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Original Research: Pulmonary Vascular Disease |

Sex Differences in Response to Tadalafil in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension and Tadalafil

Stephen C. Mathai, MD, MHS, FCCP; Paul M. Hassoun, MD, FCCP; Milo A. Puhan, MD, PhD; Yi Zhou, PhD; Robert A. Wise, MD, FCCP
Author and Funding Information

From the Division of Pulmonary and Critical Care Medicine (Drs Mathai, Hassoun, and Wise), Johns Hopkins University School of Medicine, Baltimore, MD; Institute of Social and Preventive Medicine (Dr Puhan), University of Zurich, Zurich, Switzerland; and United Therapeutics Corporation (Dr Zhou), Research Triangle Park, NC.

CORRESPONDENCE TO: Stephen C. Mathai, MD, MHS, FCCP, Johns Hopkins University School of Medicine, Division of Pulmonary and Critical Care Medicine, 1830 E Monument St, Room 540, Baltimore, MD, 21205; e-mail: smathai4@jhmi.edu


This study was presented in abstract form at the American Thoracic Society International Meeting 2013, May 17-22, 2013, Philadelphia, PA.

FUNDING/SUPPORT: This study was supported by the National Heart, Lung, and Blood Institute [Grant K23 HL093387 to Dr Mathai].

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;147(1):188-197. doi:10.1378/chest.14-0263
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BACKGROUND:  Pulmonary arterial hypertension (PAH) is a progressive disease with high rates of morbidity and mortality. Current therapies improve symptoms, functional capacity, and, in select cases, survival. Little is known about patient factors that may predict the likelihood of patient-important, clinically relevant responses to therapy such as the 6-min walk distance (6MWD) and health-related quality of life (HRQoL).

METHODS:  Data from the randomized clinical trial of tadalafil in PAH were used. Adjusted logistic regression models were created to examine the relationship between baseline characteristics and odds of achieving the minimal important difference (MID) in three parameters, defined as either a > 33-m increase in 6MWD, a > 5-unit increase in physical component summary score of the Medical Outcomes Study Short Form-36 (SF-36), or a > 5-unit increase in mental component summary score of the SF-36.

RESULTS:  The study included 405 subjects. Younger age, male sex, lower baseline 6MWD, and disease etiology were associated with greater odds of achieving the MID for the 6-min walk test. Active treatment, younger age, and male sex were associated with greater odds of achieving the MID for the physical component summary score. Male sex was associated with greater odds of achieving the MID for the mental component summary score.

CONCLUSIONS:  Age, sex, baseline functional capacity, and disease etiology are variably associated with the likelihood of achieving clinically relevant responses in patient-important outcomes to PAH-specific therapy such as 6MWD and HRQoL. The increased likelihood of response in men compared with women is a novel finding and may reflect pathophysiologic differences between sexes.

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