Clinical and hemodynamic benefit of macitentan and riociguat upfront combination in patients with pulmonary arterial hypertension

Sulica, Roxana; Sangli, Swathi; Chakravarti, Aloke; Steiger, David

doi:10.1177/2045894019826944

Cited by 21 publications

(14 citation statements)

References 34 publications

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“…This exploratory analysis has allowed evaluation of patients who had only recently (within the previous three to six months) started ERA therapy before receiving riociguat, showing that early sequential combination therapy with an ERA plus riociguat was effective and well tolerated in this patient population. This is consistent with a recent report in which upfront combination therapy with riociguat and macitentan in patients with newly diagnosed PAH was associated with significant improvements in 6MWD, brain natriuretic peptide, and hemodynamic parameters 19 …”

Section: Discussionsupporting

confidence: 93%

“…This is consistent with a recent report in which upfront combination therapy with riociguat and macitentan in patients with newly diagnosed PAH was associated with significant improvements in 6MWD, brain natriuretic peptide, and hemodynamic parameters. 19 Limitations of the present analysis include its post hoc exploratory nature, and the limited patient numbers, particularly in the prostanoid group, with some outliers potentially biasing the data. There is no formal definition of ''early sequential'' combination therapy.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of riociguat in combination therapy for patients with pulmonary arterial hypertension (PATENT studies)

Ghofrani

Grünig

Jansa³

et al. 2020

Pulm. circ.

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Many patients with pulmonary arterial hypertension do not achieve treatment goals with monotherapy, and therefore combination therapy is becoming the standard of care. The soluble guanylate cyclase stimulator riociguat is licensed for the treatment of pulmonary arterial hypertension; here we present findings from patients who were receiving combined riociguat plus endothelin receptor antagonists or non-intravenous prostanoids in the randomized, placebo-controlled PATENT-1 study and its open-label extension (PATENT-2). Moreover, we include new data from patients receiving early sequential combination therapy (three to six months of endothelin receptor antagonist treatment) or long-term background endothelin receptor antagonist therapy (>6 months). Patients were randomized to riociguat 2.5 mg–maximum ( N = 131 pretreated patients) and placebo ( N = 60 pretreated patients). Riociguat improved 6-min walking distance (PATENT-1 primary endpoint), functional capacity, and hemodynamics after 12 weeks in pretreated patients. The placebo-corrected changes in 6-min walking distance were +24 m in endothelin receptor antagonist-pretreated patients and +106 m in the small group of prostanoid-pretreated patients. In the early sequential combination and long-term background endothelin receptor antagonist groups, the placebo-corrected changes in 6-min walking distance were +65 m (95% CI: 17 to 113 m) and +13 m (95% CI: –8 to 33 m), respectively. In conclusion, these data suggest that early sequential combination of an endothelin receptor antagonist plus riociguat is a feasible treatment option. Both early sequential therapy and long-term background endothelin receptor antagonist plus riociguat were well tolerated in the PATENT studies.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of riociguat in combination therapy for patients with pulmonary arterial hypertension (PATENT studies)

Ghofrani

Grünig

Jansa³

et al. 2020

Pulm. circ.

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“…[ 24 ] Other study demonstrated that riociguat obviously decreased mean pulmonary arterial pressure (47.3– 38.9 mmHg) and PVR (9.2– 5.7 wood units), and increased cardiac index. [ 25 ] Later, the study evaluated the effects of riociguat on hemodynamic parameters in Asian patients with inoperable CTEPH, and the results indicated that riociguat significantly reduced PAP (41– 38 mmHg) and PVR (787 to 478 dyn s cm −5 ), and relieved clinical symptoms. [ 26 ] These results were consistent with our study.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of riociguat in the treatment of chronic thromboembolic pulmonary arterial hypertension

Ying¹,

Song²,

Gu³

et al. 2021

Medicine

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Background: Riociguat is a novel soluble guanylate cyclase stimulator, and has been widely used for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (CTEPH). Some studies found that riociguat had better effects on CTEPH and proved to be safe, but the results were not utterly consistent. Therefore, the purpose of this study was to comprehensively evaluate the efficacy and safety of riociguat in the treatment of CTEPH. Methods: Randomized controlled trials on riociguat for the treatment of CTEPH were searched through such electronic databases as PubMed, Embase, Cochrane Library, Web of Science, China national knowledge internet, and Wanfang. The outcomes included exercise capacity, pulmonary hemodynamics, and side effects. The fixed-effects or random-effects models were used to analyze the pooled data, and heterogeneity was assessed by the I 2 test. Results: Four studies involving 520 patients were included in this meta-analysis. Compared with the placebo group, riociguat significantly improved the hemodynamic indexes and increased 6-min walking distance ( P < .0001, standardized mean difference (SMD) = −0.24, 95%CI −0.35 to −0.12; P < .00001, SMD = 0.52, 95%CI 0.33 to 0.71), and decreased the Borg dyspnea score ( P = .002, SMD = −0.31, 95%CI −0.51 to −0.12). In addition, riociguat could also significantly reduce the living with pulmonary hypertension scores and increase the EQ-5D scores ( P = .01, SMD=−0.23, 95%CI −0.42 to −0.05; P < .00001, SMD = 0.47, 95%CI 0.27 to 0.66), but there was no significant difference in the change level of N-terminal pro-hormone B-type natriuretic peptide in patients with riociguat ( P = .20, SMD = −0.24, 95%CI −0.61 to −0.13). The common adverse events of riociguat were dyspepsia and peripheral edema, and no other serious adverse reactions were observed. Conclusions: We confirmed that riociguat had better therapeutic effects in improving the hemodynamic parameters and exercise capacity in patients with CTEPH without inducing serious adverse events. This will provide a reasonable medication regimen for the treatment of CTEPH.

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“…There were no unexpected side effects, and the transplant-free survival rate was 85% at 36 months. 56…”

Section: Author Opinionmentioning

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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Clinical and hemodynamic benefit of macitentan and riociguat upfront combination in patients with pulmonary arterial hypertension

Cited by 21 publications

References 34 publications

Efficacy and safety of riociguat in combination therapy for patients with pulmonary arterial hypertension (PATENT studies)

Efficacy and safety of riociguat in combination therapy for patients with pulmonary arterial hypertension (PATENT studies)

Efficacy and safety of riociguat in the treatment of chronic thromboembolic pulmonary arterial hypertension

Practical management of riociguat in patients with pulmonary arterial hypertension

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