Late Breaking Abstract - Switching from PDE5i to riociguat in patients with PAH: The REPLACE study

Hoeper, Marius M.; Ghofrani, Hossein‐Ardeschir; Al‐Hiti, Hikmet; Benza, Raymond L.; Chang, Sung-A; Corris, Paul A.; Gibbs, Simon; Grünig, Ekkehard; Jansa, Pavel; Klinger, James R.; Langleben, David; McLaughlin, Vallerie V.; Meyer, G.; Ota-­Arakaki, Jaquelina Sonoe; Peacock, Andrew J.; Pulido, Tomás; Rosenkranz, Stephan; Vizza, Dario; Vonk‐Noordegraaf, Anton; White, James; Chang, Mikyung; Kleinjung, Frank; Meier, Christian; Paraschin, Karen; Simonneau, Gérald

doi:10.1183/13993003.congress-2020.3802

Cited by 7 publications

(10 citation statements)

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“…25 A total of 41% of patients transitioned to riociguat achieved the primary end point of satisfactory clinical response in the absence of clinical worsening compared with 20% of the group on PDE5 inhibitors (OR 2.8; 95% CI, 1.5–5.1; P = .0007). 26 …”

Section: Currently Approved Therapiesmentioning

confidence: 99%

Novel Treatment Pathways in Pulmonary Arterial Hypertension

Qaiser¹,

Tonelli²

2021

Methodist DeBakey Cardiovascular Journal

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Pulmonary arterial hypertension (PAH) is a severe and progressive vascular disease characterized by pulmonary vascular remodeling, proliferation, and inflammation. Despite the availability of effective treatments, PAH may culminate in right ventricular failure and death. Currently approved medications act through three well-characterized pathways: the nitric oxide, endothelin, and prostacyclin pathways. Ongoing research efforts continue to expand our understanding of the molecular pathogenesis of this complex and multifactorial disease. Based on recent discoveries in the pathobiology of PAH, several new treatments are being developed and tested with the goal of modifying the disease process and ultimately improving the long-term prognosis.

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Section: Currently Approved Therapiesmentioning

confidence: 99%

Novel Treatment Pathways in Pulmonary Arterial Hypertension

Qaiser¹,

Tonelli²

2021

Methodist DeBakey Cardiovascular Journal

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“…Therapy evaLuated Against Continued PDE-5i thErapy) trial, presented at the 2020 European Respiratory Society by Hoeper et al, 25 add to the available knowledge. The basis of the study involved the conversion from a PDE5 inhibitor to riociguat or continuation of a PDE5 inhibitor in an open-label, randomized fashion with follow-up assessments at 24 weeks.…”

Section: Replace (Riociguat Replacing Pde-5imentioning

confidence: 99%

“…Notably, 41% in the riociguat arm met the primary end point compared with 20% continuing PDE5 inhibitor without change (odds ratio, 2.78; 95% CI, 1.53 to 5.06; P¼.0007). 25 The study builds on the results of the phase 3 RESPITE study, 26 indicating that conversion from PDE5 inhibition to riociguat may be reasonable in select patients who have persistent NYHA functional class III symptoms and 6MWD less than 440 m.…”

Section: Replace (Riociguat Replacing Pde-5imentioning

confidence: 99%

Topic-Based, Recent Literature Review on Pulmonary Hypertension

Burger

DuBrock

Cartin‐Ceba

et al. 2021

Mayo Clinic Proceedings

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Pulmonary hypertension is a complex condition but a relatively common manifestation of severe cardiopulmonary disease. By contrast, pulmonary arterial hypertension is uncommon and is more prevalent in young women. To better categorize patients and to guide clinical decision-making, 5 diagnostic groups and associated subgroups characterize the spectrum of disease. A multidisciplinary approach to evaluation and treatment is recommended by published guidelines and often entails referral to a designated pulmonary hypertension center. Several key publications during the last couple of years merit review. The PubMed database was searched for English-language studies and guidelines relating to pulmonary hypertension. The following terms were searched, alone and in combination: pulmonary hypertension, pulmonary arterial hypertension, portopulmonary hypertension, and chronic thromboembolic pulmonary hypertension. The focus was on those publications with new information on evaluation and management of pulmonary hypertension between January 1, 2019, and January 31, 2021. Of the subgroups, 2 were of particular interest for this review: portopulmonary hypertension and chronic thromboembolic pulmonary hypertension. Last, available data on the impact of the coronavirus disease 2019 pandemic and newer treatment agents in early trials were selectively reviewed. The review is therefore intended to serve as a practical, focused review of important topics germane to those clinicians caring for patients with pulmonary hypertension.pulmonary hypertension, pulmonary arterial hypertension, right ventricular failure

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“…The frequency of AEs was similar between treatment groups, but in the PDE5i group, there were more deaths (3 vs 0%) and more patients reported serious AEs (17 vs 7%) compared with riociguat. 92 The CTEPH early access study was an open-label, uncontrolled, single-arm, phase IIIb surveillance study. Of the 300 patients enrolled in the study, 84 (28%) had switched to riociguat from their prior offlabel PAH-targeted therapy.…”

Section: Studies Of Switching To Riociguatmentioning

confidence: 99%

“…None of the studies provide data on long-term outcomes, although REPLACE was able to show a difference in time to clinical worsening during the 24-week treatment period with cases of death in the control arm only. 92 Randomisation and stratification worked in the study:…”

Section: Studies Of Switching To Riociguatmentioning

confidence: 99%

Riociguat: Clinical research and evolving role in therapy

Klinger

Chakinala

Langleben

et al. 2020

Brit J Clinical Pharma

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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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Late Breaking Abstract - Switching from PDE5i to riociguat in patients with PAH: The REPLACE study

Cited by 7 publications

References 0 publications

Novel Treatment Pathways in Pulmonary Arterial Hypertension

Novel Treatment Pathways in Pulmonary Arterial Hypertension

Topic-Based, Recent Literature Review on Pulmonary Hypertension

Riociguat: Clinical research and evolving role in therapy

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