Macitentan in the treatment of severe digital ulcers

Gonçalves, Tatiana; Santos, Lèlita

doi:10.1136/bcr-2018-228295

Cited by 4 publications

(4 citation statements)

References 12 publications

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“…Furthermore, the prior use of prostanoids and bosentan for the treatment of DUs might have posed a barrier regarding recruitment in the DUAL studies, excluding patients with severe DUs, who at least theoretically would be more likely to benefit from treatment. Despite some recent positive case reports [ 34 , 35 ], macitentan is not yet a recommended treatment for DUs in the updated EULAR guidelines for the treatment of SSc.…”

Section: Resultsmentioning

confidence: 99%

Treatment of digital ulcers in systemic sclerosis: recent developments and future perspectives

Sagonas

Daoussis

2023

Clin Rheumatol

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Digital ulcers (DUs) comprise the main manifestation of vasculopathy and are a major cause of disability in patients with systemic sclerosis (SSc). A literature search in Web of Science, PubMed and Directory of Open Access Journals was performed in December 2022 to identify articles published in the last decade regarding the management of DUs. Prostacyclin analogues, endothelin antagonists and phosphodiesterase 5 inhibitors have shown promising results both as a stand-alone treatment and in combination for the treatment of existing and prevention of new DUs. Moreover, autologous fat grafting and botulinum toxin injections, although not readily available, can be of use in recalcitrant cases. Many investigational treatments with promising results could pave the way for a paradigm shift in the treatment of DUs in the future. Despite these recent advances, challenges remain. Better-designed trials are of paramount importance to optimise DU treatment in the years to come. Key Points• DUs are a major cause of pain and reduced quality of life in patients with SSc.• Prostacyclin analogues and endothelin antagonists have shown promising results both as a stand-alone treatment and in combination for the treatment of existing and prevention of new DUs.• In the future, a combination of more powerful vasodilatory drugs, perhaps in conjunction with topical approaches, may improve outcomes.

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Section: Resultsmentioning

confidence: 99%

Treatment of digital ulcers in systemic sclerosis: recent developments and future perspectives

Sagonas

Daoussis

2023

Clin Rheumatol

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“…However, macitentan did not meet the primary outcome (the cumulative number of new DUs from baseline to week 16) in clinical trials (DUAL-1 and DUAL-2) [18]. Patients on PDE5 inhibitors and prostaglandin therapy in the three months prior to screening and those with comorbidities affecting hand functionality or who were smokers were excluded from the macitentan trials [18][19][20]. Patients were randomized to receive placebo, macitentan 3 mg, or macitentan 10 mg (the only dose marketed after the SERAPHIN pivotal trial in PAH [20]).…”

Section: Discussionmentioning

confidence: 99%

“…Macitentan is a newer generation ERA that achieves more sustained receptor binding and superior tissue penetration compared to other drugs in the same family [16,17]. However, two clinical trials did not reach statistical significance in terms of efficacy in preventing new DUs, although there are case reports that have demonstrated its efficacy, even in some of the patients included in the DUAL-2 trial [18][19][20]. In clinical practice, treatment with macitentan for DUs has achieved excellent course evolution as well as prevention of recurrences [19].…”

Section: Introductionmentioning

confidence: 99%

Macitentan for the Treatment of Refractory Digital Ulcers in Patients With Connective Tissue Diseases

Abánades¹,

Mozo²,

Hernán³

et al. 2023

Cureus

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Systemic sclerosis (SSc) is a chronic autoimmune disease with complex pathogenesis, characterized by vascular dysfunction and fibrosis. Digital ulcers (DUs) are a common and severe complication in SSc patients, negatively impacting their quality of life. This retrospective study evaluates the use of macitentan, an endothelin receptor antagonist, in six female patients with connective tissue disease (CTD) and sclerodermiform features (five SSc and one mixed connective tissue disease) for the treatment of refractory DUs. Macitentan demonstrated a safe and effective alternative to bosentan, reducing DU relapses, hospitalizations, and the use of systemic prostaglandin therapy. The findings suggest that macitentan may be a valuable therapeutic option in specific cases of recurrent or refractory DUs and warrant further investigation in larger, long-term studies.

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“…Such conditions include hypertension, renal disease, occlusive vascular disease, coronary artery disease, restenosis, atherosclerosis and transplant-associated arteriosclerosis, pulmonary arterial hypertension, congestive heart failure and left ventricular dysfunction (see Lüscher and Barton 2000). In addition, the ET receptor antagonists, macicentan and bosentan, have been used to treat digital ulcers (Combalia et al 2018;Gonçalves and Santos 2019).…”

Section: Introductionmentioning

confidence: 99%

Endothelin-1, endothelin receptor antagonists, and vein graft occlusion in coronary artery bypass surgery: 20 years on and still no journey from bench to bedside

Dashwood

Loesch

2020

Can. J. Physiol. Pharmacol.

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The saphenous vein is the most commonly used bypass graft in patients with coronary artery disease. During routine coronary artery bypass grafting the vascular damage inflicted on the vein is likely to stimulate the release of endothelin-1, a potent endothelium-derived vasoconstrictor that also possesses cell proliferation and inflammatory properties, conditions associated with vein graft failure. In both in vitro and in vivo studies, endothelin receptor antagonists reduce neointimal thickening. The mechanisms underlying these observations are multi-factorial and include an effect on cell proliferation and cell/tissue damage. Much of the data supporting the beneficial action of endothelin-1 receptor antagonism at reducing intimal thickening and occlusion in experimental vein grafts was published over 20 years ago. The theme of the recent ET-16 conference in Kobe was “Visiting Old and Learning New”. This short review article provides an overview of studies showing the potential of endothelin receptor antagonists to offer an adjuvant therapeutic approach for reducing saphenous vein graft failure and poses the question why this important area of research has not been translated from bench to bedside given the potential benefit for coronary artery bypass patients?

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Macitentan in the treatment of severe digital ulcers

Cited by 4 publications

References 12 publications

Treatment of digital ulcers in systemic sclerosis: recent developments and future perspectives

Treatment of digital ulcers in systemic sclerosis: recent developments and future perspectives

Macitentan for the Treatment of Refractory Digital Ulcers in Patients With Connective Tissue Diseases

Endothelin-1, endothelin receptor antagonists, and vein graft occlusion in coronary artery bypass surgery: 20 years on and still no journey from bench to bedside

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