FDA approves blood disorder drug made by Japan's Shionogi
The U.S. Food and Drug Administration on Tuesday approved Japan-based Shionogi&Co Ltd's treatment for low blood-platelet count or thrombocytopenia in patients with chronic liver disease.
Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures, but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.
Lusutrombopag is an oral, small molecule thrombopoietin receptor agonist approved in Japan and US for treatment of thrombocytopenia (TCP), and in EU for severe TCP, associated with chronic liver disease (CLD) in patients undergoing planned invasive procedures. The degree of TCP may impact treatment response to lusutrombopag and the need for platelet transfusion (PT). This analysis evaluates the increase in platelet count (PC) and maximum PC achieved according to baseline PC.
Lusutrombopag (LUSU) is a thrombopoietin receptor agonist (TPO-RA) approved in Japan and US for treatment of thrombocytopenia (TCP), and in EU for severe TCP, associated with chronic liver disease (CLD) in patients undergoing planned invasive procedures (IP). TPO-RAs have been associated with increased risk of thrombotic events in patients with CLD and a safety assessment of new agents is critical. LUSU safety was assessed in a pooled retrospective analysis of three clinical studies.
Lusutrombopag (LUSU) is an oral, small molecule thrombopoietin receptor agonist approved in Japan and US for treatment of thrombocytopenia (TCP), and in EU for severe TCP, associated with chronic liver disease (CLD) in patients undergoing planned invasive procedures (IPs). This integrated analysis assessed the consistency of the efficacy and safety of LUSU clinical trial data across a larger population.
Gaucher disease (GD), a rare lysosomal storage disorder caused by deficient glucocerebrosidase activity and consequent accumulation of glycosphingolipids in the mononuclear phagocyte system, may progress to disabling and potentially life-threatening complications when left undiagnosed and untreated. Unfortunately, because of non-specific signs and symptoms and lack of awareness, patients with type 1 GD, the most common non-neuropathic variant, frequently experience diagnostic delays. Since splenomegaly and thrombocytopenia are the dominant clinical features in many GD patients leading to first medical contact, the hepatolo...
CONCLUSIONS: Peritransplant interventions for spontaneous splenorenal shunt may reduce posttransplant acute kidney injury. In patients without intervention, spontaneous splenorenal shunt predominantly persisted 1 year posttransplant. PMID: 32039670 [PubMed - as supplied by publisher]
ConclusionsUnder a combination of leflunomide and methotrexate, liver toxicity and, for the first time, thrombotic microangiopathy occurred as side effects. Non-alcoholic fatty liver disease may have predisposed for the drug-induced liver toxicity.
Background: Variceal upper gastrointestinal bleeding (UGIB) is common in sub-Saharan Africa (SSA). However, poor access to endoscopy services precludes the diagnosis of varices.Objectives: We determined the diagnostic accuracy of routine clinical findings for detection of esophageal varices among patients with UGIB in rural SSA where schistosomiasis is endemic.Methods: We studied patients with a history of UGIB. The index tests included routine clinical findings and the reference test was diagnostic endoscopy. Multivariable regression with post-estimation provided measures of association and diagnostic accuracy.Results: We...
Clinical Liver Disease, Volume 14, Issue 5, Page 183-186, November 2019.
Authors: Elsaid MI, Rustgi VK, Loo N, Aggarwal K, Li-McLeod J, Niu X, Poordad F Abstract Background: Thrombocytopenia (TCP), a common complication of chronic liver disease (CLD), can cause uncontrolled bleeding during procedures. As such, CLD patients with TCP and platelet counts