Abstract Objectives: Although rectal non-steroidal anti-inflammatory drugs (NSAIDs) reduce the incidence of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP), their optimal dosage is unknown. Given possible inter-individual variability in the pharmacodynamics of NSAIDs, we hypothesized that the dose required to achieve adequate PEP prophylaxis varies with body weight. Methods: We conducted an analysis using single-center, prospective, observational cohort study data. The primary outcome was PEP incidence by NSAID dosage per body weight (mg/kg). Patients meeting the inclusion criteria were classified into three groups. Results: We included 891 patients, with 400, 454, and 37 patients in the control group with no NSAID therapy, the NSAID <1.0 mg/kg group, and the NSAID ≥1.0 mg/kg group, respectively. In the adjusted cohort, the odds ratio of PEP was 0.18 (95% confidence interval [CI]: 0.041-0.79; p = 0.023) for NSAID ≥1.0 mg/kg and 1.3 (95%CI: 0.76-2.3; p = 0.31) for NSAID <1.0 mg/kg compared to the control group without NSAID. Conclusions: PEP was not prevented by NSAID dosages below 1.0 mg/kg body weight whereas a dosage above 1.0 mg/kg body weight had a significant prophylactic effect. An NSAID dosage adjusted to body weight may be necessary to achieve an adequate prophylactic effect against PEP.
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