Risk of cancer in association with ranitidine and nizatidine vs other h2 blockers: Analysis of the japan medical data center claims database 2005–2018

M Iwagami, R Kumazawa, Y Miyamoto, Y Ito… - Drug Safety, 2021 - Springer
M Iwagami, R Kumazawa, Y Miyamoto, Y Ito, M Ishimaru, K Morita, S Hamada, N Tamiya…
Drug Safety, 2021Springer
Abstract Introduction In September 2019, ranitidine and nizatidine were suggested to
contain N-nitrosodimethylamine, a carcinogenic substance. People have since been
concerned about the potential impact of ranitidine/nizatidine use on the risk of cancer.
Objective The objective of this study was to investigate the risk of cancer among people
receiving ranitidine or nizatidine compared with other histamine 2 receptor antagonists (H2
blockers)[cimetidine, famotidine, roxatidine, and lafutidine]. Methods In the Japan Medical …
Introduction
In September 2019, ranitidine and nizatidine were suggested to contain N-nitrosodimethylamine, a carcinogenic substance. People have since been concerned about the potential impact of ranitidine/nizatidine use on the risk of cancer.
Objective
The objective of this study was to investigate the risk of cancer among people receiving ranitidine or nizatidine compared with other histamine 2 receptor antagonists (H2 blockers) [cimetidine, famotidine, roxatidine, and lafutidine].
Methods
In the Japan Medical Data Center claims database (comprising people aged < 75 years) from 2005 to 2018, we identified new adult users of H2 blockers and classified them into ranitidine/nizatidine users and other H2 blocker users. We estimated the incidence of cancer diagnosis in each group and conducted a multivariable Cox regression analysis.
Results
We identified 113,745 new users of ranitidine/nizatidine (median age 41.2 years [interquartile range 31.7–51.1]; 49.1% men; median follow-up 2.4 years [1.1–4.5]) and 503,982 new users of other H2 blockers (median age 40.9 years [31.1–51.2]; 51.0% men; median follow-up 2.3 years [0.9–4.2]). The incidence rate of cancer diagnosis was 6.39 (95% confidence interval 6.13–6.66) cases per 1000 person-years (top three sites: breast 14.8%; colorectal 14.6%; and stomach 11.5%) in the ranitidine/nizatidine group and 6.17 (6.05–6.30) cases per 1000 person-years (colorectal 14.7%; breast 13.5%; and stomach 11.2%) in the other H2 blockers group. The adjusted hazard ratio (ranitidine/nizatidine users vs other H2 blocker users) was 1.02 (0.98–1.07). The results were similar by follow-up length, by cancer site, and when ranitidine and nizatidine users were separately compared with the other H2 blockers group. By cumulative dose, the adjusted hazard ratio (95% confidence interval) was 1.03 (0.98–1.08) from 1 to 180 defined daily doses (DDDs), 1.00 (0.73–1.39) from 181 to 365 DDDs, 0.95 (0.61–1.48) from 366 to 730 DDDs, and 0.83 (0.45–1.55) at > 730 DDDs.
Conclusions
We found no evidence that ranitidine/nizatidine is associated with an increased risk of cancer, although further studies with more accurate measurement of exposure, inclusion of older people, and longer follow-up may be needed.
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