Trial reportAnnals of the rheumatic diseases2011
Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial.
Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 170 papers, 12 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO
A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis
Who cites it
170 citing papers in PubMed, 12 syntheses or guidelines pooled it, 493 citations in OpenAlex.
- Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- The 2024 British Society for Rheumatology guideline for management of systemic sclerosis.Rheumatology (Oxford, England) · 2024Guideline
- 2023 Brazilian Society of Rheumatology guidelines for the treatment of systemic sclerosis.Advances in rheumatology (London, England) · 2024Guideline
- Systemic pharmacological treatment of digital ulcers in systemic sclerosis: a systematic literature review.Rheumatology (Oxford, England) · 2023Pooled it
- Locoregional Treatments for Digital Ulcers in Systemic Sclerosis: A Systematic Review.Acta dermato-venereologica · 2021Pooled it
- Therapeutic options for patients with rare rheumatic diseases: a systematic review and meta-analysis.Orphanet journal of rare diseases · 2020Pooled it
- Pharmacological treatment for Buerger's disease.The Cochrane database of systematic reviews · 2020Pooled it
- Association of oral endothelin receptor antagonists with risks of cardiovascular events and mortality: meta-analysis of randomized controlled trials.European journal of clinical pharmacology · 2017Pooled it
- Clinical Adverse Effects of Endothelin Receptor Antagonists: Insights From the Meta-Analysis of 4894 Patients From 24 Randomized Double-Blind Placebo-Controlled Clinical Trials.Journal of the American Heart Association · 2016Pooled it
- Pharmacological treatment for Buerger's disease.The Cochrane database of systematic reviews · 2016Pooled it
- Efficacy of Raynaud's phenomenon and digital ulcer pharmacological treatment in systemic sclerosis patients: a systematic literature review.Rheumatology international · 2015Pooled it
- Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards.Rheumatology (Oxford, England) · 2015Pooled it
- New horizons in systemic sclerosis treatment: advances and emerging therapies in 2025.RMD open · 2025Trial
- Zibotentan in systemic sclerosis-associated chronic kidney disease: a phase II randomised placebo-controlled trial.Arthritis research & therapy · 2022Trial
- Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study).Arthritis research & therapy · 2019Trial
- A feasibility study of a novel low-level light therapy for digital ulcers in systemic sclerosis.The Journal of dermatological treatment · 2019Trial
- Expression of the oxygen-sensitive transcription factor subunit HIF-1α in patients suffering from secondary Raynaud syndrome.Acta pharmacologica Sinica · 2019Trial
- Trial
- Ultrasound characterization of cutaneous ulcers in systemic sclerosis.Clinical rheumatology · 2018Trial
- Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study.Arthritis & rheumatology (Hoboken, N.J.) · 2017Trial
110 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 15 institutions in 7 countries.
Funding
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.