Tracleer (Bosentan) by Actelion

Digital Ulcers, Pulmonary Fibrosis,
Pulmonary Hypertension (PH), Raynaud's, Scleroderma Renal Crisis, and Skin Fibrosis

Tracleer for Digital Ulcers
Tracleer for Pulmonary Fibrosis
Tracleer for Pulmonary Hypertension
Tracleer for Raynaud's
Tracleer for Scleroderma Renal Crisis
Tracleer for Skin Fibrosis
Also See


Tracleer® (bosentan) is made by Actelion Pharmaceuticals, Inc. The medication was initially developed for treatment of pulmonary hypertension, but has since proven useful in treating a variety of systemic scleroderma symptoms.

Tracleer (Bosentan) is proving useful for a variety of scleroderma symptoms, including pulmonary fibrosis, pulmonary hypertension, Raynaud's, and skin fibrosis. Bosentan is in a class of drugs called endothelin receptor antagonists by preventing an overproduction of endothelin.

Therefore, scleroderma researchers suggest that an early use of this drug should be considered for systemic scleroderma patients.

Tracleer (Bosentan) Drug Information including precautions, side effects and interactions. It may cause serious liver problems. Liver function should be monitored closely to decrease the risk of liver-related side effects. MedicineNet.

Tracleer (Bosentan) for Digital Ulcers

Tracleer is approved for the treatment of digital ulcers.

Blood flow in the hands of a predefined homogeneous systemic sclerosis population: the presence of digital ulcers (DUs) and the improvement with bosentan. No relationship was found between blood flow in the hands and the presence of DUs. After 12 weeks of bosentan treatment, blood flow had increased in the SSc patients but had not normalized to that of healthy subjects. PubMed, Rheumatology, 2014 Aug 22. (Also see Digital Ulcers)

Longterm Treatment with Endothelin (ET-1) Receptor Antagonist Bosentan and Iloprost (ILO) Improves Fingertip Blood Perfusion in Systemic Sclerosis (SSc). Long term treatment of SSc patients with ET-1 antagonism, in combination with ILO, seems to increase fingertip blood perfusion, as well as both capillary dilation capacity and number. PubMed, J Rheumatol, 2014 Apr 1. (Also see Treatment for Digital Ulcers: Iloprost)

Tracleer (Bosentan) for Heart Involvement in Systemic Sclerosis

Tracleer is approved for the treatment of pulmonary hypertension.

Bosentan increases myocardial perfusion and function in systemic sclerosis: a magnetic resonance imaging and Tissue-Doppler echography study. Short-term treatment with bosentan simultaneously improves myocardial perfusion and function, as evaluated by highly sensitive and quantitative methods, in patients with SSc. Whether additional remodeling effect may be observed after longterm treatment with bosentan remains to be determined. J Rheumatol. 2006 Dec;33(12):2464-9.

Tracleer (Bosentan) for Pulmonary Fibrosis (PF)

Tracleer is approved for the treatment of pulmonary hypertension.

Pulmonary (lung) fibrosis, is a scarring of the lungs, and is the consequence of untreated pulmonary inflammation (alveolitis). It is often also referred to as interstitial lung disease. ISN.

Randomized, prospective, placebo–controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Although many outcome variables were stable, bosentan did not reduce the frequency of clinically important worsening. These data do not support the use of endothelin receptor antagonists as therapy for ILD secondary to SSc. Arthritis Rheum, 2010 Mar 26;62(7):2101-2108. (Also see Pulmonary Fibrosis Treatments)

Tracleer (Bosentan) for Pulmonary Hypertension (PH, PAH)

Tracleer (Bosentan) is approved for the treatment of pulmonary hypertension.
The Actelion Pathways program is a free patient support program for people on Tracleer (Bosentan). It was formerly known as Sure Steps.

Actelion Pathways. We provide help getting started on your new treatment, programs to help you pay for your medicine, and information about specialty pharmacies and mail delivery. Actelion.

Bosentan and macitentan (ERA's) prevent the endothelial–to–mesenchymal transition (EndoMT) in systemic sclerosis: in vitro study. The present study provides further in vitro evidence of the use of ERA in inhibiting the EndoMT process, supporting the clinical efficacy of these drugs in SSc therapy and their usefulness for interfering with progressive fibrosis. PMC, Arthritis Res Ther, October 2016; 18: 228. (Also see Macitentan (Opsumit™) and Fibroblasts)

Beneficial effects of long–term treatment with bosentan on the development of pulmonary arterial hypertension in patients with systemic sclerosis. Long–term treatment with bosentan reduces the risk of developing PAH in patients with systemic sclerosis. PubMed, J Int Med Res, 2016 Sep;44(1 suppl):85-89.

Long-term outcomes in pulmonary arterial hypertension in the first-line epoprostenol or first-line bosentan era. First-line epoprostenol treatment may lead to greater improvement in exercise capacity than first-line bosentan. However, these greater exercise improvements did not translate into longer time to disease progression or survival. Jacobs W. (PubMed) J Heart Lung Transplant, 2010 Jun 24. (Also see Flolan)

Real-World Bosentan Therapy Successful in Pulmonary Arterial Hypertension (PAH): Presented at ATS. Real-life experiences in treating patients with pulmonary arterial hypertension with bosentan appears to provide similar efficacy as seen in clinical trials -- despite patients being somewhat older and having more scleroderma. Ed Susman. Doctor's Guide. 05/17/10.

Pulmonary Hypertension (PH) is high blood pressure in the arteries which take blood between the heart and lungs. It can be caused by scleroderma and also by other diseases, such as pulmonary heart disease, pulmonary artery blood clots, mitral valve narrowing, and cirrhosis of the liver. ISN. (Also see What is Scleroderma?)

Tracleer (Bosentan) for Raynaud's

Bosentan study for Raynaud's shows positive results.

Raynaud's is an extreme spasm of blood vessels in response to cold or stress. The fingers and/or toes become white and/or blue, and may become red on re-warming. (Also see Raynaud's Treatments)

Combination therapy with Bosentan and Sildenafil improves Raynaud's phenomenon and fosters the recovery of microvascular involvement in systemic sclerosis (SSc). Patients treated with Bosentan + Sildenafil show a significant improvement and this combination therapy may exert a vascular activity achieving an amelioration of the structure of microvasculature in SSc. PubMed, Clin Rheumatol, 12/03/2015. (Also see Raynaud's Treatments)

Successful Treatment with Bosentan of Lower Extremity Ulcers in a Scleroderma Patient. Lower extremity ulcers in patients with systemic sclerosis, refractory to conventional treatments, can be responsive to treatment with bosentan, especially when the ulcers are surrounded with cyanosis. Hindawi, 03/14/2014. (Also see Raynaud's Treatments)

Bosentan for Scleroderma Renal Crisis

Clinical Trial in France

Effect of Bosentan in Scleroderma Renal Crisis (ScS-REINBO). This French clinical trial will be completed in June 2014.

Tracleer (Bosentan) for Systemic Scleroderma Skin Fibrosis

Tracleer study for systemic scleroderma skin fibrosis shows positive results.

Sclerodactyly by Sherrill KnaggsSkin fibrosis is a process that follows chronic inflammation. Fibrotic tissue is like a scar tissue, thick, and rigid, due to an excess accumulation of protein below the skin. The diagnosis is clinical, and requires no laboratory or special testing. (Photo: Sclerodactyly, the culminating result of fibrosis affecting the hands of a systemic scleroderma patient.)

Also See

Digital Ulcers

Pulmonary Fibrosis

Pulmonary Hypertension

Raynaud's Treatments

Scleroderma Medical News

Systemic Scleroderma Symptoms (Main list; treatments are listed on each symptom page.)

Scleroderma Treatments and Clinical Trials

Skin Fibrosis

Go to Scleroderma Clinical Trials: Stem Cell Transplants

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