BACKGROUND: N-Nitrosodimethylamine (NDMA), classified as a probable human carcinogen, has been found as a contaminant in the antihypertensive drug valsartan. Potentially carcinogenic effects associated with the consumption of NDMAcontaminated valsartan have not yet been analyzed in large-scale cohort studies. We therefore carried out the study reported here to explore the association between NDMA-contaminated valsartan and the risk of cancer. METHODS: This cohort study was based on longitudinal routine data obtained from a large German statutory health insurance provider serving approximately 25 million insurees. The cohort comprised patients who had filled a prescription for valsartan in the period 2012-2017. The endpoint was an incident diagnosis of cancer. Hazard ratios (HR) for cancer in general and for certain specific types of cancer were calculated by means of Cox regression models with time-dependent variables and adjustment for potential confounders. RESULTS: A total of 780 871 persons who had filled a prescription for valsartan between 2012 and 2017 were included in the study. There was no association between exposure to NDMA-contaminated valsartan and the overall risk of cancer. A statistically significant association was found, however, between exposure to NDMA-contaminated valsartan and hepatic cancer (adjusted HR 1.16; 95% confidence interval [1.03; 1.31]). CONCLUSION: These findings suggest that the consumption of NDMA-contaminated valsartan is associated with a slightly increased risk of hepatic cancer; no association was found with the risk of cancer overall. Close observation of the potential long-term effects of NDMA-contaminated valsartan seems advisable.
BACKGROUND: N-Nitrosodimethylamine (NDMA), classified as a probable human carcinogen, has been found as a contaminant in the antihypertensive drug valsartan. Potentially carcinogenic effects associated with the consumption of NDMAcontaminated valsartan have not yet been analyzed in large-scale cohort studies. We therefore carried out the study reported here to explore the association between NDMA-contaminated valsartan and the risk of cancer. METHODS: This cohort study was based on longitudinal routine data obtained from a large German statutory health insurance provider serving approximately 25 million insurees. The cohort comprised patients who had filled a prescription for valsartan in the period 2012-2017. The endpoint was an incident diagnosis of cancer. Hazard ratios (HR) for cancer in general and for certain specific types of cancer were calculated by means of Cox regression models with time-dependent variables and adjustment for potential confounders. RESULTS: A total of 780 871 persons who had filled a prescription for valsartan between 2012 and 2017 were included in the study. There was no association between exposure to NDMA-contaminated valsartan and the overall risk of cancer. A statistically significant association was found, however, between exposure to NDMA-contaminated valsartan and hepatic cancer (adjusted HR 1.16; 95% confidence interval [1.03; 1.31]). CONCLUSION: These findings suggest that the consumption of NDMA-contaminated valsartan is associated with a slightly increased risk of hepatic cancer; no association was found with the risk of cancer overall. Close observation of the potential long-term effects of NDMA-contaminated valsartan seems advisable.
Authors: Clyde W Yancy; Mariell Jessup; Biykem Bozkurt; Javed Butler; Donald E Casey; Monica M Colvin; Mark H Drazner; Gerasimos S Filippatos; Gregg C Fonarow; Michael M Givertz; Steven M Hollenberg; JoAnn Lindenfeld; Frederick A Masoudi; Patrick E McBride; Pamela N Peterson; Lynne Warner Stevenson; Cheryl Westlake Journal: J Am Coll Cardiol Date: 2017-04-28 Impact factor: 24.094
Authors: Paul K Whelton; Robert M Carey; Wilbert S Aronow; Donald E Casey; Karen J Collins; Cheryl Dennison Himmelfarb; Sondra M DePalma; Samuel Gidding; Kenneth A Jamerson; Daniel W Jones; Eric J MacLaughlin; Paul Muntner; Bruce Ovbiagele; Sidney C Smith; Crystal C Spencer; Randall S Stafford; Sandra J Taler; Randal J Thomas; Kim A Williams; Jeff D Williamson; Jackson T Wright Journal: J Am Soc Hypertens Date: 2018-08
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Authors: Paula Jakszyn; Carlos A González; Leila Luján-Barroso; Martine M Ros; H Bas Bueno-de-Mesquita; Nina Roswall; Anne M Tjønneland; Frederike L Büchner; Lars Egevad; Kim Overvad; Ole Raaschou-Nielsen; Françoise Clavel-Chapelon; Marie-Christine Boutron-Ruault; Marina S Touillaud; Jenny Chang-Claude; Naomi E Allen; Lambertus A Kiemeney; Timothy J Key; Rudolf Kaaks; Heiner Boeing; Steffen Weikert; Antonia Trichopoulou; Eleni Oikonomou; Dimosthenis Zylis; Domenico Palli; Franco Berrino; Paolo Vineis; Rosario Tumino; Amalia Mattiello; Petra H M Peeters; Christine L Parr; Inger T Gram; Guri Skeie; Maria-Jose Sánchez; Nerea Larrañaga; Eva Ardanaz; Carmen Navarro; Laudina Rodríguez; David Ulmert; Roy Ehrnström; Göran Hallmans; Borje Ljungberg; Andrew Wilfred Roddam; Sheila A Bingham; Kay-Tee Khaw; Nadia Slimani; Paolo A Boffetta; Mazda Jenab; Traci Mouw; Dominique S Michaud; Elio Riboli Journal: Cancer Epidemiol Biomarkers Prev Date: 2011-01-14 Impact factor: 4.254
Authors: E J Mitacek; K D Brunnemann; M Suttajit; N Martin; T Limsila; H Ohshima; L S Caplan Journal: Food Chem Toxicol Date: 1999-04 Impact factor: 6.023
Authors: Yun Zhu; Peizhon Peter Wang; Jing Zhao; Roger Green; Zhuoyu Sun; Barbara Roebothan; Josh Squires; Sharon Buehler; Elizabeth Dicks; Jinhui Zhao; Michelle Cotterchio; Peter T Campbell; Meera Jain; Patrick S Parfrey; John R Mclaughlin Journal: Br J Nutr Date: 2013-10-25 Impact factor: 3.718