Incidence of Severe Illness in Pediatric Influenza Outpatients Treated with Baloxavir or Neuraminidase Inhibitors.

Introduction: A single oral dose of baloxavir marboxil, a cap-dependent endonuclease inhibitor, is approved for patients with influenza A or B infection; however, real-world evidence is limited. We evaluated the effectiveness of baloxavir vs neuraminidase inhibitors in reducing the incidence of severe illness in influenza outpatients aged 5-11 years.

Methods: In this retrospective cohort study, we analyzed individual-level data from patients treated with these antivirals, using a large, Japanese health insurance claims database (JMDC).

Ensitrelvir for the treatment of COVID-19: Final analysis of a post-marketing surveillance from Japan.

Background: Ensitrelvir received approval in Japan for emergency use in the management of patients with coronavirus disease (COVID-19) in November 2022. A post-marketing surveillance (PMS) was conducted to evaluate the safety and effectiveness of ensitrelvir in Japanese real-world clinical practice, and the interim analysis results (data cutoff: July 20, 2023) have been published. This report describes the final analysis of the PMS for ensitrelvir in a Japanese clinical setting.

Comparison of the Effectiveness of Baloxavir and Oseltamivir in Outpatients With Influenza B.

This retrospective cohort study analyzed data from a Japanese health insurance database to assess the effectiveness of baloxavir (n = 4822) for preventing severe events compared with oseltamivir (n = 10,523) in patients with influenza B. The primary endpoint was hospitalization incidence (Days 2-14). The secondary endpoints included intravenous antibacterial drug use, pneumonia hospitalization, heart failure hospitalization, inhalational oxygen requirement, and use of other anti-influenza drugs.

Comparison of Hospitalization Incidence in Influenza Outpatients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study.

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.

Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study.

Background: Baloxavir marboxil (baloxavir) is expected to reduce influenza transmission by rapid reduction of viral load. The incidence of household transmission was compared between index patients (IPs) treated with baloxavir and those treated with neuraminidase inhibitors.

Methods: Using a Japanese claims database, the first family members with influenza diagnosis during the 2018-2019 influenza season were identified as IPs, and the diagnosis date was designated day 1.

Safety and effectiveness of baloxavir marboxil for the treatment of influenza in Japanese clinical practice: A postmarketing surveillance of more than 3000 patients.

Baloxavir marboxil is an oral anti-influenza drug that inhibits the cap-dependent endonuclease of the virus polymerase acidic protein. In clinical trials, baloxavir reduced the time to alleviation of influenza symptoms and time to resolution of fever in adults, adolescents, and children. The purpose of this study is to collect data on the safety and effectiveness of baloxavir when used in clinical practice.

Clinical Drug-Drug Interaction Studies to Evaluate the Effects of a P-Glycoprotein Inhibitor, CYP3A Inhibitors, and a CYP3A Inducer on the Pharmacokinetics of Naldemedine in Healthy Subjects.

Background: Naldemedine is a peripherally acting μ-opioid receptor antagonist that is indicated to treat opioid-induced constipation.

Objectives: To assess the potential for drug-drug interactions between a single oral dose of naldemedine and the oral P-glycoprotein inhibitor cyclosporine, cytochrome P450 (CYP) 3A inhibitors itraconazole and fluconazole, and CYP3A inducer rifampin.

Methods: Three Phase 1, open-label studies were conducted in healthy subjects.

Obesity in hospitalized type 2 diabetes patients: a descriptive study.

Background: The association between obesity and type 2 diabetes has been well documented in epidemiological studies. Patients with type 2 diabetes have a higher body weight than control populations. Relatively few studies, however, have examined the prevalence of obesity in a cohort of hospitalized type 2 diabetes mellitus patients using an electronic health records database.

Incipient intranuclear inclusion body disease in a 78-year-old woman.

We report an incipient case of intranuclear inclusion body disease (INIBD) in a 78-year-old woman. No apparent neurological symptoms were noticed during the clinical course. Post mortem examination revealed widespread occurrence of eosinophilic intranuclear inclusions in neuronal and glial cells of the central and peripheral nervous systems, as well as in parenchymal cells of the visceral organs.

Development of tumor-induced osteomalacia in a subcutaneous tumor, defined by venous blood sampling of fibroblast growth factor-23.

A 25-year-old man with severe lumbago was referred to our department for further evaluation. Serum phosphate and TmP/GFR levels were decreased. Physical examination revealed an elastic tumor in the instep of the right foot, which the patient reported having since the age of 10 years.

Effects of estradiol on regulation of corticotropin-releasing factor gene and interleukin-6 production via estrogen receptor type beta in hypothalamic 4B cells.

Corticotropin-releasing factor (CRF) is produced in the hypothalamic paraventricular nucleus (PVN) in response to stress and stimulates the release of adrenocorticotropic hormone in the corticotrophs. Estrogens acting centrally are able to modulate the stress responses. In fact, direct estrogenic regulation of CRF gene expression has been demonstrated in various tissues.

Mutations in type I collagen genes in Japanese osteogenesis imperfecta patients.

Background: Osteogenesis imperfecta (OI) is an autosomal dominant disorder of connective tissue characterized by bone fragility and low bone mass. COL1A1 and COL1A2 genes are very large and have been rarely analyzed systematically in Japan. The aim of this project was to develop an effective and convenient method of finding mutations in the COL1A1 and COL1A2 gene by using denaturing high-performance liquid chromatography (DHPLC).

Inhibitory effects of glucocorticoids on urocortin-mediated increases in interleukin-6 gene expression in rat aortic smooth muscle cells.

Urocortin (Ucn) 1, Ucn2, and Ucn3 have potent effects on appetite and the cardiovascular system. Endogenous Ucns in combination with CRF receptor type 2beta may have a physiological role in the cardiovascular system. We previously demonstrated that both Ucn1 and Ucn2 increased IL-6 output levels in A7r5 aortic smooth muscle cells.