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https://www.readbyqxmd.com/read/27906472/long-term-clinical-impact-and-cost-effectiveness-of-obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis
#1
Sumeyye Samur, Matthew Klebanoff, Reiner Banken, Daniel S Pratt, Rick Chapman, Daniel A Ollendorf, Anne M Loos, Kathleen Corey, Chin Hur, Jagpreet Chhatwal
: Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA...
November 7, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27895393/emerging-role-of-obeticholic-acid-in-the-management-of-nonalcoholic-fatty-liver-disease
#2
EDITORIAL
Evangelia Makri, Evangelos Cholongitas, Konstantinos Tziomalos
Nonalcoholic fatty liver disease (NAFLD) is the commonest chronic liver disease and its prevalence is increasing driven by the pandemic of obesity and type 2 diabetes mellitus. NAFLD can progress to cirrhosis and is associated with increased risk for cardiovascular disease and hepatocellular cancer. Diet and exercise are limited by suboptimal long-term adherence in patients with NAFLD. On the other hand, current pharmacological treatment of NAFLD has limited efficacy and unfavorable safety profile. In this context, obeticholic acid (OCA), a selective agonist of the farnesoid X receptors, might represent a useful option in these patients...
November 7, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/27865854/obeticholic-acid-protects-against-carbon-tetrachloride-induced-acute-liver-injury-and-inflammation
#3
Da-Gang Zhang, Cheng Zhang, Jun-Xian Wang, Bi-Wei Wang, Hua Wang, Zhi-Hui Zhang, Yuan-Hua Chen, Yan Lu, Li Tao, Jian-Qing Wang, Xi Chen, De-Xiang Xu
The farnesoid X receptor (FXR) is a ligand-activated transcription factor that plays important roles in regulating bile acid homeostasis. The aim of the present study was to investigate the effects of obeticholic acid (OCA), a novel synthetic FXR agonist, carbon tetrachloride (CCl4)-induced acute liver injury. Mice were intraperitoneally injected with CCl4 (0.15ml/kg). In CCl4+OCA group, mice were orally with OCA (5mg/kg) 48, 24 and 1h before CCl4. As expected, hepatic FXR was activated by OCA. Interestingly, OCA pretreatment alleviated CCl4-induced elevation of serum ALT and hepatic necrosis...
November 16, 2016: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/27825634/obeticholic-acid-in-primary-biliary-cholangitis
#4
Serge Erlinger
In a double-blind, randomized, placebo-controlled study including 217 patients with primary biliary cholangitis, the authors show that obeticholic acid (a potent farnesoid X agonist) administered with ursodeoxycholic acid or as monotherapy significantly decreases serum alkaline phosphatase and bilirubin when compared to placebo. Pruritus (and serious adverse effects) was observed more frequently in obeticholic acid-treated patients than in controls, in spite of a decrease in serum bile acid concentration. These results are encouraging, but more studies are needed on clinical efficacy and safety before obeticholic acid can be widely recommended...
November 4, 2016: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/27821667/obeticholic-acid-protects-against-lipopolysaccharide-induced-fetal-death-and-intrauterine-growth-restriction-through-its-anti-inflammatory-activity
#5
Yuan-Hua Chen, Xiao-Guang Hu, Yan Zhou, Zhen Yu, Lin Fu, Gui-Bin Zhang, Qing-Li Bo, Hua Wang, Cheng Zhang, De-Xiang Xu
Farnesoid X receptor (FXR) is expressed in human and rodent placentas. Nevertheless, its function remains obscure. This study investigated the effects of obeticholic acid (OCA), a novel synthetic FXR agonist, on LPS-induced fetal death and intrauterine growth restriction. All pregnant mice except controls were i.p. injected with LPS (100 μg/kg) daily from gestational day (GD) 15 to GD17. Some pregnant mice were orally administered with OCA (5 mg/kg) daily from GD13 to GD17. As expected, placental FXR signaling was activated by OCA...
December 15, 2016: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/27804232/obeticholic-acid-improves-adipose-morphometry-and-inflammation-and-reduces-steatosis-in-dietary-but-not-metabolic-obesity-in-mice
#6
Fahrettin Haczeyni, Laurence Poekes, Hans Wang, Auvro R Mridha, Vanessa Barn, W Geoffrey Haigh, George N Ioannou, Matthew M Yeh, Isabelle A Leclercq, Narcissus C Teoh, Geoffrey C Farrell
OBJECTIVE: Nonalcoholic steatohepatitis (NASH) is the outcome of interactions between overnutrition, energy metabolism, and adipose function. Obeticholic acid (OCA) improves steatosis in patients but for unknown reasons does not resolve NASH pathology. This study therefore investigated OCA effects in Wt mice, which develop obesity with atherogenic dietary feeding, and appetite-dysregulated, Alms1 mutant foz/foz mice fed the same diet, which develop metabolic obesity and diabetes. METHODS: OCA (1 mg/kg) was administered orally to female foz/foz mice and Wt littermates from weaning until 28 weeks...
November 2, 2016: Obesity
https://www.readbyqxmd.com/read/27756999/pharmaceutical-approval-update
#7
Michele B Kaufman
Obeticholic acid (Ocaliva) for primary biliary cholangitis; sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa) for chronic hepatitis C virus infection; and daclizumab (Zinbryta) for relapsing multiple sclerosis.
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27743502/modeling-and-experimental-studies-of-obeticholic-acid-exposure-and-the-impact-of-cirrhosis-stage
#8
J E Edwards, C LaCerte, T Peyret, N H Gosselin, J F Marier, A F Hofmann, D Shapiro
Obeticholic acid (OCA), a semisynthetic bile acid, is a selective and potent farnesoid X receptor (FXR) agonist in development for the treatment of chronic nonviral liver diseases. Physiologic pharmacokinetic models have been previously used to describe the absorption, distribution, metabolism, and excretion (ADME) of bile acids. OCA plasma levels were measured in healthy volunteers and cirrhotic subjects. A physiologic pharmacokinetic model was developed to quantitatively describe the ADME of OCA in patients with and without hepatic impairment...
December 2016: Clinical and Translational Science
https://www.readbyqxmd.com/read/27729634/non-alcoholic-fatty-liver-diseases-update-on-the-challenge-of-diagnosis-and-treatment
#9
REVIEW
Hyunwoo Oh, Dae Won Jun, Waqar K Saeed, Mindie H Nguyen
The prevalence of non-alcoholic fatty liver disease (NAFLD) is estimated to be 25-30% of the population, and is the most common cause of elevated liver enzymes in Korea. NAFLD is a "hot potato" for pharmaceutical companies. Many clinical trials are underway to develop a first-in-class drug to treat NAFLD. However, there are several challenging issues regarding the diagnosis of NAFLD. Currently, liver biopsy is the gold standard method for the diagnosis of NAFLD and steatohepatitis. Ideally, globally recognized standards for histological diagnosis and methods to optimize observer agreement on biopsy interpretation should be developed...
September 2016: Clinical and Molecular Hepatology
https://www.readbyqxmd.com/read/27727520/the-therapeutic-landscape-of-non-alcoholic-steatohepatitis
#10
Hugo Perazzo, Jean-François Dufour
Non-alcoholic steatohepatitis (NASH) is characterized by lobular inflammation and hepatocellular ballooning, and may be associated with liver fibrosis leading to cirrhosis and its complications. A pharmacological approach is necessary to treat NASH because of failure to change dietary habits and lifestyle in most patients. Insulin resistance with an increased release of free fatty acids, oxidative stress and activation of inflammatory cytokines seem to be key features for disease progression. Thiazolidinediones, such as pioglitazone and antioxidant agents, such as vitamin E, were the first pharmacological options to be evaluated for NASH...
October 11, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/27700211/primary-biliary-cholangitis-medical-and-specialty-pharmacy-management-update
#11
Christopher L Bowlus, James T Kenney, Gary Rice, Robert Navarro
BACKGROUND: Chronic liver disease and cirrhosis are a leading cause of morbidity and mortality in the United States. Primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis and which has been designated an orphan condition, is a chronic autoimmune disease resulting in the destruction of the small bile ducts in the liver. Without effective treatment, disease progression frequently leads to liver failure and death. Until May 2016, the only FDA-approved treatment for PBC was ursodiol (UDCA), an oral hydrophilic bile acid, which can slow progression of liver damage due to PBC...
October 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27646933/current-and-upcoming-pharmacotherapy-for-non-alcoholic-fatty-liver-disease
#12
REVIEW
Yaron Rotman, Arun J Sanyal
Given the high prevalence and rising incidence of non-alcoholic fatty liver disease (NAFLD), the absence of approved therapies is striking. Although the mainstay of treatment of NAFLD is weight loss, it is hard to maintain, prompting the need for pharmacotherapy as well. A greater understanding of disease pathogenesis in recent years was followed by development of new classes of medications, as well as potential repurposing of currently available agents. NAFLD therapies target four main pathways. The dominant approach is targeting hepatic fat accumulation and the resultant metabolic stress...
September 19, 2016: Gut
https://www.readbyqxmd.com/read/27634375/fxr-agonist-obeticholic-acid-reduces-hepatic-inflammation-and-fibrosis-in-a-rat-model-of-toxic-cirrhosis
#13
Len Verbeke, Inge Mannaerts, Robert Schierwagen, Olivier Govaere, Sabine Klein, Ingrid Vander Elst, Petra Windmolders, Ricard Farre, Mathias Wenes, Massimiliano Mazzone, Frederik Nevens, Leo A van Grunsven, Jonel Trebicka, Wim Laleman
Hepatic inflammation drives hepatic stellate cells (HSC), resulting in liver fibrosis. The Farnesoid-X receptor (FXR) antagonizes inflammation through NF-κB inhibition. We investigated preventive and therapeutic effects of FXR agonist obeticholic acid (OCA) on hepatic inflammation and fibrosis in toxic cirrhotic rats. Cirrhosis was induced by thioacetamide (TAA) intoxication. OCA was given during or after intoxication with vehicle-treated rats as controls. At sacrifice, fibrosis, hemodynamic and biochemical parameters were assessed...
2016: Scientific Reports
https://www.readbyqxmd.com/read/27621676/obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis-in-adult-patients-clinical-utility-and-patient-selection
#14
REVIEW
Christopher L Bowlus
Primary biliary cholangitis (PBC), previously known as primary biliary "cirrhosis", is a rare autoimmune liver disease characterized by the hallmark autoantibodies to mitochondrial antigens and immune-mediated destruction of small bile duct epithelial cells leading to cholestasis and cirrhosis. Surprisingly, while immune modulators have not been effective in the treatment of PBC, supplementation with the hydrophilic bile acid (BA) ursodeoxycholic acid (UDCA) has been demonstrated to slow the disease progression...
2016: Hepatic Medicine: Evidence and Research
https://www.readbyqxmd.com/read/27589928/obeticholic-acid-for-the-treatment-of-primary-biliary-cirrhosis
#15
David E J Jones
INTRODUCTION: There is significant unmet need in Primary Biliary Cholangitis (PBC) in patients under-responsive to the only approved therapy Ursodeoxycholic Acid (UDCA) who are at increased risk of progressing to end-stage liver disease. Obeticholic Acid (OCA) is a farnesoid X receptor (FXR) agonist which has been evaluated as a second line therapy in PBC and has recently been licenced by the FDA. AREAS COVERED: The pharmacology and biology of OCA as an FXR agonist and its clinical benefits...
September 2, 2016: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27580686/therapy-obeticholic-acid-for-pbc
#16
Hugh Thomas
No abstract text is available yet for this article.
October 2016: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27575614/the-role-of-obeticholic-acid-in-gut-bacterial-translocation-and-inflammation
#17
Richard S Kalman, David S Goldberg
No abstract text is available yet for this article.
October 2016: Gastroenterology
https://www.readbyqxmd.com/read/27564402/emerging-and-future-therapies-for-nonalcoholic-steatohepatitis-in-adults
#18
Gesthimani Mintziori, Stergios A Polyzos
INTRODUCTION: Nonalcoholic steatohepatitis (NASH) is a disease of increasing prevalence with morbidity and mortality closely related to cardiovascular disease, malignancies and cirrhosis. Despite the need for pharmacological treatment and intense research in the field, there is currently no approved agent for NASH. AREAS COVERED: There are medications shown to improve hepatic steatosis, including thiazolidinediones, vitamin E and pentoxifylline. However, hepatic fibrosis, the hard prognostic end-point for NASH, has shown little improvement with pharmaceutical intervention...
October 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27543499/non-alcoholic-fatty-liver-disease-in-2016
#19
REVIEW
S A Townsend, Philip N Newsome
INTRODUCTION: Non-alcoholic fatty liver disease is the commonest cause of liver disease worldwide, and is rapidly becoming the leading indication for liver transplantation. SOURCES OF DATA: Original articles, reviews and meta-analyses, guidelines. AREAS OF AGREEMENT: NAFLD strongly correlates with obesity and insulin resistance; currently, the best management strategy is weight loss and treatment of the metabolic syndrome. AREAS OF CONTROVERSY: Recent data suggest that the presence of fibrosis and not non-alcoholic steatohepatitis (NASH) is the predictor of clinical outcome...
September 2016: British Medical Bulletin
https://www.readbyqxmd.com/read/27532829/a-placebo-controlled-trial-of-obeticholic-acid-in-primary-biliary-cholangitis
#20
RANDOMIZED CONTROLLED TRIAL
Frederik Nevens, Pietro Andreone, Giuseppe Mazzella, Simone I Strasser, Christopher Bowlus, Pietro Invernizzi, Joost P H Drenth, Paul J Pockros, Jaroslaw Regula, Ulrich Beuers, Michael Trauner, David E Jones, Annarosa Floreani, Simon Hohenester, Velimir Luketic, Mitchell Shiffman, Karel J van Erpecum, Victor Vargas, Catherine Vincent, Gideon M Hirschfield, Hemant Shah, Bettina Hansen, Keith D Lindor, Hanns-Ulrich Marschall, Kris V Kowdley, Roya Hooshmand-Rad, Tonya Marmon, Shawn Sheeron, Richard Pencek, Leigh MacConell, Mark Pruzanski, David Shapiro
BACKGROUND: Primary biliary cholangitis (formerly called primary biliary cirrhosis) can progress to cirrhosis and death despite ursodiol therapy. Alkaline phosphatase and bilirubin levels correlate with the risk of liver transplantation or death. Obeticholic acid, a farnesoid X receptor agonist, has shown potential benefit in patients with this disease. METHODS: In this 12-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 217 patients who had an inadequate response to ursodiol or who found the side effects of ursodiol unacceptable to receive obeticholic acid at a dose of 10 mg (the 10-mg group), obeticholic acid at a dose of 5 mg with adjustment to 10 mg if applicable (the 5-10-mg group), or placebo...
August 18, 2016: New England Journal of Medicine
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