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

BACKGROUND

Pediatric short bowel syndrome (SBS) poses management challenges, and teduglutide is a potential therapy. However, comprehensive data on its pediatric safety are lacking.

AIM: To evaluate the impact of teduglutide on infection and gastrointestinal adverse events in pediatric SBS patients via systematic review and meta-analysis.

METHODS

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 vs 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 2 ≠ 0). Trial sequential analysis and GRADE were applied.

RESULTS

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); P = 0.57; I 2 = 0%; 2 studies, n = 55]. Similarly, no significant differences were found for secondary outcomes: Upper respiratory tract infection [RR = 0.68; (95%CI: 0.32-1.47); P = 0.33; I 2 = 0%], catheter site infection [RR = 1.86; (95%CI: 0.23-14.78); P = 0.56; I 2 = 0%], vomiting [RR = 1.35; (95%CI: 0.10-18.23); P = 0.82; I 2 = 72%], abdominal pain [RR = 2.47; (95%CI: 0.50-12.16); P = 0.27; I 2 = 0%], nausea [RR = 1.31; (95%CI: 0.24-7.22); P = 0.75; I 2 = 0%], diarrhea [RR = 1.02; (95%CI: 0.23-4.43); P = 0.98; I 2 = 0%], and abdominal distension [RR = 1.49; (95%CI: 0.18-12.35); P = 0.71; I 2 = 0%]. The overall certainty of evidence assessed by GRADE was moderate.

CONCLUSION

Teduglutide does not increase infection or gastrointestinal adverse event risk in pediatric SBS, but small sample sizes limit conclusions. Larger studies are needed.