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Teduglutide required less parenteral support among patients with short bowel syndrome, intestinal failure
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Teduglutide safely and effectively reduced dependency on parenteral support in patients with short bowl syndrome and intestinal failure, according to recent results.
In a multicenter prospective study, researchers administered either 0.05 mg/kg subcutaneous teduglutide (n=43) or placebo (n=43) once daily for 24 weeks to patients with short bowel syndrome with intestinal failure (SBS-IF). All patients had been dependent on parenteral support (PS) for 1 year or longer as a result of SBS-IF.
Significantly more patients receiving teduglutide were responsive to treatment (defined as a reduction of weekly PS volume between 20% and 100%) than those receiving placebo (63% vs. 30%, P=.002). Investigators noted that small bowel length was not predictive of treatment response. Patients without colon in continuity had a greater response rate than those with colon in continuity, but this difference was not statistically significant.
The volume of reduced parenteral support was greater in the treated group at 24 weeks (4.4 ± 3.8 L per week compared with 2.3 ± 2.7 L per week for placebo patients, P<.001 for difference), as was the percentage reduction from baseline (32% ± 19% for treated patients vs. 21% ± 25% among those receiving placebo, P=.03). Significantly more evaluable patients experienced a reduction of 1 day or more in their weekly need for support (54% of treated patients compared with 23% of placebo patients, P=.005).
The majority of patients (83% of treated; 79% of placebo) experienced one or more treatment-emergent adverse events. Serious events occurred in 36% of cases in the treated group and 28% of those in the placebo group. Commonly reported events among treated patients included abdominal pain or distension, nausea and GI stoma complications. Two treated patients and three receiving placebo discontinued treatment because of nonserious treatment-related events.
“In a 24-week study, teduglutide was safe and well tolerated, facilitated reduction in PS volume, and provided days off PS in patients with SBS-IF,” the researchers wrote. “In this relatively rare and heterogeneous condition, teduglutide can reduce malabsorption-related consequences … PS-related inconveniences … and potentially life-threatening complications. Based on the findings of this study, teduglutide could positively add to the limited treatment armamentarium.”
Disclosure: See the study for a full list of relevant disclosures.
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