A 52-week efficacy and safety study of enavogliflozin versus dapagliflozin as an add-on to metformin in patients with type 2 diabetes mellitus: ENHANCE-M extension study.

AIM: To evaluate the long-term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: After 24 weeks of a randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open-label extension period. RESULTS: Eighty-two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28-week open-label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p < .0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p < .0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose-creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p < .0001). CONCLUSIONS: Enavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose-creatinine ratio.

Hemorrhoids Are Associated with Urinary Incontinence.

Background: Hemorrhoids are a common anal disorder and are more frequent in women than in men. Urinary incontinence (UI) also occurs more frequently in women than in men. Although both diseases share similar risk factors, research on the association between the two diseases is lacking. This study aimed to investigate the relationship between hemorrhoids and UI in adult Korean women. Methods: This study was based on the data of the 2008-2009 Korean National Health and Nutrition Examination Survey. Logistic regression test was performed to determine the relationship between hemorrhoids and UI after adjusting for age, body mass index (BMI), smoking, heavy drinking, physical activity, education level, income, diabetes mellitus, and hypertension. Results: Analysis of the data of 8,139 adult women revealed that the prevalence of hemorrhoids, which were self-reported and diagnosed by a physician, was 17.5% and 7.9%, respectively. Both types of hemorrhoids were more prevalent in older women with spouses, those with a large waist circumference, and those with a high BMI. The prevalence of UI was significantly high in the hemorrhoid group, regardless of whether it was self-reported or diagnosed by a physician. Multiple logistic regression analyses revealed a significant association between the prevalence of UI and hemorrhoids, both of which were found to peak at 19-39 years of age. Conclusions: Our findings demonstrate that hemorrhoids are significantly correlated with UI in adult Korean women. When treating adult women with hemorrhoids, it is, therefore, necessary to consider other pelvic floor diseases such as UI.

The Association between Tobacco Smoke and Serum Immunoglobulin E Levels in Korean Adults.

Objective Smoking is common in patients with allergic diseases. The aim of this study was to evaluate the cross-sectional association between the current smoking status and total and specific Immunoglobulin E (IgE) levels in Korean adults. Methods Data were obtained from the 2010 Korean National Health and Nutrition Examination Survey, a national cross-sectional study. We analyzed the data of subjects whose smoking status and serum IgE levels were of acceptable quality. Results A total of 1,963 subjects (1,118 never smokers, 340 ex-smokers, and 505 current smokers) were included. The total IgE levels and specific IgE levels to house dust mite Dermatophagoides farinae (Df), cockroach, and dog allergens in never smokers were significantly (p<0.0001) lower than in ex-smokers or current smokers. After adjusting for other variables, current smokers independently had significantly higher levels of total IgE and cockroach-specific IgE than ex-smokers or never smokers. The proportions of subjects with total IgE ≥150 kU/L and specific IgE ≥0.35 kU/L to Df-specific IgE were significantly (p value for trend <0.05) increased in ex-smokers and current smokers. The total IgE levels and IgE levels specific to Df, cockroaches, and dogs significantly (p value for trend <0.05) and proportionally increased with increasing numbers of cigarettes smoked daily. Conclusion Smoking was associated with elevated total IgE levels and IgE levels specific to Df, cockroach, and dog allergens in a cumulative, dose-dependent manner. Furthermore, current smoking status was an independent risk factor for elevated total IgE levels and IgE levels specific to cockroach allergen.

Association between Cockroach-specific Immunoglobulin E and periodontitis in Korean male adults Based on Korean National Health and Nutrition Examination Survey.

Periodontitis is an inflammatory disease affecting the tooth supporting tissues (periodontium) and associated with chronic diseases such as cardiovascular disease and insulin resistance. However, there has been no nation-wide population based epidemiologic study regarding any association between periodontitis and serum IgE. Among the 8,958 participants in the 2010 Korean National Health and Nutrition Examination Survey (KNHANES V-1), 1,731 adults aged 19 to 64 who had measured serum IgE were included in the analysis. Dentists examined the periodontal status of the participants. Multiple logistic regression analyses were used to evaluate the odds ratio of periodontitis in association with total IgE and specific IgE to cockroach and house dust mite. In males, total IgE showed a positive correlation with the presence of periodontitis. The participants in the highest tertile of cockroach specific IgE (T3, >31.6 kU/L) had a significantly increased risk of periodontitis (OR = 2.108; 95% CI, 1.233-3.606). In females, the inverse association occurred between total IgE and periodontitis (OR = 0.409; 95% CI, 0.200-0.839). The present study firstly demonstrated the association between periodontitis and serum IgE, using the Korean nationwide, population-based, cross-sectional health examination and survey. This study suggested a positive correlation between periodontitis and cockroach-specific IgE in Korean male adults.

Prevalence and risk factors for reduced pulmonary function in diabetic patients: The Korea National Health and Nutrition Examination Survey.

BACKGROUND/AIMS: An association between reduced pulmonary function and diabetes has been observed. Our aim was to evaluate the prevalence and risk factors associated with reduced pulmonary function in diabetic patients. METHODS: We analyzed data from the Korea National Health and Nutrition Examination Survey 2011 to 2013. The study population included data from 8,784 participants (including 1,431 diabetics) aged ≥ 40 years. Reduced pulmonary function was defined as patients with restrictive (forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] ≥ 0.7 and FVC < 80% of predicted value) or obstructive (FEV1/FVC < 0.7) patterns. RESULTS: Subjects with diabetes had a higher prevalence of restrictive (18.4% vs. 9.4%, p < 0.001) and obstructive impairments (20% vs. 12.6%, p < 0.001) than those without diabetes. The adjusted odds ratios (aORs) (95% confidence interval [CI]) for obstructive and restrictive pulmonary impairment were 0.91 (0.75 to 1.11) and 1.57 (1.30 to 1.89), respectively. In the diabetes population, age (aOR, 1.04; 95% CI, 1.02 to 1.06), male sex (aOR, 1.40; 95% CI, 1.04 to 1.88), and body mass index (aOR, 1.15; 95% CI, 1.10 to 1.21) were independently associated with restrictive pulmonary impairment. Age (aOR, 1.12; 95% CI, 1.09 to 1.14), male sex (aOR, 4.24; 95% CI, 2.42 to 7.44), and smoking at any point (ever-smoker: aOR, 1.96; 95% CI, 1.16 to 3.33) were independent risk factors for obstructive pulmonary impairment in diabetics. Diabetes duration or glycated hemoglobin had no association with pulmonary impairment in diabetes. CONCLUSIONS: Subjects with diabetes had a higher risk of restrictive pulmonary impairment than those without diabetes after adjusting for confounding factors. Older age, male sex, body mass index, and smoking were associated with reduced lung function in diabetes.

Prevalence and risk factors of periodontitis among adults with or without diabetes mellitus.

BACKGROUND/AIMS: This study examined prevalence and risk factors of periodontitis in representative samples of Korean adults, with and without diabetes mellitus (DM). METHODS: Data from the 2012 Korean National Health and Nutritional Examination Survey were analyzed. A total of 4,477 adults (≥ 30 years old) were selected from 8,057 individuals who completed a nutrition survey, a self-reported general health behavior questionnaire, an oral examination, an oral hygiene behaviors survey, and laboratory tests. DM was defined as a fasting plasma glucose ≥ 126 mg/dL, or self-reported diagnosed diabetes, or current use of oral hypoglycemic agents and/or insulin. The community periodontal index was used to assess periodontitis status and comparisons between the periodontitis and the non-periodontitis group, were performed, according to the presence of DM. Risk factors for periodontitis in adults with DM and without DM were evaluated by multiple logistic regression analysis. RESULTS: The prevalence of periodontitis was significantly higher in adults with DM (43.7%) than in those without DM (25%, p < 0.001). In adults without DM, risk factors for periodontitis were older age, male, urban habitation, waist circumference, smoking, oral pain, and less frequent tooth brushing. Significant risk factors for periodontitis in adults with DM were the smoking, oral pain, and not-using an oral hygiene product. CONCLUSIONS: Adults with DM have an increased risk of periodontitis than those without DM. Current smoking and oral pain increase this risk. Using an oral hygiene product can reduce risk of periodontal disease in adults with DM.

Serum 25-hydroxyvitamin D concentration and arterial stiffness among type 2 diabetes.

AIM: To evaluate the association between serum 25-hydroxyvitamin D [25(OH)D] and arterial stiffness in patients with type 2 diabetes. METHODS: Serum 25(OH)D was measured in a cross-sectional sample of 131 men and 174 women aged 30 years and over in Korea. Arterial stiffness was assessed by pulse wave velocity (PWV) obtained with a VP-2000 pulse wave unit. Fasting plasma glucose, insulin, lipid profile, HbA1c, calcium, phosphorous, and HS-CRP were measured. RESULTS: The prevalence of vitamin D deficiency was high (85.9%). Those with lower vitamin D levels had increased PWV. Using multivariate regression analysis, low 25(OH)D concentrations independently predicted PWV (p<0.001) in people with type 2 diabetes after adjustment for other risk factors such as age, smoking, hypertension, HS-CRP, diabetes duration, hypertension duration, HbA1c, and BMI. CONCLUSIONS: Vitamin D deficiency is common in type 2 diabetes, and a low 25(OH)D level is significantly associated with increased arterial stiffness in these patients. Vitamin D may influence the development of cardiovascular disease. Clinical intervention studies are needed to clarify whether treatment with vitamin D decreases the risk of cardiovascular disease in patients with type 2 diabetes.