Original ResearchClinical—Alimentary TractTeduglutide Reduces Need for Parenteral Support Among Patients With Short Bowel Syndrome With Intestinal Failure
Section snippets
Materials and Methods
All authors had access to the study data and have reviewed and approved the final manuscript.
Patients
From November 2008 to January 2011, one hundred and thirty-two patients who signed informed consent forms were screened, 86 were randomized, and 78 completed the dosing period (Supplementary Figure 1). There were no significant differences between treatment groups regarding demographic characteristics and medications at baseline (Table 3). A total of 39 patients (17 in the teduglutide group and 22 in the placebo group) required optimization of PN/IV volume before entering the stabilization
Discussion
In this phase 3 study, teduglutide met the primary efficacy end point, defined as the percentage of patients who achieved a 20% to 100% reduction in weekly PS volume at weeks 20 and 24 compared with baseline. There were 27/43 (63%) responders in the teduglutide group and 13/43 (30%) in the placebo group (P = .002). When addressing the proabsorptive effects of teduglutide, improvements in intestinal fluid absorption under ideal circumstances should be counterbalanced by equivalent PN/IV volume
Appendix
The participating investigators for this study were as follows: C. Compher, University of Pennsylvania School of Nursing, Philadelphia, PA; D. Kirby, Cleveland Clinic, Cleveland, OH; T. Ziegler, Atlanta Clinical and Translational Science Institute, Atlanta, GA; K. Fujioka, Scripps Clinical Research Services, LaJolla, CA; K. Olden, Washington Hospital Center, Washington, DC; J. Allard, Toronto General Hospital, University Health Network, Toronto, ON, Canada; K. Jeejeebhoy, Polyclinic Family and
Acknowledgments
The authors thank the Investigators in the Teduglutide 020 Study Group (Appendix) and Professor Augusta Palmo of the Physiopathology Department, University of Turin, and Professor Peter Layer of the Israelitischen Krankenhauses in Hamburg for their contributions to the study design, and Benjamin Li and Henry Chu of NPS Pharmaceuticals (Bedminster, NJ) for their statistical analyses.
Editorial assistance was provided by Peter A. Rittenhouse, PhD and Maryann Travaglini, PharmD, of Complete
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Conflicts of interest The authors disclose the following: Palle B. Jeppesen, Marek Pertkiewicz, Bernard Messing, Kishore Iyer, Douglas L. Seidner, Stephen J. D. O'Keefe, and Alastair Forbes have served on the advisory board of and as consultants for NPS Pharmaceuticals. Hartmut Heinze is an employee at Nycomed GmbH and Bo Joelsson is an employee at NPS Pharmaceuticals.
Funding This research was funded by NPS Pharmaceuticals and Nycomed, a Takeda company.