The Annals of pharmacotherapy · 2014
Teduglutide for the Treatment of Short Bowel Syndrome.
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Wilhelm Sheila M, Lipari Melissa, Kulik Janice K, Kale-Pradhan Pramodini B
Аннотация
OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of the newly approved drug, teduglutide, for the treatment of short bowel syndrome (SBS).
DATA SOURCES: Literature was retrieved through PubMed (1966-March 2014) using the search term teduglutide. The authors applied the filters Humans and English language, resulting in 47 publications.
STUDY SELECTION AND DATA EXTRACTION: The authors reviewed the 47 citations to extract those that were published clinical trials. Bibliographies of recent review articles and editorials were evaluated for additional pertinent publications for inclusion. The methods and results from each of the trials were extracted.
DATA SYNTHESIS: Teduglutide has been studied in SBS in 3 phase III trials. Teduglutide decreases parenteral nutrition (PN) volume requirements, with 1 study showing a reduction of 4.4 ± 3.8 L/wk with teduglutide 0.05 mg/kg versus 2.3 ± 2.7 L/wk with placebo; P < 0.001. In another study, teduglutide improved graded response scores, which are based on the intensity and duration of the reduction of PN use (16/35 assigned to teduglutide 0.05 mg/kg vs 1/16 assigned to placebo; P = 0.007). The dosing range studies have indicated that the optimal dose of teduglutide is 0.05 mg/kg daily subcutaneously. There are a number of adverse effects reported in the trials, including abdominal pain or distention, injection site reactions, nausea, headaches, and fluid overload among others. There is also a concern for the development of malignancy with teduglutide, and therefore, it is not recommended in patients with active gastrointestinal malignancies.
CONCLUSIONS: Overall, teduglutide appears to be a promising agent for the treatment of SBS.
DATA SOURCES: Literature was retrieved through PubMed (1966-March 2014) using the search term teduglutide. The authors applied the filters Humans and English language, resulting in 47 publications.
STUDY SELECTION AND DATA EXTRACTION: The authors reviewed the 47 citations to extract those that were published clinical trials. Bibliographies of recent review articles and editorials were evaluated for additional pertinent publications for inclusion. The methods and results from each of the trials were extracted.
DATA SYNTHESIS: Teduglutide has been studied in SBS in 3 phase III trials. Teduglutide decreases parenteral nutrition (PN) volume requirements, with 1 study showing a reduction of 4.4 ± 3.8 L/wk with teduglutide 0.05 mg/kg versus 2.3 ± 2.7 L/wk with placebo; P < 0.001. In another study, teduglutide improved graded response scores, which are based on the intensity and duration of the reduction of PN use (16/35 assigned to teduglutide 0.05 mg/kg vs 1/16 assigned to placebo; P = 0.007). The dosing range studies have indicated that the optimal dose of teduglutide is 0.05 mg/kg daily subcutaneously. There are a number of adverse effects reported in the trials, including abdominal pain or distention, injection site reactions, nausea, headaches, and fluid overload among others. There is also a concern for the development of malignancy with teduglutide, and therefore, it is not recommended in patients with active gastrointestinal malignancies.
CONCLUSIONS: Overall, teduglutide appears to be a promising agent for the treatment of SBS.