Phosphodiesterase type 5 inhibitor to riociguat transition is associated with hemodynamic and symptomatic improvement in pulmonary hypertension

Davey, Ryan; Benza, Raymond L.; Murali, Srinivas; Raina, Amresh

doi:10.1177/2045893217708566

Cited by 12 publications

(17 citation statements)

References 12 publications

(14 reference statements)

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“…These participants were predominantly female (Table 1) with a pre-transition WHO FC of II-III (Table S2). All the participants had a diagnosis of group one PAH with the exception of the Kuroda et al study in which 1 of the 7 participants had a diagnosis of chronic thromboembolic pulmonary hypertension [15]. Primary outcomes were quite heterogeneous, with studies examining either clinical outcomes, such as a change in 6MWTD and WHO FC, or hemodynamic endpoints such as change in mPAP (Table 1) [8, [13][14][15][16][17].…”

Section: Resultsmentioning

confidence: 99%

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The Efficacy of Transitioning Patients With Pulmonary Hypertension From Phosphodiesterase Type 5 Inhibitors To Riociguat: A Systematic Analysis And Retrospective Chart-Review

Sun

Kendzerska

Foxhall

et al. 2021

Preprint

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Purpose: Pulmonary arterial hypertension (PAH) is a rare, progressive disease with significant mortality. Phosphodiesterase type 5 inhibitors (PDE5i) are an effective therapy, however, patients often progress despite treatment. This review examined the efficacy of transitioning patients from a PDE5i to riociguat by analyzing changes in the 6-minute walk test distance (6MWTD) and hemodynamic parameters in adults with PAH. Methods: This was a combined systematic review and meta-analysis of current literature (Jan 2013 – Oct 2019) and a retrospective database study (Jan 2013-Aug 2017) from a tertiary pulmonary hypertension center in Ontario, Canada. All English language studies were searched through PubMed, EMBASE, the Web of Science and EBSCO from 2013 to 2019. Results were combined using a random effect model. We used an I² statistic estimate (percent) to quantify inconsistency.Results: The results were combined from a total of 6 published studies (4 cohort studies, 1 case report and 1 case series), and a retrospective database study. Mean difference across studies demonstrates a 6MWTD improvement of 43.7m (CI 3.72- 83.7, P=0.03, I2=77%), favouring riociguat. There was an improvement in all the secondary outcomes examined, including World Health Organization functional class, mean pulmonary arterial pressure, pulmonary vascular resistance and cardiac index, demonstrating a propensity to favour riociguat.Conclusion: This review demonstrates significant improvement in both clinical and hemodynamic outcomes when patients with PAH are transitioned to riociguat from PDE5i. However, the number of studies included was small, and the quality of studies was moderate with limited evidence regarding outcomes of interest. PROSPERO registration #: CRD42020154661Registered April, 2020

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Section: Resultsmentioning

confidence: 99%

“…The transition protocol is displayed in Table 2. Three of 7 studies had a 24h washout period for sildena l, one study had a washout period of 12h and another had no washout period [8, [13][14][15][16][17]. Tadala l washouts also were variable from 24 to 72h documented [8,16].…”

Section: Resultsmentioning

confidence: 99%

The Efficacy of Transitioning Patients With Pulmonary Hypertension From Phosphodiesterase Type 5 Inhibitors To Riociguat: A Systematic Analysis And Retrospective Chart-Review

Sun

Kendzerska

Foxhall

et al. 2021

Preprint

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“…44 A number of independent studies have also highlighted the feasibility of switching patients to riociguat from PDE5i in patients with PAH. 58–61…”

Section: Author Opinionmentioning

confidence: 99%

“…44 A number of independent studies have also highlighted the feasibility of switching patients to riociguat from PDE5i in patients with PAH. [58][59][60][61] Author opinion Switching from PDE5i to riociguat (usually owing to lack of PDE5i efficacy) should be performed only within expert centers participating in the ongoing REPLACE study, as all thus far completed studies of switching were not randomized controlled trials. Until further data are available, switching cannot be recommended outside clinical trials.…”

Section: Riociguat and Pde5i: Contraindication And Switching Therapymentioning

confidence: 99%

Practical management of riociguat in patients with pulmonary arterial hypertension

Halank

Tausche

Grünig

et al. 2019

Ther Adv Respir Dis

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Riociguat is one of several approved therapies available for patients with pulmonary arterial hypertension (PAH). Treatment should be initiated and monitored at an expert center by a physician experienced in treating PAH, and the dose adjusted in the absence of signs and symptoms of hypotension. In certain populations, including patients with hepatic or renal impairment, the elderly, and smokers, riociguat exposure may differ, and dose adjustments should therefore be made with caution according to the established scheme. Common adverse events are often easily managed, particularly if they are discussed before starting therapy. Combination therapy with riociguat and other PAH-targeted agents is feasible and generally well tolerated, although the coadministration of phosphodiesterase type 5 inhibitors (PDE5i) and riociguat is contraindicated. An open-label, randomized study is currently ongoing to assess whether patients who do not achieve treatment goals while receiving PDE5i may benefit from switching to riociguat. In this review, we provide a clinical view on the practical management of patients with PAH receiving riociguat, with a focus on the opinions and personal experience of the authors.The reviews of this paper are available via the supplemental material section.

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“…Эффективность замены иФДЭ-5 на риоцигуат подтверждена также в неконтролируемых исследованиях СTEPH EAS [47], R. Davey и соавт. [48], A. Andersen и соавт. [49], A. Raina и соавт.…”

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Optimization of specific therapy for pulmonary hypertension: the possibilities of riociguat

Martynyuk

Витальевна²,

Шмальц

et al. 2021

Terapevticheskii arkhiv

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Pulmonary hypertension (PH) is a severe and often rapidly progressive disease with fatal outcome. Endothelial dysfunction in PH is associated with decreased nitric oxide production. After reviewing the mechanisms of action and the evidence base for specific therapy with phosphodiesterase 5 inhibitors (PDE-5) and soluble guanylate cyclase stimulators, a reseach review on switching from PDE-5 to riociguat is conducted. A potential advantage of riociguat is its independence from endogenous nitric oxide and from the other (besides PDE-5) isoenzymes of phosphodiesterases. The favorable efficacy profile of sildenafil has been proven for the main forms of pulmonary arterial hypertension, of riociguat for the main forms of pulmonary arterial hypertension and chronic thromboembolic PH. The clinical efficacy of replacing PDE-5 with riociguat has been demonstrated in uncontrolled trials and in the randomized controlled study REPLACE. The possibility of therapy optimization by switching from IFDE-5 to riociguat is fixed in the Russian (class and level of evidence B-3) and Eurasian (class and level of evidence IIb-B) clinical guidelines, as well as in the materials of the Cologne Expert Consensus. An additional argument for switching is the lower cost as compared to combination therapy in the Russian Federation. According to the Russian and Eurasian guidelines for PH and the Russian instructions for the use of riociguat, the drug should be taken at least 24 hours after sildenafil discontinuation.

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Phosphodiesterase type 5 inhibitor to riociguat transition is associated with hemodynamic and symptomatic improvement in pulmonary hypertension

Cited by 12 publications

References 12 publications

The Efficacy of Transitioning Patients With Pulmonary Hypertension From Phosphodiesterase Type 5 Inhibitors To Riociguat: A Systematic Analysis And Retrospective Chart-Review

The Efficacy of Transitioning Patients With Pulmonary Hypertension From Phosphodiesterase Type 5 Inhibitors To Riociguat: A Systematic Analysis And Retrospective Chart-Review

Practical management of riociguat in patients with pulmonary arterial hypertension

Optimization of specific therapy for pulmonary hypertension: the possibilities of riociguat

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