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Editorials |

Pulmonary Hypertension Trials : Current End Points Are Flawed, But What Are the Alternatives?

Kari Roberts, MD; Ioana Preston, MD, FCCP; Nicholas S. Hill, MD, FCCP
Author and Funding Information

Affiliations: Boston, MA
 ,  Drs. Roberts, Preston, and Hill are affiliated with the Division of Pulmonary, Critical Care, and Sleep Medicine, Tufts-New England Medical Center.

Correspondence to: Nicholas S. Hill, MD, FCCP, Division of Pulmonary, Critical Care and Sleep Medicine, Tufts-New England Medical Center, 750 Washington St, No. 257, Boston, MA 02111; e-mail: Nhill@tufts-nemc.org



Chest. 2006;130(4):934-936. doi:10.1378/chest.130.4.934
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In the 10 years since the approval of epoprostenol by the US Food and Drug Administration, impressive progress has been made in understanding the pathogenesis, diagnostic evaluation, and therapy of pulmonary arterial hypertension (PAH).1 In this issue of CHEST (see page 1198), Stuart Rich, a leading figure in the field for > 2 decades, offers a thoughtful and provocative critique of this progress.2 He argues that our therapeutic end points are inadequate and that, with the exception of therapy with IV epoprostenol, none of the newer approved therapies have any proven benefits beyond short-term effects on functional capacity. He calls for a reassessment of end points and calls on us to “demand” that clinical trials “address the mechanism of action, define the population in whom the drug may benefit and … characterize how it has affected the status of the disease.”

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