Pulmonary arterial hypertension is a rare and serious disease that can lead to heart failure and early death despite modern treatments. Many patients are treated with a combination of medications targeting different disease pathways, but some continue to have an inadequate response.
Riociguat is a medication that acts on the nitric oxide pathway and may be beneficial in patients who do not respond well to phosphodiesterase-5 inhibitors. In routine clinical practice, some patients receiving triple therapy switch from a phosphodiesterase-5 inhibitor to riociguat.
The REAPPRAISED study evaluates outcomes in patients with pulmonary arterial hypertension who switched to riociguat while receiving triple therapy. This observational study uses data from routine clinical care and does not involve any experimental treatment. The results may help improve understanding of the effectiveness and safety of this treatment strategy in real-world practice.
Adults aged 18 years or older.
Confirmed diagnosis of pulmonary arterial hypertension (Group 1).
Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks.
Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care.
Concomitant use of phosphodiesterase-5 inhibitors and riociguat.
Inability to confirm vital status or hospitalization outcomes within 6 months.
Participation in an interventional clinical trial that mandated the treatment switch.
The study population includes adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat in routine clinical practice at a specialized referral center. All patients were followed using retrospective data from medical records to assess clinical outcomes, safety, and treatment persistence. No study-related interventions were performed.
Cohort
Retrospective
Not listed
Composite Clinical Outcome at 6 Months
Composite clinical outcome assessed at 6 months (24±8 weeks) after the switch to riociguat, defined as achievement of at least two of the following criteria: improvement in six-minute walk distance of at least 10% or 30 meters; World Health Organization functional class I or II; and reduction in BNP levels of at least 30%, in the absence of clinical worsening. Clinical worsening is defined as all-cause mortality, hospitalization due to pulmonary arterial hypertension, or unplanned therapeutic escalation.
Persistence and Time to Discontinuation of Riociguat
reatment persistence at 6 months and time to discontinuation of riociguat for any reason.
Safety Outcomes
Occurrence of adverse events, including symptomatic hypotension, syncope, serious adverse events, and treatment interruptions due to adverse events.
Health Care Utilization
Occurrence of hospitalizations due to pulmonary arterial hypertension and emergency visits in the 6 months before and after the switch to riociguat.
Functional Changes
Changes in functional level before and after the switch to riociguat.
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Caio Júlio César dos Santos Fernandes
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
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