Diabetes & Metabolism Journal

Original Articles

Drug/Regimen
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 Metab J. 2024;48(4):730-739. Published online May 20, 2024; DOI: https://doi.org/10.4093/dmj.2023.0077

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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.

Citations

Citations to this article as recorded by

Real-world safety evaluation of atorvastatin: insights from the US FDA adverse event reporting system (FAERS)
Hongbing Wan, Xiuxiu Xu, Dasong Yi, Kexin Shuai
Expert Opinion on Drug Safety.2024; : 1. CrossRef

Waist Circumference May be More Important than Body Mass Index (BMI) in Determinants of Left Ventricular Mass in Korean Hypertensive Patients.: Yoon Hyeuk Lim, Byoung Hyun Park, Sung Zoo Kim, Chung Gu Cho; Korean Diabetes J. 2007;31(2):130-135. Published online March 1, 2007; DOI: https://doi.org/10.4093/jkda.2007.31.2.130

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Abstract PDF: BACKGROUND
In many studies, obesity is highly correlated with adverse coronary risk profile. Increased left ventricular (LV) mass is an independent risk factor for cardiovascular mortality and morbidity. Hypertension is an well known factor related with LV mass. Obesity also is related with LV mass and commonly associated with hypertension. However, few data are available concerning the relations of LV mass to central obesity, especially in Korean hypertensive patients. So, this study was to evaluate the significance of waist circumference in determinants of LV mass in Korean hypertensive patients. METHODS: A total of 74 hypertensive [40 women, 34 men; mean age, 62.5 years; mean body mass index (BMI), 25.0 kg/m2, 17 with type 2 diabetes] patients without prevalent cardiovascular disease were studied. Echocardiographic LV septal thickness, LV posterior wall thickness, LV dimension and LV mass were analysed. RESULTS: LV mass, diastolic left ventricular internal dimension and epicardial fat thickness were larger in men than in female. LV mass was larger in obese patients defined by body mass index and also in central obese patients defined by waist circumference. LV mass was correlated with sex, body mass index, waist circumference, diastolic left ventricular internal dimension, left ventricular posterior wall thickness and interventricular septal thickness. After controlling for age, sex and body mass index, waist circumference was correlated with LV posterior wall thickness and LV mass. CONCLUSION: Waist circumference may be more important than BMI in determinants of left ventricular mass in Korean hypertensive patients.

Randomized Controlled Trial

Randomized, Open Label, Multicenter Clinical Trial about the Effect of Cilazapril on Vascular Endothelial Function in Patients with Type 2 Diabetes Combined with Hypertension.: Sang Youl Rhee, Jeong Taek Woo, Sei Hyun Baik, Hyoung Woo Lee, In Kyu Lee, Hye Soon Kim, Moon Kyu Lee, Min Ho Shong, Chung Gu Cho, Byoung Hyun Park, Bong Soo Cha, Young Seol Kim; Korean Diabetes J. 2006;30(6):450-458. Published online November 1, 2006; DOI: https://doi.org/10.4093/jkda.2006.30.6.450

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Abstract PDF

BACKGROUND
The angiotensin converting enzyme inhibitor (ACEi) improves the vascular endothelial cell function and has a better clinical outcome by decreasing the LDL cholesterol oxidation, hypercoagulability, oxidative stress and improving the level of endothelial nitric oxide synthesis in patients with type 2 diabetes and hypertension. However, the correlations between the ACEi and the serum markers for the vascular endothelial function in previous studies were not consistent. SUBJECTS AND METHODS: Between July 2003 and April 2005, 104 type 2 diabetes patients with hypertension, who had been admitted to 9 major university hospitals in Korea, were examined. The subjects were randomly allocated to the cilazapril (2.5~5 mg/day) and atenolol (50~100 mg/day) treatment group and given a combination of hydrochlorothiazide and amlodipine. The lipid profile and the markers for endothelial function, such as vWF, VCAM, E-selectin, tPA, fibrinogen, adiponectin, hsCRP, nitrotyrosine were evaluated and the differences in the variables were compared with those obtained 6 months later. RESULTS: A total 56 subjects completed the 6-months follow up period. Regarding the baseline characteristics, there were no significant differences in the variables observed in the two groups except for HbA1c (P = 0.037), vWF (P = 0.048), and hsCRP (P = 0.038). After 6 months, both groups showed a significant and identical decrease in the systolic and diastolic blood pressure compared with the baseline (P < 0.002). However, there were no significant differences in the endothelial markers between each group. On the other hand, there was some deterioration in the triglyceride (P = 0.009) and HbA1c (P = 0.017) levels in the atenolol treatment groups. CONCLUSIONS: There were no significant differences in the endothelial function markers observed between the cilazapril and atenolol groups. However, cilazapril had an identical effect on the blood pressure reduction compared with atenolol but had fewer adverse effects on the glucose and lipid metabolism.

Citations

Citations to this article as recorded by

Potential Protective Role of Blood Pressure-Lowering Drugs on the Balance between Hemostasis and Fibrinolysis in Hypertensive Patients at Rest and During Exercise
Annabella Braschi
American Journal of Cardiovascular Drugs.2019; 19(2): 133. CrossRef

Original Article

The Study of Physical Activity in the Korean with Type 2 Diabetes.: Kyung Wan Min, Keun Hee An, Tae Seo Sohn, Yong Moon Park, Yeong Sun Hong, Yeon Su Kim, Yi Byeong Park, Kang Seo Park, Gwan Woo Lee, In Ju Kim, Kyung Ah Han, Jae Myoung Yu, Hyun Shik Son, Sei Hyun Baik, Won Cheol Lee, Chung Gu Cho, Hyoung Woo Lee, Sung Woo Park; Korean Diabetes J. 2005;29(6):517-525. Published online November 1, 2005

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Abstract PDF: BACKGROUND
Despite the importance of exercise, little is known about the epidemiology of exercise among persons with diabetes in the Korea. We do not have any standard method to evaluate physical activity of diabetics. So exercise committee of Korean diabetic association decided to survey the physical activities of Korean type 2 diabetic patients. METHODS: Cross-sectional study including 1073 type 2 diabetics (509 males, 564 females) over 18 age. 34 general hospitals collected data about physical activity from Dec. 2004 to Feb.2005. Data were randomly collected by interviewers using numeration table. Respondents were asked about the physical activities or exercise during recent 7 days and frequency, duration of each activity. To compare with normal population, we use 2001 KNHANES (Korean National Health and Nutrition Examination Survey) results. RESULTS: People with type 2 diabetes were more likely to report exercising regularly than people without this disease (52.5% vs. 27.5%) (p<0.0001), but 47.5% of type 2 diabetics didn't take exercise. Walking time of type 2 diabetics wasmore than that of people without this disease (p<0.0001). Type 2 diabetics exerting <700kcal/week of energy expenditure with physical activity were 45.5% in the exercising type 2 diabetics (males:44.2%, females:55.8%). Energy expenditure was positively correlated with frequency of physical exercise and exercise period (p<0.001). CONCLUSION: 47.5% of Korean type 2 diabetics and 72.5% of normal population did not take exercise. 45.5% of exercising type 2 diabetics exerted energy expenditure under 700kcal/week with physical activity. Therefore, various programs for initiating physical activity and increasing energy expenditure are required.

Case Report

Two Cases of Fulminant Type 1 Diabetes.: Yu Min Lee, Kyoung Hee Kweon, Seoung Hoon Baek, Ha Young Kim, Byoung Hyun Park, Chung Gu Cho; Korean Diabetes J. 2005;29(4):378-382. Published online July 1, 2005

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Abstract PDF: Type 1 diabetes is characterized by insulin deficiency due to destruction of pancreatic beta-cells. Patients with type 1 diabetes, with no islet autoantibodies, but with acute onset, are classified as having idiopathic of type 1B diabetes. In 2000, this diabetes subtype was described and named "fulminant type 1 diabetes". The clinical characteristics of this subtype of type 1 diabetes are: a remarkably abrupt onset of disease, very short(<1 week) duration of diabetic symptoms, acidosis at diagnosis, negative status of islet-related autoantibodies, virtually no C-peptide secretion(<10 microgram/day in urine), a near normal HbA1c level and an elevated serum pancreatic enzyme level. Since 1988, several cases showing the clinical characteristics of fulminant type diabetes have been reported, with this subtype accounting for approximately 20% of Japanese type 1 diabetes. There have been few cases of fulminant type 1 diabetes in Korea. Herein, our experience of two cases of fulminant type 1 diabetes is reported, with a review of the literature.

Original Articles

Evaluation of Erectile Dysfunction in type 2 Diabetes: Prevalence, Clinical characteristics and Treatment effect of sildenafil citrate.: Byoung Hyun Park, Joung Sik Rim, Chung Gu Cho; Korean Diabetes J. 2002;26(3):199-207. Published online June 1, 2002

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Abstract PDF: BACKGROUND
The prevalence of erectile dysfunction has been reported to be three times higher in diabetics than nondiabetics. As the majority of type 2 diabetes develops later in life, any associated erectile dysfunction often ignored by physician as well as patients. The purpose of this study was to investigated the prevalence of erectile dysfunction in type 2 diabetes and to find any related clinical characteristics and the effect of sildenafil citrate treatment in these types of patient. METHODS: We studied 75 male type 2 diabetics who visited the Wonkwang University Hospital between March and July, 2000, and analyzed their International Index of Erectile Function questionaires. Erectile dysfunction was defined as a the total score less than 24 points according to the answers to six questions about erections. According to this definition, our patients were divided into two groups; the presence, and the absence, of erectile dysfunction. We also obtained details from the patients relating to their history of smoking, alcohol, consumption, diabetic foots and hypertension; measured their current weight, height, HbA1c, lipoprotein (a), lipid profile, albumin and QTc and evaluated the presence of diabetic retinopathy, nephropathy and neuropathy. A single oral dose of sildenafil, 25 mg, was started and the effect assessed by a global efficacy question every 4 weeks for 12 weeks. If there was no effect, we increased the dose to 50 or 100 mg. RESULTS: 1) The prevalence of erectile dysfunction in type 2 diabetics in this study was 77.3%. Most patients (86.2%) wanted their erectile dysfunction treated, but a minority (31%) had visited a private clinic to discuss the problem. 2) The prevalence of erectile dysfunction increased with age, increased duration of diabetes and HbA1c. The Body Mass Index (BMI) and serum albumin were inversely related to erectile dysfunction. 3) The erectile dysfunction was significantly associated with diabetic autonomic neuropathy and retinopathy. 4) The score from the questionaires of five relevant domains of sexual function (these being, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) were lower in the erectile dysfunctional group. 5) 18 patients were prescribed sildenafil, 61.6% of which reported improved erections by the end of the study, with 50% of these being satisfied with their erections. There were no side effects causing discontinuation of treatment. CONCLUSION: The prevalence of erectile dysfunction in type 2 diabetics in this study was 77.3%. The prevalence of erectile dysfunction increased with age, increased duration of diabetes and HbA1c. The BMI and serum albumin were inversely related to erectile dysfunction. The effect of sildenafil was simillar to that reported previously for other countries, and was effective in the treatment of erectile dysfunction in type 2 diabetics.

Effect of Nerve Growth Factor on Cultured Mouse Dorsal Root Ganglion Cells in Hyperglycemic Condition.: Byoung Hyun Park, Chung Gu Cho, Geun Young Jang, Ki Hun Kim, Seung Taeck Park; Korean Diabetes J. 2001;25(4):286-296. Published online August 1, 2001

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Abstract PDF: BACKGROUND
Multiple etiology of diabetic neuropathy has been proposed, including altered polyol metabolism, superoxide radical formation, protein glycation, vascular insufficiency, blunted nitric oxide production and neurotrophic factor (NTF) deficiency. Nerve growth factor (NGF) is a member and family of neurotrophic factors. NGF is produced in tissues innervated by its responsive neurons. In the peripheral nervous system, NGF messenger RNA (mRNA) is produced in target fields of small pain and temperature-mediating dorsal root ganglia (DRG) sensory neurons and sympathetic neurons. NGF has been shown to promote their survival, differentiation, and maintenance. However, the mechanism of neuronal damage in diabetes and the effect of NGF on diabetic neuropathy are not clear. METHODS: In order to clarify the effect of NGF, the changes of cell viability were evaluated by MTT assay on mouse cultured dorsal root ganglion cells which were grown with media containing concentrations of high glucose for inducing hyperglycemic condition. Furthermore, the neuroprotective effect of nerve growth factor (NGF) against hyperglycemia-induced dorsal root ganglion cell changes were also examined. RESULTS: 1. Cell viability of cultured mouse dorsal root ganglion cells treated with hyperglycemic media made with 15, 25 mM glucose was markedly decreased in a dose-dependent manner when compared with control medium (normoglycemic medium) containing concentration of 5.5 mM glucose (p<0.05). 2. Cultured dorsal root ganglion cells exposed to hyperglycemic medium made with 25 mM glucose for 72 hours showed morphological changes such as dissociations, loss of neurites and decrease of cell viability (p<0.05). 3. Pretreatment of 150 ng/mL NGF for 2 hours significantly increased the cell viability of cultured dorsal root ganglion cells which exposed to hyperglycemic medium (25 mM glucose for 72 hours). CONCLUSION: Findings from this study suggested that hyperglycemic condition induces the decrease of cell viability and morphological changes (loss of neurites, dissociation) on cultured dorsal root ganglion cells of mouse. Furthermore, selective neurotrophic factors such as NGF are very effective in preventing dysfunction and morphological changes of DRG cells induced by hyperglycemic condition.

Editorial

Clinical Assessment of Macrovascular Complications in Diabetic Patients .: Chung Gu Cho, Park Byoung Hyun; Korean Diabetes J. 2001;25(1):11-19. Published online February 1, 2001

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Abstract PDF: No abstract available.

Original Articles

Intima-media Thickness of the Common Carotid Artery and Carotid Atherosclerotic Plaques as Predictors for Occurrence of Clinical Macrovascular Complication in Type 2 Diabetes.: Byoung Hyun Park, Chung Gu Cho; Korean Diabetes J. 2000;24(5):603-613. Published online January 1, 2001

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Abstract: BACKGROUND
This study was undertaken to investigate that intima-media thickness and plaque of the carotid artery, as measured by high resolution B-mode ultrasonography, can be used as predictors for occurrence of clinical macrovascular complication in type 2 diabetes patients. METHODS: High resolution B-mode ultrasonographic examination was performed in 39 type 2 diabetes, including 16 diabetes with macrovascular complication, and in 18 non-diabetic control subjects. Concurrently serum total cholesterol, HDL cholesterol, triglyceride, lipoprotein (a), HbA1c, C-peptide levels and body mass index (BMI) were measured and history of hypertension, smoking, duration of diabetes and occurrence of macrovascular complication during the last 6 months were investigated. RESULTS: 1) Significant differences in common carotid IMT (0.72+/-0.08 mm, vs 0.93+/- 0.26 mm), existence of atherosclerotic plaque (50%, vs 69%), plaque number (0.5+/- 0.86, vs 0.69+/-2.37) and carotid stenosis (0%, vs 18%) were found between control and type 2 diabetes (p<0.05). 2) Significant differences in age (67.63+/-4.30, vs 60.6+/-12.0), lipoprotein (a) (63.65+/- 32.2 mg/dL, vs 35.22+/-34.74 mg/dL), common carotid IMT (1.08+/-0.27 mm, vs 0.82+/- 0.20 mm), existence of atherosclerotic plaque (87.5%, vs 56.5%), plaque number (2.88+/-3.16, vs 0.91+/-1.02), end diastolic ventricular septal thickness (10.82+/-1.88 mm, vs 8.76+/-2.92 mm) and end diastolic left ventricular posterior wall thickness (10.79+/-1.60 mm, vs 9.1+/-2.56 mm) were found between type 2 diabetes patients with macrovascular complication and without macrovascular complication (p<0.05). 3) Age (r=0.363, p=0.023), hypertension (r=0.32, p=0.047), carotid plaque existence (r=0.377, p=0.018) and plaque number (r=0.662, p=0.000) showed a correlation with the IMT in type 2 diabetes. 4) Most common involving site of atherosclerotic plaques was carotid bulb and more extensive involvement was showed in type 2 diabetes with macrovascular complication than without macrovascular complication. 5) The sensitivity of common carotid IMT (> control mean IMT + 2 SD; >1.22 mm) for prediction of macrovascular complication in type 2 diabetes patients was 25%, the specificity 95.7%, the positive predictive value 80%, the negative predictive value 61.8%. 6) The sensitivity of existence of carotid plaque for prediction of macrovascular complication in type 2 diabetes patients was 87.5%, the specificity 60.9%, the positive predictive value 60.9%, the negative predictive value 87.5%. CONCLUSION: Increases in IMT and plaque of the carotid artery, as measured by high resolution B-mode ultrasonography, can be used as predictors for occurrence of clinical macrovascular complication in type 2 diabetes patients.

Effect of Nerve Growth Factor on Cultured Rat Schwann Cells in Hyperglycemic Condition.: Geun Young Hyung, Kyoung Hee Kim, Seung Hoon Baek, Geun Young Jang, Chung Gu Cho; Korean Diabetes J. 2000;24(1):10-18. Published online January 1, 2001

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Abstract PDF: BACKGROUND
Nerve growth factor (NGF) is produced in tissues innervafed by its responsive neurons. In the peripheral nervous system, NGF messenger RNA (mRNA) is produced in target fields of small pain and temperature-mediating dorsal root ganglia (DRG) sensory neurons and sympathetic neurons. NGF receptors are expressed in these neurons, and NGF has been shown to promote their survival, differentiation, as well as maintenance. However, the mechanism of neuronal damage in diabetes and the effect of NGF on diabetic neuropathy are unclear. METHODS: in order to clarify the effect of hyperglycemia, the hyperglycemia-induced cytotoxic effects were evaluated by MTT assay on cultured rat Schwann cells, Schwann cells were grown with media containing concentrations of high glucose for inducing hyperglycemic condition. The neuroprotective effect of nerve growth factor (NGF) against hyperglycemia-induced Schwann cell changes were also examined. RESULT: 1. MMT50 value was at concentration of 25mM glucose after 72 hours, 2. Cell viability of cultured rat Schwann cells treated with hyperglycemic media made with 25~35mM glucose was markedly decreased in a dose-dependent manner when compared with control medium (normoglycemic medium) containing concentration of 5.5 mM glucose, While cell number did not show a dose- dependent decrease. 3. Cultured Schwann cells exposed to hyperglycemic medium made with 25mM glucose for 72 hours did nof show any morphological change as well as decrease of cell number. 4. Pretreatment of 10 ng/mL NGF for 2 hours increased remarkably the cell viability of cultured Schwann cells exposed to hyperglycemic medium(25mM glucose for 72 hours). CONCLUSIONS: The results from this study suggested that hyperglycemic condition induces the decrease of cell viability on cultured Schwann cells of rat. But it did not show the decrease of cell number and rnorphological change. The selective neurotrophic factors such as NGF are very effective in preventing dysfunction of cells induced by hyperglycemic condition.

Venous Oxygenation in the Feet of Diabetics with Neuropathic foot Ulceration.: Chung Gu Cho; Korean Diabetes J. 1997;21(1):74-81. Published online January 1, 2001

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Abstract PDF: BACKGROUND
Diabetic patients with non-infected neuropathic foot lesions frequently have prominent pedal arteries and distended dorsal foot veins, both in the ulcerated and in the non-ulcerated foot. Such patients also have increased blood flow in the lower limbs as suggested by plethysmographic and ultrasound studies. Accordingly, the aim of this study was to evaluate the venous oxygenation, as determined by partial pressure of oxygen(PO), in the feet of diabetics with and without foot ulceration and neuropathy in order to confirm the arteriovenous(A-V) shunting in the diabetic neuropathic foot may be important in the pathogenesis of ulceration. METHODS: Venous PO was measured in the feet and hands of four subject groups: 8 diabetics with neuropathy and foot ulceration(group 1); 10 diabetics with neuropathy but no ulceration(group 2); 10 diabetics with no evidence of neuropathy(group 3); and 9 non-diabetic controls(group 4). After an initial 30-min period of stabilization, veins on the dorsum of each foot and on the back of the hand were cannulated using a Butterly infusion set, 0.8mm gauge. Blood was withdrawn from each site into a heparinized glass syringe for immediate analysis of PO using a blood gas analyser. RESULTS: The mean venous PO2 in the feet of diabetic subjects with neuropathy and foot ulceration (group 1: 60.7+6.3mmHg)was significantly higher than in controls(group 4: 44.3+6.0mmHg) or the other two diabetic groups(group 2: 52.3+9.0mmHg, group 3: 46.1+5.5mmHg). Venous PO2 in the feet of the diabetic subjects with ulcers was also significantly higher than in their hands(45.4+5.8mmHg) or in the hands of the other groups(group 2:.46.6+6.3mmHg, group 3: 44.5+4.9mmHg, group 4: 44.9+5.1mmHg). CONCLUSION: These results provide further evidence of abnormal blood flow in the diabetic neuropathic foot and are compatible with arteriovenous shunting.

Mydriatic response to topical mydriatic drugs in diabetic patients.: Chung Gu Cho, Jae Duck Kim; Korean Diabetes J. 1993;17(2):201-205. Published online January 1, 2001

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Abstract PDF: No abstract available.

Neuropathy and foot lesions in diabetics.: Kyoo Hye Cho, Chung Gu Cho; Korean Diabetes J. 1993;17(1):89-98. Published online January 1, 2001

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Abstract PDF: No abstract available.

A pathological study of sural nerve in diabetes mellitus.: Chung Gu Cho, Ock Kyu Park, Dong Geun Lee, Ho Yeul Choi, Sang Ho Kim; Korean Diabetes J. 1991;15(2):221-227. Published online January 1, 2001

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Abstract PDF: No abstract available.

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