Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH.

Background: Regulators and clinical experts increasingly recognize the importance of incorporating patient-reported outcomes (PROs) in clinical studies of therapies for pulmonary arterial hypertension (PAH). No PAH-specific instruments have been developed to date in accordance with the 2009 FDA guidance for the development of PROs as endpoints in clinical trials. A qualitative research study was conducted to develop a new instrument assessing PAH symptoms and their impacts following the FDA PRO guidance.

Use of selective serotonin reuptake inhibitors and outcomes in pulmonary arterial hypertension.

Background: Selective serotonin reuptake inhibitors (SSRIs) have been suggested to offer therapeutic benefit in patients with pulmonary arterial hypertension (PAH). We conducted two analyses to explore the association between SSRI use and PAH outcomes using the Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL Registry).

Methods: First, new users (SSRI-naive patients who initiated treatment after enrollment, incident use analysis, n = 220) were matched (1:2) with non-SSRI users (nonusers, n = 440) by enrollment center, sex, date of most recent visit, age, and 6-min walk distance.

Depressive symptoms in pulmonary arterial hypertension: prevalence and association with functional status.

Background: In patients with left-heart disease, depressive symptoms have a significant impact on functional status and quality of life. The prevalence of depressive symptoms, and their impact on patients with pulmonary arterial hypertension (PAH) is understudied.

Objective: The authors investigated the prevalence of depressive symptoms in PAH and their correlation with physical functioning.