CLINICAL THERAPEUTICS

Exposure to Budesonide, Glycopyrronium, and Formoterol With a Next-Generation Propellant Does Not Exceed Exposure With Hydrofluoroalkane-134a Propellant When Administered Via Pressurized Metered-Dose Inhaler With a Spacer
Pandya H, Patel M, Gillen M, Reddy J, Bednarczyk A, Kokot M, Tan Y, Heijer M, Andersson M, Petullo D and Jassal M
Hydrofluoroalkane-134a (HFA-134a), the propellant in the marketed budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) formulation, has a global warming potential (GWP) that falls above environmental regulation thresholds and therefore will be phased out. With global efforts to minimize carbon emissions, the hydrofluoroolefin-1234ze (HFO-1234ze) propellant, with a >99% lower GWP than HFA-134a, is in development for pressurized metered-dose inhalers (pMDIs). Spacers support drug delivery in patients with poor pMDI inhalation technique, but it is unknown if BGF exposure with HFO-1234ze exceeds that observed with HFA-134a when using a spacer.
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
Patel C, Sahoo D, Sheth V, Jain MK, Koppula R, Verma S, Kumar D, Panda JK, Parmar D, Kansagra K and Pathak H
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.
Recognizing Arthralgia as a Potential Adverse Effect of CFTR Modulators: A Case Report
Charbonneau F, Dupuy-Grasset M, Languepin J and Laroche ML
Letter to the Editor Regarding "Real-World Polypharmacy and Drug-Drug Interactions in a Large Cohort of Direct Oral Anticoagulant Users With Atrial Fibrillation"
Zhu X, Liao D, Huang S and Zhuang Z
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
Christopoulos P, Assmann C, Zhang L, Dunton K, Ali A, Berktas M, Delmastro L, Strübing A, Xiong Y, Lay-Flurrie S, Hindocha P, Mehdikhanova T and Girard N
Human epidermal growth factor receptor 2 (HER2 [ERBB2]) 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 HER2-mutant (HER2m) NSCLC are needed.
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
Sakamoto N, Okamoto M, Tobino K, Ichiyasu H, Ichikado K, Ishii H, Hamada N, Yatera K, Miyazaki T, Ishimoto H, Kido T, Miyramura T, Morimoto S, Hosogaya N and Mukae H
FORZINITY (Elamipritide)
Beninger P
Diabetes Mellitus: Promising Clinical Research in a Time of Political Uncertainty
Beninger P
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
Zimmerman M, Perez R, Merlo J, Nilsson PM, Gottsäter A and Dahlin LB
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).
What is a "Cannabis User"?
Fisher R
The increasing legalization and use of cannabis necessitate robust, standardized methods for identifying and characterizing cannabis users in research and clinical settings. Variability in user demographics, consumption patterns, and product types complicates comparisons across studies, hindering the development of evidence-based policies and interventions. This commentary aims to highlight the need for urgent development and adoption of uniform methodologies to enhance the reliability and generalizability of cannabis-related research.
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"
De Angelis V, Carelli M, Spadotto A and Diemberger I
Multicenter, Randomized, Double-Blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
Shin J, Kim S, Han K, Kim M, Ahn Y, Sohn I, Kim K, Cha D, Hong S, Cho E, Lee H, Pyun W, Youn H, Kim W, Rhee M, Lee J, Ha J, Choi J, Yoo B, Jeong J, Chung W, Jeong Y and Kim C
Hypertension poses challenges for many patients in achieving adequate blood pressure control, despite using monotherapy or standard treatment regimens. A low-dose triple combination drug has recently been considered for initial hypertension therapy; however, its safety, efficacy, and dose-response relationship remain unclear. We evaluated these aspects for patients with hypertension to determine the optimal combination dose.
Phase 1 Study Evaluating the Effect of Food and Omeprazole-Induced Gastric pH Change on the Pharmacokinetics and Safety of Imlunestrant in Healthy Females
Datta-Mannan A, Shanks E, Yuen E, Guo Y and Wang XA
To assess the effect of low-fat food intake and the effect of a gastric acid reducing agent (omeprazole) on imlunestrant pharmacokinetics (PK), safety, and tolerability.
Evaluation of Colorectal Cancer Incidence in the United States From 2021 to 2024 Using a National Multi-Payer Claims Database
Greene M, Gohil S, Stieber B, Ozbay AB, Zapatier J, Bingham J, LeMaster JW, Stukalin I, Anderson JC and Karlitz JK
Colorectal cancer (CRC) remains the second leading cause of cancer-related death in the U.S. This study aimed to evaluate national CRC incidence from 2021 to 2024 using a large, multi-payer claims database.
Increased Bone Mineral Content in Response to Electrical Stimulation
Comtois AS, Hodgdon JA and Boucher JP
Osteoporosis is widespread, underdiagnosed, and disproportionately affects women and marginalized populations. With limitations in pharmacologic treatments, particularly in underserved populations, accessible, non-invasive interventions like electrical stimulation (ES) that promote osteogenesis are needed. We evaluated the effects of a portable low-frequency ES device on bone health in premenopausal women.
Evaluation of the Application of Antimicrobial Stewardship on the Rational Use of Antibiotics and Overcoming Antimicrobial Resistance in Tertiary Hospitals: A Point Prevalence Survey
Youssif Ibrahim S, Ali Y, Abdelfattah Z, Gad A, Mohamed N, Mortada N, Ahmed O, Nabil A, Refay M, Mohamed A, Goda M, Essam Abou Warda A, Selim Abougalambou S and Ehab Barakat H
Multidrug-resistant (MDR) microorganisms has emerged as a significant global health crisis leading to higher rates of morbidity. Antimicrobial resistance (AMR) presents a serious challenge in intensive care units (ICUs), where infections caused by MDR pathogens are common. Thus, implementation of antimicrobial stewardship programs (ASPs) ensures prudent antibiotic use and decreases AMR. Therefore, the current study evaluates the impact of ASP applications on empirical antibiotic prescribing practices and AMR through a Point Prevalence Survey (PPS) in ICU settings.
Letter to The Editor, Regarding "Indirect Comparison of Maralixibat and Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis" Recently Published by Lacey and Colleagues
Kaltenbach E, Jacquemin V, Briseño-Roa L, Gomez-Lievano A, Fournier MC and Elaraki F
Bioequivalence and Safety Study of Ranolazine Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Pharmacokinetic Study
Chen X, Li Y and Ma G
The bioequivalence of the generic (Test formulation, T) and the originator (Reference formulation, R) ranolazine extended-release tablets was assessed in Chinese healthy subjects under fasting and fed conditions.
High Adherence to Repeat Multitarget Stool DNA Testing and Follow-Up Colonoscopy in Average-Risk United States Adults: Results from a Nationally Insured Cohort
Greene M, Gohil S, López JVR, Lovelace J, Fendrick AM, Duarte M, Dore M, Anderson JC, Karlitz JK and Le QA
Colorectal cancer (CRC) is a leading cause of cancer-related deaths in the United States, despite available screening programs, making regular screening essential for early detection and prevention. This study evaluated adherence to repeat multitarget stool DNA (mt-sDNA) testing and follow-up colonoscopy rates among average-risk individuals in the United States METHODS: This retrospective study used mt-sDNA lab data linked to a national multipayer claims database from 2017 to 2023. Adults aged 45 to 75 years at average risk for CRC who underwent repeat mt-sDNA screening after one or more prior negative results were included. The primary outcome was adherence to repeat mt-sDNA testing, defined as the return of a successfully completed test with valid results within 365 days of shipment. The secondary outcome was the rate of follow-up colonoscopy after a positive mt-sDNA result. Baseline characteristics, adherence rates, and follow-up colonoscopy rates were summarized descriptively. Logistic regression was used to identify factors independently associated with adherence.
Recurrent Drug-induced Rhabdomyolysis in a 76-year-old Patient With Cystic Fibrosis: Drug-Drug Interactions in Older Patients With Cystic Fibrosis
Segal E, Rabkin N, Muszkat M, Sadras I, Breuer O, Cohen-Cymberknoh M, Fellig Y and Elazari A
Impact of Crrt Timing on Mortality in Oliguric Sepsis-Associated Acute Kidney Injury: A Propensity Score Matching Cohort Study
Li J, Xu C, Huang Z, Yao L, Liu H, Deng F, Zhu C and Jiang Q
This study aims to evaluate how the timing of continuous renal replacement therapy (CRRT) initiation influences survival outcomes in oliguric patients with sepsis-associated acute kidney injury (S-AKI) admitted to the intensive care unit (ICU).