Safety of intravenous pantoprazole sodium in paediatric patients aged 1 year to <2 years: a real-world retrospective cohort study in the USA.

OBJECTIVE

To estimate the incidence rates (IRs) of outcomes of interest in paediatric patients (aged 1 to <2 years) treated with intravenous pantoprazole.

METHODS

This real-world, non-interventional, retrospective study was conducted using Optum's longitudinal electronic health records database between 1 January 2007 and 31 December 2020. Eligible patients receiving ≥1 dose of intravenous pantoprazole were included. Premature patients and those with birth weight <2.36 kg were excluded. Patients were divided into three subgroups based on diagnosis of gastro-oesophageal reflux disease (GORD) and erosive oesophagitis (EO): subgroup 1 (GORD and EO), subgroup 2 (GORD and no EO) and subgroup 3 (absence of both GORD and EO). The IRs (per 1000 person-years) of outcomes of interest were estimated in the overall and subgroups and stratified by duration of intravenous pantoprazole treatment (<4 days vs ≥4 days).

RESULTS

Of 981 patients, none were identified in subgroup 1, while subgroup 2 and subgroup 3 comprised 462 (47.1%) and 519 (52.9%) patients, respectively. The highest IRs in the overall cohort were observed for vomiting (711.8), diarrhoea (412.4), abdominal distension (234.9), hypokalaemia (195.4) and hyponatraemia (182.5) with comparable IRs between subgroups 2 and 3. The IRs were higher for vomiting, diarrhoea, hypokalaemia, abdominal distension, hyponatraemia and thrombocytopenia in patients receiving ≥4 days of pantoprazole treatment versus <4 days.

CONCLUSION

The real-world incidence of the outcomes of interest is consistent with the established safety profile of pantoprazole and may provide key insights for use of intravenous pantoprazole in paediatric patients excluding those born preterm or with low birth weight.