PDF(Pubmed)
Abstract：
In recent years, regulatory agencies have raised concerns about the presence of potentially carcinogenic substances in certain formulations of Angiotensin Receptor Blockers (ARBs). Specifically, nitrosamines and azido compounds have been identified in some ARB products. Nitrosamines are known to have carcinogenic properties and are associated with an increased risk of neoplasms. Spontaneous safety reports from the EudraVigilance Data Analysis System (EVDAS) database were analyzed to investigate cases of neoplasms associated with ARBs. A disproportionality analysis was conducted, calculating the reporting odds ratio (ROR) and 95% confidence intervals (CIs) using a case/non-case approach for each ARB drug. The EVDAS database contained 68,522 safety reports related to ARBs (including Azilsartan, Candesartan, Irbesartan, Olmesartan, Losartan, Valsartan, and Telmisartan), among which 3,396 (5%) cases were associated with neoplasms. The majority of these cases were reported in Germany (11.9%), followed by France (9.7%). Approximately 70% of the reports were submitted by healthcare professionals such as physicians and nurses. Among the ARBs, valsartan had the highest ROR for neoplasm (ROR 1.949, 95% CI 1.857-2.046). This association remained significant when comparing ARBs with other classes of antihypertensive drugs, including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. Our study identifies a possible signal of an association between ARBs, particularly valsartan, and the risk of neoplasms. However, further observational and analytical studies are necessary to confirm these findings and elucidate the underlying mechanisms.
摘要：
近年来,监管机构对某些血管紧张素受体阻滞剂(ARBs)制剂中存在潜在致癌物质表示担忧.具体来说,亚硝胺和叠氮化合物已经在一些ARB产品中被鉴定。已知亚硝胺具有致癌特性并且与肿瘤的风险增加有关。分析了来自EudraVigilance数据分析系统（EVDAS）数据库的自发安全性报告，以调查与ARB相关的肿瘤病例。进行了不相称性分析，使用病例/非病例方法计算每种ARB药物的报告比值比(ROR)和95%置信区间(CIs)。EVDAS数据库包含68,522份与ARB相关的安全性报告（包括阿齐沙坦，坎地沙坦,厄贝沙坦,奥美沙坦,氯沙坦,缬沙坦,和替米沙坦)，其中3,396例(5%)与肿瘤相关。这些病例大多数在德国报告（11.9％），其次是法国(9.7%)。大约70％的报告是由医生和护士等医疗保健专业人员提交的。在ARB中，缬沙坦对肿瘤的ROR最高（ROR1.949，95％CI1.857-2.046）。当将ARB与其他类型的抗高血压药物进行比较时，这种关联仍然很重要。包括ACE抑制剂,β受体阻滞剂，钙通道阻滞剂，和利尿剂。我们的研究确定了ARB之间可能存在关联的信号，尤其是缬沙坦,和肿瘤的风险。然而,需要进一步的观察性和分析性研究来确认这些发现并阐明其潜在机制.
