In children with SBS-IF, 0.025 mg/kg teduglutide achieved PS response in 13 (54.2%) versus 1 (11.1%) with standard care (P < 0.05).
In plain wordsIn children with SBS-IF, low-dose teduglutide produced support reduction responses more often than standard care.
- Peptide
- Teduglutide
- Outcome
- IncreaseAt least 20% PS reduction at week 24
- Study
n: not reported in source
- Comparator
- Standard of care
- Analysis
- Primary
- Outcome group
- Intensive care and hospital outcomes · Gastrointestinal
- Studied dose
- 0.025 mg/kg once daily · 24 weeksAs given in this study (human).
Measurements
- Patients achieving >=20% PS reduction
- 13 patients
- 0.025 mg/kg teduglutide
- Patients achieving >=20% PS reduction
- 54.2%
- 0.025 mg/kg teduglutide
- Patients achieving >=20% PS reduction
- 1 patient
- SOC
- Patients achieving >=20% PS reduction
- 11.1%
- SOC
Source sentences
The primary end point was achieved by 13 (54.2%), 18 (69.2%), and 1 (11.1%) patients who received 0.025 mg/kg teduglutide, 0.05 mg/kg teduglutide, and SOC, respectively (P < 0.05 vs SOC).
3 context sentences(design, population, supporting numbers)
The primary efficacy/pharmacodynamic end point was the number of patients who achieved a ≥20% reduction in parenteral support (PS) from baseline at week 24.
A 24-week, phase III trial with 2 randomized, double-blind teduglutide dose groups and a nonblinded standard of care (SOC) arm was used; patients received 0.025 mg/kg or 0.05 mg/kg teduglutide once daily.
All 59 enrolled patients completed the study (0.025 mg/kg, n = 24; 0.05 mg/kg, n = 26; SOC, n = 9).