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

Abstract

Objective

Ranitidine products contain unacceptable levels of N-nitrosodimethylamine. This study aimed to investigate changes in the 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 25 September 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 until switching to alternative drugs and assess the influencing factors.

Results

In total, 7502 patients were included in this study, among which 5164 (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.

Keywords:

• Ranitidine
• N-nitrosodimethylamine
• recall
• gastrointestinal disorders
• alternative drugs

Transparency

Declaration of funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of financial/other relationships

The authors declare that they have no conflict of interest. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

M. Ku contributed to the design, analysis, and interpretation, drafted the manuscript, critically revised the manuscript, and gave final approval. N. Je contributed to the conception and design, acquisition, and interpretation, drafted the manuscript, critically revised the manuscript, and gave final approval. Both authors agree to be accountable for all aspects of work ensuring integrity and accuracy. No assistance in the preparation of this article is to be declared.

Acknowledgements

The authors used National Patient Sample data from 2019 that were collected by the Korea Health Insurance Review and Assessment Service (HIRA-NPS-2019-0010). However, the results were not related to the Ministry of Health and Welfare or HIRA.

Ethical approval

This study was performed using a HIRA-NPS dataset that did not contain any personal information of the patients and was exempt from review by the Institutional Review Board of Pusan National University College (PNU IRB/2021_30_HR).