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Eosinophilic esophitis (EOE) is a chronic inflammatory disease.
partial swallowing of corticosteroids can relieve active EOE patients, but its long-term effects have not been confirmed.
recently conducted a double-blind study to examine the efficacy and safety of clinical remission maintenance in EOE patients in two doses of Budinide dispersion tablets (BOT) compared to placebos.
204 clinical and histologically remission EEOE patients at 29 clinical centres in Europe were involved in the study and were randomly accepted with 0.5 mg BOT (2 times daily, n-68), 1.0 mg BOT (2 times daily, n-68) or placebo (n-68) for 48 weeks.
main endpoint is remission maintenance, defined as premature withdrawal without clinical and histological recurrence and without any cause.
the end of the study.
73.5 percent of patients in the 0.5 mg BOT group achieved remission maintenance, compared with 75 percent in the 1.0 mg BOT group, 4.4 percent in the placebo group, and an average of 87 days in the placebo group.
BOT group had a similar frequency of adverse events compared to placebo.
serum cortisol levels were in the normal range at baseline, there was no significant change during treatment, and asymptomatic serum cortisol levels decreased in 4 BOT patients.
16.2% of patients in the 0.5mg BOT group developed clinically suspected Candide disease, compared with 11.8% in the 1.0mg group, and the symptoms disappeared after treatment.
III study confirmed that 0.5 or 1.0 mg of Budinide dispersion tablets twice a day were effective in maintaining long-term clinical remission in patients with eosinophilic esophedritis.
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