Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia

Nezam H. Afdhal, Edoardo G. Giannini, Ghias Tayyab, Aftab Mohsin, Jin Woo Lee, Angelo Andriulli, Lennox J Jeffers, John McHutchison, Pei Jer Chen, Kwang Hyub Han, Fiona Campbell, Denise Hyde, Andres Brainsky, Dickens Theodore

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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.)

Original languageEnglish (US)
Pages (from-to)716-724
Number of pages9
JournalNew England Journal of Medicine
Volume367
Issue number8
DOIs
StatePublished - Aug 23 2012

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Thrombocytopenia
Fibrosis
Platelet Transfusion
Placebos
Liver Diseases
Chronic Disease
Platelet Count
Thrombopoietin Receptors
Hemorrhage
Portal System
eltrombopag
Incidence
Portal Vein
Thrombosis

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Afdhal, N. H., Giannini, E. G., Tayyab, G., Mohsin, A., Lee, J. W., Andriulli, A., ... Theodore, D. (2012). Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. New England Journal of Medicine, 367(8), 716-724. https://doi.org/10.1056/NEJMoa1110709

Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. / Afdhal, Nezam H.; Giannini, Edoardo G.; Tayyab, Ghias; Mohsin, Aftab; Lee, Jin Woo; Andriulli, Angelo; Jeffers, Lennox J; McHutchison, John; Chen, Pei Jer; Han, Kwang Hyub; Campbell, Fiona; Hyde, Denise; Brainsky, Andres; Theodore, Dickens.

In: New England Journal of Medicine, Vol. 367, No. 8, 23.08.2012, p. 716-724.

Research output: Contribution to journalArticle

Afdhal, NH, Giannini, EG, Tayyab, G, Mohsin, A, Lee, JW, Andriulli, A, Jeffers, LJ, McHutchison, J, Chen, PJ, Han, KH, Campbell, F, Hyde, D, Brainsky, A & Theodore, D 2012, 'Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia', New England Journal of Medicine, vol. 367, no. 8, pp. 716-724. https://doi.org/10.1056/NEJMoa1110709
Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A et al. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. New England Journal of Medicine. 2012 Aug 23;367(8):716-724. https://doi.org/10.1056/NEJMoa1110709
Afdhal, Nezam H. ; Giannini, Edoardo G. ; Tayyab, Ghias ; Mohsin, Aftab ; Lee, Jin Woo ; Andriulli, Angelo ; Jeffers, Lennox J ; McHutchison, John ; Chen, Pei Jer ; Han, Kwang Hyub ; Campbell, Fiona ; Hyde, Denise ; Brainsky, Andres ; Theodore, Dickens. / Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 8. pp. 716-724.
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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.)",
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AU - Afdhal, Nezam H.

AU - Giannini, Edoardo G.

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AU - Mohsin, Aftab

AU - Lee, Jin Woo

AU - Andriulli, Angelo

AU - Jeffers, Lennox J

AU - McHutchison, John

AU - Chen, Pei Jer

AU - Han, Kwang Hyub

AU - Campbell, Fiona

AU - Hyde, Denise

AU - Brainsky, Andres

AU - Theodore, Dickens

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N2 - 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.)

AB - 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.)

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