- Diabetes, obesity and metabolism
- 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)
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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
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Endocrinol Metab. 2024;39(5):722-731. Published online August 22, 2024
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DOI: https://doi.org/10.3803/EnM.2024.1995
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Abstract
PDFPubReader ePub
- 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.
- A Case of Diabetic Mastopathy.
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Seok Hong Lee, Bo Min Kim, Jae Woong Kim, Moon Ki Hong, Seonghyeop Hyeon, Mi Yi Kim, Jaetaek Kim, Jihyun Ahn
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Endocrinol Metab. 2012;27(3):244-246. Published online September 19, 2012
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DOI: https://doi.org/10.3803/EnM.2012.27.3.244
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Abstract
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- Diabetic mastopathy is an unusual fibroinflammatory breast lesion that is characteristically presented in premenopausal women with long-standing diabetes with multiple microvascular complications. This patient was a 49-year-old postmenopausal woman with diabetic nephropathy, neuropathy, and retinopathy. Although palpable mass was detected on the left breast, an ultrasonography could not distinguish it from breast cancer. Excisional biopsy was conducted. Histological findings indicated diabetic mastopathy with keloid-like fibrosis, perivascular lymphocytic infiltration, and lymphocytic lobulitis without evidence of malignancy. After excision, there has been no recurrence until now.
- A Case of Methimazole-induced Agranulocytosis and Kikuchi's Disease in a Patient with Graves' Disease.
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Seung Eun Lee, Jihyun Ahn, Jaetaek Kim, Yeon Sahng Oh, Yun Jae Chung
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J Korean Endocr Soc. 2008;23(6):420-424. Published online December 1, 2008
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DOI: https://doi.org/10.3803/jkes.2008.23.6.420
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Abstract
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- Methimazole-induced agranulocytosis is a rare, but critical side effect that should be recognized as soon as possible since it may induce a life-threatening condition when it was overlooked. Histiocytic necrotizing lymphadenitis is also called Kikuchi's lymphadenitis, and this is a rare form of lymphadenitis with a self-limited clinical course and this illness is accompanied by cervical lymph node enlargement, fever and malaise. We recently experienced a patient with methimazole-induced agranulocytosis and Graves' disease, and this was accompanied by Kikuchi's disease; the patient presented with sore throat and multiple enlarged cervical lymph nodes. To the best of our knowledge, there is no previous report on methimazole-induced agranulocytosis combined with Kikuchi's disease. Therefore, we report here on this very rare case along with a brief review of the relevant literature.
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