Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia
Journal
New England Journal of Medicine
Journal Volume
367
Journal Issue
8
Pages
716-724
Date Issued
2012
Author(s)
Afdhal N.H.
Giannini E.G.
Tayyab G.
Mohsin A.
Lee J.-W.
Andriulli A.
Jeffers L.
McHutchison J.
Han K.-H.
Campbell F.
Hyde D.
Brainsky A.
Theodore D.
Abstract
BACKGROUND: Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure. METHODS: We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period. RESULTS: A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P<0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups. CONCLUSIONS: Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number, NCT00678587.) Copyright ? 2012 Massachusetts Medical Society.
SDGs
Other Subjects
eltrombopag; placebo; abdominal pain; adult; aged; anemia; article; ascites; bleeding; cataract; chronic liver disease; controlled study; diarrhea; disease severity; dizziness; double blind procedure; drug efficacy; drug induced headache; drug safety; elective surgery; epistaxis; female; fever; gastroenteritis; hematuria; hepatic encephalopathy; human; human cell; incidence; invasive procedure; liver cirrhosis; major clinical study; male; mesenteric vein thrombosis; multicenter study; nausea; patient care; peripheral edema; portal vein thrombosis; preoperative treatment; priority journal; pyuria; randomized controlled trial; rectum hemorrhage; sepsis; side effect; splanchnic vein thrombosis; splenoportal vein thrombosis; superior mesenteric vein thrombosis; thrombocyte count; thrombocyte transfusion; thrombocytopenia; treatment outcome; treatment planning; upper abdominal pain; urinary tract infection; vein thrombosis; vomiting
Publisher
Massachussetts Medical Society
Type
journal article