| アブストラクト | 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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| ジャーナル名 | Drug safety |
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| 投稿日 | 2020/11/29 |
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| 投稿者 | Iwagami, Masao; Kumazawa, Ryosuke; Miyamoto, Yoshihisa; Ito, Yuri; Ishimaru, Miho; Morita, Kojiro; Hamada, Shota; Tamiya, Nanako; Yasunaga, Hideo |
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| 組織名 | Department of Health Services Research, Faculty of Medicine, Institutes of;Medicine, University of Tsukuba, Building #861, 1-1-1 Tenno-dai, Tsukuba,;Ibaraki, Japan. iwagami-tky@umin.ac.jp.;Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and;Population Health, London School of Hygiene and Tropical Medicine, London, UK.;iwagami-tky@umin.ac.jp.;Department of Clinical Epidemiology and Health Economics, School of Public;Health, The University of Tokyo, Tokyo, Japan.;Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.;Department of Medical Statistics, Research and Development Center, Osaka Medical;College, Osaka, Japan.;Ibaraki, Japan.;Research Department, Institute for Health Economics and Policy, Association for;Health Economics Research and Social Insurance and Welfare, Tokyo, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33247391/ |
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