1.Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
Ji Hye HEO ; Kyung Ah HAN ; Jun Hwa HONG ; Hyun-Ae SEO ; Eun-Gyoung HONG ; Jae Myung YU ; Hye Seung JUNG ; Bong-Soo CHA
Diabetes & Metabolism Journal 2024;48(5):937-948
Background:
This study assessed the efficacy and safety of triple therapy with pioglitazone 15 mg add-on versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and dapagliflozin.
Methods:
In this multicenter, double-blind, randomized, phase 3 study, patients with T2DM with an inadequate response to treatment with metformin (≥1,000 mg/day) plus dapagliflozin (10 mg/day) were randomized to receive additional pioglitazone 15 mg/day (n=125) or placebo (n=125) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) levels from baseline to week 24 (ClinicalTrials.gov identifier: NCT05101135).
Results:
At week 24, the adjusted mean change from baseline in HbA1c level compared with placebo was significantly greater with pioglitazone treatment (–0.47%; 95% confidence interval, –0.61 to –0.33; P<0.0001). A greater proportion of patients achieved HbA1c <7% or <6.5% at week 24 with pioglitazone compared to placebo as add-on to 10 mg dapagliflozin and metformin (56.8% vs. 28% for HbA1c <7%, and 23.2% vs. 9.6% for HbA1c <6.5%; P<0.0001 for all). The addition of pioglitazone also significantly improved triglyceride, highdensity lipoprotein cholesterol levels, and homeostatic model assessment of insulin resistance levels, while placebo did not. The incidence of treatment-emergent adverse events was similar between the groups, and the incidence of fluid retention-related side effects by pioglitazone was low (1.5%).
Conclusion
Triple therapy with the addition of 15 mg/day of pioglitazone to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with T2DM inadequately controlled with dapagliflozin plus metformin.
2.Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice
Young Jin YOUN ; Jun-Won LEE ; Sung Gyun AHN ; Seung-Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Sang-Yong YOO ; Woong Chol KANG ; Nam Ho LEE ; Ki Hwan KWON ; Joon Hyung DOH ; Sang-Wook LIM ; Yang Soo JANG ; Dong Woon JEON ; Jung Ho HEO ; Woong Gil CHOI ; Sungsoo CHO ; Bong-Ki LEE ; Hyonju JEONG ; Bum-Kee HONG ; Hyun-Hee CHOI
The Korean Journal of Internal Medicine 2023;38(5):683-691
Background/Aims:
The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention.
Methods:
The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.
Results:
A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%.
Conclusions
In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.
3.Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice
Young Jin YOUN ; Sang Yong YOO ; Jun Won LEE ; Sung Gyun AHN ; Seung Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Woong Gil CHOI ; Sungsoo CHO ; Sang Wook LIM ; Yang Soo JANG ; Ki Hwan KWON ; Nam Ho LEE ; Joon Hyung DOH ; Woong Chol KANG ; Dong Woon JEON ; Bong Ki LEE ; Jung Ho HEO ; Bum Kee HONG ; Hyun Hee CHOI
Korean Circulation Journal 2020;50(4):317-327
BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.
Death
;
Drug-Eluting Stents
;
Follow-Up Studies
;
Humans
;
Hypertension
;
Male
;
Multicenter Studies as Topic
;
Myocardial Infarction
;
Percutaneous Coronary Intervention
;
Polymers
;
Prospective Studies
;
Registries
;
Sirolimus
;
Stents
4.Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice
Young Jin YOUN ; Sang Yong YOO ; Jun Won LEE ; Sung Gyun AHN ; Seung Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Woong Gil CHOI ; Sungsoo CHO ; Sang Wook LIM ; Yang Soo JANG ; Ki Hwan KWON ; Nam Ho LEE ; Joon Hyung DOH ; Woong Chol KANG ; Dong Woon JEON ; Bong Ki LEE ; Jung Ho HEO ; Bum Kee HONG ; Hyun Hee CHOI
Korean Circulation Journal 2020;50(4):317-327
BACKGROUND AND OBJECTIVES:
Recently, Genoss drug-eluting stent (DES)â„¢ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DESâ„¢ stent.
METHODS:
We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DESâ„¢ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DESâ„¢ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.
RESULTS:
Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.
CONCLUSIONS
The novel Genoss DESâ„¢ stent exhibited excellent safety and efficacy in real-world practice.
5.Very deep super-resolution for efficient cone-beam computed tomographic image restoration
Jae Joon HWANG ; Yun-Hoa JUNG ; Bong-Hae CHO ; Min-Suk HEO
Imaging Science in Dentistry 2020;50(4):331-337
Purpose:
As cone-beam computed tomography (CBCT) has become the most widely used 3-dimensional (3D) imaging modality in the dental field, storage space and costs for large-capacity data have become an important issue. Therefore, if 3D data can be stored at a clinically acceptable compression rate, the burden in terms of storage space and cost can be reduced and data can be managed more efficiently. In this study, a deep learning network for super-resolution was tested to restore compressed virtual CBCT images.
Materials and Methods:
Virtual CBCT image data were created with a publicly available online dataset (CQ500) of multidetector computed tomography images using CBCT reconstruction software (TIGRE). A very deep superresolution (VDSR) network was trained to restore high-resolution virtual CBCT images from the low-resolution virtual CBCT images.
Results:
The images reconstructed by VDSR showed better image quality than bicubic interpolation in restored images at various scale ratios. The highest scale ratio with clinically acceptable reconstruction accuracy using VDSR was 2.1.
Conclusion
VDSR showed promising restoration accuracy in this study. In the future, it will be necessary to experiment with new deep learning algorithms and large-scale data for clinical application of this technology.
6.An overview of deep learning in the field of dentistry
Jae Joon HWANG ; Yun Hoa JUNG ; Bong Hae CHO ; Min Suk HEO
Imaging Science in Dentistry 2019;49(1):1-7
PURPOSE: Artificial intelligence (AI), represented by deep learning, can be used for real-life problems and is applied across all sectors of society including medical and dental field. The purpose of this study is to review articles about deep learning that were applied to the field of oral and maxillofacial radiology. MATERIALS AND METHODS: A systematic review was performed using Pubmed, Scopus, and IEEE explore databases to identify articles using deep learning in English literature. The variables from 25 articles included network architecture, number of training data, evaluation result, pros and cons, study object and imaging modality. RESULTS: Convolutional Neural network (CNN) was used as a main network component. The number of published paper and training datasets tended to increase, dealing with various field of dentistry. CONCLUSION: Dental public datasets need to be constructed and data standardization is necessary for clinical application of deep learning in dental field.
Artificial Intelligence
;
Dataset
;
Dentistry
;
Learning
7.Effect of Drug Carrier Melting Points on Drug Release of Dexamethasone-Loaded Microspheres.
Ji Hoon PARK ; Doo Yeon KWON ; Ji Yeon HEO ; Seung Hun PARK ; Joon Yeong PARK ; Bong LEE ; Jae Ho KIM ; Moon Suk KIM
Tissue Engineering and Regenerative Medicine 2017;14(6):743-753
Here, we examined the effect of melting point of drug carriers on drug release of dexamethasone (Dex)-loaded microspheres. We prepared poly(L-lactide-ran-ε-caprolactone) (PLC) copolymers with varying compositions of poly(εcaprolactone) (PCL) and poly(L-lactide) (PLLA). As the PLLA content increased, the melting points of PLC copolymers decreased from 61 to 43 ℃. PLC copolymers in vials solubilized at 40–50 ℃ according to the incorporation of PLLA into the PCL segment. Dexamethasone (Dex)-loaded PLC (MCxLy) microspheres were prepared by the oil-in-water (O/W) solvent evaporation/extraction method. The preparation yields were above 70%, and the mean particle size ranged from 30 to 90 µm. The MC(x)L(y) microspheres also showed controllable melting points in the range of 40–60 ℃. Dex-loaded MC(x)L(y) microspheres showed similar in vitro and in vivo sustained release patterns after the initial burst of Dex. The in vitro and in vivo order of the Dex release was MC₈₀L₂₀>MC₉₀L₁₀>MC₉₅L₅, which agreed well with the melting point order of the drug carrier. Using in vivo fluorescence imaging of fluorescein (FI)-loaded microspheres implanted in animals, we confirmed the sustained release of FI over an extended period. In vivo inflammation associated with the PLC microsphere implants was less pronounced than that associated with Poly(lactide-co-glycolide) (PLGA). In conclusion, we successfully demonstrated that it is possible to control Dex release using Dex-loaded MC(x)L(y) microspheres with different melting points.
Animals
;
Dexamethasone
;
Drug Carriers*
;
Drug Liberation*
;
Fluorescein
;
Freezing*
;
In Vitro Techniques
;
Inflammation
;
Methods
;
Microspheres*
;
Optical Imaging
;
Particle Size
;
Polyglactin 910
8.Clinical Improvement of Severe Reflux Esophagitis in Korea: Follow-up Observation by Endoscopy.
Bong Han KONG ; Dong Ryul KIM ; Ryong HEO ; Eung Koo LEE ; Juhee KIM ; Deok Jae HAN ; Won Jik LEE ; Jung Hwan OH
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2015;15(4):231-235
BACKGROUND/AIMS: The natural history of severe erosive reflux disease in Korea remains uncertain. We aimed to evaluate endoscopic follow-up results in subjects with severe reflux esophagitis under routine clinical care. MATERIALS AND METHODS: A total 61,891 subjects underwent an upper endoscopic examination in the health check-up program from January 2007 to December 2013. We reviewed medical charts of patients who had been diagnosed with severe reflux esophagitis. The severity of reflux esophagitis was determined by the Los Angeles (LA) classification system. Patients underwent at least one follow up endoscopy after diagnosis of severe reflux esophagitis. We classified the patients into two groups; regressed in severity and remained unchanged, according to follow up endoscopic status. RESULTS: Based on endoscopic findings, 5,938 subjects (9.6%) were found to have reflux esopohagitis: 121 subjects (0.2%) in LA-C; 39 subjects (0.06%) in LA-D. Among 31 patients who had endoscopic follow-up, 23 patients (74.2%) showed regression from LA C/D to LA A/B or minimal change disease or normal. The mean follow up duration was 42.2 months in regression group and 53.2 months in no change group. All patients had been treated with proton pump inhibitors (PPIs) on a regular or on-demand basis. Age, sex, smoking, alcohol, exercise, hypertension, diabetes mellitus, dyslipidemia, sliding hiatal hernia, body mass index, waist circumference and duration of PPIs therapy did not significantly influence regression of severe reflux esophagitis. CONCLUSIONS: The majority of severe reflux esophagitis patients under routine clinical care showed improvement on endoscopic follow-up.
Body Mass Index
;
Classification
;
Diabetes Mellitus
;
Diagnosis
;
Dyslipidemias
;
Endoscopy*
;
Esophagitis
;
Esophagitis, Peptic*
;
Follow-Up Studies*
;
Gastroesophageal Reflux
;
Hernia, Hiatal
;
Humans
;
Hypertension
;
Korea*
;
Natural History
;
Nephrosis, Lipoid
;
Proton Pump Inhibitors
;
Smoke
;
Smoking
;
Waist Circumference
9.A Case of Persistent Apical Ballooning Complicated by Apical Thrombus in Takotsubo Cardiomyopathy of Systemic Lupus Erythematosus Patient.
In Kyoung SHIM ; Bong Joon KIM ; Hyunsu KIM ; Jae Woo LEE ; Tae Joon CHA ; Jung Ho HEO
Journal of Cardiovascular Ultrasound 2013;21(3):137-139
Takotsubo cardiomyopathy, which is also known as "transient apical ballooning", is a cardiac syndrome associated with emotional and physical stress that occurs in postmenopausal women. It may mimic acute coronary syndrome but coronary angiography reveals normal epicardial coronary arteries. The prognosis is favorable with the normalization of wall motion abnormalities within weeks. We report a case of persistent apical ballooning complicated by an apical thrombus in Takotsubo cardiomyopathy of systemic lupus erythematous patient. Takotsubo cardiomyopathy may not be always transient and left ventricular thrombus can occur in the disease course as our patient.
Acute Coronary Syndrome
;
Coronary Angiography
;
Coronary Vessels
;
Female
;
Humans
;
Lupus Erythematosus, Systemic*
;
Prognosis
;
Takotsubo Cardiomyopathy*
;
Thrombosis*
10.Back pain with erectile dysfunction: A case report.
Sang Baeg HEO ; Woo Young PARK ; Jae Hoon KIM ; Kyung Bong YOON
Anesthesia and Pain Medicine 2012;7(3):217-220
A 42-year-old male was referred to our pain clinic with back pain. Four years ago, he was treated for back pain caused by falling down injury. He also complained of erectile dysfunction, which was regarded as having psychologic origin at other departments. He had grade IV leg weakness and left lower thoracic paravertebral tenderness. Thoracic CT, plane X-ray and whole body bone scan revealed normal findings. After diagnostic medial branch block at lower thoracic vertebra, pain was subsided partially, but erectile dysfunction persisted. Due to persistent symptoms, we ordered MRI, and the extramedullary mass at T9 level was found. He had undergone neurosurgical operation for tumor removal, and pathologic finding was Schwannoma. After the operation his symptoms improved completely. Although erectile dysfunctions are presumed to have psychologic origin frequently, we report a patient whose symptoms were from the spinal cord tumor.
Adult
;
Back Pain
;
Erectile Dysfunction
;
Humans
;
Leg
;
Male
;
Neurilemmoma
;
Pain Clinics
;
Spinal Cord Neoplasms
;
Spine

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