Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Background and Objectives: The serum galactomannan test (GM test) and the (1,3)-β-D-glucan test (G test) are utilized in diagnosing invasive fungal sinusitis. However, their effectiveness in detecting paranasal sinus fungus balls (FBs) has not been established. This study aimed to explore their diagnostic value in patients with FBs. Methods: We retrospectively reviewed the medical records of 105 patients (42 with FBs and 63 with chronic rhinosinusitis [CRS]) who underwent serum GM and G tests between June 2020 and May 2021. Olfactory test results and demographics were also analyzed. Results: There were 42 FB patients (10 men, 32 women) and 63 CRS patients (27 men, 36 women). The positivity rates for serum GM (7.1% in the FB group vs. 3.2% in the CRS group, p=0.640) and G test (9.5% in the FB group vs. 11.1% in the CRS group, p=0.482) did not differ significantly between groups. The sensitivities of the GM and G tests were 7.1% and 9.5%, respectively, and their specificities were 96.8% and 88.9%, respectively. The positive predictive values were 60.0% for the GM test and 36.3% for the G test, and the negative predictive values were 61.0% for the GM test and 59.6% for the G test. Conclusion Serum GM and G tests demonstrated low sensitivity and high specificity, indicating limited effectiveness in differentiating between patients with FBs and those with CRS. Histological examination remains the gold standard for the definitive diagnosis of FBs.

Background: Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin. Methods: In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500). Results: Adjusted mean change of HbA1c at week 24 was –0.80% with enavogliflozin and –0.75% with dapagliflozin (difference, –0.04%; 95% confidence interval, –0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was –32.53 and –29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (–1.85 vs. –1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (–3.77 kg vs. –3.58 kg) and blood pressure (systolic/diastolic, –5.93/–5.41 mm Hg vs. –6.57/–4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated. Conclusion Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone.

Objective: This study aimed at analyzing the clinical characteristics of patients visiting the emergency department (ED) and pre-triage clinic during the coronavirus disease 2019 (COVID-19) pandemic era in Daegu, South Korea. Methods: We conducted a retrospective observational study by using the medical records of patients who visited the ED and pre-triage clinic from February 22 to March 31, 2020 and comparing them with the corresponding period in 2019. Results: The number of patients visiting the ED per day decreased from 122 (115-138) to 77 (66-93). The percentage of patients with respiratory infection increased from 6.6% to 15.4% (P<0.001). The length of the ED stay increased from 269 (150-562) to 559 (293-941) minutes, especially in patients with fever (P<0.001). The rate of injured and less urgent patients decreased from 24.7 to 13.2 and 53.4% to 50.2%, respectively (P<0.001). Sixty-one-point nine percent of patients visiting the ED were triaged and discharged at the pre-triage clinic without entering the ED. Conclusion In the COVID-19 pandemic era, there was an increase in the proportion of patients with fever and respiratory symptoms and a decrease in the proportion of injured patients. At the pre-triage clinic, a significant number of patients with suspected COVID-19 or less urgent conditions were treated and discharged without their having to enter the ED.

Background/Aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients. Methods: Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV). Results: Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group. Conclusions BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).

Background/Aims: Vascular disease is an established risk factor for stroke in patients with atrial fibrillation (AF), which is included in CHA2DS2-VASc score. However, the role of carotid atherosclerosis remains to be determined. Methods: Three hundred-ten patients with AF who underwent carotid sonography were enrolled. Results: During a median follow-up of 31 months, 18 events (5.8%) of stroke were identified. Patients with stroke had higher carotid intima-media thickness (CIMT) (1.16 ± 0.33 mm vs. 0.98 ± 0.25 mm, p = 0.017). CIMT was significantly increased according to the CHA2DS2-VASc score (p < 0.001) and it was correlated with left ventricular mass index and early diastolic mitral annular velocity (e’), a ratio of early transmitral flow velocity to e’ (E/e’) and pulmonary artery systolic pressure (all p < 0.05). Cox regression using multivariate models showed that carotid plaque was associated with the risk of stroke (hazard ratio, 3.748; 95% confidence interval [CI], 1.107 to 12.688; p = 0.034). C-statistics increased from 0.648 (95% CI, 0.538 to 0.757) to 0.716 (95% CI, 0.628 to 0.804) in the CHA2DS2-VASc score model after the addition of CIMT and carotid plaque as a vascular component (p = 0.013). Conclusions Increased CIMT and presence of carotid plaque are associated with a high risk of ischemic stroke, and CIMT is related to myocardial remodeling and diastolic dysfunction, suggesting that carotid atherosclerosis can improve risk prediction of stroke in patients with AF, when included under vascular disease in the CHA2DS2-VASc scoring system.

Background/Aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients. Methods: Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV). Results: Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group. Conclusions BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).