Summary

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• Adempas (riociguat) is indicated for the treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; and for the treatment of adults with Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.
• This summary is based on the review of 11 systematic reviews/meta-analyses. ^[1-11]
• Functional Class (FC): Riociguat significantly improved WHO functional class in patients with PAH and CTEPH compared to placebo and PDE-5 inhibitors, with comparable efficacy to Selexipag in functional class improvement. 4. 6-Minute Walk Distance (6-MWD): Riociguat led to significant improvements in 6-MWD in PAH and CTEPH patients compared to placebo and PDE-5 inhibitors, with comparable improvements to Selexipag but less significant improvement compared to BPA.
• Hemodynamic Parameters: Riociguat significantly reduced pulmonary vascular resistance (PVR) and mean pulmonary arterial pressure (mPAP) while increasing cardiac index (CI) in PAH and CTEPH patients compared to placebo and PDE-5 inhibitors, with reductions in PVR and mPAP being less significant than with BPA.
• Clinical Worsening (CW): Riociguat significantly reduced the risk of clinical worsening in PAH and CTEPH patients compared to placebo and showed superior effectiveness in reducing clinical worsening compared to PDE-5 inhibitors.
• Riociguat vs. Placebo: Common adverse events included dyspepsia and peripheral edema, with no serious adverse reactions reported.
• Riociguat vs. PDE-5 Inhibitors: There was no observed increase in common side effects when switching from PDE-5 inhibitors to riociguat.
• Riociguat vs. BPA: Riociguat was well tolerated, with common adverse events including headache, dizziness, hypotension, and nasopharyngitis.
• Subgroup Findings: Riociguat demonstrated effectiveness in improving clinical and hemodynamic outcomes in patients with connective tissue disease-associated PAH (CTD-PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), with limited impact on survival and NT-proBNP levels in CTD-PAH. In heart failure (HF) patients, riociguat did not significantly reduce all-cause or cardiovascular mortality but showed improvements in hemodynamics for those with combined post-capillary and pre-capillary PH due to heart failure with reduced ejection fraction.