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Abstract
Objectives Increased acid-suppressive therapy (AST) usage during infancy is seen worldwide, while the data on the risk for paediatric fractures associated with these drugs are scarce. We aimed to evaluate the risk for fractures associated with early-life usage of AST.
Methods This population-based retrospective propensity-matched cohort study included children born between 2005 and 2016 who used AST during the first year of life, and a 3:1 matched unexposed group. Study subjects were followed from the end of the first year of life until the earliest of the following: an outcome event (either fracture or non-fracture injury, separately), age of 10 or August 2022. The cumulative incidence of fractures and the HR of AST for fracture and non-fracture injury as negative control were calculated.
Results A total of 13 894 eligible AST users and 41 418 propensity score-matched non-users were included in the analysis. The cumulative incidence of fracture among children with AST (23.7%) was significantly (p<0.001) higher than non-users (21.7%) corresponding to an HR of 1.11 (95% CI 1.06 to 1.16). The HR for one to two AST purchases versus none was 1.09 (95% CI 1.04 to 1.14) and the HR for 3+ AST purchases versus none was 1.25 (95% CI 1.13 to 1.39). AST was also associated with injuries by an HR of 1.09 (95% CI 1.04 to 1.13).
Conclusions AST was associated with a small but statistically significant increased incidence of fractures. We cannot exclude reporting bias or residual confounders. The clinical inference is currently unclear.
- gastroenterology
- epidemiology
- paediatrics
Data availability statement
According to the Israel Ministry of Health regulations, individual-level data cannot be shared openly. Specific requests for remote access to de-identified community-level data should be referred to Maccabitech, Maccabi Healthcare Services Institute for Research & Innovation.
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Data availability statement
According to the Israel Ministry of Health regulations, individual-level data cannot be shared openly. Specific requests for remote access to de-identified community-level data should be referred to Maccabitech, Maccabi Healthcare Services Institute for Research & Innovation.
Footnotes
AB-T and IG are joint senior authors.
AB-T and IG contributed equally.
Presented at This work was presented at the 55th ESPGHAN Annual Conference, Vienna, Austria, May 2023 (G-O045), and at the IESPGHAN Annual Conference, Jerusalem, Israel, November 2022.
Contributors TA conceptualised and designed the study and drafted the initial manuscript. GC, SC and RS conceptualised the study and critically reviewed the manuscript for important intellectual content. IG and AB-T conceptualised and designed the study, coordinated, and supervised data collection, and critically reviewed the manuscript for important intellectual content. AB-T
is the guarantor. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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