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.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
3.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
4.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2020;44(S1):e46-
Background:
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM).
Methods:
From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated.
Results:
In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9± 14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, –1.1%±1.2%; P<0.001). The number of patients with HbA1c <7% increased significantly from 5 to 68 (P<0.005). In addition, lipid profiles and liver enzyme levels were also improved whereas no changes in body weight. There was no significant safety issue in patients treated with quadruple OHA therapy.
Conclusion
This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
5.Clinical Course and Outcomes of 3,060 Patients with Coronavirus Disease 2019 in Korea, January–May 2020
Ho Kyung SUNG ; Jin Yong KIM ; Jeonghun HEO ; Haesook SEO ; Young soo JANG ; Hyewon KIM ; Bo Ram KOH ; Neungsun JO ; Hong Sang OH ; Young Mi BAEK ; Kyung-Hwa PARK ; Jeung A SHON ; Min-Chul KIM ; Joon Ho KIM ; Hyun-Ha CHANG ; Yukyung PARK ; Yu Min KANG ; Dong Hyun LEE ; Dong Hyun OH ; Hyun Jung PARK ; Kyoung-Ho SONG ; Eun Kyoung LEE ; Hyeongseok JEONG ; Ji Yeon LEE ; Ja-Young KO ; Jihee CHOI ; Eun Hwa RYU ; Ki-hyun CHUNG ; Myoung-don OH ;
Journal of Korean Medical Science 2020;35(30):e280-
Background:
The fatality rate of patients with coronavirus disease 2019 (COVID-19) varies among countries owing to demographics, patient comorbidities, surge capacity of healthcare systems, and the quality of medical care. We assessed the clinical outcomes of patients with COVID-19 during the first wave of the epidemic in Korea.
Methods:
Using a modified World Health Organization clinical record form, we obtained clinical data for 3,060 patients with COVID-19 treated at 55 hospitals in Korea. Disease severity scores were defined as: 1) no limitation of daily activities; 2) limitation of daily activities but no need for supplemental oxygen; 3) supplemental oxygen via nasal cannula; 4) supplemental oxygen via facial mask; 5) non-invasive mechanical ventilation; 6) invasive mechanical ventilation; 7) multi-organ failure or extracorporeal membrane oxygenation therapy; and 8) death. Recovery was defined as a severity score of 1 or 2, or discharge and release from isolation.
Results:
The median age of the patients was 43 years of age; 43.6% were male. The median time from illness onset to admission was 5 days. Of the patients with a disease severity score of 3–4 on admission, 65 (71.5%) of the 91 patients recovered, and 7 (7.7%) died due to illness by day 28. Of the patients with disease severity scores of 5–7, 7 (19.5%) of the 36 patients recovered, and 8 (22.2%) died due to illness by day 28. None of the 1,324 patients who were < 50 years of age died; in contrast, the fatality rate due to illness by day 28 was 0.5% (2/375), 0.9% (2/215), 5.8% (6/104), and 14.0% (7/50) for the patients aged 50–59, 60–69, 70–79, and ≥ 80 years of age, respectively.
Conclusion
In Korea, almost all patients of < 50 years of age with COVID-19 recovered without supplemental oxygen. In patients of ≥ 50 years of age, the fatality rate increased with age, reaching 14% in patients of ≥ 80 years of age.
6.Analysis of Clinical Characteristics and Correct Diagnosis Rate Associated with Spontaneous Intracranial Hypotension in the Emergency Department.
Ki yong HONG ; Dong Woo SEO ; Sang sik CHOI ; Chang Hwan SHON ; Won Young KIM ; Kyoung Soo LIM
Journal of the Korean Society of Emergency Medicine 2011;22(6):690-695
PURPOSE: Spontaneous Intracranial Hypotension (SIH) is rare condition and may accompany other clinical symptoms which inhibit accurate diagnosis in an emergency department (ER). Only a few studies have reported the clinical characteristics and root causes associated with SIH. This study evaluates the rate of accuracy of SIH diagnosis and compares clinical characteristics and diagnostic test results for correct versus incorrect diagnosis groups. METHODS: Medical records of SIH patients admitted to an emergency department (ER) over a twelve year period were retrospectively reviewed. Patients were grouped as having received correct or incorrect diagnosis, and their clinical characteristics and diagnostic test results were compared. In the incorrect diagnosis group, the number of times they were misdiagnosed, and the specialties of the clinic (s) they visited prior to arrival at this ER were reviewed. RESULTS: Adhering to the inclusion criteria of our study, 72 patients were enrolled with 54 patients in the correct diagnosis group and 18 patients in the incorrect diagnosis group. Of the twenty one cases in the incorrect diagnosis group, the majority 7 cases (33.3%) had been examined by an emergency physician. Among the clinical symptoms observed, there was significant variability in the location of the headache (p=0.020) and time interval between symptom onset and diagnosis (p=0.035). CONCLUSION: There were no differences in most of the clinical observations and diagnostic test results between the correct and incorrect diagnosis groups. To improve the correct diagnosis rate, it is suggested to have 'SIH' included as a differential diagnosis when encountering patients reporting headache in the emergency department. Emergency physicians should be required to recognize clinical SIH characteristics such as orthostatic headache.
Diagnosis, Differential
;
Diagnostic Errors
;
Diagnostic Tests, Routine
;
Emergencies
;
Headache
;
Humans
;
Intracranial Hypotension
;
Medical Records
;
Retrospective Studies
7.Follow-up Study of the Cemented Polished Femoral Stem for More than Five Years.
Ju Won YI ; Won Yong SHON ; Chang Yong HUH ; Ho Hyun YUN ; Young Jae HUH
Journal of the Korean Hip Society 2011;23(1):25-31
PURPOSE: Surface finishing of a cemented femoral stem is a subject of controversy even though the contemporary cementing techniques have improved results. Using the Versys Heritage femoral stem, we evaluated the outcome of using a polished surface. MATERIALS AND METHODS: The subjects of this study were 95 hip arthroplasties in 82 patients and we used a cemented polished femoral stem with the 3rd generation cement technique and all the surgeries were done between October 2000 and August 2003. There were 58 male patients (64 hips) and 24 female patients (31 hips). The mean age at the time of the index arthroplasty was 52.3 years (26~74 years), and the average body mass index was 24.2+/-2.75 (19.1~29.8). The average follow up period was 80.7 months (64~109 months). All the hips were evaluated clinically by the Harris hip score and the thigh pain, and they were radiologically assessed by the cement grade and the presence of osteolysis around the femoral stem, as well as the presence of stress shielding of the proximal femur. RESULTS: At the final follow up, the Harris hip score for all the patients had improved from preoperative 58.9 (17-83) to post operative 91.7 (72~100). The cement grade was measured using Barrack's method. Of the 95 hips, 45 (47.3%) cases were grade A, 48 (50.5%) cases were grade B and 2 (2.1%) cases were grade C1 at the final follow up. There was 1 case of definite loosening. Stress shielding was noted in 65 (68.4%) cases of the zero grade and 19 (20.0%) cases of the 1st grade. CONCLUSION: In this study, the cemented polished femoral stem showed excellent results at the mid term with a minimum follow up of 5 years. But a longer-term follow-up study will be needed for further understanding the implications of cemented polished femoral stem.
Arthroplasty
;
Body Mass Index
;
Female
;
Follow-Up Studies
;
Hip
;
Humans
;
Male
;
Osteolysis
;
Thigh
8.Eight to Eighteen Years Follow Up Study of Primary Hybrid Total Hip Arthroplasty Using a Precoat Femoral Stem.
Sang Heon SONG ; Young Jae HUR ; Ho Hyun YUN ; Jong Keon OH ; Chang Yong HU ; Won Yong SHON
The Journal of the Korean Orthopaedic Association 2011;46(2):107-113
PURPOSE: The purpose of this study was to evaluate the 15.5 year long term survival rate of the Precoat femoral stem. MATERIALS AND METHODS: We reviewed the results of 105 primary hybrid total hip replacements (98 patients) that were performed by one surgeon between October 1990 and August 1995 using a cemented polymethyl-methacrylate coated femoral prosthesis (Precoat) and contemporary cementing techniques. Thirty four patients (34 hips) died and seventeen patients (17 hips) were lost to follow-up. Forty seven patients (54 hips) were available for clinical follow-up, with an average follow-up period of 15.5 years (range: 8.4 to 18.3 years). The average age of the patients at the time of the index operation was 46 years (range: 22 to 67 years). There were 32 male patients (37 hips) and 15 female patients (17 hips). RESULTS: For the acetabular component, 15 hips (27.8%) were revised for cup loosening and isolated liner exchange was performed in 12 hips (22.2%) for liner wear and osteolysis. For the femoral component, 12 hips (22.2%) were revised due to aseptic loosening. Of these twelve hips, 3 hips had Grade B cement mantles and 9 had Grade C cement mantles. The clinical results of the 54 retained hips were good or excellent in 52 hips (96.3%) with the average Harris hip score being 88 points (range: 72 to 96 points). CONCLUSION: The mean 15.5 years' survival rate of the Precoat cemented femoral stem was 78%. We think that there were several factors for the failure of femoral stem fixation, including age, physical activity and the body weight, as well as the stem design and the surgical technique had an influence on the stem's survival.
Arthroplasty
;
Arthroplasty, Replacement, Hip
;
Body Weight
;
Chimera
;
Female
;
Follow-Up Studies
;
Hip
;
Humans
;
Lost to Follow-Up
;
Male
;
Motor Activity
;
Osteolysis
;
Prostheses and Implants
;
Survival Rate
9.2-5 Year Results of the Cemented Polished Versys Heritage(R) Femoral Stem.
Won Yong SHON ; Chang Yong HUR ; Jun Gyu MOON ; Sang Whan HAN ; Jae Hyuk YANG ; Ki Mo JANG
The Journal of the Korean Orthopaedic Association 2008;43(1):9-16
PURPOSE: Surface finishing of a cemented femoral stem is a subject of controversy even though contemporary cementing techniques have improved results. Versys Heritage femoral stem was used with a contemporary cementing technique to determine the outcome of using a polished surface. MATERIALS AND METHODS: Between October 2000 and August 2003, 131 primary hybrid hip arthroplasty procedures were performed in 117 patients. The mean age at the time of the index arthroplasty was 52 years and 9 months (24-78 years). The average follow up period was 49 months (range, 24-71 months). All the hips were evaluated clinically by the Harris hip score and radiologically by the cement grade, osteolysis as well as stress shielding. RESULTS: At the final follow up, the Harris hip score for all patients had improved from preoperative 59.1 (range, 17-91) to post operative 92.8 (range, 78-100). The cement grade was measured using Barrack's method. Of 131 hips, 75, 54 and 2 were grade A, grade B and grade C1 at the final follow up, respectively. None of the hips showed a C2 or D grade. There was no evidence of aseptic loosening or osteolysis on the femoral side during follow up. 45% of stems showed grade 1 and 2 stress shielding according to Engh's criteria. CONCLUSION: In this study, the Polished Versys Heritage femoral stem(R) showed excellent results at the short to mid term follow up period. However, a longer-term follow-up study will be needed to clarify the implications of the femoral prosthesis surface finish or design.
Arthroplasty
;
Chimera
;
Follow-Up Studies
;
Hip
;
Humans
;
Osteolysis
;
Prostheses and Implants
10.Result of Sugioka's Transtrochanteric Osteotomy forOsteonecrosis of Femoral Head.
Sung Kwang CHUN ; Jae Young HONG ; Sang Hwan HAN ; Jun Kyu MOON ; Chang Young HUR ; Won Yong SHON
The Journal of the Korean Orthopaedic Association 2008;43(2):213-219
PURPOSE: The results of Sugioka's transtrochanteric rotational osteotomy are controversial. While many Japanese studies have reported favorable results, European and American studies have been disappointing. We present the results of Sugioka's rotational osteotomy for extensive osteonecrosis of the femoral head in young patients. METHODS AND MATERIALS: Between April. 1994 and May. 2004, Sugioka's osteotomy was performed for osteonecrosis involving a large part of the weight bearing area on 49 hips (46 patients). Of these 49 hips, 45 (43 patients) were available for follow-up. The patients were followed up for at least 2 years with an average of 52 months (range: 24-132 months). The major causes of osteonecrosis were chronic alcohol abuse in 33 hips. The mean age of the patients at the time of surgery was 31 years (range: 21-46), and the male to female ratio was 39:6. Six, 17 and 22 hips were classified as stage IIA, IIb and III using the Ficat and Alert classification, respectively. RESULTS: Thirty three of the 45 hips (74%) survived clinically and radiologically. Of these, the clinical results were excellent, good and fair in 15, 12 and 6 hips, respectively. Major complications were encountered in 12 hips [Progressive severe varus deformity in 7 hips (15%)], femur neck fracture in 3 hips (6%) and deep infection in 2 hips (4%). Among these 12 hips, seven hips (15%) required secondary THA. Five other hips (11%) were also subsequently converted to THA due to progressive collapse of the femoral head after the transtrochanteric osteotomy. CONCLUSION: Transtrochanteric osteotomy can be used to treat osteonecrosis of the femoral head in young patients with extensive necrotic lesions of the femoral head. However, Sugioka osteotomy should be used with caution due to its high incidence of complications.
Alcoholism
;
Asian Continental Ancestry Group
;
Congenital Abnormalities
;
Female
;
Femoral Neck Fractures
;
Follow-Up Studies
;
Head
;
Hip
;
Hip Joint
;
Humans
;
Incidence
;
Male
;
Osteonecrosis
;
Osteotomy
;
Tacrine
;
Weight-Bearing

Result Analysis
Print
Save
E-mail