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.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.
3.Comparative outcomes of acute colonic diverticulitis in immunocompromised versus immunocompetent patients: a systematic review and meta-analysis
Jae Gon LEE ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Shin Hee LEE ; Myung-Won YOU ; Seong-Eun KIM
Intestinal Research 2023;21(4):481-492
Background/Aims:
Immunocompromised patients with acute colonic diverticulitis are at high risk for complications and failure of non-surgical treatment. However, evidence on the comparative outcomes of immunocompromised and immunocompetent patients with diverticulitis is lacking. This systematic review and meta-analysis investigated the outcomes of medical treatment in immunocompromised and immunocompetent patients with diverticulitis.
Methods:
A comprehensive literature search was conducted in PubMed, Embase, and the Cochrane Library. Studies comparing the clinical outcomes of immunocompromised and immunocompetent patients with diverticulitis were included.
Results:
A total of 10 studies with 1,946,461 subjects were included in the quantitative synthesis. The risk of emergency surgery and postoperative mortality after emergency surgery was significantly higher in immunocompromised patients than in immunocompetent patients with diverticulitis (risk ratio [RR], 1.76; 95% confidence interval [CI], 1.31–2.38 and RR, 3.05; 95% CI, 1.70–5.45, respectively). Overall risk of complications associated with diverticulitis was non-significantly higher in immunocompromised than in immunocompetent patients (RR, 1.24; 95% CI, 0.95–1.63). Overall mortality irrespective of surgery was significantly higher in immunocompromised than in immunocompetent patients with diverticulitis (RR, 3.65; 95% CI, 1.73–7.69). By contrast, postoperative mortality after elective surgery was not significantly different between immunocompromised and immunocompetent patients with diverticulitis. In subgroup analysis, the risk of emergency surgery and recurrence was significantly higher in immunocompromised patients with complicated diverticulitis, whereas no significant difference was shown in mild disease.
Conclusions
Immunocompromised patients with diverticulitis should be given the best medical treatment with multidisciplinary approach because they had increased risks of surgery, postoperative morbidity, and mortality than immunocompetent patients.
4.Diagnosis and management of acute colonic diverticulitis: results of a survey among Korean gastroenterologists
Jae Gon LEE ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Shin Hee LEE ; Myung-Won YOU ; Seong-Eun KIM
The Korean Journal of Internal Medicine 2023;38(5):672-682
Background/Aims:
Some management strategies for acute colonic diverticulitis remain controversial in Korean real-world practice because their clinical features differ from those in the West. This study aimed to investigate the opinions of Korean physicians regarding the diagnosis and treatment of acute diverticulitis.
Methods:
A web-based survey was conducted among gastroenterologists specializing on treating lower gastrointestinal disorders. The questionnaires concerned overall management strategies for colonic diverticulitis, including diagnosis, treatment, and follow-up.
Results:
In total, 209 gastroenterologists responded to the survey. Less than one-fourth of the respondents (23.6%) answered that left-sided colonic diverticulitis is more likely to be complicated than right-sided colonic diverticulitis. Most respondents agreed that immunocompromised patients with diverticulitis have worse clinical outcomes than immunocompetent patients (71.3%). Computed tomography was the most preferred tool for diagnosing diverticulitis (93.9%). Approximately 89% of the respondents answered that they believed antibiotic treatment is necessary to treat acute uncomplicated diverticulitis. Most respondents (92.6%) agreed that emergency surgery is not required for diverticulitis with an abscess or microperforation without panperitonitis. Further, 94.7% of the respondents agreed that colon cancer screening is necessary in patients aged ≥ 50 years with diverticulitis after they have recovered from acute illness. Many respondents (71.4%) agreed that surgery for recurrent diverticulitis should be individualized.
Conclusions
Opinions regarding management strategies for colonic diverticulitis among Korean gastroenterologists were well agreed upon in some areas but did not agree well in other areas. Evidence-based guidelines that meet the practical needs of the Korean population should be developed.
5.Korean Association for the Study of Intestinal Diseases guidance for clinical practice of adult inflammatory bowel disease during the coronavirus disease 2019 pandemic: expert consensus statements
Yong Eun PARK ; Yoo Jin LEE ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Miyoung CHOI ; Seong-Eun KIM ; Seung-Jae MYUNG
Intestinal Research 2022;20(4):431-444
Many unexpected problems have resulted from the unprecedented coronavirus disease 2019 (COVID-19) pandemic. The optimal management of patients with inflammatory bowel disease (IBD) during the COVID-19 pandemic has also been a challenge. Therefore, the Korean Association for the Study of Intestinal Diseases (KASID) developed a consensus statement of experts regarding the management of IBD during the COVID-19 pandemic. This consensus statement made recommendations regarding the risk and treatment of COVID-19 in IBD patients. This statement emphasizes that IBD is not a risk factor for COVID-19, and care should be taken not to exacerbate IBD in patients in remission state by maintaining their medications, except for corticosteroids.
6.SARS-CoV-2 vaccination for adult patients with inflammatory bowel disease: expert consensus statement by KASID
Yoo Jin LEE ; Seong-Eun KIM ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Miyoung CHOI ; Seung-Jae MYUNG ;
Intestinal Research 2022;20(2):171-183
Coronavirus disease 2019 (COVID-19), caused by the novel coronavirus, is threatening global health worldwide with unprecedented contagiousness and severity. The best strategy to overcome COVID-19 is a vaccine. Various vaccines are currently being developed, and mass vaccination is in progress. Despite the very encouraging clinical trial results of these vaccines, there is insufficient information on the safety and efficacy of vaccines for inflammatory bowel disease (IBD) patients facing various issues. After reviewing current evidence and international guidelines, the Korean Association for the Study of Intestinal Diseases developed an expert consensus statement on COVID-19 vaccination issues for Korean IBD patients. This expert consensus statement emphasizes that severe acute respiratory syndrome coronavirus 2 vaccination be strongly recommended for IBD patients, and it is safe for IBD patients receiving immunomodulatory therapy.
7.Update on SARS-CoV-2 vaccination of patients with inflammatory bowel disease: what clinicians need to know
Yoo Jin LEE ; Seong-Eun KIM ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Seung-Jae MYUNG ;
Intestinal Research 2022;20(3):386-388
8.SARS-CoV-2 Vaccination for Adult Patients with Inflammatory Bowel Disease: Expert Consensus Statements by KASID
Yoo Jin LEE ; Seong-Eun KIM ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Miyoung CHOI ; Seung-Jae MYUNG ;
The Korean Journal of Gastroenterology 2021;78(2):117-128
Coronavirus disease 2019 (COVID-19), caused by the novel coronavirus, is threatening global health worldwide with unprecedented contagiousness and severity. The best strategy to overcome COVID-19 is a vaccine. Various vaccines are currently being developed, and mass vaccination is in progress. Despite the very encouraging clinical trial results of these vaccines, there is insufficient information on the safety and efficacy of vaccines for inflammatory bowel disease (IBD) patients facing various issues. After reviewing current evidence and international guidelines, the Korean Association for the Study of Intestinal Diseases (KASID) developed an expert consensus statement on COVID-19 vaccination issues for Korean IBD patients. This expert consensus statement emphasizes that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination be strongly recommended for IBD patients, and it is safe for IBD patients receiving immunomodulatory therapy.
9.KASID Guidance for Clinical Practice Management of Adult Inflammatory Bowel Disease during the COVID-19 Pandemic: Expert Consensus Statement
Yong Eun PARK ; Yoo Jin LEE ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Miyoung CHOI ; Seong-Eun KIM ; Seung-Jae MYUNG ;
The Korean Journal of Gastroenterology 2021;78(2):105-116
The coronavirus disease 2019 (COVID-19) pandemic has reduced the ability to prevent or control chronic disease due to the concerns about safety in accessing health care. Inflammatory bowel disease (IBD) is a chronic condition requiring long- term sustained treatment, which is difficult in the current panedemic situation. The Korean Association for the Study of Intestinal Diseases (KASID) has developed an expert consensus statement on the clinical practice management of adult inflammatory bowel disease during the COVID-19 pandemic. This expert consensus statement is based on guidelines and clinical reports from several countries around the world. It provides recommendations to deal with the risk of COVID-19 and medication use in IBD patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and emphasizes the importance of right treatment approach to avoid worsening of the disease condition in IBD patients.
10.SARS-CoV-2 Vaccination for Adult Patients with Inflammatory Bowel Disease: Expert Consensus Statements by KASID
Yoo Jin LEE ; Seong-Eun KIM ; Yong Eun PARK ; Ji Young CHANG ; Hyun Joo SONG ; Duk Hwan KIM ; Young Joo YANG ; Byung Chang KIM ; Jae Gon LEE ; Hee Chan YANG ; Miyoung CHOI ; Seung-Jae MYUNG ;
The Korean Journal of Gastroenterology 2021;78(2):117-128
Coronavirus disease 2019 (COVID-19), caused by the novel coronavirus, is threatening global health worldwide with unprecedented contagiousness and severity. The best strategy to overcome COVID-19 is a vaccine. Various vaccines are currently being developed, and mass vaccination is in progress. Despite the very encouraging clinical trial results of these vaccines, there is insufficient information on the safety and efficacy of vaccines for inflammatory bowel disease (IBD) patients facing various issues. After reviewing current evidence and international guidelines, the Korean Association for the Study of Intestinal Diseases (KASID) developed an expert consensus statement on COVID-19 vaccination issues for Korean IBD patients. This expert consensus statement emphasizes that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination be strongly recommended for IBD patients, and it is safe for IBD patients receiving immunomodulatory therapy.

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