Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial.

Administration, Oral Adult Aged Atrial Fibrillation / etiology Benzoates / adverse effects Female Humans Hydrazines / adverse effects Immunoglobulins, Intravenous / adverse effects Male Middle Aged Pancreatitis / etiology Perioperative Care Platelet Count Pulmonary Embolism / etiology Pyrazoles / adverse effects Thrombocytopenia / drug therapy Treatment Outcome Vertigo / etiology

Journal

The Lancet. Haematology

ISSN: 2352-3026

Titre abrégé: Lancet Haematol

Pays: England

ID NLM: 101643584

Informations de publication

Date de publication:
Sep 2020

Historique:

received: 06 03 2020

revised: 12 06 2020

accepted: 15 06 2020

entrez: 28 8 2020

pubmed: 28 8 2020

medline: 9 9 2020

Statut: ppublish

Résumé

Patients with immune thrombocytopenia are at risk of bleeding during surgery, and intravenous immunoglobulin is commonly used to increase the platelet count. We aimed to establish whether perioperative eltrombopag was non-inferior to intravenous immunoglobulin. We did a randomised, open-label trial in eight academic hospitals in Canada. Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100 × 10 Between June 5, 2013, and March 7, 2019, 92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to eltrombopag and 36 to intravenous immunoglobulin. Median follow-up was 50 days (IQR 49-55). By intention-to-treat analysis, perioperative platelet targets were achieved for 30 (79%) of 38 patients assigned to eltrombopag and 22 (61%) of 36 patients assigned to intravenous immunoglobulin (absolute risk difference 17·8%, one-sided lower limit of the 95% CI 0·4%; p Eltrombopag is an effective alternative to intravenous immunoglobulin for perioperative treatment of immune thrombocytopenia. However, treatment with eltrombopag might increase risk of thrombosis. The decision to choose one treatment over the other will depend on patient preference, resource limitations, cost, and individual risk profiles. GlaxoSmithKline and Novartis.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

We did a randomised, open-label trial in eight academic hospitals in Canada. Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100 × 10

FINDINGS RESULTS

Between June 5, 2013, and March 7, 2019, 92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to eltrombopag and 36 to intravenous immunoglobulin. Median follow-up was 50 days (IQR 49-55). By intention-to-treat analysis, perioperative platelet targets were achieved for 30 (79%) of 38 patients assigned to eltrombopag and 22 (61%) of 36 patients assigned to intravenous immunoglobulin (absolute risk difference 17·8%, one-sided lower limit of the 95% CI 0·4%; p

INTERPRETATION CONCLUSIONS

Eltrombopag is an effective alternative to intravenous immunoglobulin for perioperative treatment of immune thrombocytopenia. However, treatment with eltrombopag might increase risk of thrombosis. The decision to choose one treatment over the other will depend on patient preference, resource limitations, cost, and individual risk profiles.

FUNDING BACKGROUND

GlaxoSmithKline and Novartis.

Identifiants

DOI: 10.1016/S2352-3026(20)30227-1 PMID: 32853584

pubmed: 32853584

pii: S2352-3026(20)30227-1

doi: 10.1016/S2352-3026(20)30227-1

pii:

doi:

Substances chimiques

Benzoates 0

Hydrazines 0

Immunoglobulins, Intravenous 0

Pyrazoles 0

eltrombopag S56D65XJ9G

Banques de données

ClinicalTrials.gov

['NCT01621204']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

e640-e648

Commentaires et corrections

Type : CommentIn