WEDNESDAY, Dec. 12 (HealthDay News) -- For patients with short bowel syndrome with intestinal failure (SBS-IF), the glucagon-like peptide 2 analogue teduglutide appears to be safe and reduces the number of days off parenteral support, according to a phase 3 study published in the December issue of Gastroenterology.
Palle B. Jeppesen, M.D., from Rigshospitalet in Copenhagen, Denmark, and colleagues conducted a 24-week study involving patients with SBS-IF who were given once-daily subcutaneous teduglutide (0.05 mg/kg/day; 43 patients) or placebo (43 patients). If 48-hour urine volumes exceeded baseline values by 10 percent or more, parenteral support was reduced.
The researchers found that at weeks 20 and 24 there were significantly more patients with >20 percent reduction in parenteral support volume from baseline among those in the teduglutide group (63 percent) compared with the placebo group (30 percent). The mean reduction in parenteral support volume at 24 weeks was 4.4 ± 3.8 L/week and 2.3 ± 2.7 L/week in the teduglutide and placebo groups, respectively. There was a significantly greater percentage of patients in the teduglutide group with a one-day or more reduction in the weekly need for parenteral support (54 percent) compared to the placebo group (23 percent). Plasma concentrations of citrulline, a biomarker of mucosal mass, increased with teduglutide. Treatment-emergent adverse events were similar between the two groups (two in the teduglutide group and three in the placebo group).
"Twenty-four weeks of teduglutide treatment was generally well tolerated in patients with SBS-IF," the authors write. "Treatment with teduglutide reduced volumes and numbers of days of parenteral support for patients with SBS-IF."
Several authors disclosed financial ties to NPS Pharmaceuticals and Nycomed, both of which funded the study.