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Long-term teduglutide associated with reduced parenteral nutrition/IV support
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SAN DIEGO — Extended treatment with teduglutide resulted in significantly lower parenteral nutrition and/or intravenous fluid volume requirements among patients with intestinal failure associated with short bowel syndrome, a speaker said here.
“Teduglutide on a daily basis reduces their TPN [total parenteral nutrition] and IV fluid requirements by enhancing intestinal absorption,” Lauren K. Schwartz, MD, of the division of gastroenterology at Mount Sinai School of Medicine, said during the American College of Gastroenterology Annual Scientific Meeting. “Use of this drug actually reduces their diarrheal symptoms, improves their enteral tolerance and ultimately reduces their need for supplemental fluid.”
Researchers in the 2-year, multicenter, open-label STEPS-2 clinical trial extended research begun in the 24-week, placebo-controlled STEPS trial. The study enrolled 88 patients to receive 24 months of subcutaneous teduglutide (Gattex, NPS Pharmaceuticals); group 1 (n=37) had previously received 24 weeks of teduglutide, group 2 (n=39) had received placebo in the previous trial, and group 3 (n=12) was composed of individuals who qualified for the previous trial but were not enrolled.
At 24 months, 93% of patients who remained in group 1 achieved clinical response of 20% to 100% reduction from baseline in weekly PN/IV volume, while 55% of group 2 and 67% of group 3 reached similar responses.
Group 1 patients displayed a mean PN/IV volume reduction from baseline of 66%; group 2, 28% reduction; and group 3, 39% reduction.
Sixty percent of group 1 patients also achieved at least 3 fewer days per week off PN/IV, compared with 17% of group 2 and 33% of group 3. Thirteen patients, 10 from group 1, achieved independence from PN/IV.
Sixty-four percent of patients reported serious adverse events; and treatment-emergent adverse events occurred in 95% of cases, including abdominal pain (34%), catheter sepsis (28%) and decreased weight (25%). Twenty-three patients discontinued treatment.
Disclosure: Schwartz is a consultant for NPS Pharmaceuticals, which funded the research.
For more information:
Schwartz L. #171: Long-term Safety and Efficacy of Teduglutide for the Treatment of Intestinal Failure Associated with Short Bowel Syndrome: Final Results of the STEPS-2 Study, a 2-year, Multicenter, Open-label Clinical Trial. Presented at: the 2013 American College of Gastroenterology Annual Scientific Meeting; Oct. 11-16, San Diego.