The risk of nephrotic syndrome with non-VEGF inhibitory antineoplastic drugs: from viewpoint of the adverse event report
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LETTER TO THE EDITOR
The risk of nephrotic syndrome with non‑VEGF inhibitory antineoplastic drugs: from viewpoint of the adverse event reports in Japan Kouji Okada1,2 · Kensuke Usui1,2 · Daisuke Kikuchi2 · Masanori Takahashi2 · Yoshiteru Watanabe1,2 Received: 14 July 2020 / Accepted: 12 August 2020 © Japanese Society of Nephrology 2020
To the Editor, The nephrotoxicity caused by antineoplastic drugs is a problem in continuing treatment for cancer, and poor control may affect prognosis [1]. Although nephrotic syndrome (NS) due to antineoplastic drugs with non-vascular endothelial growth factor (VEGF) inhibitory action has been reported [2], its risk has not been sufficiently clarified. We assessed the risk of NS associated with antineoplastic drugs without VEGF inhibitory activity by using the Japanese Adverse Drugs Event Report (JADER) database. The JADER database is a large spontaneous reporting system that reflects the realities of clinical practice in Japan released by the Pharmaceutical and Medical Devices Agency. The adverse event signal, reporting odds ratio (ROR), is the ratio of the odds of reporting of one specific adverse drugs event (ADE) versus all other ADEs for a suspected medicine compared to this reporting odds for all other medicines in the database. In this study, the ROR was calculated from the following formula, with a, b, c, and d as; a: number of cases with a NS after using the suspected medicine, b: number of cases with a NS after using all other medicines, c: number of cases with all other ADEs after using the suspected medicine, d: number of cases with all other ADEs after using all other medicines [3].
ROR = (a∕b)∕(c∕d) = ad∕bc In the JADER database, the ADEs are coded according to the preferred terms (PTs) in the Medical Dictionary for * Kouji Okada kokada@tohoku‑mpu.ac.jp 1
Division of Clinical Pharmaceutics and Pharmacy Practice, Tohoku Medical and Pharmaceutical University, 1‑12‑1 Fukumuro, Miyagino‑ku, Sendai, Miyagi 983‑8512, Japan
Department of Pharmacy, Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, Japan
2
Regulatory Activities (MedDRA). In this study, NS targeted “nephrotic syndrome” (PT 10029164) defined in MedDRA. There were 580,911 reports submitted to the Pharmaceuticals and Medical Devices Agency between April 2004 and March 2019. There were 1221 reports limited to suspected drugs, of which 545 were antineoplastic drugs, and NS. Table 1 shows a list of drugs with a signal presence for NS. NS signals were obtained for 10 drugs, of which almost drugs were VEGF inhibitors, and of which the non-VEGF inhibitors were dasatinib and lorlatinib. Dasatinib and lorlatinib with a signal for NS have not been used in combination with VEGF inhibitors in general. In this study, we also found no combination dasatinib or lorlatinib with VEGF inhibitors from data on concomitant drugs. Dasatinib is not a VEGF inhibitor, but inhibition of VEGF-induced phosphorylation of FAK and paxillin via Src family kinases inhibition are considered [2]. The anaplastic ly
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