How are digital ulcers treated?
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The basic treatment of digital ulcerations includes regular local wound care, dressing exchange and pain management. Digital ulcerations are at risk of infection. Therefore, antibiotics are often necessary.
- Until 2008, there was no approved therapy for digital ulcerations. In the treatment practice, calcium channel blockers and other vasodilatory therapies, as well as intravenous prostaglandin were applied. There are no standard recommendations for the treatment of digital ulcerations.
What is the role of bosentan in the treatment of digital ulceration?
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Bosentan has been approved in the European Union since 2007 to reduce the number of newly occurring digital ulcers in patients with systemic scleroderma and persistent digital ulcers. Bosentan is the first and only drug approved for the treatment of digital ulcers.
- The basis for the approval of bosentan in this indication is the two placebo-controlled, randomised studies RAPIDS-1 and RAPIDS-23(RAndomized Placebo-controlled Investigation of Digital ulcers in Scleroderma)
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- In RAPIDS-1, the number of new ulcers was significantly reduced in the bosentan-treated patients. On average, 2.7 new ulcers occurred in the placebo group, compared to 1.4 in the bosentan group. This means a 48 - percent reduction.
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Bosentan was able to reduce the incidence of new ulcers in patients suffering from digital ulcers at baseline.
- In RAPIDS-2, this effect of bosentan was confirmed (2.7 new ulcers in the placebo group versus 1.9 in the bosentan group, a 30% reduction). The effect of the treatment was already evident after 12 weeks.
- Bosentan improves the quality of life: A subgroup analysis showed that the decrease in the number of digital ulcers is associated with an improvement in the quality of life.
