Early treatment with Tracleer (bosentan) may delay the development of pulmonary arterial hypertension (PAH) in people with scleroderma, according to a study that compared patients who had never used this medicine with those taking it for digital ulcers.
If confirmed in other studies, the finding has the potential to radically change the prognosis for numerous scleroderma patients, deemed at risk of PAH.
The study, “Beneficial effects of long-term treatment with bosentan on the development of pulmonary arterial hypertension in patients with systemic sclerosis,” was published in the Journal of International Medical Research.
Scleroderma patients, particularly those with limited cutaneous disease, are at risk of developing PAH, a condition that currently affects up to 30 percent of all patients. Tracleer is approved in both the European Union and the U.S. as a PAH treatment, and is also prescribed in Europe to treat digital ulcers in scleroderma patients — a symptom that typically develops earlier than PAH.
Since Tracleer, an oral medication, prevents disease-causing events that change the anatomy of blood vessels — the underlying cause of PAH as well as digital ulcers — researchers at the University of Genoa in Italy explored if Tracleer could be used not only to treat PAH when it emerges, but possibly to prevent it from developing in the first place.
The team recruited 69 scleroderma patients during 2003, and followed them until the end of 2014. No patients had any signs of PAH when they entered the study. Those who developed digital ulcers during the study received treatment with Tracleer 62.5 mg twice daily for 4 weeks, and then 125 mg twice a day. Patients who did not develop ulcers were considered the control group.
Those receiving Tracleer were treated for an average of 6.75 years, and none of these 25 patients developed PAH during the 12 years they were monitored. Researchers also noted that their lung arterial pressure dropped during the study, along with improvements in the 6-minute walking distance test (a test to assess exercise capacity) and the Borg dyspnoea index, measuring shortness of breath.
In contrast, seven control patients developed PAH, and the average lung arterial pressure in the group increased during the study. Their results on the 6-minute walking distance test and the Borg dyspnoea index also worsened. In addition, levels of NT-proBNP, a marker of heart disease, increased in control patients during the study, while it was lowered in the group treated with Tracleer.
“In conclusion, long-term treatment with bosentan improves endothelial function and reduces the risk of PAH development in patients with systemic sclerosis. Early initiation of bosentan treatment may reduce the progression of pulmonary arterial impairment in these patients,” the researchers concluded.
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