean (SD) age for FDI (n=26) 61.6 (10.1) years vs placebo (n=28; 57.8 (12.9) years) and mean eGFR (32.1 (9.6) vs. 29.1 (9.6) ml/min/1.73m2) at baseline, respectively. Adjusting for baseline measurements, six-minute walk test (6MWT) showed no statistically significant difference between arms at 1 month (p=0.736), or 3 months (p=0.741). There were non-significant increases in 6MWT from baseline to 1 and 3 months in the FDI arm. Hemoglobin (Hb) at 1 and 3 months remained stable. There were statistically significant increases in ferritin (SF) and transferrin saturation (TSAT) at 1 and 3 months (p<0.001). There was a modest numerical improvement in QoL parameters. There were no adverse events attributable to IV iron. Conclusion This study demonstrated a short-term beneficial effect of FDI on exercise capacity, but it was not significant despite improvements in parameters of iron status, maintenance of Hb concentration, and numerical increases in functional capacity and quality of life scores. A larger study will be required to confirm if intravenous iron is beneficial in iron deficient non-anemic non-dialysis CKD patients without heart failure to improve the 6MWT.Trial Registration: European Clinical Trials Database (EudraCT) No: 2014-004133-16https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004133-16/GBREC no: 14/YH/1209Date First Registered: 2015-02-17 and date of end of trail 2015-05-23Sponsor ref R1766 and Protocol No: IHI 141

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Section: Discussionmentioning

confidence: 84%

A Multicenter Prospective Double Blinded Randomized Controlled Pilot Trial of Intravenous Iron (Ferric Derisomaltose (FDI)) in Iron Deficient but not Anemic Patients with Chronic Kidney Disease on Functional Status.

Bhandari

Allgar

Lamplugh

et al. 2020

Preprint

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“…This, in turn, reduces the expression of FXR, which leads to liver diseases [8]. This drew attention to the manufacture of drugs like obeticholic acid that activate FXR and reduce unnecessary inflammation in the liver [82].…”

Section: Microbiota Effects On Other Liver Diseasesmentioning

confidence: 99%

Interaction of the microbiota with the human body in health and diseases

Altveş

Yıldız

Vural

2020

Bioscience of Microbiota, Food and Health

312

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The human body contains many microorganisms, including a large number of bacteria, viruses, fungi, and protozoa, which are referred to as the microbiota. Compared with the number of cells comprising the human body, that of the microbiota has been found to be much larger. The microbiome is defined as microorganisms and their genomes have been shown to contain about 100 times more genes than the human genome. The microbiota affects many vital functions in the human body. It contributes to regulation of the immune system, digestion of food, production of vitamins such as B12 and K, metabolization of xenobiotic materials, and many other tasks. Many factors affect the microbiota biodiversity, such as diet, medicines including antibiotics, relationships with the environment, pregnancy, and age. Studies have shown that the lack of microbiota diversity leads to many diseases like autoimmune diseases such as diabetes type I, rheumatism, muscular dystrophy, problems in blood coagulation due to lack of vitamin K, and disturbances in the transfer of nerve cells due to lack of vitamin B12, in addition to its involvement in a number of conditions such as cancer, memory disorders, depression, stress, autism, and Alzheimer's disease. The aim of this review is to summarize the latest studies discussing the relationship between the microbiota and the human body in health and diseases.

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“…A significant reduction in steatosis, lobular inflammation and hepatocyte ballooning was accomplished as well. Decreased body weight and reduced ALT levels occurred in the group of patients treated with OCA [65]. Currently, OCA is being investigated in the phase 3 of the REGENER-ATE study (ClinicalTrails.gov Identifier: NCT02548351) to evaluate its impact on NASH with fibrosis and in phase 3 of the REVERSE trial (ClinicalTrails.gov Identifier: NCT03439254) to evaluate its efficacy and safety in subjects with compensated cirrhosis due to NASH.…”

Section: Obeticholic Acidmentioning

confidence: 99%

New therapeutic strategies in nonalcoholic fatty liver disease: a focus on promising drugs for nonalcoholic steatohepatitis

et al. 2020

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The prevalence of nonalcoholic fatty liver disease (NAFLD) is increasing worldwide. Globally, it is currently the most common liver disease and is estimated to affect up to 25% of the population. In the first stage, NAFLD is characterized by simple hepatic steatosis (NAFL, nonalcoholic fatty liver) that might progress to nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis or hepatocellular carcinoma. In this review, we discuss the global burden of NAFLD, together with future perspectives on how this epidemic could be restrained. There is also an urgent need for the development of new medical strategies for NAFLD patients. We aim to present the beneficial effects of life-style modifications that should be advised to both non-obese and obese NAFLD patients. Since there are currently no medications directly used for the treatment of more advanced NAFLD stages, the central part of this review summarizes ongoing and recently completed clinical trials testing promising drugs for NASH resolution. The marketing of new therapeutic agents would greatly increase the odds of reducing the global burden of NAFLD.

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Obeticholic Acid: A New Era in the Treatment of Nonalcoholic Fatty Liver Disease

Cited by 69 publications

References 52 publications

A Multicenter Prospective Double Blinded Randomized Controlled Pilot Trial of Intravenous Iron (Ferric Derisomaltose (FDI)) in Iron Deficient but not Anemic Patients with Chronic Kidney Disease on Functional Status.

A Multicenter Prospective Double Blinded Randomized Controlled Pilot Trial of Intravenous Iron (Ferric Derisomaltose (FDI)) in Iron Deficient but not Anemic Patients with Chronic Kidney Disease on Functional Status.

Interaction of the microbiota with the human body in health and diseases

New therapeutic strategies in nonalcoholic fatty liver disease: a focus on promising drugs for nonalcoholic steatohepatitis

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