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Association between Nafamostat Mesylate and In-Hospital Mortality in Patients with Coronavirus Disease 2019: A Multicenter Observational Study

Inokuchi et al., Journal of Clinical Medicine, doi:10.3390/jcm11010116, Dec 2021
Mortality -27% Improvement Relative Risk Nafamostat  Inokuchi et al.  LATE TREATMENT Is late treatment with nafamostat beneficial for COVID-19? Retrospective 15,859 patients in Japan (January - December 2020) Higher mortality with nafamostat (not stat. sig., p=0.52) c19early.org Inokuchi et al., J. Clinical Medicine, Dec 2021 Favorsnafamostat Favorscontrol 0 0.5 1 1.5 2+
Retrospective multicenter observational study of 15,859 hospitalized COVID-19 patients in Japan showing no significant difference in in-hospital mortality with nafamostat mesylate. Very few patients received treatment and they had more severe disease on average. There may be significant residual confounding by indication.
Standard of Care (SOC) for COVID-19 in the study country, Japan, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
Study covers TMPRSS2 inhibitors and nafamostat.
risk of death, 27.0% higher, OR 1.27, p = 0.52, treatment 121, control 15,738, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Inokuchi et al., 26 Dec 2021, retrospective, Japan, peer-reviewed, 11 authors, study period 1 January, 2020 - 31 December, 2020. Contact: iwagami-tky@umin.ac.jp (corresponding author), inokuchir-icu@md.tsukuba.ac.jp, jun.komi33@gmail.com, abetoshi111@gmail.com, ishimaru.miho.kf@u.tsukuba.ac.jp, adomimotohiko@gmail.com, ntamiya@md.tsukuba.ac.jp, tkuno@montefiore.org, taniguchi.yuta.ma@alumni.tsukuba.ac.jp, udakazuaki-tky@umin.ac.jp, ymiyamoto70@gmail.com.
Association between Nafamostat Mesylate and In-Hospital Mortality in Patients with Coronavirus Disease 2019: A Multicenter Observational Study
Ryota Inokuchi, Toshiki Kuno, Jun Komiyama, Kazuaki Uda, Yoshihisa Miyamoto, Yuta Taniguchi, Toshikazu Abe, Miho Ishimaru, Motohiko Adomi, Nanako Tamiya, Masao Iwagami
Journal of Clinical Medicine, doi:10.3390/jcm11010116
Nafamostat mesylate may be effective against coronavirus disease 2019 (COVID-19). However, it is not known whether its use is associated with reduced in-hospital mortality in clinical practice. We conducted a retrospective observational study to evaluate the effect of nafamostat mesylate in patients with COVID-19 using the Medical Data Vision Co. Ltd. hospital-based database in Japan. We compared patients with COVID-19 who were (n = 121) and were not (n = 15,738) administered nafamostat mesylate within 2 days of admission between January and December 2020. We conducted a 1:4 propensity score matching with multiple imputations for smoking status and body mass index and combined the 20 imputed propensity score-matched datasets to obtain the adjusted odds ratio for in-hospital mortality. Crude in-hospital mortality was 13.2% (16/121) and 5.0% (790/15,738), respectively. In the propensity score-matched analysis with multiple imputations, the adjusted odds ratio (use vs. no use of nafamostat mesylate) for in-hospital mortality was 1.27 (95% confidence interval: 0.61-2.64; p = 0.52). Sensitivity analyses showed similar results. The results of this retrospective observational study did not support an association between nafamostat mesylate and improved in-hospital outcomes in patients with COVID-19, although further studies with larger sample sizes are warranted to assess the generalizability of our findings.
Conflicts of Interest: The authors declare no conflict of interest.
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DOI record: { "DOI": "10.3390/jcm11010116", "ISSN": [ "2077-0383" ], "URL": "http://dx.doi.org/10.3390/jcm11010116", "abstract": "<jats:p>Nafamostat mesylate may be effective against coronavirus disease 2019 (COVID-19). However, it is not known whether its use is associated with reduced in-hospital mortality in clinical practice. We conducted a retrospective observational study to evaluate the effect of nafamostat mesylate in patients with COVID-19 using the Medical Data Vision Co. Ltd. hospital-based database in Japan. We compared patients with COVID-19 who were (n = 121) and were not (n = 15,738) administered nafamostat mesylate within 2 days of admission between January and December 2020. We conducted a 1:4 propensity score matching with multiple imputations for smoking status and body mass index and combined the 20 imputed propensity score-matched datasets to obtain the adjusted odds ratio for in-hospital mortality. Crude in-hospital mortality was 13.2% (16/121) and 5.0% (790/15,738), respectively. In the propensity score-matched analysis with multiple imputations, the adjusted odds ratio (use vs. no use of nafamostat mesylate) for in-hospital mortality was 1.27 (95% confidence interval: 0.61–2.64; p = 0.52). Sensitivity analyses showed similar results. The results of this retrospective observational study did not support an association between nafamostat mesylate and improved in-hospital outcomes in patients with COVID-19, although further studies with larger sample sizes are warranted to assess the generalizability of our findings.</jats:p>", "alternative-id": [ "jcm11010116" ], "author": [ { "ORCID": "https://orcid.org/0000-0001-6343-2298", "affiliation": [ { "name": "Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan" } ], "authenticated-orcid": false, "family": "Inokuchi", "given": "Ryota", "sequence": "first" }, { "affiliation": [ { "name": "Montefiore Medical Center, Division of Cardiology, Albert Einstein College of Medicine, New York, NY 10461, USA" } ], "family": "Kuno", "given": "Toshiki", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan" }, { "name": 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Late treatment
is less effective
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