Tadalafil use is associated with a lower incidence of Type 2 diabetes in men with benign prostatic hyperplasia: A population-based cohort study

BACKGROUND: Tadalafil, commonly prescribed for benign prostatic hyperplasia (BPH), may benefit patients with Type 2 diabetes mellitus (T2DM) for glycemic markers and complications. However, the association between the long-term use of tadalafil and the incidence of T2DM has not been investigated. METHODS: We emulated a target trial of tadalafil use (5 mg/day) and the risk of T2DM using a population-based claims database in Japan. Patients who initiated tadalafil or alpha-blockers for BPH and had no history of diabetes diagnosis, no dispensing of glucose-lowering drugs, and no history of hemoglobin A1c levels of ≥6.5% (47–48 mmol/mol) were included. The primary outcome was the incidence of T2DM. Pooled logistic regression was used to estimate adjusted risk ratios (RRs) and 5-year cumulative incidence differences (CIDs). RESULTS: A total of 5180 participants initiated tadalafil treatment and were compared with 20, 049 patients who initiated alpha-blockers. The median follow-up time for each arm was 27.2 months (interquartile range [IQR], 12.0–47.9) in tadalafil users and 31.3 months (IQR, 13.7–57.2) in alpha-blocker users. The incidence rates of T2DM in tadalafil and alpha-blocker users were 5.4 (95% confidence interval [CI], 4.0–7.2) and 8.8 (95% CI, 7.8–9.8) per 1000-person years, respectively. Initiation of tadalafil was associated with a reduced risk of T2DM (RR, 0.47; 95% CI, 0.39–0.62; 5-year CID, −0.031; 95% CI, −0.040 to −0.019). CONCLUSION: The incidence of T2DM was lower in men with BPH treated with tadalafil than in those treated with alpha-blockers. Thus, tadalafil may be more beneficial than alpha-blockers in preventing T2DM

Impact of Potentially Inappropriate Medications on Kidney Function in Chronic Kidney Disease: Retrospective Cohort Study

Introduction: Chronic kidney disease (CKD) represents a major public health burden. Potential inappropriate medications (PIMs) are common in patients with CKD. However, its impact on kidney outcomes has not been adequately elucidated for middle-aged patients. This study aimed to clarify the prescription status of PIMs for middle-aged patients with CKD and its effect on kidney function decline. Methods: Using an administrative claims database in Japan, a retrospective cohort study was conducted among Japanese patients with CKD (aged 20–74) who underwent annual health check-ups at least three times between April 2008 and December 2020. PIM exposure was defined as medications to be avoided in older adults as defined by the 2019 American Geriatrics Society Beers Criteria. The association between the number of prescribed PIMs and the decline in estimated glomerular filtration rate (eGFR) was examined using logistic regression models adjusted for clinical characteristics and laboratory variables. Results: A total of 43, 143 patients with CKD (mean age 57 years, median eGFR: 52 mL/min/1.73 m2) were analyzed, and approximately 40% of the patients were prescribed one or more PIMs. The most commonly prescribed PIMs were pain medications (18.5%), followed by gastrointestinal medications (9.8%), central nervous system medications (8.6%), and cardiovascular medications (8.6%). After adjustment, exposure to 2 or ≥3 PIMs was associated with an increased risk of 30% eGFR decline (adjusted odds ratio 1.71 [95% confidence interval, 1.24–2.37] and 1.65 [95% confidence interval, 1.08–2.52], respectively) as compared to the control group. Conclusion: This study showed that middle-aged patients with CKD who were prescribed ≥2 PIM had an increased risk of progression of CKD. Further studies are needed to analyze whether deprescribing steps contribute to reduce PIM prescriptions and prevent CKD progression

Impact of workplace smoke-free policy on secondhand smoke exposure from cigarettes and exposure to secondhand heated tobacco product aerosol during COVID-19 pandemic in Japan: the JACSIS 2020 study

[Objectives] Promoting smoke-free policies is a key intervention for reducing secondhand smoke (SHS) exposure. During the COVID-19 pandemic in Japan, many indoor smoking spaces in workplaces were closed. This study aimed to reveal the association between a workplace smoke-free policy and SHS exposure among non-smoking employees, distinguishing between SHS exposure from cigarettes and exposure to secondhand heated tobacco product (HTP) aerosol, which have recently become popular in Japan. [Design and setting] We used data from the Japan COVID-19 and Society Internet Survey conducted in August–September 2020. [Participants] Among the 25 482 eligible respondents, 8196 non-smoking employees were analysed. [Primary outcome measure] Multivariable logistic regression models were used to examine the impact of smoke-free policies in the workplace. [Results] Compared with complete smoking bans, the ORs and 95% CIs for workplace SHS exposure at least once a week from cigarettes were 2.06 (95% CI: 1.60 to 2.65) for partial bans with no longer available smoking spaces, 1.92 (95% CI: 1.63 to 2.25) for partial smoking bans with still available smoking spaces and 5.33 (95% CI: 4.10 to 6.93) for no smoking bans. The corresponding ORs and 95% CIs for exposure to secondhand HTP aerosol were 4.15 (95% CI: 3.22 to 5.34), 2.24 (95% CI: 1.86 to 2.71) and 3.88 (95% CI: 2.86 to 5.26), respectively. [Conclusions] The effect of partial bans was limited, and temporary closure of smoking spaces might contribute to increased exposure to secondhand HTP aerosol. Complete smoking bans in the workplace were reaffirmed to be the best way to reduce SHS exposure from cigarettes and exposure to secondhand HTP aerosol

Maternal multivitamin intake and orofacial clefts in offspring: Japan Environment and Children's Study (JECS) cohort study

Objectives: Orofacial clefts are common birth defects with a lack of strong evidence regarding their association with maternal nutrition. We aimed to determine whether a relationship exists between maternal nutrient or multivitamin intake and orofacial clefts. Design: This is a prospective, population-based nationwide cohort study. Setting: The study was conducted in 15 regional centres, consisting of local administrative units and study areas. Participants: A total of 98 787 eligible mother–child pairs of the Japan Environment and Children’s Study were included. Intervention: Exposures were maternal nutrition and the use of supplemental multivitamins in mothers. Primary and secondary outcome measures: Outcomes were the occurrence of any orofacial cleft at birth. Multinomial logistic regression analyses were used to evaluate the association between maternal multivitamin intake and the incidence of orofacial clefts. Results: Of the 98 787 children, 69 (0.07%) were diagnosed with cleft lip alone, 113 (0.11%) were diagnosed with cleft lip and palate, and 52 (0.05%) were diagnosed with cleft palate within 1 month after birth. Regarding the total orofacial cleft outcome, statistically significant point estimates of relative risk ratios (RR) were determined for multivitamin intake before pregnancy (RR=1.71; 95% CI 1.06 to 2.77) and during the first trimester (RR=2.00; 95% CI 1.18 to 3.37), but the association was not significant for multivitamin intake after the first trimester (RR=1.34; 95% CI 0.59 to 3.01). Maternal micronutrient intake via food was not associated with the incidence of orofacial clefts in offspring. Conclusions: Intake of multivitamin supplements shortly before conception or during the first trimester of pregnancy was found to be associated with an increased incidence of orofacial clefts at birth. Pregnant women and those intending to become pregnant should be advised of the potential risks of multivitamin supplementation

ANTIBACTERIAL ACTIVITY OF BIFIDOBACTERIA ISOLATED FROM INFANT FAECES

Antibacterial activity of bifidobacteria isolated from Mongolian infant faeces was elucidated on pathogenic intestinal bacteria for the development of a new antibacterial bifidobacteria, the permission for which was granted by the Mongolian Medical Ethics Committee Approval (MMECA). A total of forty-nine single colonies were obtained from 3 samples by using a BL medium enrichment. Among them, 29 isolates had Gram−positive, catalase−negative properties, and maul−like or Y−shaped morphology, and then, 20 Bifidobacterium breve and 9 Bifidobacterium longum strains were detected by the B. breve and B. longum specific primers. Organic acids produced by the isolated bifidobacteria in their cell-free supernatants were quantitatively analyzed by a spectrophotometric absorbance at 340 nm, suggesting that D−lactic, L−lactic, and acetic acids were produced, and the pH of the supernatants was at 3.86−4.55. The isolated bifidobacteria showed antibacterial activity toward Escherichia coli and Salmonella typhimurium as high as that of a standard bifidobacteria, however, lower activity against Staphylococcus aureus. The antibacterial activity was probably due to the production of organic acids

Clinical epidemiology and pharmacoepidemiology studies with real-world databases

Hospital-based registry data, including patients’ information collected by academic societies or government based research groups, were previously used for clinical research in Japan. Now, real-world data routinely obtained in healthcare settings are being used in clinical epidemiology and pharmacoepidemiology. Real-world data include a database of claims originating from health insurance associations for reimbursement of medical fees, diagnosis procedure combinations databases for acute inpatient care in hospitals, a drug prescription database, and electronic medical records, including patients’ medical information obtained by doctors, derived from electronic records of hospitals. In the past ten years, much evidence of clinical epidemiology and pharmacoepidemiology studies using real-world data has been accumulated. The purpose of this review was to introduce clinical epidemiology and pharmacoepidemiology approaches and studies using real-world data in Japan

validity of dietary diversity

The validity of dietary variety score (DVS) using a short-form questionnaire has not been investigated using dietary diversity based on a quantitative distribution of consumed foods in older Japanese. We examined the association between DVS and objective dietary diversity using a Quantitative Index for Dietary Diversity (QUANTIDD) based on the quantitative distribution of foods consumed by older Japanese community dwellers. The subjects were 65 older Japanese community dwellers aged 60–79 years. We used two kinds of scores for assessment of dietary diversity. At first, dietary diversity was determined using DVS calculated from answers to a questionnaire about frequencies of intake of 10 food groups. Second, dietary intake was assessed using a 3-day dietary record with photographs, and dietary diversity was determined using QUANTIDD. The relationships between DVS and QUANTIDD were assessed using partial correlation coefficients controlling for confounders. The correlation coefficient between DVS and QUANTIDD was moderate (r = 0.212-0.458). After controlling for confounders, those correlation coefficient between DVS and QUANTIDD remained moderate. The findings suggest that there was a moderate relationship between DVS and QUANTIDD, and DVS using a short-form questionnaire may be useful for assessing dietary diversity in older Japanese community dwellers