Clinical therapeutics最新文献

{"title":"Clinical Study of Cardiac Electrophysiology Affected After Percutaneous Transluminal Septal Myocardial Ablation for Obstructive Cardiomyopathy","authors":"Tianzhu Li MD ,&nbsp;Jinzhao Li MD ,&nbsp;Jun Zhang MD ,&nbsp;Nimin Lu MD","doi":"10.1016/j.clinthera.2025.09.006","DOIUrl":"10.1016/j.clinthera.2025.09.006","url":null,"abstract":"<div><h3>Purpose</h3><div>Hypertrophic cardiomyopathy has an estimated prevalence of approximately 1/200, driven by advancements in genetic testing and high-sensitivity cardiac imaging. This study evaluates the efficacy of percutaneous transluminal septal myocardial ablation (PTSMA) in treating hypertrophic obstructive cardiomyopathy (HOCM) and its impact on cardiac electrophysiology.</div></div><div><h3>Methods</h3><div>A cohort of 38 patients with HOCM, admitted between June 2022 and June 2023, underwent PTSMA. Cardiac function classifications, interventricular septal thickness, left ventricular end-diastolic diameter (LVEDD), left ventricular outflow tract (LVOT) diameter, mitral valve early diastolic velocity (E peak), mitral annular early diastolic velocity (e′), and cardiac electrophysiological parameters (Tp-Te interval and QTcd) were assessed before and 1 month postprocedure.</div></div><div><h3>Findings</h3><div>One month post-PTSMA, significant reductions were observed in cardiac function classification, interventricular septal thickness, and E/e′ ratio (<em>P</em> &lt; 0.05), alongside increases in LVEDD and LVOT diameter (<em>P</em> &lt; 0.05). The Tp-Te interval and QTcd were significantly shortened (<em>P</em> &lt; 0.05).</div></div><div><h3>Implications</h3><div>PTSMA shows potential to improve cardiac function and reduce LVOT obstruction in HOCM patients, with favorable effects on cardiac electrophysiology. However, further multi-center studies with long-term follow-up are required to validate these findings and establish its broader therapeutic role.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1124-1129"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Differential Effects of Anti-Seizure Medications on Sarcopenia in Patients With Epilepsy","authors":"Yu-Shiue Chen MSc ,&nbsp;Ming-Chi Lai MD, PhD ,&nbsp;Huai-Chun Huang BSc ,&nbsp;Huai-Ying Ingrid Huang BSc ,&nbsp;Chin-Wei Huang MD, PhD","doi":"10.1016/j.clinthera.2025.09.014","DOIUrl":"10.1016/j.clinthera.2025.09.014","url":null,"abstract":"<div><h3>Purpose</h3><div>Epilepsy is a chronic neurological disorder that often requires long-term use of anti-seizure medications (ASMs). While ASMs are known to affect bone health, their impact on muscle mass and the development of sarcopenia has not been well studied. This study investigated the association between ASM use and sarcopenia in patients with epilepsy and identified specific medications associated with increased risk.</div></div><div><h3>Methods</h3><div>This cross-sectional study was conducted from March to September 2022. Adult epilepsy patients were recruited from a neurology outpatient clinic. Information on current and past ASM use was obtained from electronic medical records and patient interviews. ASMs were categorized into 4 groups: enzyme-inhibiting ASM (Valproate), enzyme-inducing ASMs (EIASMs), weak EIASMs, and non-EIASMs. Sarcopenia was defined using standard criteria based on muscle mass, strength, and physical performance. Statistical analyses included descriptive statistics and logistic regression using IBM SPSS Statistics Version 26.0.</div></div><div><h3>Results</h3><div>A total of 200 patients were included. Univariate analysis showed significant differences in current EIASM use, duration of EIASM use, and phenytoin use between sarcopenia and non-sarcopenia groups (<em>P</em> = 0.030, <em>P</em> = 0.029, and <em>P</em> = 0.045, respectively). Logistic regression identified age (<em>P</em> = 0.030; OR = 1.045), body mass index (<em>P</em> = 0.001; OR = 0.672), and EIASM use (<em>P</em> = 0.023; OR = 5.091) as independent factors associated with sarcopenia.</div></div><div><h3>Conclusion</h3><div>Enzyme-inducing ASMs, particularly phenytoin, are associated with sarcopenia diagnosis in epilepsy patients. Older age and lower BMI were also associated with sarcopenia. Individualized ASM selection and early screening are recommended.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1130-1136"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Metered Dose Inhaler Formulation of Triple-Drug Fixed-Dose Combination of Vilanterol, Glycopyrronium, and Fluticasone Furoate: A Phase III, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety in Indian Patients With Uncontrolled Asthma","authors":"Chintan Patel ,&nbsp;Diptikant Sahoo ,&nbsp;Vaishal Sheth ,&nbsp;Manish Kumar Jain ,&nbsp;Ravi Koppula ,&nbsp;Sanjay Verma ,&nbsp;Deepak Kumar ,&nbsp;Jayanta Kumar Panda ,&nbsp;Deven Parmar ,&nbsp;Kevinkumar Kansagra ,&nbsp;Hardik Pathak","doi":"10.1016/j.clinthera.2025.09.020","DOIUrl":"10.1016/j.clinthera.2025.09.020","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of vilanterol 12.5 µg, glycopyrronium 25 µg, and fluticasone furoate 100 µg (VIL-GLY-FF)–metered dose inhaler (MDI) (developed by M/s. Zydus Healthcare Limited) in comparison with the approved FDC of indacaterol 150 µg, glycopyrronium 50 µg, and mometasone furoate 160 µg (IND-GLY-MF)–dry powder inhaler (DPI) in patients with persistent asthma.</div></div><div><h3>Methods</h3><div>Patients were randomized (1:1) in either the test (VIL-GLY-FF-MDI) or reference (IND-GLY-MF-DPI) group. Fixed-dose combinations were administered once daily for 12 weeks; for VIL-GLY-FF-MDI, patients were instructed to administer TWO actuations at 1 time in a day, doubling the final doses delivered of its components. For IND-GLY-MF-DPI, (Zydus Healthcare Limited, Ahmedabad) patients inhaled 1 capsule via the Respihaler device once daily. The primary objective was to compare the between-group difference in the change in trough forced expiratory volume in 1 second (FEV1) at week 12 from baseline.</div></div><div><h3>Findings</h3><div>A total of 256 patients were enrolled. The change in least square mean (SE) in trough FEV1 at week 12 from baseline was 287.15 (18.00) mL and 284.94 (17.93) mL for the test and reference groups, respectively. For a predefined −150 mL noninferiority margin, 2-sided 95% CIs (−47.83 to 52.26 mL) for the difference in the mean change in trough FEV1 (2.21 mL) between the 2 groups reported the noninferiority of VIL-GLY-FF-MDI to IND-GLY-MF-DPI. The test FDC was well tolerated.</div></div><div><h3>Implications</h3><div>Efficacy and safety of VIL-GLY-FF-MDI were found to be similar to those of IND-GLY-MF-DPI in Indian patients with persistent asthma. Clinical Trial Registry India identifier: CTRI/2024/01/061230.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1170-1175"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145408467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Rosuvastatin/Amlodipine FDC in Patients With Hypertension and Dyslipidemia: A Multicenter, Prospective, Observational Study","authors":"Jae Hyoung Park MD, PhD ,&nbsp;Kyung Hoon Cho MD, PhD ,&nbsp;Seong-Il Woo MD, PhD ,&nbsp;Seung-Woon Rha MD, PhD ,&nbsp;Yun-Hyeong Cho MD, PhD ,&nbsp;Kwang Soo Cha MD, PhD ,&nbsp;Hong Euy Lim MD, PhD ,&nbsp;Wonho Kim MD, PhD ,&nbsp;Namho Lee MD, PhD ,&nbsp;Seong Wook Cho MD, PhD ,&nbsp;Sung Uk Kwon MD, PhD ,&nbsp;Shin-Jae Kim MD, PhD ,&nbsp;Se Hun Kang MD, PhD ,&nbsp;Jin Oh Choi MD, PhD ,&nbsp;Jung-Woo Son MD, PhD ,&nbsp;Seongwoo Han MD, PhD ,&nbsp;Yongwhi Park MD, PhD ,&nbsp;Seo-Won Choi MD, PhD ,&nbsp;Sangmin Lee MD ,&nbsp;Moo Hyun Kim MD, PhD","doi":"10.1016/j.clinthera.2025.09.012","DOIUrl":"10.1016/j.clinthera.2025.09.012","url":null,"abstract":"<div><h3>Background</h3><div>A fixed-dose combination of rosuvastatin and amlodipine (Ros/Aml) offers a simplified approach to simultaneously address hypertension and dyslipidemia. While pivotal trials have demonstrated the efficacy and safety of this regimen, real-world evidence on its clinical outcomes related to major adverse cardiovascular and cerebrovascular events (MACCE) had been limited.</div></div><div><h3>Methods</h3><div>This multicenter, prospective, non-interventional study was conducted across 39 sites in South Korea (2020–2024) to evaluate the 12-month effectiveness and safety of Ros/Aml in adults with coexisting hypertension and dyslipidemia. The primary endpoint was the incidence of MACCE. Secondary endpoints included changes in blood pressure, lipid profiles, and safety outcomes.</div></div><div><h3>Results</h3><div>A total of 5018 patients were enrolled, with 5009 (99.82%) included in the Safety and Efficacy Sets. The mean age was 66.80 years, and 60.39% were male. In the efficacy set, the 12-month MACCE incidence was 0.54% [95% CI: 0.36–0.78], with no significant differences among four dose groups. Ros/Aml significantly reduced systolic and diastolic blood pressure at 6 and 12 months (both <em>P</em> &lt; 0.001), and LDL-C levels (<em>P</em> &lt; 0.0001). Adverse drug reactions were reported in 3.11% of patients; with only 0.06% experiencing serious ADRs and no ADR-related deaths occurred, suggesting a tolerable safety profile.</div></div><div><h3>Conclusions</h3><div>In this large real-world study, Ros/Aml demonstrated a favorable safety profile and was effective in reducing MACCE risk, blood pressure, and lipid levels over 12 months. These findings in patients with hypertension and dyslipidemia support its use as a viable strategy for integrated cardiovascular risk management in clinical practice.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1104-1112"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Characteristics, Treatment Patterns, and Outcomes in Advanced HER2 (ERBB2)-Mutant Non-Small Cell Lung Cancer: A Retrospective Study of Single Centers in France and Germany","authors":"Petros Christopoulos MD, PhD ,&nbsp;Christin Assmann MD ,&nbsp;Lirong Zhang MSc ,&nbsp;Kyle Dunton MSc ,&nbsp;Ahmed Ali PhD ,&nbsp;Mehmet Berktas MD, MSc ,&nbsp;Lisa Delmastro BSc ,&nbsp;Alessandria Strübing MSPH ,&nbsp;Yan Xiong MS ,&nbsp;Sarah Lay-Flurrie PhD ,&nbsp;Pooja Hindocha MSc ,&nbsp;Tarana Mehdikhanova MSc ,&nbsp;Nicolas Girard MD, PhD","doi":"10.1016/j.clinthera.2025.09.019","DOIUrl":"10.1016/j.clinthera.2025.09.019","url":null,"abstract":"<div><h3>Purpose</h3><div>Human epidermal growth factor receptor 2 (<em>HER2</em> [<em>ERBB2</em>]) gene mutations occur in ∼3–5% of non-small cell lung cancer (NSCLC) cases and are associated with poor prognosis. However, real-world data on patients with <em>HER2</em>-mutant (HER2m) NSCLC are needed.</div></div><div><h3>Methods</h3><div>This retrospective, observational study evaluated characteristics, treatment patterns, and clinical outcomes of patients with advanced nonsquamous HER2m NSCLC from the Institut Curie (France) and Thoraxklinik Heidelberg (Germany) between 2011 and 2022.</div></div><div><h3>Findings</h3><div>Of the 55 patients (Curie: n = 17; Heidelberg: n = 38) included in the study, median age at diagnosis was 66 years (range, 22–90), 63.6% were female, and 50.9% had no history of smoking. Forty-eight (87.3%) patients received ≥1 line of therapy, 29 (52.7%) received ≥2 lines of therapy, and 19 (34.5%) received ≥3 lines of therapy. The most common first-line treatment was platinum-based and non-platinum-based chemotherapy (54.2%, n/n = 26/48); treatment patterns in the second- and third-line settings were more diverse than in the first-line setting. Median overall survival was 14.2 months (95% confidence interval [CI] 11.2, 23.2; <em>n</em> = 55) from the diagnosis of advanced disease and 16.5 months (12.3, 29.8; n = 48) from the start of first-line treatment. Median progression-free survival was 5.1 months (95% CI 3.5, 8.5; n = 48) and 4.0 months (2.4, 6.3; n = 29) from the start of first- and second-line treatment, respectively.</div></div><div><h3>Implications</h3><div>Patients with advanced HER2m NSCLC had a poor prognosis despite treatment with standard-of-care regimens available during the study period. These findings highlight the need for novel therapeutic options to improve clinical outcomes for patients with HER2m NSCLC.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1161-1169"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145430334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statin Treatment Is Associated With a Higher Risk of Carpal Tunnel Syndrome, But not of Ulnar Nerve Entrapment, in Type 2 Diabetes—A Nationwide Register Study","authors":"Malin Zimmerman ,&nbsp;Raquel Perez ,&nbsp;Juan Merlo ,&nbsp;Peter M. Nilsson ,&nbsp;Anders Gottsäter ,&nbsp;Lars B. Dahlin","doi":"10.1016/j.clinthera.2025.10.002","DOIUrl":"10.1016/j.clinthera.2025.10.002","url":null,"abstract":"<div><h3>Background</h3><div>Individuals with diabetes (DM) are often treated with statins, which have a rare side effect: peripheral neuropathy. We aimed to study whether statin treatment affects the risk of carpal tunnel syndrome (CTS) and ulnar nerve entrapment (UNE) in type 2 DM (T2DM).</div></div><div><h3>Methods</h3><div>We combined multiple national registers in Sweden to identify individuals diagnosed with CTS or UNE in specialized care 2011–2014. Individuals diagnosed with T2DM within 5 years before CTS or UNE diagnosis were included in the diabetes group. Statin treatment was defined as a prescription within 5 years before baseline. Multinominal regression analysis assessed the Relative Risk (RR) [95% confidence interval; CI] of CTS and UNE with statin treatment, using the general population as a reference.</div></div><div><h3>Results</h3><div>In total, 4,771,118 individuals were included; 765,114 (16%) were treated with statins. There were 45,706 cases of CTS, 8,082 cases of UNE, and 244,220 individuals with T2DM. Statin treatment increased the risk of CTS (RR 1.5 [1.4–1.5]) and UNE (RR 1.4 [1.3–1.5]), adjusted for age, sex, diabetes, cardiovascular diseases, and socioeconomy. In individuals without diabetes, risks for CTS (RR 1.5 [1.4–1.5]) and UNE (RR 1.5 [1.4–1.6]) remained higher. In T2DM patients, statins increased the risk of CTS (RR 1.3 [1.2–1.4]) but not of UNE (RR 1.1 [0.9–1.3]). In all included individuals, cardiovascular diseases elevated the risk of CTS (RR 1.2 [1.1–1.2]) and UNE (RR 1.5 [1.4–1.7]).</div></div><div><h3>Conclusion</h3><div>Statin treatment is associated with a higher risk of CTS and UNE in individuals without T2DM but only of CTS in individuals with T2DM. CTS and UNE may have different aetiologies.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1097-1103"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145502496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to: Letter to the Editor Regarding “Real-World Polypharmacy and Drug-Drug Interactions in a Large Cohort of Direct Oral Anticoagulant Users With Atrial Fibrillation”","authors":"Veronica De Angelis MSc ,&nbsp;Maria Carelli PhD ,&nbsp;Alberto Spadotto MD, PhD ,&nbsp;Igor Diemberger MD, PhD","doi":"10.1016/j.clinthera.2025.10.013","DOIUrl":"10.1016/j.clinthera.2025.10.013","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Page 1182"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145562926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Note of Thanks","authors":"","doi":"10.1016/S0149-2918(25)00394-7","DOIUrl":"10.1016/S0149-2918(25)00394-7","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages A1-A3"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145617039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Upper Respiratory Tract Infection Associated with Anti-HER2 Antibody Blockade for HER2-Positive Breast Cancer: A Bayesian Disproportionality Analysis Using Data From the FDA Adverse Event Reporting System","authors":"Jie Zhao MD ,&nbsp;Yang Yang MD ,&nbsp;Xi Chen PhD ,&nbsp;Yuan Zhang PhD","doi":"10.1016/j.clinthera.2025.09.015","DOIUrl":"10.1016/j.clinthera.2025.09.015","url":null,"abstract":"<div><h3>Purpose</h3><div>The impact of anti-HER2 antibodies and antibody-drug conjugates (ADCs) on adverse events related to upper respiratory tract infection (URTI) in patients with HER2-positive breast cancer (BC) remains inadequately elucidated. This study sought to identify safety signals related to URTI associated with anti-HER2 antibodies and to compare the incidence and severity of these infections among patients treated with various anti-HER2 antibodies. The results may serve as a valuable reference for clinical decision-making.</div></div><div><h3>Methods</h3><div>Medical records of HER2-positive BC patients receiving anti-HER2 treatments from January 2015 to June 2024 were extracted from the Food and Drug Administration (FDA) Adverse Event Reporting System database. The URTI adverse events included nasopharyngitis, URTI, tonsillitis, laryngitis, rhinitis, herpangina, and pharyngitis. Four anti-HER2 treatments were identified: pertuzumab, trastuzumab deruxtecan (T-DXd), trastuzumab, and ado-trastuzumab emtansine (T-DM1). The primary endpoint was the pharmacovigilance (PV) of URTI. The secondary endpoint was the pairwise comparison of the incidence and severity of URTI.</div></div><div><h3>Findings</h3><div>The analysis included 458 reports. For the primary endpoint, the PV signal regarding URTI was detected in the pertuzumab group (ROR = 1.38, 95% CI: 1.16–1.64; IC₀₂₅ = 0.12) and the T-DM1 group (PRR = 2.06, 95% CI: 1.72–2.47; a = 135, χ² = 62.40; ROR = 2.07, 95% CI: 1.72–2.49; IC₀₂₅ = 0.63), whereas no such signal was observed in the trastuzumab and T-DXd groups. For the secondary endpoint, the incidence of URTI was significantly higher in the T-DM1 group than in the trastuzumab (OR = 2.19, 95% CI: 1.74–2.75), pertuzumab (OR = 1.45, 95% CI: 1.15–1.83), and T-DXd (OR = 15.16, 95% CI: 5.77–42.23) groups. The incidence of URTI associated with pertuzumab treatment was notably higher compared to trastuzumab (OR = 1.5, 95% CI: 1.21–1.88) and T-DXd (OR = 10.74, 95% CI: 3.98–28.99) treatments. In comparison to trastuzumab (OR = 8.03, 95% CI: 4.58–14.09), both pertuzumab (OR = 6.37, 95% CI: 3.72–10.93) and T-DM1 were associated with a significant increase in the severity of URTI. However, there was no significant difference in URTI severity between the trastuzumab and pertuzumab treatments.</div></div><div><h3>Implications</h3><div>T-DM1 treatment has a higher possibility for URTI development with higher severity, followed by pertuzumab, trastuzumab, and T-DXd. Patients receiving anti-HER2 antibody treatment, particularly T-DM1, should receive special attention regarding URTI incidence and severity.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1155-1160"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to Letter to the Editor: Efficacy and Safety of Nintedanib in Japanese Patients With Early-Stage Idiopathic Pulmonary Fibrosis: A One-Year Interim Analysis From a Multicenter Observational Study in Kyushu and Okinawa, Japan","authors":"Noriho Sakamoto ,&nbsp;Masaki Okamoto ,&nbsp;Kazunori Tobino ,&nbsp;Hidenori Ichiyasu ,&nbsp;Kazuya Ichikado ,&nbsp;Hiroshi Ishii ,&nbsp;Naoki Hamada ,&nbsp;Kazuhiro Yatera ,&nbsp;Taiga Miyazaki ,&nbsp;Hiroshi Ishimoto ,&nbsp;Takashi Kido ,&nbsp;Takuto Miyramura ,&nbsp;Shimpei Morimoto ,&nbsp;Naoki Hosogaya ,&nbsp;Hiroshi Mukae","doi":"10.1016/j.clinthera.2025.10.005","DOIUrl":"10.1016/j.clinthera.2025.10.005","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 12","pages":"Pages 1178-1179"},"PeriodicalIF":3.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}