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Publication Complications related to oral corticosteroid use in asthma patients: a retrospective cohort study.(2025-04)Background: Asthma patients requiring oral corticosteroids (OCS) are at increased risk of adverse effects. Research focusing on asthma patients adhering to guideline-directed therapy remains limited. This study evaluates the adverse effects of corticosteroids in asthma patients treated with high-dose inhaled corticosteroids (ICS) who required additional OCS due to inadequate disease control. Research design and methods: We conducted a retrospective cohort study of asthma patients from Taiwan’s asthma pay-for-performance program, who had used high-dose ICS for at least 90 days, categorizing them based on OCS use. In the short-term period (3 months), patients were classified into a control group (no OCS) and an OCS group (≥450 mg OCS within 90 days). In the long-term period (6 months), the OCS group consisted of patients receiving ≥ 900 mg OCS within 180 days. Results: A total of 173,835 patients were enrolled for analysis. We assessed the risks of osteoporosis, diabetes, hypertension, infections, cardiovascular diseases, mental health disorders, and ocular conditions. Both short- and long-term OCS users exhibited significantly higher risks of these adverse outcomes compared to the control group. Conclusions: These findings highlight the substantial health risks associated with OCS. Clinicians should carefully consider alternative strategies to minimize harm while ensuring effective disease control. - Some of the metrics are blocked by yourconsent settings
Publication Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report.(2025-01-24)Introduction: Amivantamab, an EGFR-MET bispecific antibody, is approved for multiple indications in EGFR-mutated advanced NSCLC as monotherapy or combined with other agents. Intravenous amivantamab is associated with a 67% infusion-related reaction (IRR) rate. Methods: The phase 2 SKIPPirr study (NCT05663866) enrolled participants with EGFR-mutated (exon 19 deletion or exon 21 L858R) advanced NSCLC after progression on osimertinib and platinum-based chemotherapy who received intravenous amivantamab plus oral lazertinib (amivantamab-lazertinib), a third-generation tyrosine kinase inhibitor. Aiming to mitigate IRRs, four independent prophylactic approaches were evaluated using Simon's two-stage design with an expansion stage if a cohort passed both stages: oral dexamethasone 4 mg twice daily given on cycle (C) 1 day (D) −1 (two doses); oral dexamethasone 8 mg twice daily given on C1D−2, C1D−1, and the morning of C1D1 (five doses); oral montelukast 10 mg once daily given on C1D−4, C1D−3, C1D−2, C1D−1, and C1D1 (five doses); subcutaneous methotrexate 25 mg (one dose) given anytime between C1D−7 and C1D−3. The primary end point was C1D1 IRR incidence. Results: As of June 24, 2024, 68 participants were treated across all cohorts. The dexamethasone 8 mg cohort passed stages 1 and 2 proceeding to the expansion stage, with 24 additional participants treated. At C1D1, nine of 40 participants (22.5%) experienced IRRs, resulting in an approximately threefold decrease versus historical data (67.4%). By the end of C3, 10 of 41 participants (24.4%) in the dexamethasone 8 mg cohort experienced IRRs (grades 1–2, except one grade 3 on C2D1). Amivantamab-lazertinib's safety and efficacy were consistent with previous reports. Conclusions: Prophylaxis with 8 mg oral dexamethasone meaningfully reduced IRRs and can be readily implemented in clinical practice. - Some of the metrics are blocked by yourconsent settings
Publication Pharmacokinetics and Safety Profile of SNS812, a First in Human Fully Modified siRNA Targeting Wide-Spectrum SARS-CoV-2, in Healthy Subjects.(2025-03)Severe acute respiratory syndrome caused by the coronavirus (SARS-CoV-2) in the COVID-19 pandemic has highlighted the need for effective treatments, as rapid viral mutations complicate therapeutic development. SNS812, a fully modified inhaled siRNA that targets the conserved RNA-dependent RNA polymerase (RdRP) gene of SARS-CoV-2, has been shown to possess its suppression ability against wide-spectrum SARS-COV-2 variants preclinically. To evaluate the safety and tolerability of inhaled SNS812 in healthy participants, a randomized, double-blind, placebo-controlled phase 1 trial was conducted. To justify the first-in-human inhalation study, this research was divided into two parts: single ascending doses (0.3, 0.6, and 1.2 mg/kg) and multiple doses (0.6 and 1.2 mg/kg) of daily inhalation for seven consecutive days to assess the safety, tolerability, immunogenicity, and pharmacokinetics of SNS812. Of the 44 participants, 3 in the 0.3 mg/kg single-dose group, 2 in the 1.2 mg/kg multiple ascending doses group, and 1 in the placebo group reported treatment-emergent adverse events (TEAEs). No serious adverse events (SAEs), treatment-related adverse events (TRAEs), or TEAEs caused discontinuation or deaths were observed. PK showed rapid absorption of SNS812, with peak concentrations (median T) reached at 1.5-2 h, and an elimination half-life (t ) between 4.96 and 7.08 h. No antidrug antibodies (ADAs) were detected in either group. The results demonstrated that the first-in-human, fully modified with wide-spectrum anti-SARS-COV2 siRNA by inhalation following a single dose and multiple doses was safe and well tolerated in healthy participants. Trial Registration: NCT05677893. - Some of the metrics are blocked by yourconsent settings
Publication AI integrations with lung cancer screening: Considerations in developing AI in a public health setting.(2025-05-02)Lung cancer screening implementation has led to expanded imaging of the chest in older, tobacco-exposed populations. Growing numbers of screening cases are also found to have CT-detectable emphysema or elevated levels of coronary calcium, indicating the presence of coronary artery disease. Early interventions based on these additional findings, especially with coronary calcium, are emerging and follow established protocols. Given the pace of diagnostic innovation and the potential public health impact, it is timely to review issues in developing useful chest CT screening infrastructure as chest CT screening will soon involve millions of participants worldwide. Lung cancer screening succeeds because it detects curable, early primary lung cancer by characterizing and measuring changes in non-calcified, lung nodules in the size-range from 3mm to 15 mm in diameter. Therefore, close attention to imaging methodology is essential to lung screening success and similar image quality issues are required for reliable quantitative characterization of early emphysema and coronary artery disease. Today's emergence of advanced image analysis using artificial intelligence (AI) is disrupting many aspects of medical imaging including chest CT screening. Given these emerging technological and volume trends, a major concern is how to balance the diverse needs of parties committed to building AI tools for precise, reproducible, and economical chest CT screening, while addressing the public health needs of screening participants receiving this service. A new consortium, the Alliance for Global Implementation of Lung and Cardiac Early Disease Detection and Treatment (AGILE) is committed to facilitate broad, equitable implementation of multi-disciplinary, high quality chest CT screening using advanced computational tools at accessible cost. - Some of the metrics are blocked by yourconsent settings
Publication Effect of SGLT2 Inhibitors on Diabetes Progression in Statin-Treated Patients: A Population-Based Cohort Study.(2025)Background: Statins, though widely used, may accelerate diabetes progression, necessitating interventions to counteract this effect. Purpose: To compare the effect of sodium-glucose co-transporter 2 inhibitors (SGLT2is) and sulfonylureas or meglitinides on diabetes progression in individuals receiving statins. Patients and Methods: This retrospective cohort study utilized data from the National Health Insurance Research Database of Taiwan. We included patients with diabetes receiving statins and newly initiated SGLT2is or sulfonylureas/meglitinides between July 1, 2016 and December 31, 2020. Diabetes progression was defined as insulin initiation, increase in antidiabetic medication class, or occurrence of new acute hyperglycemic complications. Propensity score matching was used to adjust baseline characteristics. Cox proportional hazards regression was used to calculate the hazard ratios for diabetes progression between users of SGLT2is and those of sulfonylureas or meglitinides. The statistical significance level was set at 0.05 for all analyses. Results: SGLT2i users had a significantly lower risk of diabetes progression compared to sulfonylurea/meglitinide users (HR: 0.53, 95% CI: 0.50–0.57, p-value < 0.001). Similar results were found in insulin initiation (HR: 0.48, 95% CI: 0.38–0.61, p-value < 0.001) and increase in antidiabetic medication class (HR: 0.53, 95% CI: 0.50–0.57, p-value < 0.17). However, the risk of new acute glycemic complications did not significantly differ between groups (HR: 2.47, 95% CI: 0.67–9.08, p-value = 0.17). Conclusion: SGLT2is may be an effective second-line therapy for statin-treated patients by slowing diabetes progression and potentially mitigating statin-induced metabolic disturbances. Further research, including randomized controlled trials or observational studies with comprehensive laboratory data, is needed to confirm these findings and evaluate their broader applicability.
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Person PEI-LIN LEEPei-Lin Lee serves as Clinical Associate Professor, School of Medicine, National Taiwan University; Consultant, Center of Sleep Disorder, National Taiwan University Hospital. Her current academic positions at international sleep societies include American Academy of Sleep Medicine Fellow and Co-Chair International Assembly; Asian Society of Sleep Medicine, Sleep Medicine Education Task Force committee member. Her current research focuses on the era of new technology and big data in sleep medicine; and intervention on sleep and metabolism in sleep disordered breathing.5116 42 - Some of the metrics are blocked by yourconsent settings
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