Tracleer (bosentan) combined with Ventavis (iloprost) reduced abnormalities in the tiny blood vessels in the hands of patients with scleroderma who often experience Raynaud’s phenomenon as a consequence of disrupted blood flow in the capillaries of the hand.
The improved blood vessel appearance was linked to a lower risk of digital ulcers, another symptom of blood flow abnormalities in patients with scleroderma.
The study, “Effect of treatment with iloprost with or without bosentan on nailfold videocapillaroscopic alterations in patients with systemic sclerosis,” was published in the journal Modern Rheumatology.
To study the role of the two drugs in blood flow abnormalities, researchers at the University of Modena and Reggio Emilia recruited 95 scleroderma patients. Sixty-two of the patients were treated with Ventavis alone and 33 received a combination of Tracleer and Ventavis. The patients had initiated the treatment before the study, and were followed for one year.
Those in the combination group had been ill with scleroderma for longer — 139.4 months compared to 93 months among those treated with the single drug. Although they also had a longer duration of Raynaud’s phenomenon — 194.7 months compared to 142.4 months — the difference was not statistically significant.
The research team analyzed capillaries with the help of a method called nailfold videocapillaroscopy, which uses microscopic video recordings of tiny blood vessels at the edge of the nail.
They then calculated what is known as a capillaroscopic skin ulcer risk index. This calculates the number of giant capillaries and compares it to the number of normal vessels.
A high score has been shown to predict the development of new digital ulcers or the persistence of old ones.
The study found that both groups had fewer giant capillaries after 12 months compared to the start of treatment. Only patients receiving a combination treatment with Tracleer and Ventavis had ramified capillaries at the follow-up recording. Ramified capillaries, when a single blood vessel branches into a tree-like bushy network, are considered to represent the growth of new blood vessels.
At the study’s start, 29.1 percent of patients in the single treatment group and 54.5 percent in the group on the combination treatment had an increased skin ulcer risk index.
After 12 months, 9 percent of patients treated with both Tracleer and Ventavis had normalized their index values — a difference that was not statistically significant. In the group treated only with Ventavis, the team noted a significant worsening, with 45.2 percent of patients having an increased score.
The researchers found the therapeutic combination of Ventavis plus Tracleer can improve blood vessel anomalies such as Raynaud’s phenomenon and digital ulcers in patients with systemic sclerosis.