PMID- 32341691
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 13
DP  - 2020
TI  - Teduglutide for the treatment of adults with intestinal failure associated with 
      short bowel syndrome: pooled safety data from four clinical trials.
PG  - 1756284820905766
LID - 10.1177/1756284820905766 [doi]
LID - 1756284820905766
AB  - BACKGROUND: In multiple clinical studies, teduglutide reduced parenteral support 
      (PS) with a consistent safety profile in adults with short bowel 
      syndrome-associated intestinal failure (SBS-IF). The objective of this study was 
      to assess adverse events (AEs) from a pooled data set. METHODS: Safety data from 
      four prospective clinical trials of teduglutide in patients with SBS-IF were 
      assimilated. AEs were evaluated in patient groups based on treatment received in 
      each study and in populations stratified to create distinct subgroups based on 
      aetiology, bowel anatomy and baseline PS volume requirements. RESULTS: Safety 
      data are reported for up to 2.5 years, totalling 222 person-years exposure to 
      teduglutide. In most patients, AEs were reported as mild or moderate in severity 
      in all patient groups and occurred at comparable rates between patients who 
      received teduglutide or placebo. Several common gastrointestinal AEs, including 
      abdominal pain, nausea and abdominal distension, were reported more frequently 
      earlier in the course of treatment, with their frequency declining over time. 
      Fewer gastrointestinal AEs were reported in patients with vascular causes of 
      SBS-IF and patients with most of their colon-in-continuity than in other patient 
      subgroups. Across the patient stratification subgroups, the predominant 
      treatment-emergent AEs for which patients receiving teduglutide had a 
      significantly increased relative risk were abdominal distension and 
      gastrointestinal stoma complication compared with patients receiving placebo. 
      CONCLUSIONS: Teduglutide had a safety profile consistent with prior adult data 
      and no new safety concerns were identified. The most frequently reported AEs were 
      gastrointestinal in origin, consistent with the underlying disease condition and 
      intestinotrophic actions of teduglutide. CLINICAL TRIAL REGISTRY INFORMATION: 
      NCT00081458/EudraCT, 2004-000438-35; NCT00798967/EudraCT, 2008-006193-15; 
      NCT00172185/EudraCT, 2004-000439-27; NCT00930644/EudraCT, 2009-011679-65.
CI  - (c) The Author(s), 2020.
FAU - Pape, Ulrich-Frank
AU  - Pape UF
AUID- ORCID: 0000-0002-5238-8348
AD  - Department of Internal Medicine and Gastroenterology, Asklepios Klinik St. Georg, 
      Lohmuhlenstr. 5, Hamburg, 20099 Germany.
FAU - Iyer, Kishore R
AU  - Iyer KR
AD  - Department of Surgery, Mount Sinai Medical Centre, New York, NY, USA.
FAU - Jeppesen, Palle B
AU  - Jeppesen PB
AD  - Department of Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, 
      Denmark.
FAU - Kunecki, Marek
AU  - Kunecki M
AD  - Department of Nutrition and Department of General and Vascular Surgery, M. 
      Pirogow Hospital, Lodz, Poland.
FAU - Pironi, Loris
AU  - Pironi L
AD  - Department of Digestive System, St. Orsola Hospital, University of Bologna, 
      Bologna, Italy.
FAU - Schneider, Stephane M
AU  - Schneider SM
AD  - Gastroenterologie et Nutrition Clinique, Universite Cote D'Azur, Nice, France.
FAU - Seidner, Douglas L
AU  - Seidner DL
AD  - Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, 
      Vanderbilt University Medical Centre Nashville, TN, USA.
FAU - Lee, Hak-Myung
AU  - Lee HM
AD  - Biostatistics & Statistical Programming, Shire Human Genetic Therapies, Inc., 
      Lexington, MA, USA, a member of the Takeda group of companies.
FAU - Caminis, John
AU  - Caminis J
AD  - Global Drug Safety, Shire, Cambridge, MA, USA, a member of the Takeda group of 
      companies.
LA  - eng
SI  - ClinicalTrials.gov/NCT00930644
PT  - Journal Article
DEP - 20200420
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC7171995
OTO - NOTNLM
OT  - diarrhoea
OT  - gastrointestinal cancer
OT  - gastrointestinal polyps
OT  - inflammatory bowel disease
OT  - large intestine
OT  - malabsorption
OT  - nutrition
OT  - small intestine
OT  - teduglutide
COIS- Conflict of interest statement: The authors declare the following conflicts of 
      interest: Shire is a member of the Takeda group of companies. U-FP and SMS have 
      served as advisory board members for Shire and have received honoraria and 
      research funding from Shire. KRI has served as a consultant for Shire and as a 
      scientific/medical advisory board member for Zealand Pharma. PBJ has served as a 
      speaker's bureau member and consultant for Shire and Zealand Pharma. DLS has 
      served as a consultant for Shire and Zealand Pharma. MK received honoraria as a 
      speaker from Shire. LP has served as a consultant for Baxter, B. Braun, 
      Fresenius-Kabi and Shire. H-ML is an employee of Shire, and JC is a former 
      employee of Shire, a member of the Takeda group of companies.
EDAT- 2020/04/29 06:00
MHDA- 2020/04/29 06:01
PMCR- 2020/04/20
CRDT- 2020/04/29 06:00
PHST- 2019/09/12 00:00 [received]
PHST- 2020/01/02 00:00 [accepted]
PHST- 2020/04/29 06:00 [entrez]
PHST- 2020/04/29 06:00 [pubmed]
PHST- 2020/04/29 06:01 [medline]
PHST- 2020/04/20 00:00 [pmc-release]
AID - 10.1177_1756284820905766 [pii]
AID - 10.1177/1756284820905766 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 
      10.1177/1756284820905766. eCollection 2020.