GATTEX was evaluated in 2 clinical trials
In the 6-month STEPS study
- 86 adults with SBS were studied
- Adults with SBS needed PS at least 3 times a week for at least a year
- Of the 86 participants, 43 received GATTEX and 43 received placebo once a day
In the 24-month STEPS-2 study
- 88 adults with SBS were studied
- 76 adults had participated in STEPS (37 received GATTEX, 39 received placebo) and were enrolled in STEPS-2 after STEPS ended
- 12 of the 88 adults had not participated in STEPS and had never been treated with GATTEX before
- In STEPS-2, all participants were treated with GATTEX once a day and were told that they were being treated with GATTEX
GATTEX was studied in a range of adults
Characteristics of participants at the beginning of the STEPS study
Tertiary Subtle
Tertiary
AVERAGE
RANGE
Age
50 years old
18-82 years
Estimated small bowel length
77.3 cm
5-343 cm
Length of time on PS
6 years
1-26 years
Prescribed days per week on PS
5.73 days
3-7 days
Infusion volume
13 L/week
0.9-35 L/week
Study patients had varying types of intestinal resection; for example, some kept an intact large intestine and/or lower small intestine, some required a stoma, and some did not.
The most common reasons for intestinal resection included vascular disease, Crohn’s disease, or other.
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