6533b82cfe1ef96bd128f657
RESEARCH PRODUCT
Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia
Afdhal NhGiannini EgTayyab GMohsin ALee JwAndriulli AJeffers LMchutchison JChen PjHan KhCampbell FHyde DBrainsky ATheodore DElevate Study Group […Akram JBessonova EBilodeau MBloomer JBotta Fridlund DBzowej NCalmus YCarbonell NCaro Patón ACholewinska GChuang WlColombato LColombo MCraxi ADi Leo ADiago MDumortier JElkasahab MEverson GFallon MFedeli GFinazzi RFontanella AFrancavilla AGadano AGambarin Gelwan MGordon FGraus Morales JGrieco AGugenheim JHomenda WIaquinto GKang HKhan ZKuliczkowski KKwo PLee JhLee WLee YsMazur WMoreno CMorozov VMuñoz ANavasa Anadón MNijhawan SPinzello GPoordad FPrieto Castillo MRafalsky VRapaccini GRegenstein FRewak WRiley TRipoll Noiseux CRizzetto MRodrigo Lopez JRusso MSamuel DSánchez Antolín GSatyanaryana RSavarino VShiffman MSigal SSolá Lamoglia RSterling RTanno HTe HTerg RThuluvath PTrepo CVargas HXiol Quingles XZaman AFontana RKim KAbrams CGish RCardenas APietro AndreoneGiuseppe Mazzellasubject
Liver CirrhosisMaleCirrhosisChronic liver diseaseBenzoateslaw.inventionchemistry.chemical_compoundRandomized controlled triallawReceptorsClinical endpoint80 and overMedicineCIRRHOSISAged 80 and overBenzoic AcidsGeneral MedicineCHRONIC LIVER DISEASEMiddle AgedHydrazinesThrombopoietinElective Surgical ProceduresAnesthesiaFemaleElective Surgical ProcedureReceptors ThrombopoietinAdultAdolescentEltrombopagELTROMBOPAGHemorrhagePlatelet TransfusionPlaceboYoung AdultDouble-Blind MethodElectiveSurgical Procedures ElectiveHumansAgedTHROMBOCYTOPENIA; ELTROMBOPAG; CIRRHOSIS; CHRONIC LIVER DISEASESurgical Proceduresbusiness.industryPlatelet CountTHROMBOCYTOPENIAcirrhosisSettore MED/09 - MEDICINA INTERNAmedicine.diseaseThrombocytopeniaPlatelet transfusionchemistryChronic DiseasePyrazolesbusinessdescription
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.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.A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P0.001). 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.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.).
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-01-01 |