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Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals.

Publication ,  Journal Article
Schneeweiss, S; Carver, PL; Datta, K; Galar, A; Johnson, MD; Letourneau, AR; Marty, FM; Nagel, J; Najdzinowicz, M; Saul, M; Schuster, M ...
Published in: J Antimicrob Chemother
January 1, 2020

BACKGROUND: Liver tumours observed in rats exposed to micafungin led to a black box warning upon approval in Europe in 2008. Micafungin's risk for liver carcinogenicity in humans has not been investigated. We sought to describe the risk of fatal hepatocellular carcinoma (HCC) among persons who received micafungin and other parenteral antifungals (PAFs) with up to 12 years of follow-up. METHODS: We assembled a US multicentre cohort of hospitalized patients who received micafungin or other PAFs between 2005 and 2012. We used propensity score (PS) matching on patient characteristics from electronic medical records to compare rates of HCC mortality identified through the National Death Index though to the end of December 2016. We computed HRs and 95% CIs. RESULTS: A total of 40110 patients who received a PAF were identified; 6903 micafungin recipients (87% of those identified) were successfully matched to 16317 comparator PAF users. Ten incident HCC deaths, one in the micafungin-exposed group and nine among comparator PAF users, occurred in 71285 person-years of follow-up. The HCC mortality rate was 0.05 per 1000 person-years in micafungin patients and 0.17 per 1000 person-years in comparator PAF patients. The PS-matched HR for micafungin versus comparator PAF was 0.29 (95% CI 0.04-2.24). CONCLUSIONS: Both micafungin and comparator PAFs were associated with HCC mortality rates of <0.2 per 1000 person-years. Given the very low event rates, any potential risk for HCC should not play a role in clinical decisions regarding treatment with micafungin or other PAFs investigated in this study.

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Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

January 1, 2020

Volume

75

Issue

1

Start / End Page

221 / 228

Location

England

Related Subject Headings

  • Time Factors
  • Risk Factors
  • Retrospective Studies
  • Propensity Score
  • Middle Aged
  • Microbiology
  • Micafungin
  • Male
  • Liver Neoplasms
  • Infusions, Parenteral
 

Citation

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Schneeweiss, S., Carver, P. L., Datta, K., Galar, A., Johnson, M. D., Letourneau, A. R., … Walker, A. M. (2020). Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals. J Antimicrob Chemother, 75(1), 221–228. https://doi.org/10.1093/jac/dkz396
Schneeweiss, Sebastian, Peggy L. Carver, Kausik Datta, Alicia Galar, Melissa D. Johnson, Alyssa R. Letourneau, Francisco M. Marty, et al. “Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals.J Antimicrob Chemother 75, no. 1 (January 1, 2020): 221–28. https://doi.org/10.1093/jac/dkz396.
Schneeweiss S, Carver PL, Datta K, Galar A, Johnson MD, Letourneau AR, et al. Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals. J Antimicrob Chemother. 2020 Jan 1;75(1):221–8.
Schneeweiss, Sebastian, et al. “Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals.J Antimicrob Chemother, vol. 75, no. 1, Jan. 2020, pp. 221–28. Pubmed, doi:10.1093/jac/dkz396.
Schneeweiss S, Carver PL, Datta K, Galar A, Johnson MD, Letourneau AR, Marty FM, Nagel J, Najdzinowicz M, Saul M, Schuster M, Shoham S, Silveira FP, Varughese C, Wilck M, Weatherby L, Oene JV, Walker AM. Long-term risk of hepatocellular carcinoma mortality in 23220 hospitalized patients treated with micafungin or other parenteral antifungals. J Antimicrob Chemother. 2020 Jan 1;75(1):221–228.
Journal cover image

Published In

J Antimicrob Chemother

DOI

EISSN

1460-2091

Publication Date

January 1, 2020

Volume

75

Issue

1

Start / End Page

221 / 228

Location

England

Related Subject Headings

  • Time Factors
  • Risk Factors
  • Retrospective Studies
  • Propensity Score
  • Middle Aged
  • Microbiology
  • Micafungin
  • Male
  • Liver Neoplasms
  • Infusions, Parenteral