Impact of teduglutide on pediatric short bowel syndrome: A systematic review and trial sequential meta-analysis.

Abstract

<h4>Background</h4>Pediatric short bowel syndrome (SBS) poses management challenges, and teduglutide is a potential therapy. However, comprehensive data on its pediatric safety are lacking.<h4>Aim</h4>To evaluate the impact of teduglutide on infection and gastrointestinal adverse events in pediatric SBS patients <i>via</i> systematic review and meta-analysis.<h4>Methods</h4>Following PRISMA 2009 guidelines and PROSPERO registration, we searched PubMed, Web of Science, and EMBASE for randomized controlled trials (RCTs) (pediatric SBS patients ≤ 18 years; teduglutide <i>vs</i> placebo/standard care). Two reviewers screened studies, extracted data, and assessed bias (ROB2). Meta-analyses used RevMan 5.4 (Mantel-Haenszel method, random-effects if <i>I</i> ² ≠ 0). Trial sequential analysis and GRADE were applied.<h4>Results</h4>Three RCTs involving 115 pediatric patients were included. Pooled analysis revealed no statistically significant differences between the teduglutide and control groups for the primary outcome of infection events [RR = 0.83; (95%CI: 0.44-1.56); <i>P</i> = 0.57; <i>I</i> ² = 0%; 2 studies, <i>n</i> = 55]. Similarly, no significant differences were found for secondary outcomes: Upper respiratory tract infection [RR = 0.68; (95%CI: 0.32-1.47); <i>P</i> = 0.33; <i>I</i> ² = 0%], catheter site infection [RR = 1.86; (95%CI: 0.23-14.78); <i>P</i> = 0.56; <i>I</i> ² = 0%], vomiting [RR = 1.35; (95%CI: 0.10-18.23); <i>P</i> = 0.82; <i>I</i> ² = 72%], abdominal pain [RR = 2.47; (95%CI: 0.50-12.16); <i>P</i> = 0.27; <i>I</i> ² = 0%], nausea [RR = 1.31; (95%CI: 0.24-7.22); <i>P</i> = 0.75; <i>I</i> ² = 0%], diarrhea [RR = 1.02; (95%CI: 0.23-4.43); <i>P</i> = 0.98; <i>I</i> ² = 0%], and abdominal distension [RR = 1.49; (95%CI: 0.18-12.35); <i>P</i> = 0.71; <i>I</i> ² = 0%]. The overall certainty of evidence assessed by GRADE was moderate.<h4>Conclusion</h4>Teduglutide does not increase infection or gastrointestinal adverse event risk in pediatric SBS, but small sample sizes limit conclusions. Larger studies are needed.