| 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. |
| 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) |
| 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.). |
| 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. |
|
 Bosentan
For The Treatment Of Scleroderma. Includes comments about
SureSteps™ program. Discussion started 12-02-06.
Sclero Forums. |
| Long-term Effects of Bosentan Treatment on Survival in Patients with Pulmonary Arterial Hypertension (PAH) Related to Connective Tissue Disease (CTD). The 2-year survival of patients treated with bosetan far exceeds the natural history of survival in untreated PAH-CTD, and supports a long-term benefit of bosentan treatment in patients with PAH-CTD. Janet E. Pope. 1199/431. ACR 2007. |
| 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. |
| Long-term Effects of Bosentan in Pulmonary Arterial Hypertension Related to Connective Tissue Disease (PAH-CTD): The TRUST Study Results. Bosentan therapy for 48 weeks led to improvement or stabilization of PAH symptoms and QoL in a majority of patients with PAH-CTD. Survival rate was 92%. Christopher P. Denton. 1862/534 ACR 2006. (Also see: Bosentan) |
| Bosentan Down-Regulates Endothelial Activation in Systemic Sclerosis Associated Pulmonary Arterial Hyperthension. This study confirms that endothelial activation occurrs in SSc and suggests that changes of T-cell/endothelium interplay take place in in PAH-SSc. Bosentan, beside improving PHA-SSc, seems to be capable of restoring endothelium functions in these patients. Florenzo Iannone. 1857/529 ACR 2006. (Also see: Bosentan) |
| 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) |
| Protective
Effect of Bosentan on Vascular Endothelium in Patients with
Pulmonary Arterial Hypertension (PAH) Related to Systemic
Sclerosis. Treatment with Bosentan results in rapid and
significant improvement of paramenters of endothelial damage
in patients with SSc, suggesting a crucial role of endothelin
in vascular injury. Moreover, the significant association
between CECs (circulating endothelial cells) and pulmonary
hypertension suggests that CECs could represent a promising
new clinical marker for SSc vascular lung disease. N.
Del Papa. FRI0143 EULAR 2005. (Also see: Pulmonary
Hypertension) |
| Long-Term
Safety Profile of Bosentan in Patients with Systemic Sclerosis
and Pulmonary Arterial Hypertension: Results from the TRAX
Database. The TRAX data confirm that bosentan was well
tolerated with a frequency and severity of liver function
test abnormalities consistent with those observed in controlled
clinical trials. C. P. Denton. FRI0123 EULAR 2005. (Also
see: Pulmonary
Hypertension) |
| Bosentan
Therapy for Pulmonary Arterial Hypertension Related to Systemic
Sclerosis: A Subgroup Analysis of the Pivotal Studies and
their Extensions. In PAH-SSc, there was a trend for improvement
in 6-min walk test with short-term bosentan treatment, as
compared to placebo. C. P. Denton. FRI0124 EULAR 2005. (Also
see: Pulmonary
Hypertension) |
| Treatment
of Severe Pulmonary Arterial Hypertension Related to Systemic
Sclerosis: Experience with Bosentan. Bosentan treatment
was safe and effective in the present cohort of SSc patients
with severe PAH. K. Ahmadi-Simab. FRI0122 EULAR 2005.
(Also see: Pulmonary
Hypertension) |
| 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) |
| Systemic
Sclerosis: Improvement of Cutaneous Fibrosis on Bosentan
Therapy. Bosentan is effective for the treatment of well-stablished
CF in patients with SSc. Taken together all the benefits
reported with bosentan therapy, an early use of this drug
should be considered in patients with SSc. J. J. Alegre-Sancho.
FRI0312 EULAR 2004. |
| 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 |
