Drug updated on 4/24/2024
| Dosage Form | Tablet (oral; 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg) |
| Drug Class | Soluble guanylate cyclase (sGC) stimulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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.
Summary
- Riociguat (Adempas) is indicated for the treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), to improve exercise capacity, WHO functional class, and delay clinical worsening.
- Eleven studies were reviewed, focusing on various aspects of riociguat's efficacy in treating PAH and CTEPH, including comparisons with other medications, detailed outcome analyses, and subgroup considerations.
- Compared to conventional therapies such as phosphodiesterase type 5 inhibitors (PDE-5is), endothelin receptor antagonists (ERAs), selexipag, etc., riociguat significantly improved parameters like the 6-minute walk distance, mean pulmonary arterial pressure, among others, without significantly increasing side effects.
- The safety profile of riociguat was found to be comparable to other PAH-targeted therapies; common side effects included dyspepsia and peripheral edema but did not increase adverse events compared to control interventions.
- Subgroup analysis showed that riociguat benefits various subgroups, including patients with specific connective tissue disease-associated PAH, although its impact on survival rates was unclear or not significantly different from controls.
- Special consideration should be given when comparing Balloon Pulmonary Angioplasty for inoperable CTEPH, where BPA might provide greater improvements except for cardiac output, though riociguat offers a well-tolerated oral option.
- Riociguat displayed similar or slightly superior efficacy against Selexipag while offering cost-saving benefits, making it valuable in PAH management strategies.
- Special attention should be given to patients unresponsive to traditional treatments or those having comorbidities like systemic sclerosis, where indications suggest that riociguat can potentially delay disease progression among these patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Adempas (riociguat) Prescribing Information. | 2023 | Bayer HealthCare Pharmaceuticals Inc.,Whippany, NJ |