-- Study available online in Gastroenterology --
“This crucial study demonstrates the potential of Gattex to be an
important treatment option for patients with short bowel syndrome,” said
Methodology and Results
Researchers performed a 24-week study of patients with SBS-IF who were given either daily subcutaneous dosing of 0.05 mg/kg teduglutide (n=43) or placebo (n=43). Parenteral support (PS) was reduced if 48-hour urine volumes exceeded baseline values by 10 percent. The primary efficacy endpoint was defined as the number of patients who achieved a 20 to 100 percent reduction in weekly PS volume, from baseline, at Weeks 20 and 24.
There were significantly more responders in the teduglutide group (27 of 43) than the placebo group (13 of 43, p=.002). At Week 24, patients who received teduglutide experienced an average 4.4 liter reduction in weekly PS volume from a baseline of 12.9 liters. Patients who received placebo experienced an average 2.3 liter reduction from a baseline of 13.2 liters (p<.001).
After completing 24 weeks of treatment, 54 percent (21 of 39) of teduglutide-treated patients were able to reduce the number of infusion days per week by one or more days, compared to 23 percent (9 of 39) of those treated with placebo (p=0.005).
The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n=2) or placebo (n=3). The most commonly reported adverse events were gastrointestinal-related and appear to be consistent with the pharmacological effects of the drug.
The research was funded by NPS and Nycomed, a Takeda company. The study, titled “Teduglutide Reduces Need for Parenteral Support Among Patients with Short Bowel Syndrome with Intestinal Failure,” is now published online at http://www.gastrojournal.org/current.
About Short Bowel Syndrome
Short bowel syndrome (SBS) is a highly disabling condition that can impair a patient's quality of life and lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions. SBS patients often suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for SBS is nutritional support, including parenteral nutrition (PN) and/or intravenous (IV) fluids to supplement and stabilize nutritional needs.
Although PN can provide nutritional support for SBS patients, it does not improve the body's own ability to absorb nutrients. PN is associated with serious complications, such as infections, blood clots or liver damage, and the risks increase the longer patients are on PN. Patients on PN often experience poor quality of life with difficulty sleeping, and frequent urination, and patients receiving chronic PN often experience a loss of independence.
About Gattex® (teduglutide)
Gattex (teduglutide) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. It has been developed to reduce dependence on parenteral nutrition (PN) in adult patients with short bowel syndrome (SBS). Significant reductions in mean PN/IV infusion volume from baseline to end of treatment were seen in the Phase 3 studies of teduglutide. In addition, some patients were able to be weaned off PN during these trials. The most common treatment-emergent adverse events with Gattex in the placebo-controlled studies that occurred at a higher frequency with Gattex were abdominal pain, upper respiratory tract infections, nausea, injection site reactions, abdominal distension, headaches, and gastrointestinal stoma complications.
Gattex has received orphan drug designation for the treatment of SBS
In 2007, NPS granted Nycomed, a Takeda company, the rights to develop
and commercialize teduglutide outside
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