Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis PDF Print E-mail
Saturday, 02 October 2010 23:27
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 Sweiss, Mittie K Doyle, Bernhard Hellmich, Thomas A Medsger Jr, Adele Morganti, Fabrice Kramer, Joseph H Korn, James R Seibold
Ann Rheum Dis published online August 30, 2010
doi: 10.1136/ard.2010.130658

Objectives
Ischaemic 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, Placebocontrolled 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.

Methods
This 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.

Results
Over 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.

Conclusions
Bosentan 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.

Login to download your own copy of the full and original article from the link provided below

 
More articles :

» Study Reveals New Genetic Link To Scleroderma

An international research consortium including scientists from T (UTHealth) has identified a new genetic link to the systemic form of . Researchers believe a thorough understanding of the genetic nature of the disease is crucial to developing a...

» A Perspective on Juvenile Systemic Sclerosis

Juvenile systemic sclerosis is one of the most serious rheumatologic diseases diagnosed in children and adolescents, according to Dr. Ivan Foeldvari. This complex disorder is characterized by fibrosis of the skin, subcutaneous tissues, and internal...

» Researchers Identify Core Genetic Switch As A Viable Target For New Scleroderma Treatments

Scleroderma is a rare, autoimmune disease. Often fatal, it causes the fibrosis or thickening of the connective tissue which support the skin and other vital organs within the body, through the overproduction of . The disease currently lacks a cure...

» Neutrophil Elastase Regulator Needed in Systemic Sclerosis

, which promotes and fibrosis, is suspected of playing a role in (SSc). Theresa C. Barnes, MD, from University of Liverpool, Aintree University Hospital, United Kingdom, and colleagues  of Rheumatology that the problem may not be too...

» Lupus, A Widespread and Chronic Autoimmune Disease

Lupus is a widespread and chronic disease that, for unknown reasons, causes the immune system to attack the body’s own tissues and organs, including the joints, kidneys, heart, lungs, brain and skin. Lupus, an important disease for...

» January 26th Lunch & Learn Event on Sjogren’s Syndrome

For those of you in the state of Texas, Northwest Rheumatology, a division of Northwest Diagnostic Clinic, will host a free Lunch & Learn event on Sjogren’s Sydrome: The Forgotten Disease on Tuesday, Jan. 26, from 11:45 a.m. – 1 p.m. at the...