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Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study

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Abstract

Objective

To estimate the incidence rates (IR) of prespecified outcomes of interest in pediatric patients (1 month to < 1 year) treated with intravenous (IV) pantoprazole using Optum’s longitudinal electronic health records database (Optum Market Clarity) from the United States (US).

Methods

This real-world, non-interventional, retrospective cohort study was conducted from 01 January 2007 to 31 December 2020 in patients who received IV pantoprazole. Premature patients and those weighing < 2.36 kg were excluded. Patients were categorized based on diagnosis of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) into: Subgroup 1 (GERD and EE), Subgroup 2 (GERD and no EE), and Subgroup 3 (absence of GERD and EE). Overall IRs (per 1000 person-years [PY]) and 95% confidence intervals (CI) of outcomes were estimated (overall and subgroups) and stratified by duration of IV pantoprazole treatment (< 4 days versus ≥ 4 days).

Results

Of 1879 eligible patients, none were identified in Subgroup 1; 851 (45.3%) and 1028 (54.7%) patients were identified in Subgroups 2 and 3, respectively. IRs of outcomes of interest ranged from 0.0 to 742.8 per 1000 PY. IRs were highest for vomiting (742.80), diarrhea (377.77), abdominal distension (214.31), hyponatremia (204.99), and hypokalemia (203.49). IRs were comparable between Subgroups 2 and 3. For most outcomes, IRs were higher among patients treated with IV pantoprazole for ≥ 4 days versus those treated for < 4 days.

Conclusion

These results are consistent with the known safety profile of pantoprazole and emphasize the utility of using real-world data from pediatric populations for assessment of safety outcomes.

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Data Availability

Upon request, and subject to review, Aetion will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Aetion may also provide access to the related individual de-identified participant data.

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Acknowledgements

The authors acknowledge Kanchan Bhati (M. Pharm) and Kripa Madnani (PhD, CMPP™), employees of Pfizer Inc. for providing editorial assistance.

Funding

Funding is supported by Pfizer, Inc. Sampada Gandhi, Nancy Sherman, Kanti Chittuluru and Kevin Wolter are employees and stockholders of Pfizer, Inc. Ben Taylor, Lexie Rubens and Nileesa Gautam are employees and have ownership of equity at Aetion, Inc.

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Authors and Affiliations

  1. Pfizer Inc., New York, USA

    Sampada Gandhi, Nancy Sherman, Kanti Chittuluru & Kevin Wolter

  2. Aetion, Inc., New York, USA

    Benjamin Taylor, Lexie Rubens & Nileesa Gautam

Authors
  1. Sampada Gandhi
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  2. Benjamin Taylor
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  3. Lexie Rubens
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  4. Nileesa Gautam
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  6. Kanti Chittuluru
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  7. Kevin Wolter
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Contributions

Conceptualization/design (SG, BT, LR, NS, KC, KW); Funding acquisition (SG); Methodology (SG, BT, LR, NS, KC, KW); Formal Analysis (BT, LR, NG); Supervision/oversight (SG, BT, NS); Investigation (LR, NG); Data Curation (NG); SG and BT drafted the manuscript and all authors reviewed, edited, and provided their approval on the final version.

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Correspondence to Sampada Gandhi.

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Gandhi, S., Taylor, B., Rubens, L. et al. Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study. Ther Innov Regul Sci 58, 166–174 (2024). https://doi.org/10.1007/s43441-023-00582-6

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