1.Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial
Ji-Yeon PARK ; Joonyub LEE ; Yoon-Hee CHOI ; Kyung Wan MIN ; Kyung Ah HAN ; Kyu Jeung AHN ; Soo LIM ; Young-Hyun KIM ; Chul Woo AHN ; Kyung Mook CHOI ; Kun-Ho YOON ;
Diabetes & Metabolism Journal 2024;48(5):915-928
Background:
Guidelines for switching to triple combination therapy directly after monotherapy failure are limited. This study investigated the efficacy, long-term sustainability, and safety of either mono or dual add-on therapy using alogliptin and pioglitazone for patients with type 2 diabetes mellitus (T2DM) who did not achieve their target glycemic range with metformin monotherapy.
Methods:
The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK) was a multicenter, placebo-controlled, double-blind, randomized trial. A total of 214 participants were randomized to receive alogliptin+pioglitazone (Alo+Pio group, n=70), alogliptin (Alo group, n=75), or pioglitazone (Pio group, n=69). The primary outcome was the difference in glycosylated hemoglobin (HbA1c) levels between the three groups at baseline to 24 weeks. For durability, the achievement of HbA1c levels <7% and <6.5% was compared in each group. The number of adverse events was investigated for safety.
Results:
After 24 weeks of treatment, the change of HbA1c in the Alo+Pio, Alo, and Pio groups were –1.38%±0.08%, –1.03%±0.08%, and –0.84%±0.08%, respectively. The Alo+Pio group had significantly lower HbA1c levels than the other groups (P=0.0063, P<0.0001) and had a higher proportion of patients with target HbA1c achievement. In addition, insulin sensitivity and β-cell function, lipid profiles, and other metabolic indicators were also improved. There were no significant safety issues in patients treated with triple combination therapy.
Conclusion
Early combination triple therapy showed better efficacy and durability than the single add-on (dual) therapy. Therefore, combination therapy with metformin, alogliptin, and pioglitazone is a valuable early treatment option for T2DM poorly controlled with metformin monotherapy.
2.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.
3.Impact of Coronavirus Disease 2019 on Gastric Cancer Diagnosis and Stage:A Single-Institute Study in South Korea
Moonki HONG ; Mingee CHOI ; JiHyun LEE ; Kyoo Hyun KIM ; Hyunwook KIM ; Choong-Kun LEE ; Hyo Song KIM ; Sun Young RHA ; Gyu Young PIH ; Yoon Jin CHOI ; Da Hyun JUNG ; Jun Chul PARK ; Sung Kwan SHIN ; Sang Kil LEE ; Yong Chan LEE ; Minah CHO ; Yoo Min KIM ; Hyoung-Il KIM ; Jae-Ho CHEONG ; Woo Jin HYUNG ; Jaeyong SHIN ; Minkyu JUNG
Journal of Gastric Cancer 2023;23(4):574-583
Purpose:
Gastric cancer (GC) is among the most prevalent and fatal cancers worldwide.National cancer screening programs in countries with high incidences of this disease provide medical aid beneficiaries with free-of-charge screening involving upper endoscopy to detect early-stage GC. However, the coronavirus disease 2019 (COVID-19) pandemic has caused major disruptions to routine healthcare access. Thus, this study aimed to assess the impact of COVID-19 on the diagnosis, overall incidence, and stage distribution of GC.
Materials and Methods:
We identified patients in our hospital cancer registry who were diagnosed with GC between January 2018 and December 2021 and compared the cancer stage at diagnosis before and during the COVID-19 pandemic. Subgroup analyses were conducted according to age and sex. The years 2018 and 2019 were defined as the “before COVID” period, and the years 2020 and 2021 as the “during COVID” period.
Results:
Overall, 10,875 patients were evaluated; 6,535 and 4,340 patients were diagnosed before and during the COVID-19 period, respectively. The number of diagnoses was lower during the COVID-19 pandemic (189 patients/month vs. 264 patients/month) than before it.Notably, the proportion of patients with stages 3 or 4 GC in 2021 was higher among men and patients aged ≥40 years.
Conclusions
During the COVID-19 pandemic, the overall number of GC diagnoses decreased significantly in a single institute. Moreover, GCs were in more advanced stages at the time of diagnosis. Further studies are required to elucidate the relationship between the COVID-19 pandemic and the delay in the detection of GC worldwide.
4.Natural Course of Swallowing Recovery and Associated Factors in Post-Ischemic Stroke Dysphagia
Jin-Woo SUH ; Han-Sol LIM ; Dong-Kun KIM ; Hyun Seung LEE ; Yong-Taek LEE ; Young Sook PARK ; Chul-Hyun PARK ; Kyung-Jae YOON
Journal of the Korean Dysphagia Society 2022;12(2):115-122
Objective:
To identify factors associated with swallowing recovery in patients with dysphagia after ischemic stroke.
Methods:
Patients admitted to Kangbuk Samsung Hospital from 2011 to 2019 for first acute ischemic stroke and dysphagia, as confirmed by a videofluoroscopic swallowing study (VFSS), were enrolled in this retrospective study. Patients whose Dysphagia Outcome and Severity Scale (DOSS) level was <6 as determined by VFSS were monitored in a dysphagia clinic and additional VFSS was performed periodically until one year after stroke. Follow-up was discontinued when the DOSS level reached 6 or 7. The main study outcomes were full recovery and tube removal rate. Cox regression analysis was used to identify prognostic factors of dysphagia. The Kaplan-Meier method was used to generate curves of the proportions of patients that achieved full recovery.
Results:
One hundred and thirteen patients were enrolled. Multivariate analysis showed that only initial DOSS was significantly associated with swallowing recovery (13.0% for non-oral feeding vs. 35.6 % for a modified diet).
Conclusion
Initial swallowing status (as determined by VFSS findings) is strongly associated with swallowing recovery in post-ischemic stroke patients. Assessments of dysphagia are important for predicting dysphagia recovery and planning management strategies.
5.Early postoperative treatment of mastectomy scars using a fractional carbon dioxide laser: a randomized, controlled, split-scar, blinded study
Hyun Woo SHIN ; Sangwoo SUK ; Seoung Wan CHAE ; Kun Chul YOON ; Junekyu KIM
Archives of Plastic Surgery 2021;48(4):347-352
Background:
Mastectomy leaves unsightly scarring, which can be distressing to patients. Laser therapy for scar prevention has been consistently emphasized in recent studies showing that several types of lasers, including fractional ablation lasers, are effective for reducing scar formation. Nonetheless, there are few studies evaluating the therapeutic efficacy of ablative CO2 fractional lasers (ACFLs).
Methods:
This study had a randomized, comparative, prospective, split-scar design with blinded evaluation of mastectomy scars. Fifteen patients with mastectomy scars were treated using an ACFL. Half of each scar was randomized to “A,” while the other side was allocated to group “B.” Laser treatment was conducted randomly. Scars were assessed using digital photographs of the scar and Vancouver scar scale (VSS) scores. Histological assessments were also done.
Results:
The mean VSS scores were 2.20±1.28 for the treatment side and 2.96±1.40 for the control side. There was a significant difference in the VSS score between the treatment side and the control side (P=0.002). The mean visual analog scale (VAS) scores were 4.13±1.36 for the treatment side and 4.67±1.53 for the control side. There was a significant difference in VAS score between the treatment side and the control side (P=0.02).
Conclusions
This study demonstrated that early scar treatment using an ACFL significantly improved the clinical results of the treatment compared to the untreated scar, and this difference was associated with patient satisfaction.
6.Early postoperative treatment of mastectomy scars using a fractional carbon dioxide laser: a randomized, controlled, split-scar, blinded study
Hyun Woo SHIN ; Sangwoo SUK ; Seoung Wan CHAE ; Kun Chul YOON ; Junekyu KIM
Archives of Plastic Surgery 2021;48(4):347-352
Background:
Mastectomy leaves unsightly scarring, which can be distressing to patients. Laser therapy for scar prevention has been consistently emphasized in recent studies showing that several types of lasers, including fractional ablation lasers, are effective for reducing scar formation. Nonetheless, there are few studies evaluating the therapeutic efficacy of ablative CO2 fractional lasers (ACFLs).
Methods:
This study had a randomized, comparative, prospective, split-scar design with blinded evaluation of mastectomy scars. Fifteen patients with mastectomy scars were treated using an ACFL. Half of each scar was randomized to “A,” while the other side was allocated to group “B.” Laser treatment was conducted randomly. Scars were assessed using digital photographs of the scar and Vancouver scar scale (VSS) scores. Histological assessments were also done.
Results:
The mean VSS scores were 2.20±1.28 for the treatment side and 2.96±1.40 for the control side. There was a significant difference in the VSS score between the treatment side and the control side (P=0.002). The mean visual analog scale (VAS) scores were 4.13±1.36 for the treatment side and 4.67±1.53 for the control side. There was a significant difference in VAS score between the treatment side and the control side (P=0.02).
Conclusions
This study demonstrated that early scar treatment using an ACFL significantly improved the clinical results of the treatment compared to the untreated scar, and this difference was associated with patient satisfaction.
7.Aggressive cutaneous squamous cell carcinoma of the scalp
Sangwoo SUK ; Hyun Woo SHIN ; Kun Chul YOON ; Junekyu KIM
Archives of Craniofacial Surgery 2020;21(6):363-367
Cutaneous squamous cell carcinoma (cSCC) is the second most common nonmelanoma skin cancer, and its incidence is increasing globally. In Korea, there were 12,516 diagnosed cases of cSCC between 1999 and 2014. Surgical treatment, for which several options are available, is the standard of care for cSCC and securing a sufficient surgical resection margin is always important. cSCC of the scalp sometimes exhibits unusually aggressive behavior. In this article, we report a case of cSCC of the scalp with invasion into the skull and dura mater.
8.A case report of Madelung’s disease
Nam JANG ; Hyun Woo SHIN ; Junekyu KIM ; Kun Chul YOON
Archives of Craniofacial Surgery 2020;21(5):305-308
Madelung’s disease (MD) otherwise known as Launois-Bensaude syndrome, multiple symmetrical lipomatosis, or benign symmetric lipomatosis, is a rare disease characterized by abnormal diffuse lipomatosis in proximal upper limbs and neck. Here, we report a rare case of MD. A 66-year-old man presented with massive growth of soft tissues in the cervico-occipital region of more than 2 years duration. Physical examination showed diffuse enlargement of the anterior neck (Madelung’s collar) and three huge humps at the posterior neck. Under a diagnosis of MD, lipectomy via a single anterior transverse incision and liposuction were performed. This rare case report may be helpful for assessing patients with abnormal diffuse lipomatosis in the neck and proximal upper limbs.
9.Limited retromuscular fibrofatty tissue resection in upper blepharoplasty for senile patients
Seo Gil CHOI ; Sang Woo SUK ; Kun Chul YOON
Archives of Aesthetic Plastic Surgery 2019;25(4):131-136
BACKGROUND: Studies of eyelid anatomy suggest an absence of supratarsal folds and a redundancy of retromuscular tissue in many Asians. Aggressive retromuscular tissue resection during senile blepharoplasty can lead to complications such as hematoma and extra fold formation. A thin fold is considered aesthetically pleasing, but upper eyelid hollowness is undesirable. Therefore, senile blepharoplasty allows relatively little room for retromuscular resection. METHODS: Between January 2016 and March 2019, blepharoplasty without a brow procedure was performed in 48 patients aged 55 years and older. In some patients with thin eyelids, the upper retromuscular tissue was explored, and the surgeon decided intraoperatively whether to perform resection. In total, 36 of 48 patients underwent retromuscular tissue resection, which was confined to the central and lateral aspects of the eyelid within 7–10 mm from the incision in the superior direction to create a crisp, thin fold without hollowness. The skin was closed, with the closure including the levator palpebrae superioris (levator) muscle, to create a weak, natural-looking, and dynamic fold instead of the buried dermo-levator suture typically created during double eyelid surgery. RESULTS: In the 72 eyelids that underwent resection, hematoma or extra fold formation was absent. In all cases, thin folds were achieved without an increase in the hollowness of the upper eyelid. Most patients were satisfied with their natural-looking postoperative appearance. CONCLUSIONS: When indicated, limited retromuscular resection is recommended in cases of senile blepharoplasty. The resection should be confined to the central and the lateral aspects of the eyelid, within 7–10 mm in the superior direction from the incision, to create a crisp thin fold without hollowness.
Asian Continental Ancestry Group
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Blepharoplasty
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Eyelids
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Hematoma
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Humans
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Orbit Evisceration
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Skin
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Sutures
10.Preparation of harvested skin using the Versajet Hydrosurgery System in full-thickness skin grafts
Seo Gil CHOI ; Hyun Woo SHIN ; Kun Chul YOON
Archives of Plastic Surgery 2019;46(6):603-607
During a full-thickness skin graft procedure, the thickness of the harvested donor skin is adjusted based on the location of the recipient site and the judgment of the surgeon. Conventionally, the thickness of the harvested skin is roughly adjusted using surgical instruments such as scalpels and scissors. However, this method is not only time-consuming, but also requires effort to obtain both the desired thickness of the harvested skin and a smooth surface of that skin. Moreover, there is a possibility of skin perforation. Hence, the authors devised a method of adjusting harvested skin thickness using the Versajet Hydrosurgery System. The Versajet device is a handheld hydrosurgical tool that delivers a high-speed jet stream of saline solution, which enables the precise debridement of tissue. This method makes it easier and faster for the surgeon to obtain the desired thickness of harvested skin. In addition, by obtaining a smooth surface and an even thickness of harvested donor skin, this technique may lead to improved graft viability.

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