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N‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users

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Title: N‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users
Authors: Imène Mansouri, Jeremie Botton, Laura Semenzato, Nadia Haddy, Mahmoud Zureik
Source: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 11, Iss 24 (2022)
Publisher Information: Wiley, 2022.
Publication Year: 2022
Collection: LCC:Diseases of the circulatory (Cardiovascular) system
Subject Terms: health claims data, liver cancer, melanoma, N‐nitrosodimethylamine (NDMA), valsartan, Diseases of the circulatory (Cardiovascular) system, RC666-701
More Details: Background Since July 2018, numerous lots of valsartan have been found to be contaminated with N‐nitrosodimethylamine (NDMA). We aimed to assess the association between exposure to valsartan products contaminated with NDMA and the risk of cancer. Methods and Results This study was based on data from the Système National des Données de Santé, which is a national database that includes all French residents' health‐related expenses. The target population was consumers of valsartan between January 1, 2013 and December 31, 2017, aged between 40 and 80 years old. The association of exposure to contaminated valsartan with the occurrence of any malignancy and cancer by location was evaluated by fitting Cox proportional hazards models weighted by the inverse probability of treatment. A total of 1.4 million subjects without any history of cancer were included. A total of 986 126 and 670 388 patients were exposed to NDMA‐contaminated and uncontaminated valsartan, respectively. The use of the NDMA‐contaminated valsartan did not increase the overall risk of cancer (adjusted hazard ratio [aHR], 0.99 [95% CI, 0.98–1.0]). However, exposed patients had a higher risk of liver cancer (aHR, 1.12 [95% CI, 1.04–1.22]) and melanoma (aHR, 1.10 [95% CI, 1.03–1.18]). We estimated a mean of 3.7 and 5.8 extra cases per year per 100 000 person‐years of liver cancer and melanoma, respectively. Conclusions Our study was the largest to date to examine cancer risks associated with exposure to NDMA‐contaminated valsartan. Our findings suggest a slight increased risk of liver cancer and melanoma in patients exposed to NDMA in regularly taken medications.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2047-9980
Relation: https://doaj.org/toc/2047-9980
DOI: 10.1161/JAHA.122.026739
Access URL: https://doaj.org/article/6e5e07cb2f3049be979a4b67120e2b93
Accession Number: edsdoj.6e5e07cb2f3049be979a4b67120e2b93
Database: Directory of Open Access Journals
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  Data: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 11, Iss 24 (2022)
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  Data: 2022
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  Data: Background Since July 2018, numerous lots of valsartan have been found to be contaminated with N‐nitrosodimethylamine (NDMA). We aimed to assess the association between exposure to valsartan products contaminated with NDMA and the risk of cancer. Methods and Results This study was based on data from the Système National des Données de Santé, which is a national database that includes all French residents' health‐related expenses. The target population was consumers of valsartan between January 1, 2013 and December 31, 2017, aged between 40 and 80 years old. The association of exposure to contaminated valsartan with the occurrence of any malignancy and cancer by location was evaluated by fitting Cox proportional hazards models weighted by the inverse probability of treatment. A total of 1.4 million subjects without any history of cancer were included. A total of 986 126 and 670 388 patients were exposed to NDMA‐contaminated and uncontaminated valsartan, respectively. The use of the NDMA‐contaminated valsartan did not increase the overall risk of cancer (adjusted hazard ratio [aHR], 0.99 [95% CI, 0.98–1.0]). However, exposed patients had a higher risk of liver cancer (aHR, 1.12 [95% CI, 1.04–1.22]) and melanoma (aHR, 1.10 [95% CI, 1.03–1.18]). We estimated a mean of 3.7 and 5.8 extra cases per year per 100 000 person‐years of liver cancer and melanoma, respectively. Conclusions Our study was the largest to date to examine cancer risks associated with exposure to NDMA‐contaminated valsartan. Our findings suggest a slight increased risk of liver cancer and melanoma in patients exposed to NDMA in regularly taken medications.
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      – TitleFull: N‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users
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