More data on teduglutide indicate its potential for short bowel syndrome (SBS) (Gastroenterol 2012; 143: 1473-81, editorial 1416-20). Treatments for SBS are needed. One year of parenteral nutrition often costs the health care system in excess of $100,000 per year. This cost does not account for laboratory studies, health care visits, complications, and hospitalizations. Treatment of intestinal failure with transplantation “may cost upwards of $1 million.”
In this study of adult patients with an average of 50 years, teduglutide was given in a prospective randomized double-blind study to 42 patients and another 43 patients received placebo. The dose of 0.05 mg/kg/day via subcutaneous injection was chosen based on a previous trial which showed that a higher dose was less effective. Among these patients, the most common reasons for SBS were vascular disease (34%), Crohn’s disease (21%), volvulus (11%), and injury ((9%).
- Teduglutide over a 24-week study was more effective than placebo. 63% of study patients had a drop in parenteral nutrition requirement of more than 20% compared with only 30% of the placebo group.
- The mean reduction in parenteral nutrition support of teduglutide-treated patients was 4.4 L/week compared with 2.3 L/week for placebo-treated patients.
- Citrulline, a biomarker of mucosal mass, was increased in the teduglutide group. In the treatment group, citrulline increased by 20.6 μmol/L compared with 0.7 μmol/L for the placebo group.
How does teduglutide work? Teduglutide is a much more stable analog of glucagon-like peptide-2 (GLP-2). The latter is released by the distal small bowel and colon. GLP-2 promotes intestinal epithelial growth and increases transit time.
What are the adverse effects of teduglutide? First, there is a concern that teduglutide could promote colonic adenomas based on studies in mice. GLP-2 receptors are present in the lung, and brain (including hypothalamus); its effects in these areas is poorly understood. In addition, abdominal pain, distention, nausea, peripheral edema, and nasopharyngitis were more common in the treatment group. The long-term consequences of teduglutide therapy are not known.