Budesonide ER for Ulcerative Colitis Safe Regardless of Gender, Age
Adults with mild to moderate UC symptoms for ≥6 months received 1 of 2 doses of oral budesonide MMX or placebo once per day for up to 8 weeks.
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DENVER — Budesonide extended-release tablets (multimatrix [MMX]) for ulcerative colitis (UC) remission is safe to use regardless of age or gender, according to research presented at the American Association of Nurse Practitioners (AANP) 2018 National Conference.
Brian P. Bosworth, MD, from NYU Langone Medical Center in New York City, and colleagues conducted a pooled analysis of data derived from separate phase 3, randomized, double-blind, placebo-controlled studies to assess the safety of budesonide MMX treatment in specific patient subgroups. A total of 767 adults with mild to moderate UC symptoms for a duration of ≥6 months were randomly assigned to receive oral budesonide MMX 6 mg (n=254), budesonide MMX 9 mg (the recommended dose; n=255), or placebo (n=258) once per day for up to 8 weeks. The majority of patients were aged ≤60 years (89%), men (56.1%), and white (74.6%).
Exacerbation, relapse, or worsening of UC (16.5% vs 13.3% vs 14.0%); headache (14.6% vs 11.4% vs 10.5%); and nausea (4.7% vs 5.1% vs 4.3%) were the most frequently noted adverse events in the overall population for budesonide MMX 6 mg vs 9 mg vs placebo, respectively. For patients aged ≤60 years, common adverse events were exacerbation, relapse, or worsening of UC (15.8% vs 13.9% vs 13.8%); headache (15.3% vs 11.8% vs 11.6%); and nausea (4.5% vs 5.1% vs 4.5%). In patients aged >60 years, exacerbation, relapse, or worsening of UC (21.9% vs 5.6% vs 14.7%); headache (9.4% vs 5.6% vs 2.9%); and upper abdominal pain (6.3% vs 16.7% vs 0.0%) were the adverse events reported most frequently. Men and women experienced a similar incidence of adverse events across all treatment groups.
“Budesonide MMX for the induction of UC remission was generally safe and well tolerated and was not influenced by age or gender,” the authors concluded. “Furthermore, as the subgroup analyses show, no new safety signals were identified that should concern nurse practitioners when treating patients [with UC].”
Disclosure: The study was supported by Salix Pharmaceuticals. The authors report being either a consultant to or employee of Salix Pharmaceuticals.
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Bosworth BP, Landers M, Slatkin N. Lack of influence of elderly age and gender on the safety profile of budesonide extended-release tablets for ulcerative colitis. Presented at the American Association of Nurse Practitioners (AANP) 2018 National Conference. June 26-July 1, 2018; Denver, CO. Industry Scientific Poster 16.