Home blood pressure-lowering effect of esaxerenone versus trichlormethiazide for uncontrolled hypertension: a predefined subanalysis of the EXCITE-HT randomized controlled trial by basal calcium channel blocker versus angiotensin receptor blocker.

This prespecified subanalysis of the multicenter, randomized, open-label, parallel-group EXCITE-HT study aimed to examine the non-inferiority of esaxerenone to trichlormethiazide as a second-line antihypertensive agent according to the basal antihypertensive agent used (angiotensin receptor blocker [ARB] or calcium channel blocker [CCB]). The primary endpoint, change in morning home systolic/diastolic blood pressure (SBP/DBP) from baseline to end of treatment was similar between the two groups (intergroup difference in least squares mean change [95% confidence interval]: -1.3 [-3.

Burden of respiratory syncytial virus infections in older adults with acute respiratory infection in Japan: An epidemiological study among outpatients.

Background: Respiratory syncytial virus (RSV) is a leading cause of acute respiratory illness, with severe outcomes in older adults. Information on the prevalence, hospitalization rate, and impact on the health-related quality of life (HRQoL) of RSV in older adults with acute respiratory infections (ARI) in outpatient settings in Japan is limited.

Methods: This multi-center epidemiological study included outpatients aged ≥60 years presenting with ARI between August 2021 and February 2023.

Home blood pressure-lowering effect of a non-steroidal mineralocorticoid receptor blocker, esaxerenone, versus trichlormethiazide for uncontrolled hypertension: the EXCITE-HT randomized controlled study.

The EXCITE-HT study aimed to evaluate the efficacy and safety of esaxerenone versus thiazide diuretics (trichlormethiazide) as second-line treatment for Japanese patients with uncontrolled essential hypertension. This was a 12-week, multicenter, randomized, open-label, parallel-group study. The non-inferiority of esaxerenone to trichlormethiazide was confirmed if the upper limit of the two-sided 95% confidence interval (CI) for the difference in systolic blood pressure (SBP)/diastolic blood pressure (DBP) change between groups was below 3.

Effects of Ninjin'yoeito on Patients with Chronic Obstructive Pulmonary Disease and Comorbid Frailty and Sarcopenia: A Preliminary Open-Label Randomized Controlled Trial.

Purpose: To present the preliminarily findings regarding the effects of a herbal medicine, Ninjin'yoeito, on comorbid frailty and sarcopenia in patients with chronic obstructive pulmonary disease (COPD).

Patients And Methods: Patients with COPD (GOLD II or higher) and fatigue were randomly assigned to Group A (n = 28; no medication for 12 weeks, followed by 12-week administration) or B (n= 25; 24-week continuous administration). Visual analog scale (VAS) symptoms of fatigue, the COPD assessment test (CAT), and the modified Medical Research Council (mMRC) Dyspnea Scale were examined.

Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand.

Background: Ivermectin is an antiparasitic drug administered to hundreds of millions of people worldwide. Fundamental research suggests that ivermectin is effective against coronavirus disease 2019 (COVID-19); therefore, we investigated the efficacy and safety of ivermectin as a COVID-19 treatment option.

Methods: This multi-regional (Japan and Thailand), multicenter, placebo-controlled, randomized, double-blind, parallel-group, Phase III study evaluated the efficacy and safety of ivermectin in patients with mild COVID-19 (IVERMILCO Study).

Prevalence of Uncontrolled Asthma despite Treatment with Medium- or High-Dose ICS/LABA Using Patient-Reported Outcomes in Japan: The KOCU (KnOwing the Controlled statUs of Asthma in Japan) Study.

Introduction: Evidence on the prevalence of uncontrolled asthma upon the standard of care in Japan is scarce and inconsistent. We report the prevalence of uncontrolled asthma using the Japanese Guidelines for Asthma (JGL) 2018 and Global Initiative for Asthma (GINA) 2019 classifications in patients who are currently receiving standard-of-care treatment in a real-life setting.

Methods: In this prospective, 12-week, noninterventional study, patients with asthma aged 20-75 years and continuously treated with medium- or high-dose inhaled corticosteroid (ICS)/LABA, with or without other controller(s), were assessed for their asthma control status.

Analysis of the impact on efficacy of lubiprostone dose reduction to manage adverse events in the treatment of chronic constipation in Japan.

Objective: To compare outcomes between two doses of lubiprostone in patients with chronic constipation (CC), to assess whether dose reduction affects efficacy.

Methods: This open-label exploratory study involved 146 patients with CC treated initially with lubiprostone 24 mcg twice daily for a planned duration of 4 weeks. Patients who experienced adverse events (AEs) had their dose reduced to 12 mcg twice daily (for 4 weeks).

[CHARACTERISTICS OF BUDEFORU FOR BUDESONIDE AND FORMOTEROL MIXTURE].

Background: Recently, BudeForu (BF), a generic of Symbicort Turbuhaler (SMB), is widely used in Japan. Although appearance of BF resembles to SMB, several differences in length, weight, and side-hole sizes are seen with precise inspection. As particle releases from the inhalation device is strongly influenced by its mechanical characteristics, we compared their particle release patterns.

Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study.

Purpose: The pivotal CAPTAIN study reported a favorable safety profile with once-daily inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β-agonist (ICS/LAMA/LABA) triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with inadequately controlled asthma, some of whom were Japanese. Here, we evaluate the long-term (52 weeks) safety of FF/UMEC/VI in Japanese patients with asthma.

Patients And Methods: This was a Phase III, 52-week, multicenter, non-comparator, non-randomized, open-label study (NCT03184987) in Japanese adults receiving maintenance therapy with ICS/LABA, with or without LAMA.

Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study.

Objective: In CAPTAIN, a double-blind, parallel-group, Phase IIIA study, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, symptoms and asthma control versus FF/VI in patients with inadequately controlled asthma. Here, we report efficacy and safety from a Japanese cohort in CAPTAIN.

Methods: Adults with inadequately controlled asthma despite inhaled corticosteroid/long-acting β-agonist (ICS/LABA) were randomized (1:1:1:1:1:1) to once-daily FF/VI (100/25 mcg or 200/25 mcg) or FF/UMEC/VI (100/31.

Comparison of User Satisfaction and Preference with Inhalant Devices Between a Pressurized Metered-Dose Inhaler and Ellipta in Stable Asthma Patients: A Randomized, Crossover Study.

Introduction: Inhalation therapy involves two types of adherence: adherence to the drug and adherence to the procedures for the inhalation device. User satisfaction and preference are key factors for maintaining good adherence of both types, and they should be evaluated based on three conditions being well maintained: asthma control level (ACL), adherence, and adequate device operability during usage duration. We compared user satisfaction and preference between a pressurized metered-dose inhaler (pMDI) and a dry powder inhaler (Ellipta), while maintaining the three conditions during usage in stable asthma patients.

Open-label study to evaluate the treatment continuation rate after a dose reduction of lubiprostone due to onset of adverse events.

Objective: To investigate the continuation rate with a reduced lubiprostone dose (12 mcg twice daily, BD) after the onset of adverse events (AEs) in patients with chronic constipation (CC).

Methods: In this exploratory, open-label, multicenter study, patients with CC received lubiprostone 24 mcg BD and the dose was reduced to 12 mcg BD in subjects experiencing AEs. The primary objective was the continuation rate after dose reduction due to nausea/vomiting.

Serum periostin reflects dynamic hyperinflation in patients with asthma.

Introduction: Dynamic hyperinflation (DH) is sometimes observed and is associated with impaired daily life activities of asthma. We assessed the relationship between DH and asthma biomarkers (blood eosinophil, fractional exhaled nitric oxide ( ) and serum periostin) in patients with asthma.

Methods: Fifty patients with stable asthma were prospectively recruited and underwent blood test, measurement, spirometry and metronome-paced tachypnoea (MPT) test to assess DH.

[IS IT NECESSARY TO PROHIBIT SIDE-HOLE CLOSURE IN USE OF THE DRY POWDER INHALERS?].

Background: In use of Ellipta (EPT), Diskus (DKS) or Turbuhaler (TBH), an instruction not to close side holes is sometimes given, but validity of such instruction has not been proved.

Method: Using an inhalation simulator we measured peak inhaled flow (PIF), peak inhaled pressure (PIP) and amount of the drug release from these DPIs before and after closure of side holes (SHC). In the case of EPT, incomplete obstruction was also assessed.

Evaluation of Rapid Onset of Action of ICS/LABA Combination Therapies on Respiratory Function in Asthma Patients: A Single-Center, Open-Label, Randomized, Crossover Trial.

Introduction: Products based on inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations may provide different clinical benefits. This study was conducted to compare the rapid effects of three such combination products: formoterol/fluticasone (FFC) aerosol (pMDI), formoterol/budesonide (FBC) dry powder inhaler (DPI), and vilanterol/fluticasone furoate (VFC) DPI.

Methods: The study design was a three-armed, randomized, crossover study.

Effect of canagliflozin on nocturnal home blood pressure in Japanese patients with type 2 diabetes mellitus: The SHIFT-J study.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have beneficial effects on several cardiometabolic biomarkers, but this is not sufficient to fully explain the significant reduction in cardiovascular risk and mortality reported with SGLT2 inhibitor treatment in patients with diabetes mellitus. The 8-week, randomized, open-label SHIFT-J study investigated the effects of adding canagliflozin vs intensified antihyperglycemic therapy on nocturnal home blood pressure (BP) in patients with poorly controlled type 2 diabetes and nocturnal BP on existing therapy. Patients were randomized to oral canagliflozin 100 mg/d or control (increased hypoglycemic dosage/addition of another hypoglycemic agent).

Comparison of the rapid effects of single inhalations of formoterol and tiotropium bromide on respiratory function and COPD symptoms in a randomized crossover study.

Background: This study aimed to compare rapid improvements in respiratory function and symptoms following single inhalation of formoterol (FOM) dry power inhaler (DPI) or tiotropium bromide (TIO) DPI in patients with chronic obstructive pulmonary disease (COPD).

Methods: Fifty-two outpatients with COPD (GOLD stage 2 or 3) received either a single inhalation of FOM DPI (9 μg via a Turbuhaler) or TIO DPI (18μg via a HandiHaler) in a randomized crossover manner. Respiratory function testing was performed before, and 15, 60, and 120min after drug administration.

Pharmacological effects of lysozyme on COPD and bronchial asthma with sputum: A randomized, placebo-controlled, small cohort, cross-over study.

Background: Mucolytic agents are often used in Japan to ease excessive mucus production in patients with chronic obstructive pulmonary disease (COPD) or bronchial asthma (BA); the treatment ameliorates dyspnea and improves quality of life (QOL).

Aim: Efficacy and safety of lysozyme hydrochloride (LYS), an oral mucolytic enzyme preparation, for patients with COPD or BA were investigated.

Patients And Methods: This study was a placebo-controlled, double-blind, randomized, cross-over design.

Cough variant and cough-predominant asthma are major causes of persistent cough: a multicenter study in Japan.

Objective: Persistent cough is a frequent cause of doctor and hospital visits, and its incidence may be increasing. However, diagnosis of the cause of cough remains difficult. Because different causes of cough have different treatments, accurate diagnosis of the cause of cough is critical.

Pretreatment with inhaled procaterol improves symptoms of dyspnea and quality of life in patients with severe COPD.

Background: The clinical efficacy of short-acting β(2)-agonists administered before performing daily activities in chronic obstructive pulmonary disease (COPD) is unclear. The aim of this study was to investigate the clinical effect of supplementary inhaled procaterol hydrochloride in patients with COPD.

Methods: Thirty outpatients with moderate to severe COPD (Stage II-IV) regularly using inhaled tiotropium bromide alone and with dyspnea during daily activities were enrolled.

Influence of dentures on residual inhaled corticosteroids in the mouths of elderly asthma patients.

Background: The influence of dentures on residual inhaled corticosteroids (ICSs) in the mouths of elderly asthmatic patients and the appropriate time for gargling after inhaling ICSs are unclear.

Methods: Twenty elderly patients in whom moderate persistent asthma was stably controlled using fluticasone propionate Diskus (FP, n = 10) or hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP, n = 10) for more than 3 months and who wore dentures daily were switched to the other type of ICS for 4 weeks in a crossover manner. The residual amount of each ICS in their mouths after inhalation was measured along with determination of peak inspiratory flow (PIF) and pharyngeal culture for detecting Candida albicans.

[Examination of the inspiratory flow rates of COPD patients in Japanese medical facilities].

Unlabelled: Chronic obstructive pulmonary disease (COPD) is treated primarily with inhalation therapy. However, as many COPD patients are elderly, whether or not patients inhale dry powder at an adequate inspiratory flow rate requires investigation. We therefore conducted a multicenter investigation of the effects of height, body weight, age, disease severity, and other factors on inspiratory flow rate in COPD patients.

Current situation of asthma therapy by allergists in primary medical facilities in Japan.

Background: To reduce deaths from asthma, further use of inhaled corticosteroids (ICS) in accordance with the guidelines is required. The present study was conducted because specialists are responsible for increasing the use of guidelines, but the current state of asthma care provided by specialists in primary clinical settings has not been clarified.

Methods: In collaboration with five primary medical facilities throughout Japan, severity of asthma, contents of asthma therapy, and the implementation rate of pulmonary function testing and peak flow measurements were analyzed for 1007 outpatients ≥40 years old with stable bronchial asthma.