Prevalence and Clinical Characteristics of Patients with Moderate-to-Severe Asthma in Japan Using a JMDC Claims Database.

INTRODUCTION: Although the prevalence and burden of asthma are continuously increasing, there is a lack of evidence on the landscape of moderate-to-severe asthma in Japan. Here, we report the prevalence of moderate-to-severe asthma and describe patient's demographics and clinical characteristics from 2010 to 2019 using the JMDC claims database. METHODS: Patients (≥12 years) from the JMDC database with ≥2 asthma diagnoses in 2 different months in each index year were stratified as moderate-to-severe asthma based on the definition of asthma prevention and management guideline (Japanese Guidelines for Asthma, JGL) or Global Initiative for Asthma (GINA). PRIMARY OBJECTIVE: 10-year trend (2010-2019) in the prevalence of moderate-to-severe asthma. SECONDARY OBJECTIVE: Demographics and clinical characteristics of patients from 2010 to 2019. RESULTS: Of 7,493,027 patients from the JMDC database, 38,089 and 133,557 were included in JGL and GINA cohorts, respectively, by 2019. Both cohorts presented an increasing trend in the prevalence rate of moderate-to-severe asthma from 2010 to 2019, irrespective of age groups. Demographics and clinical characteristics were consistent across the cohorts in each calendar year. Majority of patients were in the age group of 18-60 years in both JGL (86.6%) and GINA (84.2%) cohorts. Allergic rhinitis was the most frequent comorbidity and anaphylaxis the least frequent comorbidity reported in both the cohorts. CONCLUSIONS: In Japan, the prevalence rate of patients with moderate-to-severe asthma, as per JGL or GINA in the JMDC database, increased from 2010 to 2019. The demographics and clinical characteristics were similar in both cohorts over the assessment duration.

Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial.

BACKGROUND: Based on non-clinical data, it is expected that azilsartan, an angiotensin II receptor blocker, will help improve insulin resistance in addition to its hypotensive action. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. METHODS: This multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. We also evaluated its safety and efficacy on other diabetes-related variables and blood pressure. FINDINGS: The mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, -1.09-1.52) in the azilsartan group and -0.23 (95% CI, -0.72-0.27) in the telmisartan group. We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-ß, or 1,5-anhydroglucitol. Reductions in clinic systolic and diastolic blood pressure were observed at week 4 and the reduced levels were maintained throughout the treatment period in both groups. No serious treatment-emergent adverse events (TEAEs) were observed. Only one drug-related TEAE (mild decrease in blood pressure) was reported in one patient in the azilsartan group. CONCLUSION: Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT02079805.