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.Surgical Outcomes of Centrifugal Continuous-Flow Implantable Left Ventricular Assist Devices: Heartmate 3 versus Heartware Ventricular Assist Device
Kinam SHIN ; Won Chul CHO ; Nara SHIN ; Hong Rae KIM ; Min-Seok KIM ; Cheol Hyun CHUNG ; Sung-Ho JUNG
Journal of Chest Surgery 2024;57(2):184-194
Background:
Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD).
Methods:
Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications.
Results:
In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013).Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure.
Conclusion
The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.
3.Mechanical versus Bioprosthetic Aortic Valve Replacement in Patients Aged 50 to 70 Years
Youngkwan SONG ; Ki Tae KIM ; Soo Jin PARK ; Hong Rae KIM ; Jae Suk YOO ; Pil Je KANG ; Sung-Ho JUNG ; Cheol Hyun CHUNG ; Joon Bum KIM ; Ho Jin KIM
Journal of Chest Surgery 2024;57(3):242-251
Background:
This study compared the outcomes of surgical aortic valve replacement (AVR) in patients aged 50 to 70 years based on the type of prosthetic valve used.
Methods:
We compared patients who underwent mechanical AVR to those who underwent bioprosthetic AVR at our institution between January 2000 and March 2019. Competing risk analysis and the inverse probability of treatment weighting (IPTW) method based on propensity score were employed for comparisons.
Results:
A total of 1,580 patients (984 patients with mechanical AVR; 596 patients with bioprosthetic AVR) were enrolled. There was no significant difference in early mortality between the mechanical AVR and bioprosthetic AVR groups (0.9% vs. 1.7%, p=0.177).After IPTW adjustment, the risk of all-cause mortality was significantly higher in the bioprosthetic AVR group than in the mechanical AVR group (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.07–1.80; p=0.014). Competing risk analysis revealed lower risks of stroke (sub-distributional hazard ratio [sHR], 0.44; 95% CI, 0.28–0.67; p<0.001) and anticoagulation-related bleeding (sHR, 0.35; 95% CI, 0.23–0.53; p<0.001) in the bioprosthetic AVR group. Conversely, the risk of aortic valve (AV) reintervention was higher in the bioprosthetic AVR group (sHR, 6.14; 95% CI, 3.17–11.93; p<0.001).
Conclusion
Among patients aged 50 to 70 years who underwent surgical AVR, those receiving mechanical valves showed better survival than those with bioprosthetic valves.The mechanical AVR group exhibited a higher risk of stroke and anticoagulation-related bleeding, while the bioprosthetic AVR group showed a higher risk of AV reintervention.
4.Medial Arterial Calcification and the Risk of Amputation of Diabetic Foot Ulcer in Patients With Diabetic Kidney Disease
Joon Myeong SO ; Ji Ho PARK ; Jin Gyeong KIM ; Il Rae PARK ; Eun Yeong HA ; Seung Min CHUNG ; Jun Sung MOON ; Chul Hyun PARK ; Woo-Sung YUN ; Tae-Gon KIM ; Woong KIM ; Ji Sung YOON ; Kyu Chang WON ; Hyoung Woo LEE
Journal of Korean Medical Science 2023;38(21):e160-
We assessed the risk factors for major amputation of diabetic foot ulcers (DFUs) in patients with diabetic kidney disease (DKD) stages 3b–5. For DFU assessment, in addition to DFU location and presence of infection, ischemia, and neuropathy, vascular calcification was assessed using the medial arterial calcification (MAC) score. Of 210 patients, 26 (12.4%) underwent major amputations. Only the location and extension of DFU, represented by Texas grade differed between the minor and major amputation groups. However, after adjusting for covariates, ulcer location of mid- or hindfoot (vs. forefoot, odds ratio [OR] = 3.27), Texas grades 2 or 3 (vs. grade 0, OR = 5.78), and severe MAC (vs. no MAC, OR = 4.46) was an independent risk factor for major amputation (all P < 0.05). The current use of antiplatelets was a possible protective factor for major amputations (OR = 0.37, P = 0.055). In conclusion, DFU with severe MAC is associated with major amputation in patients with DKD.
5.Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Jun Sung MOON ; Il Rae PARK ; Hae Jin KIM ; Choon Hee CHUNG ; Kyu Chang WON ; Kyung Ah HAN ; Cheol-Young PARK ; Jong Chul WON ; Dong Jun KIM ; Gwan Pyo KOH ; Eun Sook KIM ; Jae Myung YU ; Eun-Gyoung HONG ; Chang Beom LEE ; Kun-Ho YOON
Diabetes & Metabolism Journal 2023;47(6):808-817
Background:
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods:
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results:
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
6.Descemet Membrane Endothelial Keratoplasty after Penetrating Keratoplasty Graft Failure
Woo Young SON ; Min Ji HA ; Woong Joo WHANG ; Yong-Soo BYUN ; Hyung Bin HWANG ; Kyung Sun NA ; Chang Rae RHO ; Hyun Soo LEE ; So Hyang CHUNG ; Eun Chul KIM ; Yang Kyung CHO ; Hyun Seung KIM ; Ho Sik HWANG
Journal of the Korean Ophthalmological Society 2021;62(6):848-854
Purpose:
To report a case of a successful secondary Descemet membrane endothelial keratoplasty in failed penetrating keratoplasty. Case summary: A 46-year-old male with keratoconus in both of his eyes underwent penetrating keratoplasty in his right eye 30 years ago and in his left eye 14 years ago. From one and a half year ago, the patient’s visual acuity decreased in his left eye due to graft failure. For treatment, secondary Descemet membrane endothelial keratoplasty was performed. Partial detachment of Descemet membrane was observed at 13 days after the operation, and an additional air injection was performed. At 8 months after the operation, the patient’s uncorrected visual acuity improved to 0.5 and the cornea maintained its clearance without rejection.
Conclusions
Secondary Descemet membrane endothelial keratoplasty was successfully performed in a patient with failed penetrating keratoplasty.
7.Repeat Descemet Membrane Endothelial Keratoplasty after Descemet Membrane Endothelial Keratoplasty Graft Failure
Gee-Hyun KIM ; Min Ji HA ; Dong Jin CHANG ; Woong Joo WHANG ; Yong-Soo BYUN ; Hyung Bin HWANG ; Kyung Sun NA ; Chang Rae RHO ; Hyun Soo LEE ; So Hyang CHUNG ; Eun Chul KIM ; Yang Kyung CHO ; Hyun Seung KIM ; Man Soo KIM ; Ho Sik HWANG
Journal of the Korean Ophthalmological Society 2021;62(5):702-708
Purpose:
To report a case of secondary Descemet membrane endothelial keratoplasty (DMEK) for graft failure after primary DMEK.Case summary: A 47-year-old female underwent primary DMEK in her left eye with a diagnosis of Fuchs’ endothelial dystrophy. At 6 weeks later, corneal stromal edema with epithelial and subepithelial bullae was first observed. From that point on, the condition of the cornea and the visual acuity continued to degrade. After 7 months, a second DMEK procedure (i.e., a repeat DMEK) for graft failure was performed successfully without any complications. Since the second procedure, the cornea has been clear, and the best-corrected visual acuity has remained at 0.6 for 8 months.
Conclusions
To manage graft failure after primary DMEK, we performed a second DMEK procedure. The removal of the previous graft was easy, and there were no complications. Thus, repeat DMEK may be a feasible procedure.
8.Descemet Membrane Endothelial Keratoplasty after Penetrating Keratoplasty Graft Failure
Woo Young SON ; Min Ji HA ; Woong Joo WHANG ; Yong-Soo BYUN ; Hyung Bin HWANG ; Kyung Sun NA ; Chang Rae RHO ; Hyun Soo LEE ; So Hyang CHUNG ; Eun Chul KIM ; Yang Kyung CHO ; Hyun Seung KIM ; Ho Sik HWANG
Journal of the Korean Ophthalmological Society 2021;62(6):848-854
Purpose:
To report a case of a successful secondary Descemet membrane endothelial keratoplasty in failed penetrating keratoplasty. Case summary: A 46-year-old male with keratoconus in both of his eyes underwent penetrating keratoplasty in his right eye 30 years ago and in his left eye 14 years ago. From one and a half year ago, the patient’s visual acuity decreased in his left eye due to graft failure. For treatment, secondary Descemet membrane endothelial keratoplasty was performed. Partial detachment of Descemet membrane was observed at 13 days after the operation, and an additional air injection was performed. At 8 months after the operation, the patient’s uncorrected visual acuity improved to 0.5 and the cornea maintained its clearance without rejection.
Conclusions
Secondary Descemet membrane endothelial keratoplasty was successfully performed in a patient with failed penetrating keratoplasty.
9.Repeat Descemet Membrane Endothelial Keratoplasty after Descemet Membrane Endothelial Keratoplasty Graft Failure
Gee-Hyun KIM ; Min Ji HA ; Dong Jin CHANG ; Woong Joo WHANG ; Yong-Soo BYUN ; Hyung Bin HWANG ; Kyung Sun NA ; Chang Rae RHO ; Hyun Soo LEE ; So Hyang CHUNG ; Eun Chul KIM ; Yang Kyung CHO ; Hyun Seung KIM ; Man Soo KIM ; Ho Sik HWANG
Journal of the Korean Ophthalmological Society 2021;62(5):702-708
Purpose:
To report a case of secondary Descemet membrane endothelial keratoplasty (DMEK) for graft failure after primary DMEK.Case summary: A 47-year-old female underwent primary DMEK in her left eye with a diagnosis of Fuchs’ endothelial dystrophy. At 6 weeks later, corneal stromal edema with epithelial and subepithelial bullae was first observed. From that point on, the condition of the cornea and the visual acuity continued to degrade. After 7 months, a second DMEK procedure (i.e., a repeat DMEK) for graft failure was performed successfully without any complications. Since the second procedure, the cornea has been clear, and the best-corrected visual acuity has remained at 0.6 for 8 months.
Conclusions
To manage graft failure after primary DMEK, we performed a second DMEK procedure. The removal of the previous graft was easy, and there were no complications. Thus, repeat DMEK may be a feasible procedure.
10.Descemet Membrane Endothelial Keratoplasty to Treat Graft Failure after Descemet Stripping Endothelial Keratoplasty
Si Eun OH ; Min Ji HA ; Woong Joo WHANG ; Yong-Soo BYUN ; Hyung Bin HWANG ; Kyung Sun NA ; Chang Rae RHO ; Hyun Soo LEE ; So-Hyang CHUNG ; Eun Chul KIM ; Yang Kyung CHO ; Hyun Seung KIM ; Man Soo KIM ; Ho Sik HWANG
Journal of the Korean Ophthalmological Society 2020;61(12):1532-1537
Purpose:
We report a case of secondary Descemet membrane endothelial keratoplasty (DMEK) to treat graft failure after Descemet stripping endothelial keratoplasty (DSEK).Case summary: A 66-year-old female underwent DSEK of her right eye to treat pseudophakic bullous keratopathy that developed after cataract surgery and intraocular lens exchange. After 5 years, she complained of decreased vision; graft failure was observed. Secondary DMEK was performed; no additional air injection was needed. The corrected visual acuity was 0.2, 3 months after surgery, and the cornea became clear.
Conclusions
Visual recovery can be achieved by performing secondary DMEK after primary DSEK graft failure.

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