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Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS2 randomised, double-blind, placebo-controlled trial

Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS2 randomised, double-blind, placebo-controlled trial,10.113

Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS2 randomised, double-blind, placebo-controlled trial   (Citations: 7)
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Marco Matucci-Cerinic, Christopher P Denton, Daniel E Furst, Maureen D Mayes, Vivien M Hsu, Patrick Carpentier, Fredrick M Wigley, Carol M Black, Barri J Fessler, Peter A Merkel, Janet E Pope, Nadera J Sweisshttp://academic.research.microsoft.com/io.ashx?type=5&id=29682670&selfId1=0&selfId2=0&maxNumber=12&query=
ObjectivesIschaemic digital ulcers (DUs) are common in patients with systemic sclerosis (SSc) and are a cause of disease-related morbidity. In an earlier trial, treatment with bosentan, an oral endothelin receptor antagonist, reduced the occurrence of new DUs by 48%. The present study (RAPIDS-2, for ‘RAndomized, double-blind, Placebo-controlled study with bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis’) was conducted to more fully evaluate the effects of bosentan treatment on DUs associated with SSc.MethodsThis double-blind, placebo-controlled trial conducted at 41 centres in Europe and North America randomised 188 patients with SSc with at least 1 active DU (‘cardinal ulcer’) to bosentan 62.5 mg twice daily for 4 weeks and 125 mg twice daily thereafter for 20 weeks (n=98) or matching placebo (n=90; total 24 weeks). The two primary end points were the number of new DUs and the time to healing of the cardinal ulcer. Secondary end points included pain, disability and safety.ResultsOver 24 weeks, bosentan treatment was associated with a 30% reduction in the number of new DUs compared with placebo (mean±standard error: 1.9±0.2 vs 2.7±0.3 new ulcers; p=0.04). This effect was greater in patients who entered the trial with more DUs. There was no difference between treatments in healing rate of the cardinal ulcer or secondary end points of pain and disability. Peripheral oedema and elevated aminotransferases were associated with bosentan treatment.ConclusionsBosentan treatment reduced the occurrence of new DUs in patients with SSc but had no effect on DU healing. Bosentan was well tolerated and may be a useful adjunct in the management of patients with SSc with recurrent DUs.
Journal: Annals of The Rheumatic Diseases - ANN RHEUM DIS , vol. 70, no. 1, pp. 32-38, 2011
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    • ...The ET receptor antagonist bosentan has been shown to be effective in the treatment of adult patients with SSc–PAH [2, 7]. Furthermore, it has been shown that bosentan ameliorates decreased skin perfusion and digital ulceration secondary to SSc [5, 6]. A previous report showed that bosentan was effective for treatment of children with primary and secondary PAH [3]...
    • ...Bosentan has been shown to be effective for the treatment of patients with SSc–PAH [2, 7]. Recently, it has been shown that bosentan also ameliorates decreased skin perfusion and digital ulceration secondary to SSc [5, 6]. These effects might be mediated through vasodilatory and antifibrotic effects, indicating that these agents may be attractive potential disease modifying agents for SSc...

    Masaki ShimizuYokoet al. Successful Treatment with Bosentan for Pulmonary Hypertension and Redu...

    • ...A more recent study that compared bosentan to placebo in the prevention of digital ulcers (RAPIDS-2) showed that amputation frequently complicates the course of SSc, aVecting 1–2% of the patients per year [4]...
    • ...The incidence of digital gangrene seems to be lower in comparison with the very large case study of Pittsburgh in which 11% of the patients incurred in digital gangrene or amputation [3] and with the recent RAPIDS-2 study that reported a digital amputation annual incidence in 1–2% of the patients [4]...

    Paola Caramaschiet al. Severe vascular complications in patients affected by systemic scleros...

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