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Prescription changes in patients with gastrointestinal disorders after withdrawal of ranitidine: as nationwide population-based cohort study.

Minhee KuNam Kyung Je
Published in: Current medical research and opinion (2022)
Objective: Ranitidine products contain unacceptable levels of N-nitrosodimethylamine. This study aimed to investigate changes in treatment regimen and their influencing factors after the ranitidine recall. Methods: This retrospective study used data from nationwide Korean claims from 2019. Patients with gastrointestinal disorders treated with ranitidine for at least a month on September 25, 2019, were selected for this study. Other histamine-2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs), potassium-competitive acid blockers (PCABs), and prostaglandin E1 analogs were administered as alternatives to ranitidine. Kaplan--Meier survival and Cox proportional hazards regression analyses were performed to gauge the time before switching to alternative drugs and assess the influencing factors. Results: In total, 7,502 patients were included in this study, among which 5,164 (68.8%) switched from ranitidine to an alternative drug. The most prescribed alternative drugs were H2RAs, followed by PPIs, PCABs, and prostaglandin E1 analogs. Increasing age; Medical Aid insurance (MedAid); and a history of hypertension, diabetes mellitus, asthma, and osteoarthritis were associated with a higher probability of switching treatments. Patients with concomitant gastroesophageal reflux disease and peptic ulcers were more likely to switch to alternative drugs than patients with gastritis. Conclusions: Approximately two-thirds of patients with gastrointestinal disorders switched from ranitidine to alternative drugs within 3 months after ranitidine withdrawal. The Cox regression analysis showed that age (>55 years); insurance type (MedAid); comorbidities, such as hypertension, diabetes mellitus, asthma, and osteoarthritis, and gastrointestinal disorder severity influenced the switch from ranitidine to alternative drugs.
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