Findings over 16 weeks among patients with systemic sclerosis and active ischemic digital ulcers
WEDNESDAY, May 11, 2016 (HealthDay News) — The endothelin-1 blocker macitentan does not reduce the number of new digital ulcers over 16 weeks among patients with systemic sclerosis and active ischemic digital ulcers, according to a study published in the May 10 issue of the Journal of the American Medical Association.
Dinesh Khanna, M.D., from the University of Michigan Scleroderma Program in Ann Arbor, and colleagues randomized patients with systemic sclerosis and active digital ulcers to receive oral doses of 3 mg macitentan, 10 mg macitentan, or placebo once daily in two international trials (DUAL-1, DUAL-2).
The researchers found that among the 226 randomized patients who completed DUAL-1, the adjusted mean number of new digital ulcers per patient over 16 weeks was 0.94, 1.08, and 0.85 in the 3-mg macitentan, 10-mg macitentan, and placebo groups, respectively (absolute differences, 0.09 [95 percent confidence interval, −0.37 to 0.54] for 3 mg of macitentan versus placebo and 0.23 [95 percent confidence interval, −0.27 to 0.72] for 10 mg of macitentan versus placebo). Among the 216 randomized patients who completed DUAL-2, the adjusted mean number of new digital ulcers was 1.44, 1.46, and 1.21 in the 3-mg macitentan, 10-mg macitentan, and placebo groups, respectively (absolute differences, 0.23 [95 percent confidence interval, −0.35 to 0.82] for 3 mg of macitentan versus placebo and 0.25 [95 percent confidence interval, −0.34 to 0.84] for 10 mg of macitentan versus placebo). Headache, peripheral edema, skin ulcer, anemia, upper respiratory tract infection, diarrhea, and nasopharyngitis were more frequently associated with macitentan versus placebo.
“These results do not support the use of macitentan for the treatment of digital ulcers in this patient population,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Actelion, which manufactures macitentan and funded DUAL-1 and DUAL-2.
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