Updating clinical endpoint definitions

Paul M. Hassoun, Sylvia Nikkho, Erika B. Rosenzweig, Gail Moreschi, John Lawrence, John Teeter, Christian Meier, Ardeshir H. Ghofrani, Omar Minai, Paula Rinaldi, Evangelos Michelakis, Ronald J. Oudiz

Research output: Contribution to journalArticlepeer-review

Abstract

The 6-Minute Walk Distance (6-MWD) has been the most utilized endpoint for judging the efficacy of pulmonary arterial hypertension (PAH) therapy in clinical trials conducted over the past two decades. Despite its simplicity, widespread use in recent trials and overall prognostic value, the 6-MWD has often been criticized over the past several years and pleas from several PAH experts have emerged from the literature to find alternative endpoints that would be more reliable in reflecting the pulmonary vascular resistance as well as cardiac status in PAH and their response to therapy. A meeting of PAH experts and representatives from regulatory agencies and pharmaceutical companies was convened in early 2012 to discuss the validity of current as well as emerging valuable endpoints. The current work represents the proceedings of the conference.

Original languageEnglish (US)
Pages (from-to)206-216
Number of pages11
JournalPulmonary Circulation
Volume3
Issue number1
DOIs
StatePublished - Jan 2013

Keywords

  • Clinical trials
  • End-points
  • Pulmonary arterial hypertension

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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