SBS is a highly disabling condition that impairs quality of life and can lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel. There are an estimated 10,000 to 15,000 SBS patients in North America who are dependent on parenteral nutrition (PN), the cost of which can exceed $100,000 annually per patient. SBS patients suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to an inability to absorb adequate amounts of nutrients, fluid, and electrolytes. The goals of current treatment are to maintain fluid, electrolytes and nutrient balances through dietary management, including the use of PN. Long-term complications of the condition may include an increased risk of systemic infections due to the presence of an intravenous feeding line, degenerative changes in the bones and nerves due to vitamin and mineral deficiencies, and liver failure. Potential benefits derived from reduced dependence on PN may include improved nutrition and hydration, lower rates of infections, and improved quality of life due to more time away from PN, which may provide greater mobility and improved sleep. 

Patient enrollment has begun in a Phase 3 registration study to confirm previously reported data that demonstrated GATTEX(TM) (teduglutide) was well tolerated and reduced parenteral nutrition (PN) dependence in short-bowl syndrome (SBS) patients. The international, double-blind, placebo-controlled safety and efficacy study of GATTEX is known as STEPS (Study of TEduglutide in PN-dependent Short-bowel syndrome). For more information on STEPS, please click here.