The Medical Impact of Emergent Banning of N-nitrosodimethylamine (NDMA)- contaminated Antihypertensive Drug: A nationwide longitudinal cohort study
Ahn, J.; Won, S.; Park, J.-H.; Shimbo, D.; Lee, H.-Y.
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OBJECTIVETo study the association of NDMA-contaminated generic valsartan with cancer incidence. DESIGNNationwide longitudinal observational cohort study. SETTINGClaims data from the National Health Insurance Service of South Korea was analyzed using 1:1:1 pairwise propensity score matching (PSM) of NDMA-uncontaminated original, NDMA-contaminated generic, and initially-suspended-but-finally confirmed as NDMA-uncontaminated generic valsartan user-groups. Time-dependent Cox models and dose- response evaluation were used to evaluate carcinogenicity. PARTICIPANTSA total of 3,231,212 participants with satisfactory minimal adherence, followed up from January 1, 2013 until December 31, 2020. INTERVENTIONSAt least one tablet of valsartan. MAIN OUTCOME MEASURESThe primary outcome was primary cancer incidence and secondary outcome was 12 prevalent organ-specific cancer incidences. All-cause and cardiovascular mortality risks were estimated before and after valsartan withdrawal. RESULTSAmong participants (mean [standard deviation] age 59.5 [13.1] years; male, 53.5%), new users had adjusted hazard ratios and 95% confidence intervals (CI) of 1.069 (1.054 to 1.085) and 1.142 (1.100 to 1.186) for any cancer in the NDMA-exposed period (versus NDMA-unexposed) before and after 1:1:1 PSM, respectively. Regardless of PSM, lung and prostate cancer risks increased significantly during the NDMA-exposed period whereas, post-PSM, cancer risk did not increase in the eventually-NDMA-uncontaminated group, even in new users. All-cause and cardiovascular mortality did not differ significantly with NDMA exposure before and after emergent banning. CONCLUSIONSNDMA-contaminated valsartan increased cancer risk, especially of lung and prostate cancers. All-cause and cardiovascular mortality did not evidently increase following banning. This supports emergent health-policy action against potentially carcinogenic drugs.
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