Surrogate and combined end points in pulmonary arterial hypertension.
Pulmonary arterial hypertension is a rare and often devastating disease, although various effective therapies are now available. Clinical trials have used hemodynamic, cardiac imaging, laboratory, and exercise measurements as surrogate and intermediate end points in pulmonary arterial hypertension. Yet, based on the current literature, it is difficult to surmise which of these (if any) have been definitively validated. In addition, investigators have advocated the use of combined clinical end points in future clinical trials. The dependence of clinical trials and clinical management on such end points warrants a review of their use.
Ventetuolo
Corey E
CE
Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
Benza
Raymond L
RL
Peacock
Andrew J
AJ
Zamanian
Roham T
RT
Badesch
David B
DB
Kawut
Steven M
SM
D000959:Antihypertensive Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood*; D006801:Humans; D006976:Hypertension, Pulmonary / Q000097:blood* / Q000188:drug therapy; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
D000959:Antihypertensive Agents; D015415:Biomarkers