Comparison of adverse events of poly adenosine diphosphate ribose polymerase inhibitors in patients with ovarian cancer using the United States Food and Drug Administration Adverse Event Reporting System.

Background: Olaparib, niraparib, and rucaparib are the three primary poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors that are currently available in the market. Previous studies indicate different incidences of adverse events based on the PARP inhibitor or country.

Research Design And Methods: This study used data from the United States Food and Drug Administration Adverse Event Reporting System collected between January 2018 and December 2023.

Comparison of Adverse Events Following Immunosuppressant Administration for Pediatric Patients With Renal Transplants Categorized by Two-Year Age Increments Using the U.S. Food and Drug Administration Adverse Event Reporting System.

Background Immunosuppressants are frequently administered to prevent transplant rejection in patients with renal transplants but cause various adverse events. The incidence of each adverse event may differ between pediatric and adult patients with renal transplants. Because the development of organs and bodies in pediatric patients varies greatly annually, the incidence of each adverse event following immunosuppressant administration may vary by age.

An investigation of broad-spectrum antibiotic-induced liver injury based on the FDA Adverse Event Reporting System and retrospective observational study.

Tazobactam/piperacillin and meropenem are commonly used as an empiric treatment in patients with severe bacterial infections. However, few studies have investigated the cause of tazobactam/piperacillin- or meropenem-induced liver injury in them. Our objective was to evaluate the association between tazobactam/piperacillin or meropenem and liver injury in the intensive care unit patients.

Hyperkalemic effect of drug-drug interaction between esaxerenone and trimethoprim in patients with hypertension: a pilot study.

Background: We examined whether the pharmacodynamic drug-drug interaction between esaxerenone and trimethoprim enhances the hyperkalemic effect.

Methods: A retrospective observational study was conducted to identify patients >18 years undertaking esaxerenone alone or esaxerenone plus trimethoprim at Mie University Hospital from May 2019 to December 2022. We performed propensity score-matching (1:1) to compare between-group differences in the maximum change in serum potassium levels (ΔK) using the Mann-Whitney U test.

Efficacy of Prednisone Avoidance in Patients With Liver Transplant Using the U.S. Food and Drug Administration Adverse Event Reporting System.

Background Immunosuppressants are administered in various combinations to prevent immune-induced transplant rejection in patients with liver transplant, as each immunosuppressant acts on different cellular sites. However, the use of multiple immunosuppressants also increases the risk for adverse events. Therefore, it is desirable to reduce the types of immunosuppressants administered without increasing the incidence of transplant rejection.

Diagnostic performance of fluoroscopic video analysis for pulmonary embolism: a prospective observational study.

Purpose: Dynamic chest radiography using X-ray fluoroscopic video analysis has shown potential for the diagnosis of pulmonary embolism (PE), but its diagnostic performance remains uncertain. We aimed to evaluate the diagnostic performance of fluoroscopic video analysis for diagnosing PE.

Methods: A prospective single-center observational study was conducted between October 2020 and January 2022.

[Evaluation of Pharmacy Students' Understanding of Clinical Trials and Research through Questionnaires Before and After the Hospital Practical Training].

A questionnaire survey was conducted to evaluate practical training and improve education on clinical trial and research. This survey was based on the results of questionnaire before and after the practical training undertaken by 240 pharmaceutical students (Kanto region; 1 university, Tokai region; 2 university, Kinki region; 9 university) at Mie University Hospital between 2011 and 2022. In the questionnaire before practical training, lectures in university (n=219, 91%) were the main source of information on clinical trials and research.

Analysis of Adverse Events Following Phenobarbital Administration for Pediatric Patients Categorized by One-Year Age Increments Using the U.S. Food and Drug Administration Adverse Event Reporting System.

Background Organ and body development greatly varies in pediatric patients from year to year. Therefore, the incidence of each adverse event following phenobarbital (PB) administration would vary with age. However, in clinical trials, increasing the sample size of pediatric patients in each age group has been challenging.

Prevalence and risk factors of ankle osteoarthritis in a population-based study.

Background: This study aimed to investigate the prevalence of radiographic ankle osteoarthritis (AOA) in Japan and identify its risk factors.

Methods: The analysis included data from the population-based cohort study, radiographs of the knees and ankles, ultrasonography of the ankle to examine chronic ankle instability (CAI), and questionnaires on ankle pain, job history, height, and body weight. A total of 597 individuals aged > 50 years were included in the study.

Analysis of death avoidance by concomitant use of prednisone in patients with renal transplant using the Food and Drug Administration Adverse Event Reporting System.

Background: Patients with renal transplant are frequently administered immunosuppressants to prevent transplant-related adverse events. There are mainly nine immunosuppressants on the market, and multiple immunosuppressants are frequently administered for patients with renal transplant. Identifying which immunosuppressant was responsible when efficacy or safety was observed in patients taking multiple immunosuppressants is difficult.

Efficacy and Safety of Warfarin for the Treatment of Venous Thromboembolism - A Multicenter Prospective Observational Cohort Study in Japan (AKAFUJI Study).

Background: A large-scale prospective study of the efficacy and safety of warfarin for the treatment of venous thromboembolism (VTE) has not been conducted in Japan. Therefore, we conducted a real-world prospective multicenter observational cohort study (AKAFUJI Study; UMIN000014132) to investigate the efficacy and safety of warfarin for VTE.

Methods and results: Between May 2014 and March 2017, 352 patients (mean [±SD] age 67.

The usefulness of image-enhanced endoscopy to distinguish gastric carcinoma in tumors initially diagnosed as adenomas by endoscopic biopsy: A retrospective study.

Superficial epithelial gastric neoplasms can be divided into adenomas and early carcinomas. Histological diagnosis by endoscopic forceps biopsy is crucial for the diagnosis and management of gastric neoplasms. It is difficult to distinguish features of gastric neoplasms in small biopsy specimens; hence, gastric carcinomas can be underdiagnosed as adenomas.

Hyperkalemia by eplerenone or esaxerenone in the presence or absence of clarithromycin in hypertensive patients: a retrospective observational cohort study.

Objective: Mineralocorticoid receptor antagonists (MRAs), eplerenone and esaxerenone, cause hyperkalemia dose-dependently. We investigated the cytochrome P450 3A4-mediated drug-drug interaction between the MRAs and clarithromycin.

Methods: This retrospective observational study included adult hypertensive patients with MRA plus clarithromycin or MRA alone with a propensity score matching (1:1).

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System.

Background And Objective: Various dipeptidyl peptidase-4 (DPP-4) inhibitors have been approved for the treatment of diabetes. The frequencies of known serious side effects might differ among DPP-4 inhibitors, therefore a large sample size is needed to study them in prospective clinical trials. We examined the adverse events that occurred during the administration of a DPP-4 inhibitor in patients with diabetes using FDA Adverse Event Reporting System (FAERS) data.

Psychological characteristics of Japanese patients and their family members receiving genetic counseling: A single-institute exploratory study.

In Japan, clinical genetic services became available in the 1970s, and genomic medicine, including genetic counseling (GC), developed rapidly. However, research on the outcomes of GC in Japan is limited. Japan has a unique cultural context, and appropriate GC methods have not yet been optimized for this population.

Tadalafil treatment for fetuses with early-onset growth restriction: a protocol for a multicentre, randomised, placebo-controlled, double-blind phase II trial (TADAFER IIb).

Introduction: TheTADAlafil treatment for Fetuses with early-onset growth Restriction: multicentrer, randomizsed, phase II trial (TADAFER II) study showed the possibility of prolonging the pregnancy period in cases of early-onset fetal growth restriction; however, it was an open-label study. To establish further evidence for the efficacy of tadalafil in this setting, we planned a multicentre, randomised, placebo-controlled, double-blind trial.

Methods And Analysis: This trial will be conducted in 180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers will be randomised into three groups: arm A, receiving two times per day placebo; arm B, receiving one time per day 20 mg tadalafil and one time per day placebo and arm C, receiving 20 mg two times per day tadalafil.

Predictive risk factors for early recurrence in patients with localized pancreatic ductal adenocarcinoma who underwent curative-intent resection after preoperative chemoradiotherapy.

Background: The optimal surgical indication after preoperative chemoradiotherapy (CRT) remains a subject of debate for patients with pancreatic ductal adenocarcinoma (PDAC) because early recurrence often occurs even after curative-intent resection. The present study aimed to identify perioperative risk factors of early recurrence for patients with PDAC who underwent curative-intent resection after preoperative CRT.

Methods: Two hundred three patients with PDAC who underwent curative-intent resection after preoperative CRT from February 2005 to December 2018 were retrospectively analyzed.