論文

査読有り 国際誌
2019年3月

Adverse event profiles of solvent-based and nanoparticle albumin-bound paclitaxel formulations using the Food and Drug Administration Adverse Event Reporting System

SAGE OPEN MEDICINE
  • Misa Naganuma
  • ,
  • Kohei Tahara
  • ,
  • Shiori Hasegawa
  • ,
  • Akiho Fukuda
  • ,
  • Sayaka Sasaoka
  • ,
  • Haruna Hatahira
  • ,
  • Yumi Motooka
  • ,
  • Satoshi Nakao
  • ,
  • Ririka Mukai
  • ,
  • Kouseki Hirade
  • ,
  • Tomoaki Yoshimura
  • ,
  • Takeshi Kato
  • ,
  • Hirofumi Takeuchi
  • ,
  • Mitsuhiro Nakamura

7
開始ページ
2050312119836011
終了ページ
2050312119836011
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1177/2050312119836011
出版者・発行元
SAGE PUBLICATIONS INC

Objectives: Paclitaxel is a highly effective antitumor agent with notable adverse events, including hypersensitivity reactions, peripheral neuropathy, arthralgia, myalgias, and neutropenia. Solvent-based paclitaxel causes severe allergic, hypersensitivity, and anaphylactic reactions. Nanoparticle albumin-bound paclitaxel was recently developed and provides an advantage over solvent-based paclitaxel in avoiding solvent/surfactant-related adverse events. The aim of this study was to assess the adverse event profiles of solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel formulations using data from the spontaneous adverse event reporting system of the US Food and Drug Administration Adverse Event Reporting System database. Methods: This study relied on Medical Dictionary for Regulatory Activities preferred terms and standardized queries, and calculated the reporting ratio and reporting odds ratios of paclitaxel formulations. Results: Of 8,867,135 reports recorded in the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to December 2016, 3469 and 4447 adverse events corresponded to solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel, respectively. Reporting odds ratios (95% confidence interval) for anaphylactic reaction (standardized MedDRA query code: 20000021) associated with the use of solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel were 1.69 (1.56-1.84) and 0.75 (0.68-0.83), respectively. Reporting odds ratio signal for anaphylactic reaction was not detected for nanoparticle albumin-bound paclitaxel. Reporting odds ratios (95% confidence interval) for acute renal failure (standardized MedDRA query code: 20000003) associated with the use of solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel were 0.75 (0.58-0.98) and 1.60 (1.37-1.89), respectively. Conclusion: This is the first study to evaluate the adverse event profile of nanoparticle albumin-bound paclitaxel using US Food and Drug Administration Adverse Event Reporting System data. Considering that the US Food and Drug Administration Adverse Event Reporting System database does not allow to infer causality or risk ranking, the different reporting frequencies of anaphylactic reaction and acute renal failure between solvent-based paclitaxel and nanoparticle albumin-bound paclitaxel must be further investigated via analytical observational research.

Web of Science ® 被引用回数 : 1

リンク情報
DOI
https://doi.org/10.1177/2050312119836011
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30886713
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413422
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000460904200001&DestApp=WOS_CPL

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