Updating clinical endpoint definitions

被引：19

作者：

Hassoun, Paul M. ^{[1
]}

Nikkho, Sylvia ^{[2
]}

Rosenzweig, Erika B. ^{[3
]}

Moreschi, Gail ^{[4
]}

Lawrence, John ^{[4
]}

Teeter, John ^{[5
]}

Meier, Christian ^{[2
]}

Ghofrani, Ardeshir H. ^{[6
]}

Minai, Omar ^{[7
]}

Rinaldi, Paula ^{[8
]}

Michelakis, Evangelos ^{[9
]}

Oudiz, Ronald J. ^{[10
]}

机构：

[1] Johns Hopkins Univ, Baltimore, MD USA

[2] Bayer Pharma AG, Berlin, Germany

[3] Columbia Univ, New York, NY USA

[4] US FDA, Silver Spring, MD USA

[5] Pfizer Inc, New London, CT USA

[6] Univ Giessen, Giessen, Germany

[7] Cleveland Clin, Cleveland, OH 44106 USA

[8] Novartis Pharmaceut, E Hanover, NJ USA

[9] Univ Alberta, Edmonton, AB, Canada

[10] Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA

来源：

PULMONARY CIRCULATION | 2013年 / 3卷 / 01期

关键词：

end-points; clinical trials; pulmonary arterial hypertension;

D O I：

10.4103/2045-8932.109920

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：206 / 216

页数：11

共 104 条

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