Are hemodynamics surrogate end points in pulmonary arterial hypertension?

ABSTRACT:

Background

Although frequently assessed in trials and clinical practice, hemodynamic response to therapy has never been validated as a surrogate end point for clinical events in pulmonary arterial hypertension (PAH).

Methods and results

We performed a patient-level pooled analysis of 4 randomized, placebo-controlled trials to determine whether treatment-induced changes in hemodynamic values at 12 weeks accounted for the relationship between treatment assignment and the probability of early clinical events (death, lung transplantation, atrial septostomy, PAH hospitalization, withdrawal for clinical worsening, or escalation in PAH therapy). We included 1119 subjects with PAH. The median (interquartile range) age was 48 years (37-59 years), and 23% were men. A total of 656 pati

SUBMITTER: Ventetuolo CE 

PROVIDER: S-EPMC4146736 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature