| アブストラクト | AIMS/INTRODUCTION: A recent US Food and Drug Administration report highlighted concerns over nitrosamine (7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4] triazolo-[4,3-a]pyrazine [NTTP]) impurities in sitagliptin, prompting investigations into its safety profile. The present study aimed to determine if the use of NTTP-contaminated sitagliptin, in comparison with other dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with an increased cancer risk. MATERIALS AND METHODS: This retrospective cohort study secondarily used the National Database of Health Insurance Claims and Specific Health Checkups of Japan, encompassing data on >120 million individuals. The study involved patients who initiated DPP-4 inhibitor therapy (sitagliptin or other DPP-4 inhibitors) and continued its exclusive use for 3 years. Sitagliptin users were compared with other DPP-4 inhibitor users for assessing the occurrence of cancers, as defined by diagnosis codes. Further analyses focused on specific types of cancer, using either diagnosis codes or a combination of diagnosis and procedure codes. We also carried out various sensitivity analyses, including those with different exposure periods. RESULTS: Sitagliptin users (149,120 patients, 388,356 person-years) experienced 9,643 cancer incidences (2,483.0/100,000 person-years) versus 12,621 incidences (2,504.4/100,000 person-years) among other DPP-4 inhibitor users (199,860 patients, 503,952 person-years), yielding a minimal difference (incidence rate ratio 0.99, 95% confidence interval 0.97-1.02). A multiple Cox proportional hazards model showed no significant association between sitagliptin use and overall cancer incidence (hazard ratio 1.01, 95% confidence interval 0.98-1.04). Findings were also consistent across cancer types and sensitivity analyses. CONCLUSIONS: We observed no evidence to suggest an increased cancer risk among patients prescribed NTTP-contaminated sitagliptin, although continued investigation is needed. |
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| ジャーナル名 | Journal of diabetes investigation |
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| 投稿日 | 2024/8/12 |
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| 投稿者 | Sugiyama, Takehiro; Furuno, Takashi; Ichinose, Yuichi; Iwagami, Masao; Ihana-Sugiyama, Noriko; Imai, Kenjiro; Kakuwa, Tamaki; Rikitake, Ryoko; Ohsugi, Mitsuru; Higashi, Takahiro; Iso, Hiroyasu; Ueki, Kohjiro |
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| 組織名 | Diabetes and Metabolism Information Center, Research Institute, National Center;for Global Health and Medicine, Tokyo, Japan.;Institute for Global Health Policy Research, Bureau of International Health;Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.;Department of Health Services Research, Institute of Medicine, University of;Tsukuba, Ibaraki, Japan.;Health Services Research and Development Center, University of Tsukuba, Ibaraki,;Japan.;Division of Health Services Research, National Cancer Center, Tokyo, Japan.;Department of Public Health/Health Policy, Graduate School of Medicine, The;University of Tokyo, Tokyo, Japan.;Department of Diabetes, Endocrinology, and Metabolism, National Center for Global;Health and Medicine, Tokyo, Japan.;Diabetes Research Center, Research Institute, National Center for Global Health;and Medicine, Tokyo, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39133197/ |
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