Bleeding and mortality outcomes in ITP clinical trials: a review of thrombopoietin mimetics data.

Published

Journal Article (Review)

Patients with ITP may have severe thrombocytopenia, putting them at risk for serious bleeding. ITP trials of new treatments must allow use of standard-of-care therapies to prevent serious bleeding. Thrombopoietin mimetic trials used platelet counts and rescue/concomitant medication use as endpoints. These trials were of insufficient size and duration to measure mortality or serious bleeding, which are infrequent with appropriate treatment. A recent Cochrane review criticized the thrombopoietin mimetic registrational trials for inadequately assessing bleeding and survival. We discuss how these endpoints are difficult to measure in clinical trials designed to improve platelet counts and minimize bleeding, in accordance with ethical trial design.

Full Text

Duke Authors

Cited Authors

  • Altomare, I; Wasser, J; Pullarkat, V

Published Date

  • October 2012

Published In

Volume / Issue

  • 87 / 10

Start / End Page

  • 984 - 987

PubMed ID

  • 22729832

Pubmed Central ID

  • 22729832

Electronic International Standard Serial Number (EISSN)

  • 1096-8652

Digital Object Identifier (DOI)

  • 10.1002/ajh.23275

Language

  • eng

Conference Location

  • United States