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.A Case of Lung Carcinoma with Rhabdoid Phenotype Mimicking an Aspergilloma in Patient with Recurrent Hemoptysis.
Moo Woong KIM ; Soo Jung REW ; Seo Joon EUN ; Ui Sin LEE ; Chan Woo PARK ; Jong Pil JEONG ; Young Choon KO
Tuberculosis and Respiratory Diseases 2014;77(1):38-41
Malignant rhabdoid tumor was first discovered in the kidney, and rhabdoid tumor of the lung was first reported in 1995. These were included as the variants of large-cell carcinoma, according to the 1999 World Health Organization classification of lung tumors. The rhabdoid tumor of the lung exhibits aggressive biological behavior and has a poor prognosis, and only a few reports of this tumor exist. We report a case of lung carcinoma with a rhabdoid phenotype, initially misdiagnosed as an aspergilloma, in a 48-year-old man who presented with recurrent hemoptysis. The chest computed tomography scans showed a huge consolidative lesion with an air crescent sign in the left upper lung and no contrast-enhancing lesion. An aspergilloma was diagnosed by the radiologist. However, after surgical excision and pathological examination, rhabdoid carcinoma was diagnosed. A surgical resection helps to make it possible to pathologically distinguish a malignancy from an aspergilloma.
Aspergillosis
;
Classification
;
Hemoptysis*
;
Humans
;
Kidney
;
Lung*
;
Middle Aged
;
Phenotype*
;
Prognosis
;
Rhabdoid Tumor
;
Thorax
;
World Health Organization
4.A Case of Lung Carcinoma with Rhabdoid Phenotype Mimicking an Aspergilloma in Patient with Recurrent Hemoptysis.
Moo Woong KIM ; Soo Jung REW ; Seo Joon EUN ; Ui Sin LEE ; Chan Woo PARK ; Jong Pil JEONG ; Young Choon KO
Tuberculosis and Respiratory Diseases 2014;77(1):38-41
Malignant rhabdoid tumor was first discovered in the kidney, and rhabdoid tumor of the lung was first reported in 1995. These were included as the variants of large-cell carcinoma, according to the 1999 World Health Organization classification of lung tumors. The rhabdoid tumor of the lung exhibits aggressive biological behavior and has a poor prognosis, and only a few reports of this tumor exist. We report a case of lung carcinoma with a rhabdoid phenotype, initially misdiagnosed as an aspergilloma, in a 48-year-old man who presented with recurrent hemoptysis. The chest computed tomography scans showed a huge consolidative lesion with an air crescent sign in the left upper lung and no contrast-enhancing lesion. An aspergilloma was diagnosed by the radiologist. However, after surgical excision and pathological examination, rhabdoid carcinoma was diagnosed. A surgical resection helps to make it possible to pathologically distinguish a malignancy from an aspergilloma.
Aspergillosis
;
Classification
;
Hemoptysis*
;
Humans
;
Kidney
;
Lung*
;
Middle Aged
;
Phenotype*
;
Prognosis
;
Rhabdoid Tumor
;
Thorax
;
World Health Organization
5.Post-operative nausea and vomiting after gynecologic laparoscopic surgery: comparison between propofol and sevoflurane.
Helen Ki SHINN ; Mi Hyeon LEE ; Sin Yeong MOON ; Sung Il HWANG ; Choon Soo LEE ; Hyun Kyoung LIM ; Jang Ho SONG
Korean Journal of Anesthesiology 2011;60(1):36-40
BACKGROUND: We compared the incidence and degree of post-operative nausea and vomiting (PONV) in patients who received general anesthesia with propofol or sevoflurane using the Rhodes index of nausea, vomiting, and retching (RINVR) to assess the degree of PONV quantitatively and objectively during the post-anesthetic period. METHODS: We performed a prospective study involving 38 patients who underwent gynecologic laparoscopic surgery in our hospital between September 2008 and August 2009. Nineteen patients were anesthetized with propofol during the entire anesthetic period and the other 19 patients received 2.0 mg/kg of propofol intravenously, followed by sevoflurane inhalation. Three patients who were anesthetized with sevoflurane were excluded from the analysis because they were omitted during the survey. We studied the patients who had PONV and RINVR scores 1, 6, and 24 hours post-operatively. RESULTS: The propofol group had a statistically lower incidence of PONV and lower RINVR scores in the following subclasses within 1 hour of surgery: symptom occurrence; symptom distress; and symptom experience. CONCLUSIONS: Propofol at induction and during maintenance of anesthesia can be used to prevent PONV within 1 hour post-operatively in patients undergoing gynecologic laparoscopic surgery.
Anesthesia
;
Anesthesia, General
;
Humans
;
Incidence
;
Inhalation
;
Laparoscopy
;
Methyl Ethers
;
Nausea
;
Postoperative Nausea and Vomiting
;
Propofol
;
Prospective Studies
;
Vomiting
6.The effect-site concentration of propofol producing respiratory depression during spinal anesthesia.
Mi Hyeon LEE ; Ki Hwan YANG ; Choon Soo LEE ; Hong Sik LEE ; Sin Yeong MOON ; Sung Il HWANG ; Jang Ho SONG
Korean Journal of Anesthesiology 2011;61(2):122-126
BACKGROUND: Propofol is used worldwide for its sedative effective; nonetheless, has the serious side effect of respiratory depression. An increased blood concentration of propofol is well known to be associated with increased respiratory depression. However, there are no studies of the effect site concentration inducing respiratory depression. The purpose of this study was to determine the effect site concentration inducing respiratory depression of propofol when sedating a patient after spinal anesthesia. METHODS: This study included thirty seven males who received operations with spinal anesthesia, which was performed on L3-4 and L4-5. All patients were monitored with the bispectral index and were continuously infused with propofol using target controlled infusion. Respiratory depression was diagnosed when one of the following was evident without upper respiratory obstructive signs: a greater than 20% increase of end tidal carbon dioxide from baseline pressure or pulse oximetry oxygen saturation lower than 95%. We obtained the EC5, EC10, and EC50 of the effect site propofol for respiratory depression. RESULTS: The EC5 of propofol for respiratory depression was 3.09 mcg/ml (95% CI, 2.60-3.58). The EC10 of propofol for respiratory depression was 3.18 mcg/ml (95% CI, 2.57-3.80). The EC50 of propofol for respiratory depression was 3.99 mcg/ml (95% CI, 2.36-5.61). CONCLUSIONS: The EC5, EC10, and EC50 of effect site propofol for respiratory depression during spinal anesthesia were 3.09 mcg/ml ,3.18 mcg/ml, and 3.99 mcg/ml, respectively.
Anesthesia, Spinal
;
Carbon Dioxide
;
Humans
;
Male
;
Oximetry
;
Oxygen
;
Propofol
;
Respiratory Insufficiency
7.Developed Extrapotine Myelinolysis after Hysteroscopic Myomectomy: A case report.
Hyo Seok KANG ; In Young OH ; Young Ju KIM ; Choon Kyu CHO ; Su Keoung LEE ; Sin Young YANG ; Yong Im KWON ; Hwan Yeong CHOI ; Yun Seok YANG
Korean Journal of Anesthesiology 2006;50(1):94-98
Transcervical resection of endometrium is under-utilized in the treatment of dysfunctional uterine bleeding, uterine myoma and menorrhagia. The procedure is similar to transurethral resection of prostate in men with a possibility of substantial absorption of irrigation fluid. Absorption of a large volume of fluid can cause excessive intravascular volume, hyponatremia, cerebral edema and death. Severe hyponatremia leading to extrapontine myelinolysis is an extremely rare complication of this procedure. So, We report a case of developed extrapontine myelinolysis after hysteroscopic myomectomy which, however, showed complete recovery.
Absorption
;
Brain Edema
;
Endometrium
;
Female
;
Humans
;
Hyponatremia
;
Leiomyoma
;
Male
;
Menorrhagia
;
Metrorrhagia
;
Myelinolysis, Central Pontine
;
Transurethral Resection of Prostate
8.Pseudobacteremic Outbreak of Leclercia adecarboxylata and Pseudomons aeruginosa Related to Contaminated Saline Cotton .
Cheol Ho SIN ; Gyong Jung KIM ; Sehe Dong LEE ; Hae Jung NAM ; Choon Kwan KIM ; Seung Chul PARK
Korean Journal of Nosocomial Infection Control 2006;11(1):15-20
BACKGROUND: During a 1-month period in 2005 , a series of 4 Leclercia adecarboxylata and 8 Pseudomonas aeruginosa bacteremias were reported from patients admitted to the emergency room. METHODS: An outbreak of L. adecarboxylata and P. aeruginosa bacteremia that occurred from February to March 2005 was investigated. The infection control nurse reviewed medical records and observed the procedures of blood cultures at the clinical microbiology laboratory. Specimens were obtained for investigational cultures from alcohol sponge, tray, sink, water of sink, saline cotton, microscope, computer, and telephone. RESULTS: L. adecarboxylata was isolated from 4 patients and P. aeruginosa from 8 patients during a 1-month period. Observation of the culture procedure revealed that saline cotton was used to prevent betadin skin discoloration. The culture of the saline solution yielded a heavy growth of P. aeruginosa, which was not isolated from any other specimens. CONCLUSIONS: This was a pseudoepidemic caused by contaminated saline cotton. The use of the saline cotton was stopped, and during the follow-up period of 3 months, no additional L. adecarboxylata or P. aeruginosa bacteremia were reported.
Bacteremia
;
Emergency Service, Hospital
;
Enterobacteriaceae*
;
Follow-Up Studies
;
Humans
;
Infection Control
;
Medical Records
;
Porifera
;
Pseudomonas aeruginosa
;
Skin
;
Sodium Chloride
;
Telephone
;
Water
9.A Case of Iodine-induced Thyrotoxicosis with Acromegaly.
Kwang Hyun KIM ; Kyu Hong KIM ; Ho Yoel RYU ; Su Min NAM ; Mi Young LEE ; Jang Hyun KOH ; Jang Yeol SIN ; Choon Hee CHUNG
Journal of Korean Society of Endocrinology 2006;21(1):63-67
Hyperthyroidism is seen in 3.5-26% of subjects with acromegaly. Hyperthyroidism can be developed by thyroid stimulating hormone (TSH) dependent mechanism in TSH-secreting adenomas with acromegaly or by TSH independent mechanism through the stimulation of thyroid cells by growth hormone (GH). So, confirming the cause of hyperthyroidism is important to treat that. We report a case of a 56-year-old man who had acromegaly with iodine-induced thyrotoxicosis. He took the sea tangle for 4 years because he had constipation. His face and hands indicated acromegaly. Thyroid function test showed that T3 and free T4 were increased and TSH was decreased. Ultrasonography of neck showed diffuse enlargement of thyroid gland and thyroid scan showed decreased uptake of thyroid gland. So we could confirm iodine-induced thyrotoxicosis due to excessive iodine intake. Serum GH and insulin-like growth factor (IGF)-1 were markedly increased and brain MRI showed heterogenous 1 cm sized pituitary mass in right side. Acromegaly was confirmed by brain MRI, pituitary stimulation test and increased level of GH, IGF-1. He stopped iodine intake. After 6 months, T3, free T4 and TSH were normalized and he is waiting for the surgical removal of pituitary adenoma.
Acromegaly*
;
Adenoma
;
Brain
;
Constipation
;
Growth Hormone
;
Hand
;
Humans
;
Hyperthyroidism
;
Insulin-Like Growth Factor I
;
Iodine
;
Magnetic Resonance Imaging
;
Middle Aged
;
Neck
;
Pituitary Neoplasms
;
Thyroid Function Tests
;
Thyroid Gland
;
Thyrotoxicosis*
;
Thyrotropin
;
Ultrasonography
10.A Case of Oligoarthritis Associated with Gastric Adenocarcinoma.
Choon Wook KIM ; Sang Jo MIN ; Dong Kyu KIM ; Ji Hyeon OH ; Kwang Soon AN ; Hyeon Jeong KIM ; Hyeon Joo SIN ; Jae Hyeon MOON ; Choong Won LEE
The Journal of the Korean Rheumatism Association 2004;11(2):179-182
Malignancy may cause variable musculoskeletal symptoms which resemble connective tissue disorder. This symptoms as a fine sign of hidden neoplasm can precede the diagnosis of underlying malignancy. But only one case of stomach cancer associated with cancer arthritis was reported in the world. This fact is very interesting in Asia which has high prevalence of stomach cancer. We experienced one case of gastric adenocarcinoma with oligoarthritis involving both knee and right elbow. A 48-year-old man was diagnosed stomach cancer by gastric endoscope and biopsy. After then, he complained pain, tenderness, heating sensation, swelling of both knee and right elbow with high fever. Both knee MRI showed abundant synovial effusion and soft tissue edema. Full dose of nonsteroidal anti-inflammatory drug was not effective to control fever and arthritis. But fever and arthritis were gone after resection of tumor.
Adenocarcinoma*
;
Arthritis
;
Asia
;
Biopsy
;
Connective Tissue
;
Diagnosis
;
Edema
;
Elbow
;
Endoscopes
;
Fever
;
Heating
;
Hot Temperature
;
Humans
;
Knee
;
Magnetic Resonance Imaging
;
Middle Aged
;
Prevalence
;
Sensation
;
Stomach Neoplasms

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