1.Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial
Jie-Eun LEE ; Seung Hee YU ; Sung Rae KIM ; Kyu Jeung AHN ; Kee-Ho SONG ; In-Kyu LEE ; Ho-Sang SHON ; In Joo KIM ; Soo LIM ; Doo-Man KIM ; Choon Hee CHUNG ; Won-Young LEE ; Soon Hee LEE ; Dong Joon KIM ; Sung-Rae CHO ; Chang Hee JUNG ; Hyun Jeong JEON ; Seung-Hwan LEE ; Keun-Young PARK ; Sang Youl RHEE ; Sin Gon KIM ; Seok O PARK ; Dae Jung KIM ; Byung Joon KIM ; Sang Ah LEE ; Yong-Hyun KIM ; Kyung-Soo KIM ; Ji A SEO ; Il Seong NAM-GOONG ; Chang Won LEE ; Duk Kyu KIM ; Sang Wook KIM ; Chung Gu CHO ; Jung Han KIM ; Yeo-Joo KIM ; Jae-Myung YOO ; Kyung Wan MIN ; Moon-Kyu LEE
Diabetes & Metabolism Journal 2024;48(4):730-739
Background:
It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia.
Methods:
This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment.
Results:
After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events.
Conclusion
The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.
2.Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial
Ji-Yeon PARK ; Joonyub LEE ; Yoon-Hee CHOI ; Kyung Wan MIN ; Kyung Ah HAN ; Kyu Jeung AHN ; Soo LIM ; Young-Hyun KIM ; Chul Woo AHN ; Kyung Mook CHOI ; Kun-Ho YOON ;
Diabetes & Metabolism Journal 2024;48(5):915-928
Background:
Guidelines for switching to triple combination therapy directly after monotherapy failure are limited. This study investigated the efficacy, long-term sustainability, and safety of either mono or dual add-on therapy using alogliptin and pioglitazone for patients with type 2 diabetes mellitus (T2DM) who did not achieve their target glycemic range with metformin monotherapy.
Methods:
The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK) was a multicenter, placebo-controlled, double-blind, randomized trial. A total of 214 participants were randomized to receive alogliptin+pioglitazone (Alo+Pio group, n=70), alogliptin (Alo group, n=75), or pioglitazone (Pio group, n=69). The primary outcome was the difference in glycosylated hemoglobin (HbA1c) levels between the three groups at baseline to 24 weeks. For durability, the achievement of HbA1c levels <7% and <6.5% was compared in each group. The number of adverse events was investigated for safety.
Results:
After 24 weeks of treatment, the change of HbA1c in the Alo+Pio, Alo, and Pio groups were –1.38%±0.08%, –1.03%±0.08%, and –0.84%±0.08%, respectively. The Alo+Pio group had significantly lower HbA1c levels than the other groups (P=0.0063, P<0.0001) and had a higher proportion of patients with target HbA1c achievement. In addition, insulin sensitivity and β-cell function, lipid profiles, and other metabolic indicators were also improved. There were no significant safety issues in patients treated with triple combination therapy.
Conclusion
Early combination triple therapy showed better efficacy and durability than the single add-on (dual) therapy. Therefore, combination therapy with metformin, alogliptin, and pioglitazone is a valuable early treatment option for T2DM poorly controlled with metformin monotherapy.
3.Korea Seroprevalence Study of Monitoring of SARS-COV-2 Antibody Retention and Transmission (K-SEROSMART): findings from national representative sample
Jina HAN ; Hye Jin BAEK ; Eunbi NOH ; Kyuhyun YOON ; Jung Ae KIM ; Sukhyun RYU ; Kay O LEE ; No Yai PARK ; Eunok JUNG ; Sangil KIM ; Hyukmin LEE ; Yoo-Sung HWANG ; Jaehun JUNG ; Hun Jae LEE ; Sung-il CHO ; Sangcheol OH ; Migyeong KIM ; Chang-Mo OH ; Byengchul YU ; Young-Seoub HONG ; Keonyeop KIM ; Sunjae JUNG ; Mi Ah HAN ; Moo-Sik LEE ; Jung-Jeung LEE ; Young HWANGBO ; Hyeon Woo YIM ; Yu-Mi KIM ; Joongyub LEE ; Weon-Young LEE ; Jae-Hyun PARK ; Sungsoo OH ; Heui Sug JO ; Hyeongsu KIM ; Gilwon KANG ; Hae-Sung NAM ; Ju-Hyung LEE ; Gyung-Jae OH ; Min-Ho SHIN ; Soyeon RYU ; Tae-Yoon HWANG ; Soon-Woo PARK ; Sang Kyu KIM ; Roma SEOL ; Ki-Soo PARK ; Su Young KIM ; Jun-wook KWON ; Sung Soon KIM ; Byoungguk KIM ; June-Woo LEE ; Eun Young JANG ; Ah-Ra KIM ; Jeonghyun NAM ; ; Soon Young LEE ; Dong-Hyun KIM
Epidemiology and Health 2023;45(1):e2023075-
OBJECTIVES:
We estimated the population prevalence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including unreported infections, through a Korea Seroprevalence Study of Monitoring of SARS-CoV-2 Antibody Retention and Transmission (K-SEROSMART) in 258 communities throughout Korea.
METHODS:
In August 2022, a survey was conducted among 10,000 household members aged 5 years and older, in households selected through two stage probability random sampling. During face-to-face household interviews, participants self-reported their health status, COVID-19 diagnosis and vaccination history, and general characteristics. Subsequently, participants visited a community health center or medical clinic for blood sampling. Blood samples were analyzed for the presence of antibodies to spike proteins (anti-S) and antibodies to nucleocapsid proteins (anti-N) SARS-CoV-2 proteins using an electrochemiluminescence immunoassay. To estimate the population prevalence, the PROC SURVEYMEANS statistical procedure was employed, with weighting to reflect demographic data from July 2022.
RESULTS:
In total, 9,945 individuals from 5,041 households were surveyed across 258 communities, representing all basic local governments in Korea. The overall population-adjusted prevalence rates of anti-S and anti-N were 97.6% and 57.1%, respectively. Since the Korea Disease Control and Prevention Agency has reported a cumulative incidence of confirmed cases of 37.8% through July 31, 2022, the proportion of unreported infections among all COVID-19 infection was suggested to be 33.9%.
CONCLUSIONS
The K-SEROSMART represents the first nationwide, community-based seroepidemiologic survey of COVID-19, confirming that most individuals possess antibodies to SARS-CoV-2 and that a significant number of unreported cases existed. Furthermore, this study lays the foundation for a surveillance system to continuously monitor transmission at the community level and the response to COVID-19.
4.Directions and Current Issues on the Policy of Prevention and Management for Hypertension and Diabetes, and Development of Chronic Disease Prevention and Management Model in Korea
Moo-Sik LEE ; Kyeong-Soo LEE ; Jung-Jeung LEE ; Tae-Yoon HWANG ; Jin-Yong LEE ; Weon-Seob YOO ; Keon-Yeop KIM ; Sang-Kyu KIM ; Jong-Yeon KIM ; Ki-Soo PARK ; Bo-Young HWANG
Journal of Agricultural Medicine & Community Health 2020;45(1):13-40
Objectives:
The purpose of this manuscript was to propose the policy and perspectives of prevention and management for hypertension and diabetes in Korea.
Methods:
Authors reviewed the chronic disease prevention and management projects and models were executed in Korea until now, and analyzed and evaluated their performances.
Results:
In the circumstances of Korea, the following several requisites should be improved ; Specific Korean strategy for development and pursuing of national level policy agenda for chronic disease management must be established. There are a need to establish several means of supplementing the weaknesses of the current chronic disease management policies and programs. Firstly, development and distribution of contents of guidelines on the systematic project execution regime (regarding systematization of local community, subjects and contents of the projects) with guarantee for the quality of chronic disease prevention and management are necessary. Secondly, there is a need for development of information system that can lead the chronic disease management programs currently being implemented. Thirdly, there is urgent need to develop resources such as cultivation of manpower and facilities for provision of education and consultation for the patients and holders of risk factors of chronic disease. Fourthly, there is a need for means of securing management system and financial resources for operation of policies and programs.
Conclusions
The results can be able to use as a road map, models, and direction and strategies of policies for chronic disease prevention and management of Korea.
5.Treatment of Recalcitrant Pyoderma Gangrenosum with Ulcerative Colitis by Adalimumab Injection.
Jin Hyup LEE ; In Kyu CHANG ; Hae Eul LEE ; Myung IM ; Young Joon SEO ; Jeung Hoon LEE ; Young LEE
Annals of Dermatology 2017;29(2):260-262
No abstract available.
Adalimumab*
;
Colitis, Ulcerative*
;
Pyoderma Gangrenosum*
;
Pyoderma*
;
Ulcer*
6.Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial.
Kyung Wan MIN ; Bon Jeong KU ; Ji Hyun LEE ; Min Seon KIM ; Kyu Jeung AHN ; Moon Kyu LEE ; Satoshi KOKUBO ; Satoshi YOSHIDA ; Hyun Ji CHO ; Bong Soo CHA
Diabetes & Metabolism Journal 2017;41(2):135-145
BACKGROUND: This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin. METHODS: This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea. RESULTS: Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were –0.97% in the ipragliflozin group and –0.31% in the placebo group, with an adjusted between-group difference of –0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of –21.4 mg/dL and –1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection. CONCLUSION: Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.
Asia
;
Blood Glucose
;
Body Weight
;
Diabetes Mellitus, Type 2*
;
Fasting
;
Humans
;
Korea
;
Metformin*
;
Urinary Tract Infections
7.Clinical Features and Awareness of Hand Eczema in Korea.
Jae Beom PARK ; Seung Ho LEE ; Kea Jeung KIM ; Ga Young LEE ; Jun Mo YANG ; Do Won KIM ; Seok Jong LEE ; Cheol Heon LEE ; Eun Joo PARK ; Kyu Han KIM ; Hee Chul EUN ; Sung Eun CHANG ; Kee Chan MOON ; Seong Hyun KIM ; Seong Jin KIM ; Byung Soo KIM ; Jun Young LEE ; Hyung Ok KIM ; Hoon KANG ; Min Geol LEE ; Soo Chan KIM ; Young Suck RO ; Joo Yeon KO ; Mi Youn PARK ; Myung Hwa KIM ; Jeong Hyun SHIN ; Hae Young CHOI ; Chang Kwun HONG ; Sung Yul LEE ; Hana BAK ; Sang Wook SON ; Ai Young LEE
Annals of Dermatology 2016;28(3):335-343
BACKGROUND: Hand eczema is one of the most common skin disorders and negatively affects quality of life. However, a large-scale multicenter study investigating the clinical features of patients with hand eczema has not yet been conducted in Korea. OBJECTIVE: To identify the prevalence of various hand diseases, which is defined as all cutaneous disease occurring in hands, and to investigate the clinical features of patients with hand eczema and the awareness about hand eczema in the general population and to compare the prevalence of hand eczema between health care providers and non-health care providers. METHODS: To estimate the prevalence of hand diseases, we analyzed the medical records of patients from 24 medical centers. Patients were assessed by online and offline questionnaires. A 1,000 from general population and 913 hand eczema patients answered the questionnaire, for a total of 1,913 subjects. RESULTS: The most common hand disease was irritant contact dermatitis. In an online survey, the lifetime prevalence of hand eczema was 31.2%. Hand eczema was more likely to occur in females (66.0%) and younger (20~39 years, 53.9%). Health care providers and housewives were the occupations most frequently associated with hand eczema. Winter (33.6%) was the most common season which people experienced aggravation. The 63.0% and 67.0% answered that hand eczema hinders their personal relationship and negatively affects daily living activities, respectively. CONCLUSION: Hand eczema is a very common disease and hinders the quality of life. The appropriate identification of hand eczema is necessary to implement effective and efficient treatment.
Activities of Daily Living
;
Dermatitis, Contact
;
Eczema*
;
Female
;
Hand*
;
Health Personnel
;
Humans
;
Korea*
;
Medical Records
;
Occupations
;
Prevalence
;
Quality of Life
;
Seasons
;
Skin
;
Surveys and Questionnaires
8.Potential Role of S100A8 in Cutaneous Squamous Cell Carcinoma Differentiation.
Jung Min SHIN ; In Kyu CHANG ; Young Ho LEE ; Min Kyung YEO ; Jin Man KIM ; Kyung Cheol SOHN ; Myung IM ; Young Joon SEO ; Chang Deok KIM ; Jeung Hoon LEE ; Young LEE
Annals of Dermatology 2016;28(2):179-185
BACKGROUND: S100A8 is differentially expressed in various cell types and is associated with a number of malignant disorders. S100A8 may affect tumor biology. However, its role in cutaneous squamous cell carcinoma (SCC) is not well established. OBJECTIVE: This study aims to investigate the relationship between S100A8 and cutaneous SCC development. METHODS: We performed immunohistochemical staining to detect S100A8 expression in facial skin specimens of premalignant actinic keratosis (AK), malignant SCC, and normal tissues. In addition, we utilized postconfluence and high calcium-induced differentiation in a culture system model. Furthermore, we constructed a recombinant adenovirus expressing GFP-tagged S100A8 to investigate the role of S100A8 in SCC cell differentiation. RESULTS: S100A8 was significantly overexpressed in human cutaneous SCC compared to that in normal and AK tissues. S100A8 was gradually upregulated in SCC cells in a post-confluence-induced differentiation model. Overexpression of S100A8 in SCC cells induced by adenoviral transduction led to increased expression levels of differentiation markers, such as loricrin, involucrin, and filaggrin. S100A8 overexpression also increased loricrin and involucrin luciferase activity. CONCLUSION: S100A8 regulates cutaneous SCC differentiation and induces well-differentiated SCC formation in skin.
Adenoviridae
;
Antigens, Differentiation
;
Biology
;
Carcinoma, Squamous Cell*
;
Cell Differentiation
;
Humans
;
Keratosis, Actinic
;
Luciferases
;
Skin
9.A Case of Actinomycosis of an Orbital Subperiosteal Abscess in a Patient with Type 2 Diabetes Mellitus.
Jong Eun PARK ; Jae Bin KANG ; Hyun Young PARK ; Ji Yeon AHN ; Jae Ho SHIN ; Kun Hee LEE ; In Jin CHO ; Yoo Cheol HWANG ; Kyu Jeung AHN ; Ho Yeon CHUNG ; In Kyung JEONG
Journal of Korean Diabetes 2016;17(3):219-223
Orbital and paranasal actinomycosis have not been commonly reported. We report a case of this uncommon infection, which was improved after endonasal endoscopic drainage and antibiotics. A 53-year-old woman with type 2 diabetes mellitus complained of inability to lift her right upper eyelid and painful swelling over the preceding two days. Broad-spectrum antibiotics did not resolve her lesion. In ophthalmic examination, decreased visual acuity, upper and medial gaze limitation, and a relative afferent pupillary defect of her right eye were observed. Computed tomography of the orbit showed aggravated orbital cellulitis, preseptal cellulitis, subperiosteal abscess, and maxillary and ethmoid sinusitis. After endonasal endoscopic drainage and systemic antibiotics, her clinical symptoms dramatically improved. Microbiological analysis of the maxillary excisional biopsy showed Actinomycosis. This case is of interest due to the rare orbital presentation of actinomycosis infection and the importance of appropriate surgical drainage and long-term antibiotics treatment in such cases. Because delayed diagnosis and treatment of rhino-orbital actinomycosis can cause permanent vision loss or intracranial abscess, it requires careful clinical attention.
Abscess*
;
Actinomycosis*
;
Anti-Bacterial Agents
;
Biopsy
;
Cellulitis
;
Delayed Diagnosis
;
Diabetes Mellitus, Type 2*
;
Drainage
;
Ethmoid Sinus
;
Ethmoid Sinusitis
;
Eyelids
;
Female
;
Humans
;
Middle Aged
;
Orbit*
;
Orbital Cellulitis
;
Pupil Disorders
;
Visual Acuity
10.Relationship between Abdominal Obesity and Proportion of Supper and Late-night Meals
Sang Kyu NA ; Shin Hye CHEON ; Yeo Jin CHOI ; Hae Jeung LEE ; Yong Kyun ROH ; Min Kyu CHOI
Korean Journal of Obesity 2016;25(2):92-98
BACKGROUND: Obesity is a serious problem, and there have been various studies to elucidate its causes. This study aims to evaluate the relationship between obesity and proportion of supper and late-night meals among the Korean general population. METHODS: The total analyzed population was 15,757 people (mean age 44.6 years). The criterion for abdominal obesity as defined by waist circumference was follows: men ≥90 cm, women ≥85 cm. Supper and late-night meals are defined as meals eaten between 6:00 p.m. and 2:00 a.m. Calories of supper and late-night meal were divided by the total calorie intake of the day and categorized into quintiles. Various variables that can affect obesity were corrected for in the model, and logistic regression models were used to confirm the relationship between supper and late-night meals and waist circumference. RESULTS: Comparing the first quintile to the second, the third, and the fifth showed statistically significant results (Odds ratio: 1.19, 1.25, and 1.21, respectively). We also compared the breakfast group and the no breakfast group. Only the breakfast group showed statistically significant results (Odds ratio: 1.28, 1.30, 1.22, and 1.21, respectively). CONCLUSION: Risk of abdominal obesity will be decreased if one reduces the proportion of supper and late-night meals to half of the recommended calorie intake.
Breakfast
;
Female
;
Humans
;
Logistic Models
;
Male
;
Meals
;
Obesity
;
Obesity, Abdominal
;
Waist Circumference

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