Key result
Riociguat improves 6-minute walk distance by ~40 meters versus placebo across PAH and CTEPH.
Why the study?
This review evaluates the original clinical trials of riociguat for PAH and CTEPH, and summarises the body of work examining its safety and efficacy for other types of pulmonary hypertension.
Does riociguat improve functional capacity in adults with PAH or CTEPH?
Does riociguat improve functional capacity in adults with PAH or CTEPH?
Riociguat, a soluble guanylate cyclase stimulator, is an effective therapy that improves exercise capacity and hemodynamics in patients with PAH and CTEPH.
Answers are grounded in this paper and cite their sources.
Supports exercise capacity gains with riociguat in PAH/CTEPH; leaves open optimal long-term sequencing and combinations.
Riociguat is a first-in-class soluble guanylate cyclase stimulator, approved for the treatment of adults with pulmonary arterial hypertension (PAH), inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after pulmonary endarterectomy. Approval was based on the results of the phase III PATENT-1 (PAH) and CHEST-1 (CTEPH) studies, with significant improvements in the primary endpoint of 6-minute walk distance vs placebo of +36 m and +46 m, respectively, as well as improvements in secondary endpoints such as pulmonary vascular resistance and World Health Organization functional class. Riociguat acts as a stimulator of cyclic guanosine monophosphate synthesis rather than as an inhibitor of cGMP metabolism. As with other approved therapies for PAH, riociguat has antifibrotic, antiproliferative and anti-inflammatory effects, in addition to vasodilatory properties. This has led to further clinical studies in patients who do not achieve a satisfactory clinical response with phosphodiesterase type-5 inhibitors. Riociguat has also been evaluated in patients with World Health Organization group 2 and 3 pulmonary hypertension, and other conditions including diffuse cutaneous systemic sclerosis, Raynaud's phenomenon and cystic fibrosis. This review evaluates the results of the original clinical trials of riociguat for the treatment of PAH and CTEPH, and summarises the body of work that has examined the safety and efficacy of riociguat for the treatment of other types of pulmonary hypertension.
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Klinger et al. (2020) conducted a review in Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Riociguat vs. Placebo was evaluated on 6-minute walk distance (+36 m (PAH) and +46 m (CTEPH)). Riociguat significantly improved 6-minute walk distance versus placebo by +36 m in patients with PAH and +46 m in patients with CTEPH.
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