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Clinical Infectious Diseases, 72(11), pp. e859-e867; 2021

Background: Baloxavir marboxil (baloxavir) is a single-dose, oral antiinfluenza drug with a novel mechanism of action. We compared the incidence of hospitalization in patients treated with baloxavir vs neuraminidase inhibitors. Methods: In this retrospective, observational, cohort study, we used real-world patient data extracted from a Japanese health insurance claims database. The enrollment period was 1 October 2018 to 17 April 2019. On day 1, eligible patients (N = 339 007) received baloxavir, oseltamivir, zanamivir, or laninamivir. Baseline characteristics were standardized using the inverse probability of treatment weighting method. The primary end point was the incidence of hospitalization (days 2–14). Secondary end points included antibacterial use, secondary pneumonia, and additional antiinfluenza drug use. Results: Compared with the baloxavir group, the incidence of hospitalization was greater in the oseltamivir group (risk ratio [RR] and 95% confidence interval [CI], 1.41 [1.00–2.00]; risk difference [RD] and 95% CI, 0.06 [.01–.12]) and zanamivir group (RR, 1.85 [1.23–2.78]; RD, 0.11 [.02–.20]). Oseltamivir-treated patients were less likely to require antibacterials than baloxavir-treated patients (RR, 0.87 [.82–.91]). However, oseltamivir-treated patients were more likely to be hospitalized with antibacterials (RR, 1.70 [1.21–2.38]) or antibacterial injection (RR, 1.67 [1.17–2.38]) than baloxavir-treated patients (post hoc analysis). Compared with baloxavir-treated patients, additional antiinfluenza drug use was greater in oseltamivir-, zanamivir-, and laninamivir-treated patients (RR, 1.51 [1.05–2.18], 2.84 [2.04–3.96], and 1.68 [1.35–2.10], respectively). Conclusions: Baloxavir is an efficacious antiinfluenza treatment that may reduce hospitalization compared with oseltamivir and zanamivir. Clinical Trials Registration: University hospital Medical Information Network Clinical Trials Registry (UMIN000038159)., Clinical Infectious Diseases, 73(5), pp. e1181–e1190; 2021

Norio Sugawara,1,* Norio Yasui-Furukori,1,* Toshinaga Tsuji,2 Shinji Hayashi,2 Yoshikazu Ajisawa,3 Toshimitsu Ochiai,3 Hideyuki Imagawa,4 Kazutaka Shimoda1 1Department of Psychiatry, Dokkyo Medical University School of Medicine, Tochigi, Japan; 2Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan; 3Biostatistics Center, Shionogi & Co., Ltd., Osaka, Japan; 4Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan*These authors contributed equally to this workCorrespondence: Norio SugawaraDepartment of Psychiatry, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, JapanTel +81-28-287-2153Fax +81-28-286-5187Email nsuga3@dokkyomed.ac.jpPurpose: The objective of this post hoc analysis was to explore the relationship, including changes over time, between baseline clinical symptom characteristics and working ability, judged by investigators, after 12 weeks of antidepressant monotherapy in Japanese patients with major depressive disorder (MDD) and painful physical symptoms (PPS) in a real-world clinical setting.Patients and Methods: This prospective, observational study in patients treated with duloxetine or selective serotonin reuptake inhibitors was conducted from 2014 to 2016. Both treatment groups were pooled and divided into 2 groups, “working ability recovered” or “working ability not recovered,” based on working ability at the end of the study. Patients were also divided into 4 subgroups by the presence or absence of previous depressive episodes and working ability. Main outcome measures included baseline demographics and clinical characteristics, and the 17-item Hamilton Rating Scale for Depression (HAM-D17).Results: Comparison between “working ability recovered” (n=122) and “working ability not recovered” (n=91) showed that the percentage of patients with complications and psychotherapy at baselin