1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION)
Byung Wan LEE ; KyungWan MIN ; Eun-Gyoung HONG ; Bon Jeong KU ; Jun Goo KANG ; Suk CHON ; Won-Young LEE ; Mi Kyoung PARK ; Jae Hyeon KIM ; Sang Yong KIM ; Keeho SONG ; Soon Jib YOO
Endocrinology and Metabolism 2023;38(3):328-337
Background:
This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin.
Methods:
In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks.
Results:
The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was –0.66% (0.07) with a 95% confidence interval of –0.80% to –0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted.
Conclusion
Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.
3.Socioeconomic Burden of Cancer in Korea from 2011 to 2015
Young Ae KIM ; Ye-Rin LEE ; Jeongjoo PARK ; In-Hwan OH ; Hoseob KIM ; Seok-Jun YOON ; Keeho PARK
Cancer Research and Treatment 2020;52(3):896-906
Purpose:
Though the socioeconomic burden of cancer on patients is increasing in South Korea, there is little research regarding the type of cancer that incurs the highest costs. This study analyzed the socioeconomic burden on cancer patients from 2011 to 2015 according to sex and age.
Materials and Methods:
A prevalence-based approach was applied utilizing claim data of the National Health Insurance Service in Korea to estimate the socioeconomic burden of cancer on patients. Patients who received treatment for cancer from 2011 to 2015 were the study subjects. The total socioeconomic burden of their disease and treatment was divided into direct and indirect costs.
Results:
There was an increase of 50.7% for 5 years, from 821,525 to 1,237,739 cancer patients. The cancer costs for men and women increased $8,268.4 million to $9,469.7 million and $3,626.5 million to $4,475.6 million, respectively. Furthermore, the 50-59-year-old age group accounted for a large portion of the total disease cost. Liver, lung, stomach, and colorectal cancers created the heaviest economic burdens on patients.
Conclusion
Overall, this study indicates new policies for cancer prevention, early detection, and postcancer treatment management are necessary to help limit the costs associatedwith cancer, especially in the elderly, and provides a foundation for establishing cancer-related health care policies, particularly by defining those cancers with heavier disease burdens.
4.The Fear of Cancer from the Standpoint of Oneself, the Opposite Sex and the Fear of Side Effects of Cancer Treatment
Keeho PARK ; Youngae KIM ; Hyung Kook YANG ; Hye Sook MIN
Cancer Research and Treatment 2020;52(4):993-1001
Purpose:
It is important to understand the differences between men and women when it comes to attitudes and risk perception toward disease. This study aimed to explore the fear of cancer from the standpoint of themselves and the opposite sex by cancer type.
Materials and Methods:
A cross-sectional survey with a representative sample was conducted.
Results:
The least and the most feared cancers in men were thyroid cancer and lung cancer, respectively. When men assumed the perspective of women, the least and the most feared cancer were thyroid cancer and stomach cancer, respectively. The least and the most feared cancers in women were thyroid cancer and stomach cancer, respectively. When women assumed the perspective of men, the least and the most feared cancer were prostate cancer and lung cancer, respectively. When both men and women assume the perspective of the opposite sex, the fear of sex-specific cancer was relatively low compared to the actual responses of both men and women. The top six of the most feared side effects of cancer treatment were pain, psychological problems, general weakness, digestive dysfunction, fatigue, and appearance change. These were the same between men and women.
Conclusion
Health care providers and caregivers in the family should provide care with more attention to the differences in thoughts about cancer between men and women. Health care providers should provide care with more attention to the differences in these problems between men and women.
5.Gap between Perceived eHealth Literacy and Ability to Use Online Cancer-Related Information
Saerom KIM ; Keeho PARK ; Heui Sug JO
Journal of Korean Medical Science 2020;35(24):e187-
Background:
The effective evaluation of health information available online is an important skill. However, consumers' self-perceptions of their eHealth literacy levels do not reflect their actual capabilities. The goal of this experimental study of online search behavior is to identify differences between self-perceived eHealth literacy and actual ability to use the accuracy of cancer information available online.
Methods:
Thirty-one adults participated in the study conducted on July 15 and 16, 2017. We first measured perceived eHealth literacy and then asked participants 5 questions concerning cancer. Bandicam (v3.3.0) and BrowsingHistoryView were used to record search behavior and uniform resource locators, respectively. A Mann-Whitney U test and Fisher's exact test were performed.
Results:
The results showed that participants most frequently searched for cancer information on blogs and café websites. Regarding search behavior, those who perceived higher knowledge in available resources tended to solve the given problem with significantly smaller number of webpages to answer a weight management question. Participants who perceived higher knowledge in helpfulness of information tended to use significantly smaller number of webpages to answer questions on red ginseng's preventive effects on caner and weight management. However, there was no proof that the high eHealth literacy group had significantly higher rates of correct answers than the low eHealth literacy group. Further, regarding cancer screening, the rates of correct answers were low for groups who considered their ability higher to find helpful resources and perceived higher knowledge in helpfulness of information.
Conclusion
There is a gap between perceived eHealth literacy and the actual ability to use online cancer-related information. To fundamentally improve eHealth literacy, it is important to evaluate the actual abilities concerning each eHealth literacy component and to provide customized education.
6.What We Talk about When We Talk about Caregiving: The Distribution of Roles in Cancer Patient Caregiving in a Family-Oriented Culture.
Ansuk JEONG ; Dongwook SHIN ; Jong Hyock PARK ; Keeho PARK
Cancer Research and Treatment 2019;51(1):141-149
PURPOSE: When it comes to cancer care, the psychological well-being of family caregivers has gotten its deserved attention. However, the specific roles that the family caregivers take have not been examined as much. The current study aimed to investigate the distribution of family caregivers' roles, particularly in a family-oriented culture, Korea. MATERIALS AND METHODS: A sample of 439 participants was recruited from 11 national and regional cancer centers in Korea. The participants who were 60 years old or above went through treatments for their gastric, colorectal, or lung cancer. The individual survey included questions regarding the family type, living arrangement, and the sources of support when it comes to their physical, emotional, financial, and decision-making needs. RESULTS: The responses from the participants showed that cancer caregiving is shared by multiple family caregivers; the major source of support for elderly cancer patients on diverse domains was their spouse; patients' reliance on their daughter(s) increased for emotional support; and patients' reliance on their son(s) stood out for financial support and decision-making support. Also, the older the patients were, the heavier their reliance was on the adult children, including sons, daughters, and daughters-in-law. CONCLUSION: Future support programs for elderly cancer patients are suggested to involve multiple family caregivers to encourage effective and efficient intervention. Also, the limitations of the current study and the suggestions for future research are discussed.
Adult Children
;
Aged
;
Caregivers
;
Financial Support
;
Humans
;
Korea
;
Lung Neoplasms
;
Nuclear Family
;
Republic of Korea
;
Residence Characteristics
;
Spouses
7.Income Difference in Attitudes towards Cancer in General Population: Findings from a National Survey.
Hye Sook MIN ; Jinsil PARK ; Young Ae KIM ; Hyung Kook YANG ; Keeho PARK
Journal of Korean Medical Science 2018;33(33):e215-
BACKGROUND: To better understand cancer-related health behaviors, it is critical to know how general populations with different socioeconomic and demographic backgrounds perceive cancer. The current paper explored differences in general attitudes and beliefs towards cancer among Koreans. METHODS: A cross-sectional national survey was conducted for 1,000 Korean participants who were not cancer patients and did not have immediate family members with cancer via proportional quota random sampling. General attitudes and beliefs about cancer were measured by face-to-face interview using the awareness and beliefs about cancer (ABC) measure. RESULTS: Most respondents (84.8%–88.5%) had optimistic attitudes towards cancer. However, 35.6% to 87.7% agreed with negative cancer beliefs across all age groups simultaneously. Socioeconomic disparity of positive cancer beliefs was not evident. Unexpectedly, the highest income group agreed more strongly with the negatively framed statements that cancer treatment is worse than the cancer itself (odds ratio [OR], 2.68; 95% confidence interval [CI], 1.31–5.53), that they would not want to know if they have cancer (OR, 1.61; 95% CI, 0.94–2.75), and that a cancer diagnosis is a death sentence (OR, 2.32; 95% CI, 1.34–4.01), than the lowest income group. CONCLUSION: The present results imply a complicated context of cancer beliefs in Korea, unlike those shown in the studies of western populations. While the contradictory attitudes toward cancer can be attributable to the dual nature of information processing, social environment might have played a role. The association between socioeconomic status and negative attitudes toward cancer may vary depending on the diversity of the contexts.
Automatic Data Processing
;
Diagnosis
;
Health Behavior
;
Humans
;
Korea
;
Social Class
;
Social Environment
;
Surveys and Questionnaires
8.Supporting Low-income Cancer Patients: Recommendations for the Public Financial Aid Program in the Republic of Korea.
Hye Sook MIN ; Hyung Kook YANG ; Keeho PARK
Cancer Research and Treatment 2018;50(4):1074-1083
PURPOSE: As the recent term of “financial toxicity” implies, cancer causes a treatment-related financial harm. Financial Aid Program for Cancer Patient (FAPCP) is a government’s financial support for low-income patients in the Republic of Korea. This study aimed to describe FAPCP applicants’ condition and to investigate factors influencing financial burden, which would provide the basis for implementing a strategy for FAPCP administration. MATERIALS AND METHODS: The telephone survey results from 2,700 FAPCP participants were analyzed, including demographic, socioeconomic, and disease characteristics and experiences associated with financial burden and the actions or measures to cope with them. RESULTS: Overall, 87.6% experienced financial burden more than moderate degree, 39.2% got financial help/a loan, 17.8% disposed of their property, and 10.2% changed or stopped treatment owing to medical costs. Monthly household income was connected to financial burden, and the highest income group was associated with the lowest financial burden (odds ratio [OR], 0.21; 95% confidence interval [CI], 0.11 to 0.38) and the lowest rate of changing/stopping care (OR, 0.23; 95% CI, 0.05 to 1.00). Parents of childhood cancer patients got financial help/a loan (OR, 2.24; 95% CI, 1.03 to 4.88) and disposed of their property (OR, 3.18; 95% CI, 1.40 to 7.22) more frequently, and Medical Aids applicants showed the highest rate of changing/stopping care (OR, 3.01; 95% CI, 1.89 to 4.78). CONCLUSION: FAPCP targets low income groups; however, financial burden and the consequent actions taken still exist disproportionately, depending on the income of the applicants. FAPCP should focus on more vulnerable groups including Medical Aid applicants and parents of childhood cancer patients, by increasing funds and expanding their support coverage.
Family Characteristics
;
Financial Management
;
Financial Support
;
Health Care Costs
;
Humans
;
Parents
;
Public Assistance
;
Republic of Korea*
;
Telephone
9.Patient's Cognitive Function and Attitudes towards Family Involvement in Cancer Treatment Decision Making: A Patient-Family Caregiver Dyadic Analysis.
Dong Wook SHIN ; Juhee CHO ; Debra L ROTER ; So Young KIM ; Jong Hyock PARK ; Hyung Kook YANG ; Hyun Woo LEE ; Sun Seog KWEON ; Yune Sik KANG ; Keeho PARK
Cancer Research and Treatment 2018;50(3):681-690
PURPOSE: Older patient populations commonly have cognitive impairment, which might impact decisional capacity. We examined patients and family caregivers preferences for family involvement in treatment decision making assuming different level of cognitive impairment, and sought to explore the factors associated with the preferences and the degree to which patients and family members agree on preferences. MATERIALS AND METHODS: A total of 358 elderly cancer patient and caregiver dyads were recruited from the 11 cancer centers in Korea andwere asked to express their preferences forfamily involvement in treatment decision making using hypothetical scenarios with three different levels of cognitive status (intact, mild impairment, and severe impairment). RESULTS: Both patients and family caregivers preferred greater family dominance in treatment decision makingwith the increasing the level of cognitive impairment (39.7%, 60.9%, and 86.6% for patients and 45.0%, 66.2%, and 89.7% for caregivers in each scenarios). Patient and family caregiver concordance in decisional control preference was small for all three scenarios (weighted κ=0.32, κ=0.26, and κ=0.36, respectively). Higher patient education was associated with preference for patient dominance in treatment decision in conditions of both mild and severe cognitive impairment. The association of higher patient education and patient-caregiver preference concordance was positive with intact cognition, while it was negative with severe cognitive impairment. CONCLUSION: Decision control preferences were affected by hypothesized cognitive status of the patients. Findings from our study would be helpful to develop effective strategy for optimizing family involvement in cancer treatment decision in the context of deteriorating cognitive function of the patients.
Aged
;
Caregivers*
;
Cognition Disorders
;
Cognition*
;
Decision Making*
;
Humans
;
Korea
;
Patient Education as Topic
10.Analysis of Hospital Volume and Factors Influencing Economic Outcomes in Cancer Surgery: Results from a Population-based Study in Korea.
Jung A LEE ; So Young KIM ; Keeho PARK ; Eun Cheol PARK ; Jong Hyock PARK
Osong Public Health and Research Perspectives 2017;8(1):34-46
OBJECTIVES: To evaluate associations between hospital volume, costs, and length of stay (LOS), and clinical and demographic outcome factors for five types of cancer resection. The main dependent variables were cost and LOS; the primary independent variable was volume. METHODS: Data were obtained from claims submitted to the Korean National Health Insurance scheme. We identified patients who underwent the following surgical procedures: pneumonectomy, colectomy, mastectomy, cystectomy, and esophagectomy. Hospital volumes were divided into quartiles. RESULTS: Independent predictors of high costs and long LOS included old age, low health insurance contribution, non-metropolitan residents, emergency admission, Charlson score > 2, public hospital ownership, and teaching hospitals. After adjusting for relevant factors, there was an inverse relationship between volume and costs/LOS. The highest volume hospitals had the lowest procedure costs and LOS. However, this was not observed for cystectomy. CONCLUSION: Our findings suggest an association between patient and clinical factors and greater costs and LOS per surgical oncologic procedure, with the exception of cystectomy. Yet, there were no clear associations between hospitals’ cost of care and risk-adjusted mortality.
Colectomy
;
Cystectomy
;
Emergencies
;
Esophagectomy
;
Hospital Costs
;
Hospitalization
;
Hospitals, Public
;
Hospitals, Teaching
;
Humans
;
Insurance, Health
;
Korea*
;
Length of Stay
;
Mastectomy
;
Mortality
;
National Health Programs
;
Ownership
;
Pneumonectomy

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