Riociguat

(Adempas®)

Adempas®

Drug updated on 11/1/2024

Dosage FormOral (Tablets; 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg)
Drug ClassSoluble guanylate cyclase (sGC) stimulators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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
  • Indicated 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.

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Summary
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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Riociguat significantly increased the 6-minute walk distance (6MWD) by 42.59 meters in patients with chronic thromboembolic pulmonary hypertension (CTEPH) compared to placebo and by 26.45 meters in patients with pulmonary arterial hypertension (PAH) compared to PDE-5 (phosphodiesterase type 5) inhibitors.
  • In terms of pulmonary vascular resistance (PVR), riociguat reduced PVR by 171.61 dyn.s.cm−5 in CTEPH patients versus placebo, and by 130.24 dyn.s.cm−5 in PAH patients compared to PDE-5 inhibitors.
  • Mean pulmonary arterial pressure (mPAP) was reduced by 4.20 mmHg in CTEPH patients compared to placebo, and by 3.53 mmHg in PAH patients compared to PDE-5 inhibitors.
  • Common adverse events (AEs) associated with riociguat include dyspepsia and peripheral edema, with no serious adverse effects observed in the CTEPH population, indicating a favorable safety profile compared to placebo.
  • Riociguat did not show a significant increase in AEs compared to PDE-5 inhibitors in the PAH population, and it had fewer adverse events compared to placebo in CTEPH patients.
  • Evaluations in the CTEPH population demonstrated significant improvements in exercise capacity and hemodynamic parameters with riociguat, while in the PAH population, it included both idiopathic and connective tissue disease-associated types. The CTD-PAH subgroup, involving systemic sclerosis and SLE, showed beneficial hemodynamic outcomes, and the dcSSc evaluations indicated non-significant but positive trends in pulmonary function improvements.

Product Monograph / Prescribing Information

Document TitleYearSource
Adempas (riociguat) Prescribing Information.2023Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines