| Scleroderma Clinical Trials (MAIN MENU) | |
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| Bosentan, Tracleer |
Digital Ulcers, Pulmonary Fibrosis,
Pulmonary Hypertension (PH), Raynaud's, and Skin Fibrosis |
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| Overview |
| Bosentan (Tracleer) 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. |
| Bosentan (Tracleer) Drug Information including precautions, side effects and interactions. Bosentan may cause serious liver problems. Liver function should be monitored closely to decrease the risk of liver-related side effects. MedicineNet. |
| Bosentan for the treatment of scleroderma. Two randomized trials have demonstrated that bosentan is effective in idiopathic pulmonary arterial hypertension and in pulmonary arterial hypertension related to connective tissue diseases, particularly scleroderma. Future Rheumatology. 2006 Oct; Vol. 1(5):549-562. (Also see: Pulmonary Hypertension and Bosentan) |
| Evaluation of Bone Mineral Density in Patients with Systemic Sclerosis (SSc), during Treatment with Bosentan (Preliminary Report). Despite small number of patients, the results of our study seem to indicate that in SSc patients, the use of bosentan (for management of pulmonary arterial hypertension and prevention of ischemic digital ulcers) should not determine significant decrease of bone mineral density. On the contrary, in this study we have observed that bosentan stabilizes pulmonary artery PA systolic pressure and pulmonary function tests in SSc patients. S. Bellissimo. (SAT0234). EULAR 2009. (Also see: Bone Density) |
| Do Liver Function Abnormalities with Bosentan Recur with Sitaxsentan? Patients failing Bosentan due to abnormal liver function tests do not appear to be at risk for cross-reactivity with Sitaxsentan. P. C. Garces. FRI0068 EULAR 2005. (Also see: Pulmonary Hypertension) |
| Bosentan for Digital Ulcers |
| Phase II Study showed positive results for the prevention (but not treatment) of digital ulcers in systemic sclerosis (scleroderma). It is only approved for this use in the EU (not in the U.S.). |
| Digital ulcers and outcomes assessment in scleroderma.. Healing has been demonstrated with intravenous iloprost and two studies with bosentan have demonstrated reduction in the occurrence of new digital ulcers (DUs) over 4-6 months of treatment. (PubMed) Matucci-Cerinic M. Rheumatology (Oxford). 2008 Oct;47 Suppl 5:v46-7. (Also see: Digital Ulcers) |
| Tracleer® (Bosentan) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease. Actelion Pharmaceuticals UK Ltd announced that Tracleer® (bosentan), a dual endothelin receptor antagonist, has been approved in the UK and Ireland for the reduction of the number of new digital ulcers (DUs) in patients with systemic sclerosis (SSc) and ongoing DU disease. Medical News Today. 04/28/08. (Also see: Digital Ulcers) |
| Bosentan (Tracleer®) Receives European (EU) Approval for Reduction of Number of New Digital Ulcerations in Systemic Sclerosis Patients. Digital ulcers are an important and painful complication of systemic sclerosis with approximately 50 percent of people with systemic sclerosis developing digital ulcers during their lifetime. PrimeNewswire. Actelion Ltd. 06/11/07. (Also see: Digital Ulcers) |
| Bosentan Reduces the Number of New Digital Ulcers in Patients with Systemic Sclerosis: Open Label Extension to a Double-Blind Trial. The sustained reduction in the number of new digital ulcers (DU) and improvement of hand function suggest the maintenance of bosentan’s beneficial clinical effects after long- term exposure. C. Black. FRI0325 EULAR 2006. (Also see: Digital Ulcers and Professor Carol Black) |
| Bosentan: a review of its use in pulmonary arterial hypertension and systemic sclerosis (SSc). Bosentan was found as an effective, and generally well tolerated agent for use in the treatment of PAH. It may be an option for the prevention of digital ulcers in SSc. PubMed. Am J Cardiovasc Drugs. 2006;6(3):189-208. (Also see: Pulmonary Hypertension) |
| Bosentan for treatment of active digital ulcers in patients with systemic sclerosis (SSc). Bosentan can be effective in the treatment of digital ulcers in some SSc patients, especially those involving substantial ischemia. PubMed. Presse Med. 2006 Apr;35(4 Pt 1):587-92. |
| Digital Ulcers in Systemic Sclerosis: Effectiveness by Treatment with Bosentan. In our series, at 6 months of treatment we have observed a important decrease in the number of digitital ulcers and scars in those patients. In general terms, we can say that bosentan was well tolerated, having only one severe adverse effect. P. García de la Peña Lefebvre. FRI0161 EULAR 2005. (Also see: Digital Ulcers) |
| Bosentan Improves Microcirculatory Modifications in Systemic Sclerosis (SSc). The capacity of ERA to improve the microcirculation and block the appearance of new ischemic ulcers is comfirmed. A. Righi. AB0187 EULAR 2005. (Also see Digital Ulcers and Pulmonary Hypertension) |
| Bosentan for Heart Involvement in Systemic Sclerosis |
| Bosentan is already approved for the treatment of pulmonary hypertension. |
| Beneficial Effects of Bosentan on Myocardial Perfusion and Function Assessed by Cardiac Magnetic Resonance Imaging and Tissue Doppler Imaging in Systemic Sclerosis. In systemic sclerosis, a short-term treatment with bosentan simultaneously improves myocardial perfusion and function, suggesting a beneficial effect on vascular dysfunction. Y. Allanore. OP0120 EULAR 2006. (Also see: Cardiac Treatments) |
| Bosentan for Pulmonary Fibrosis (PF) |
| Bosentan is already 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. |
| Bosentan. Bosentan may also have antifibrotic properties and its use in pulmonary fibrosis is being explored. PubMed. Expert Rev Cardiovasc Ther. 2004 Mar;2(2):175-82. (Also see: Pulmonary Hypertension) |
| Bosentan Use in Interstitial Lung Disease, BUILD 2 Criteria, clinics, and outcome measures. Listing by the international Scleroderma Clinical Trials Consortium. The study will be recruiting 3rd quarter 2003 through 3rd quarter 2004. SCTC 1-16-04. (Also see: Pulmonary Fibrosis and Scleroderma Care and Research Journal, Issue 1) |
| Bosentan for Pulmonary Hypertension (PH, PAH) |
| Bosentan is already approved for the treatment of pulmonary hypertension. |
| SureSteps™ is a free patient support program for people who are on Tracleer/Bosentan. |
Welcome to Sure Steps Connect. A special, LIVE conference series answering the questions of pulmonary arterial hypertension (PAH) patients. A series of unique interactive conferences offered exclusively to members of the Sure Steps ™ community. Several informative conference programs have been created and we invite you to participate in as many as you choose. PAH Pathways. Starts July 23, 2009. |
| Actelion Pharmaceuticals US, Inc. is pleased to announce the launch of Sure StepsTM, a comprehensive support program for U.S. patients enrolled in the Tracleer Access Program (T.A.P.). Sure StepsTM free services include one-to-one attention from a Nurse Counselor. Posted 11-08-06. |
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 Bosentan For The Treatment Of Scleroderma. Includes comments about SureSteps™ program. Discussion started 12-02-06. Sclero Forums. |
| Effect of Bosentan on Plasma Markers of Endothelial Cell Activity in Patients with Secondary Pulmonary Hypertension (PAH) Related to Connective Tissue Diseases. Treatment with bosentan for 3 months induced a beneficial effect by restoring endothelial function through a decrease in the markers of endothelial cell activity, leading to stabilization or improvement of severe PAH. G. Cella. J Rheumatol. January 22, 2009. |
| Tracleer(R) Shows Clinical Benefit As Combination Therapy With Sildenafil For Pulmonary Arterial Hypertension. Data from both studies suggest that Tracleer, when given in combination with sildenafil, is well-tolerated and improves hemodynamics in PAH patients. Medical News Today. 10/24/07. (Also see: Pulmonary Hypertension) |
| Use Of Bosentan And Continuous Iloprost Infusion In Scleroderma Patient With Pulmunary Hypertension. Continuous IV infusion of iloprost associated with bosentan in SSc patients with PAPs improved symptoms of PAPs, hemodynamics and physical aspects of quality of life. M. M. S. SESSAREGO AB0529 EULAR 2007. (Also see: Pulmonary Hypertension) |
| Endothelial Cell Dysfunction In Pulmonary Arterial Hypertension (PAH) Associated To Connective Tissue Diseases (CTD): Effects Of Bosentan. Our data confirm a severe endothelial cells (EC) dysfunction in patients with PAH associated to CTD, demonstrated by elevated circulating levels of soluble markers of EC activity. After three months of treatment, bosentan was able to improve exercise capacity and pulmonary haemodinamics and to reduce EC dysfunction. F. Cozzi THU0255 EULAR 2007. (Also see: Causes of Scleroderma: Endothelin) |
| Addition of sildenafil to bosentan monotherapy in pulmonary arterial hypertension. Addition of sildenafil after bosentan monotherapy failure improved NYHA and 6MWD in IPAH (idiopathic PAH) patients, but failed to improve either parameter in PAH-SSD (scleroderma-associated PAH) patients. PubMed. Eur Respir J. 2006 Nov 1. (Also see: Pulmonary Hypertension) |
| Survival in patients with pulmonary arterial hypertension treated with first-line bosentan. The present analyses suggest that first-line bosentan therapy, followed by the addition of other disease-specific therapies as required, improves survival in patients with advanced PAH. PubMed. Eur J Clin Invest. 2006 Sep;36 Suppl 3:10-5. |
| Bosentan for severe pulmonary arterial hypertension related to systemic sclerosis with interstitial lung disease. Bosentan treatment was well tolerated in this cohort of SSc patients with interstitial lung disease and was effective for treatment of severe PAH in the majority of patients. PubMed. Eur J Clin Invest. 2006 Sep;36 Suppl 3:44-8. (Also see: Pulmonary Fibrosis) |
| Drug eruption due to bosentan in a patient with systemic sclerosis (SSc). A 60-year-old female patient with SSc complicated by pulmonary hypertension developed high fever and skin eruptions ten days after the initiation of treatment with bosentan. PubMed. Mod Rheumatol. 2006;16(3):188-90. (Also see: Medications) |
| Bosentan: a review of its use in pulmonary arterial hypertension and systemic sclerosis (SSc). Bosentan was found as an effective, and generally well tolerated agent for use in the treatment of PAH. It may be an option for the prevention of digital ulcers in SSc. PubMed. Am J Cardiovasc Drugs. 2006;6(3):189-208. (Also see: Digital Ulcers) |
| Long-Term Safety and Drug Survival of Bosentan in Patients with Systemic Sclerosis. Bosentan survival has been high and similar to previous data from patients with primary PAH due to SSc. A close monitoring of liver enzymes is mandatory throughout the first year of treatment.. J. J. Alegre-Sancho. AB0260 EULAR 2006. (Also see: Digital Ulcers) |
| 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?) |
| 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) |
| Long-Term Efficacy and Safety of Bosentan in the Treatment of Ischemic Digital Ulcers due to Severe Raynaud's Phenomenon in Patients with Systemic Sclerosis. Severe Raynaud’s phenomenon and IDU in patients with SSc can be successfully prevented and treated with bosentan. Efficacy and safety of this drug remains beyond 18 months of therapy. J. J. Alegre-Sancho. FRI0099 EULAR 2005. (Also see: Raynaud's Treatments and Digital Ulcers) |
| Bosentan for Systemic Scleroderma Skin Fibrosis |
| Bosentan study for systemic scleroderma skin fibrosis shows positive results. |
 Skin 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.) |
| Systemic Sclerosis (SSc): Long-Term Efficacy of Bosentan on Cutaneous Fibrosis (CF). Bosentan remains effective, beyond 18 months of therapy, for the treatment of CF in patients with SSc. Larger studies should be addressed to confirm this benefit. Meanwhile, an early use of this drug should be considered in patients with SSc. J. J. Alegre-Sancho. FRI0097 EULAR 2005. (Also see: Skin Fibrosis and Clinical Trials) |
| Media Stories about Bosentan |
| Survey of More than 600 Patients Treated with Tracleer(R) (bosentan) Reveals Actelion Sure Steps(R) Patient Support Program Provides Valuable Educational Information. A recent Harris Interactive(R) survey shows that an overwhelming majority of Tracleer patients enrolled in Sure Steps find the patient support program valuable, and feel that their knowledge of pulmonary arterial hypertension (PAH) and Tracleer have improved due to the program. Bio-Medicine. 12/18/07. (Also see: SureSteps) |
| Health Watch: A New Drug For Scleroderma. The ulcers made simple tasks like digging in her purse made Pats fingers feel like they were receiving electric shock. But today her fingers are much better, which may be due to a drug called Bosentan, which is being studied at the Mayo Clinic. KFOX TV. 01-06-06. |
| 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 |
