BACKGROUND

Continuous epidemiological surveys using consistent methodologies are essential for assessing the prevalence of allergic diseases. In 2021, a cross-sectional survey on allergic diseases was conducted, targeting staff and their families at Designated Allergic Disease Medical Hospitals across 41 prefectures in Japan. By 2022, these hospitals had been established in all 47 prefectures of Japan.

METHODS

A prevalence survey of allergic diseases was conducted in 2022 using the same questionnaire as that used in 2021, encompassing hospitals across all 47 prefectures. Age-adjusted prevalence rates were calculated using the 2015 population model for comparison with the 2021 survey data.

RESULTS

The 2022 survey included 76 hospitals and 24,444 participants (males, 10,668; women, 13,776; median age, 35 years; interquartile range, 18–50 years). The overall prevalence of allergic diseases was 63.0% (95% confidence interval:62.3–63.6). Age-adjusted prevalence of a history per 100,000 people for each allergic disease was as follows (; 95% confidence interval): bronchial asthma (13,279; 12,776–13,782), atopic dermatitis (12,786; 12,379–13,193), food allergies (13,143; 12,689–13,596), perennial allergic rhinitis (28,132; 27,673–28,982), pollinosis (38,959; 38,216–39,703), allergic conjunctivitis (19,751; 19,188–20,313), metal allergies (2,111; 1,898–2,325), drug allergies (4,478; 4,149–4,806), and anaphylaxis (1,602; 1,417–1,787). The prevalence of perennial allergic rhinitis, pollinosis, and allergic conjunctivitis was higher than that in 2021.

CONCLUSIONS

This survey is the first in Japan to calculate the age-adjusted prevalence of allergic diseases. Moreover, pollinosis is the most common allergic disease in Japan.

The DeSC database is a commercially available administrative claims and health checkup database in Japan. The DeSC database contains health insurance claims data from three types of health insurers: the National Health Insurance (Kokuho), Health Insurance Societies (Kempo), and the Advanced Elderly Medical Service System. A previous study has shown that the population in the DeSC database is representative of the entire population of Japan. Our literature search identified 56 original articles conducted using the DeSC database between April 2022 and September 2024. Although the number of studies using the DeSC database is increasing, there are still opportunities to enhance research on various topics.

BACKGROUND

The post-authorization safety study of a vaccine is an important public health task, and its results contribute to the decisions about whether to recommend a vaccination by estimating not only the risk ratio but also the risk difference. There are few reports of adjusted risk differences. We evaluated the statistical performance of the adjusted risk difference and its variance under a post-authorization safety study’s settings (rare events, large sample, extreme exposure frequency).

METHODS

Adjusted risk differences were estimated using ordinary least squares estimators in a linear regression model with a binary outcome, and their variances were estimated using the standard error from ordinary least squares and four types of robust variance. In a simulation, we evaluated the risk differences’ performances using bias, coverage, and power and using data from the Vaccine Effectiveness, Networking, and Universal Safety study as an example of an actual post-authorization safety study.

RESULTS

The adjusted risk difference using ordinary least squares was not biased. Compared to the ordinary least squares’ standard error, the robust variance achieved more appropriate coverage and higher power. With actual data, including 2 × 2 tables of exposure and outcome with zero, both the ordinary least squares and robust variance could be estimated.

CONCLUSIONS

In post-authorization safety study settings, the estimation of the risk difference using ordinary least squares and robust variance showed better performance than the typical ordinary least squares. These findings may prove beneficial for reporting risk difference in extreme settings such as post-authorization safety studies.

BACKGROUND

Mirogabalin has a mechanism similar to that of pregabalin in the treatment of neuropathic pain. However, it remains unclear whether these drugs differ in terms of serious side effects, such as fall-related fractures, in older patients. This study aimed to investigate whether mirogabalin is associated with a decrease in adverse events, including fall-related fractures, compared with pregabalin.

METHODS

We performed a retrospective cohort study using the DeSC database, a large administrative claims database in Japan. This study included 130,244 patients ≥65 years taking mirogabalin or pregabalin between April 2019 and May 2021. The primary outcome was defined as the occurrence of fractures or switching to other medications and was compared between those receiving mirogabalin and pregabalin using Kaplan-Meier curves and multivariable Cox proportional hazards models. A sensitivity analysis was performed regarding patients who received mirogabalin or pregabalin without other analgesic medications at the initial dose.

RESULTS

During a median follow-up of 2.8 months, 29,686 (22.8%) and 100,558 (77.2%) received mirogabalin and pregabalin, respectively. The rates of the outcome in the mirogabalin and pregabalin groups were 50.1 and 42.8 per 100 person-years. Cox regression analysis showed that mirogabalin was associated with a lower risk of the outcome (hazard ratio, 0.93; 95% confidence interval, 0.87–1.00). However, sensitivity analysis did not demonstrate a difference in the outcome between the mirogabalin and pregabalin groups without other analgesic medications (hazard ratio, 0.93; 95% confidence interval, 0.86–1.01).

CONCLUSIONS

Our analyses suggest that the outcome may be less likely in the mirogabalin group; however, the difference appears to be clinically insignificant. Further studies are warranted to confirm these findings.