- The primary endpoint was defined as a patient achieving a ≥20% reduction in weekly parenteral support (PS) volume from baseline (immediately before randomization) to Weeks 20 and 24
- Efficacy analysis was performed by comparing the intent-to-treat population in the treatment group and placebo group, respectively1,5
- PS volume adjustments (up to a 30% decrease) and clinical assessments were made at Weeks 2, 4, 8, 12, 20, and 241
How GATTEX works
The half-life of naturally occurring GLP-2 is ~7 minutes. The half-life of GATTEX is ~1.3 hours in adult patients.1,2
GATTEX enhanced intestinal absorption in patients with short bowel syndrome (SBS)3
IN ADULTS, RESULTS SHOWED THAT GATTEX HAD THE ABILITY TO INCREASE INTESTINAL ABSORPTION1,3*
GATTEX enhanced gastrointestinal fluid (wet weight) absorption by approximately 750-1000 mL/day1
The ability of GATTEX to improve intestinal absorption was studied in 17 adult subjects with SBS (n=2—3 per dose group) using daily doses of 0.03, 0.1, or 0.15 mg/kg (doses ranging from 0.6 to 3 times the recommended dose) in a 21-day, open-label, multicenter, dose-ranging study. Fourteen of 17 patients were dependent on parenteral support (PS). All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750 to 1000 mL/day, and increased villus height and crypt depth of the intestinal mucosa.
The recommended dosage of GATTEX for both adult and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2) is 0.025 mg/kg once daily.