Drug may reduce transfusions but increase thrombosis in liver disease patients having elective invasive procedures
Eltrombopag, an oral thrombopoietin-receptor agonist, may reduce the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing invasive elective procedures, but risk for portal-vein thrombosis may increase, according to a new industry-funded study.
Eltrombopag, an oral thrombopoietin-receptor agonist, may reduce the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing invasive elective procedures, but risk for portal-vein thrombosis may increase, according to a new industry-funded study.
Researchers randomly assigned 292 patients with chronic liver disease and platelet counts below 50,000 mm3 to receive a 14-day course of eltrombopag, 75 mg/d, or placebo before undergoing an elective invasive procedure, which was done within five days of the last drug dose. The study's primary end point was whether platelet transfusions were avoided before, during and up to a week after the procedures. Bleeding during this period was a key secondary end point, and other adverse events were also assessed. Results of the study, which was funded by GlaxoSmithKline, appeared in the Aug. 23 New England Journal of Medicine.
One hundred forty-five patients were assigned to the eltrombopag group, and 147 were assigned to the placebo group. The median patient age was 53 years. Most patients were men, and most were white. Overall, 104 patients in the eltrombopag group (72%) and 28 in the placebo group (19%) avoided a platelet transfusion (P<0.001). Bleeding episodes did not differ significantly between the two groups, and rates of most other adverse events were also similar. Portal-vein thrombosis, however, occurred more frequently in the eltrombopag group than in the placebo group (six patients vs. one patient), and the study was terminated early as a result.
The authors concluded that patients with chronic liver disease who received eltrombopag before an elective invasive procedure were less likely to require platelet transfusion but appeared to have an elevated risk of portal-vein thrombosis. They called for further studies of eltrombopag therapy to better identify risk factors for thrombosis, appropriate dose and appropriate patients. “Until such studies have been conducted, eltrombopag is not recommended as an alternative to platelet transfusion in patients with chronic liver disease and thrombocytopenia who are undergoing an elective invasive procedure,” the authors wrote.