Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension

Background@#This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination. @*Methods@#In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998). @*Results@#Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group. @*Conclusion@#Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

Higher Non-High-Density Lipoprotein Cholesterol Was Higher Associated With Cardiovascular Disease Comparing Higher LDL-C in Nine Years Follow Up: Cohort Study

Objective@#Non-high-density lipoprotein cholesterol (non-HDL-C) may be equivalent to or superior to low-density lipoprotein cholesterol (LDL-C) for the prediction of cardiovascular disease (CVD). However, studies comparing the predictive values of LDL-C and non-HDL-C levels for CVD have yielded conflicting results. In this study, we evaluated the relationship between non-HDL-C, LDL-C, and CVD using a large-scale population dataset from the National Health Information Database (NHID). @*Methods@#We performed a retrospective observational cohort study of 3,866,366 individuals ≥ 20 years, from 2009 to 2018, using the NHID. The participants were divided into LDL-C and non-HDL-C quartiles. The outcome variables included stroke, myocardial infarction (MI), and both. All outcomes were analyzed using Cox proportional hazards regression analysis while controlling for baseline covariates (age, sex, smoking, drinking, regular exercise, body mass index, diabetes, hypertension, and statin use). @*Results@#During 9.1 years of mean follow-up, stroke was diagnosed in 60,081 (1.55%), MI in 31,234 (0.81%), and both stroke and MI in 88,513 (2.29%) participants. Multivariate-adjusted hazard ratios (HRs) for patients in the highest non-HDL-C quartile demonstrated that these patients had a higher risk of stroke (HR, 1.254; 95% confidence interval [CI], 1.224–1.285), MI (HR, 1.918; 95% CI, 1.853–1.986), and both (HR, 1.456; 95% CI, 1.427–1.486) compared with participants in the lowest quartile. These were higher than the HRs for patients in the highest LDL-C quartile for stroke (HR, 1.134; 95% CI, 1.108–1.160), MI (HR, 1.601; 95% CI, 1.551–1.653), and both (HR, 1.281; 95% CI, 1.257–1.306). @*Conclusion@#In our large population study, higher non-HDL-C levels were associated with CVD than LDL-C levels.

Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

BACKGROUND@#Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia.@*METHODS@#This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment.@*RESULTS@#After 8 weeks of treatment, the percent changes from baseline in TG (−29.8% vs. 3.6%, P<0.001) and non-HDL-C (−10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups.@*CONCLUSION@#The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.

Association of fried food intake with prehypertension and hypertension: the Filipino women's diet and health study

Consumption of Han-sik and its Association with Socioeconomic Status among Filipino Immigrant Women: the Filipino Women's Diet and Health Study (FiLWHEL) / 대한지역사회영양학회지

OBJECTIVES: This study examined the consumption of Han-sik and its association with the years of residence in Korea and the socioeconomic status among Filipino immigrant women of the Filipino Women's Diet and Health Study (FiLWHEL). METHODS: A total of 474 Filipino women married to Korean men were included in the analysis. Their dietary intake was assessed using a single-day 24-hour recall. The participants provided information on the demographics, socioeconomic, and health-related factors through face-to-face interviews. The generalized linear model and logistic regression model were used to examine the association between the socioeconomic status and consumption of Han-sik. RESULTS: The mean age of the participants was 34.3 years old, and the average duration of residence in Korea was 8.2 years. Among 474 Filipino women, a total of 467 consumed Han-sik, with an average of 6.8 food items per day. The Han-sik foods that the participants consumed most frequently were rice, cabbage kimchi, mixed-grain rice, and fried eggs. The average ratio of Han-sik was 58.57%. The ratio of Han-sik showed no significant associations with the years of residence, years of living together with their husband, education levels, total annual family income, or linguistic competence of Korean. However, the ratio of Han-sik use was associated with cohabitation with parents-in-law; the odds ratio (95% confidence interval) was 2.41 (1.18–4.92, p-trend = 0.002) comparing the fourth quartile with the first quartile of the Han-sik ratio. CONCLUSIONS: Filipino immigrant women in the FiLWHEL study consumed a larger number of Han-sik than Philippine foods. In addition, cohabitation with their parents-in-law was associated with the consumption of Han-sik. Further epidemiologic studies will be needed to determine how the diet affects the health and wellbeing of immigrant women in Korea.

Consumption of Han-sik and its Association with Socioeconomic Status among Filipino Immigrant Women: the Filipino Women's Diet and Health Study (FiLWHEL) / 대한지역사회영양학회지

OBJECTIVES: This study examined the consumption of Han-sik and its association with the years of residence in Korea and the socioeconomic status among Filipino immigrant women of the Filipino Women's Diet and Health Study (FiLWHEL). METHODS: A total of 474 Filipino women married to Korean men were included in the analysis. Their dietary intake was assessed using a single-day 24-hour recall. The participants provided information on the demographics, socioeconomic, and health-related factors through face-to-face interviews. The generalized linear model and logistic regression model were used to examine the association between the socioeconomic status and consumption of Han-sik. RESULTS: The mean age of the participants was 34.3 years old, and the average duration of residence in Korea was 8.2 years. Among 474 Filipino women, a total of 467 consumed Han-sik, with an average of 6.8 food items per day. The Han-sik foods that the participants consumed most frequently were rice, cabbage kimchi, mixed-grain rice, and fried eggs. The average ratio of Han-sik was 58.57%. The ratio of Han-sik showed no significant associations with the years of residence, years of living together with their husband, education levels, total annual family income, or linguistic competence of Korean. However, the ratio of Han-sik use was associated with cohabitation with parents-in-law; the odds ratio (95% confidence interval) was 2.41 (1.18–4.92, p-trend = 0.002) comparing the fourth quartile with the first quartile of the Han-sik ratio. CONCLUSIONS: Filipino immigrant women in the FiLWHEL study consumed a larger number of Han-sik than Philippine foods. In addition, cohabitation with their parents-in-law was associated with the consumption of Han-sik. Further epidemiologic studies will be needed to determine how the diet affects the health and wellbeing of immigrant women in Korea.

Filipino women's diet and health study (FiLWHEL): design and methods

BACKGROUND: Immigration to South Korea from neighboring Asian countries has risen dramatically, primarily due to marriage between Korean men and foreign women. Although Filipino women rank fourth among married immigrant women, little is known about the health condition of this population. This manuscript focuses on the design and methods of Filipino women's diet and health study (FiLWHEL). SUBJECTS/METHODS: FiLWHEL is a cohort of Filipino women married to Korean men, aged 19 years old or over. The data collection comprised three parts: questionnaire, physical examination, and biospecimen collection. Questionnaires focused on demographic factors, diet, other health-related behaviors, acculturation and immigration-related factors, medical history, quality of life, and children's health information. Participants visited the recruitment site and answered the structured questionnaires through a face-to-face interview. We also measured their anthropometric features and collected fasting blood samples, toenails, and DNA samples. Recruitment started in 2014. RESULTS/CONCLUSIONS: Collection of data is ongoing, and we plan to prospectively follow our cohort participants. We expect that our study, which is focused on married Filipino women immigrants, can elucidate nutritional/health status and the effects of transitional experiences from several lifestyle factors.

Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy

OBJECTIVES: To prevent hypoparathyroidism after thyroidectomy, preservation of the parathyroid glands and their vascularity are essential. The aim of this study was to determine the association between postoperative parathyroid function and the viability of the parathyroid glands during thyroidectomy. METHODS: We prospectively analyzed 111 patients who underwent total thyroidectomy and in whom all 4 parathyroid glands were preserved in situ during the operation. The surgeons scored the viability of each parathyroid gland from 0 (normal) to 3 (severely compromised viability) based on its gross appearance and vascularity intraoperatively. The index of parathyroid viability score (IPVS) was defined as the sum of the viability scores of the 4 parathyroid glands. We evaluated the relationship between postoperative parathyroid function and IPVS. RESULTS: Transient hypoparathyroidism occurred in 25 patients (22.5%), and permanent hypoparathyroidism in 4 patients (3.6%). The IPVS were significantly different in the three groups: 2.87±1.46 in the normal group, 3.68±1.41 in the transient hypoparathyroidism group and 7.50±1.00 in the permanent hypoparathyroidism group. The rates of transient hypoparathyroidism were 13.6% in patients with IPVS 0–2, 23.8% in patients with IPVS 3–4, and 42.9% in patients with IPVS 5–6. All the patients with IPVS of 7 or more had permanent hypoparathyroidism. CONCLUSION: IPVS is correlated with the incidence of hypoparathyroidism. It could be a good quantitative indicator of the probability of hypoparathyroidism after thyroidectomy.

New Drugs for Obesity Treatment / 대한내과학회지

There have recently been many advances in obesity treatment, including lifestyle modifications and pharmacological and surgical treatments. Specifically, pharmacological strategies have improved significantly. However, the history of the development of medications aimed at weight loss is complicated. The Federal Drug Administration (FDA) withdrew anti-obesity drugs such as fenfluramine, dexfenfluramine, and phenylpropylamine due to their unwanted side effects. Moreover, sibutramine was voluntarily withdrawn from the market and a new drug, rimonabant, has been suspended in the middle of a clinical trial due to unacceptable side effects. The FDA has approved four new anti-obesity drugs in recent years. Lorcaserin is a selective 5-hydroxytryptamine receptor 2c (5-HT2c) agonist. The pharmacological mechanism of action of this drug is similar to fenfluramine and dexfenfluramine, but lorcaserin is specific for 5-HT2c, which are located almost exclusively in the central nervous system and are not found in heart valves. Three phase 3 clinical trials for lorcaserin have been published recently; weight reduction was successful and no side effects involving the heart were found. Furthermore, the FDA has also approved phentermine/topiramate controlled-release (PHEN/TPM CR), which is composed of a combination of immediate-release phentermine and controlled-release topiramate. Weight reduction achieved with PHEN/TPM CR was demonstrated to be better than all other anti-obesity drugs. Lastly, the combination therapy bupropion/naltrexone activates proopiomelanocortin neurons and inhibits opioid-mediated negative feedback by synergism. Similar to liraglutide, a long-acting analogue of the hormone glucagon-like peptide-1, this treatment showed significant weight loss and metabolic improvements. However, in addition to its efficacy, clinicians should consider its side effects before use.

Glycosylated Hemoglobin Threshold for Predicting Diabetes and Prediabetes from the Fifth Korea National Health and Nutrition Examination Survey

We aimed to estimate the threshold level of glycosylated hemoglobin (HbA1c) for the fasting plasma glucose of 100 and 126 mg/dL in the Korean adult population, using the 2011 Korea National Health and Nutrition Examination Survey. A total of 4,481 participants over 19 years of age without diabetic medications and conditions to influence the interpretation of HbA1c levels, such as anemia, renal insufficiency, liver cirrhosis, and cancers, were analyzed. A point-wise area under the receiver operating characteristic curve was used to estimate the optimal HbA1c cutoff value. A HbA1c threshold of 6.35% was optimal for predicting diabetes with a sensitivity of 86.9% and a specificity of 99.1%. Furthermore, the threshold of HbA1c was 5.65% for prediabetes, with a sensitivity of 69.3% and a specificity of 71%. Further prospective studies are needed to evaluate the HbA1c cutoff point for diagnosing prediabetes and diabetes in the Korean population.