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Surrogate and Combined End Points in Pulmonary Arterial Hypertension

¹ Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York; ² Department of Medicine, University of Alabama, Birmingham, Alabama; ³ Scottish Pulmonary Vascular Unit, Western Infirmary, Glasgow, United Kingdom; ⁴ Vera Moulton Wall Center for Pulmonary Vascular Disease, Department of Medicine, Stanford University School of Medicine, Stanford, California; ⁵ Department of Medicine, University of Colorado, Denver, Colorado; and ⁶ Department of Epidemiology, Joseph L. Mailman School of Public Health, Columbia University, New York, New York

Correspondence and requests for reprints should be addressed to Steven M. Kawut, M.D., M.S., Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons, PH 8, Room 101, 622 W. 168th Street, New York, NY 10032. E-mail: sk2097{at}columbia.edu

ABSTRACT

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.

Related articles in Proceedings of the American Thoracic Society:

The Ethics of Randomized Clinical Trials in Pulmonary Arterial Hypertension

Scott D. Halpern, Ramona Doyle, and Steven M. Kawut
Proceedings of the American Thoracic Society 2008 5: 631-635. [Abstract] [Full Text]  

This article has been cited by other articles:

				S. D. Halpern, R. Doyle, and S. M. Kawut The Ethics of Randomized Clinical Trials in Pulmonary Arterial Hypertension Proceedings of the ATS, July 15, 2008; 5(5): 631 - 635. [Abstract] [Full Text] [PDF]