Clinical therapeutics最新文献

{"title":"Medical Cannabis Formulations, Administration Routes, and Dosing: Perspectives of Patients With Cancer Who Consume","authors":"Manan M. Nayak PhD, MA ,&nbsp;Peter R. Chai MD, MS ,&nbsp;Stephanie Tung MD ,&nbsp;Anna Revette PhD ,&nbsp;Ilana M. Braun MD","doi":"10.1016/j.clinthera.2025.11.004","DOIUrl":"10.1016/j.clinthera.2025.11.004","url":null,"abstract":"<div><h3>Purpose</h3><div>Medical cannabis (MC) is used by 1 in 3 patients with cancer. Scientific work suggests a disconnect between patients’ cannabis therapeutics practices and oncologists’ clinical preferences. This qualitative study explores the preferences of patients with cancer as they relate to MC formulations, administration routes, and dosing.</div></div><div><h3>Methods</h3><div>Semistructured interviews were conducted with patients with cancer consuming MC in 8 states and examined using thematic analysis.</div></div><div><h3>Findings</h3><div>Among study participants (N = 24), the mean age was 54 years, 67% were female, and 51% had metastatic disease. A powerful theme identified across interviews was of myriad MC dispensary product formulations, triggering astonishment and burden. Common strategies among participants included purchasing and sampling multiple store-bought formulations, modifying dispensary products, and altering intended routes of administration. Preferred dispensary products were not consistently available. Top-cited modes of administration included oral, followed by topical, sublingual, vaporization, combustion, and rectal suppository. Three-quarters of participants alternated between modes. Medical cannabis dosing imprecision represented another powerful theme due to the lack of dispensary quality assurance and accuracy in home measurements.</div></div><div><h3>Implications</h3><div>This investigation suggests that MC preparations, dosing, and administration routes vary among patients with cancer, and that common consumption patterns (for instance, reliance on multiple routes of cannabis administration) are not rooted in science. Although these findings should be further interrogated, they suggest a need for lay-facing cannabis therapeutics education and standardization of dispensary products to strengthen cannabis-related care.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 51-56"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741435","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":"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","authors":"Hitesh Pandya MBChB, MD ,&nbsp;Mehul Patel MBBS, PhD, FRCP ,&nbsp;Michael Gillen BS, PhD ,&nbsp;Jitendar Reddy MPharm ,&nbsp;Artur Bednarczyk MD ,&nbsp;Marek Kokot MD, MBA ,&nbsp;Yubo Tan MSc ,&nbsp;Maria Heijer MSc ,&nbsp;Magdalena Andersson MSc, MSBA ,&nbsp;David Petullo MSc ,&nbsp;Mandeep Jassal MD","doi":"10.1016/j.clinthera.2025.10.011","DOIUrl":"10.1016/j.clinthera.2025.10.011","url":null,"abstract":"<div><h3>Purpose</h3><div>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 &gt;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.</div></div><div><h3>Methods</h3><div>This Phase I study assessed systemic BGF component exposure with HFO-1234ze versus HFA-134a when using a spacer, and for HFO-1234ze with and without a spacer. Participants (<em>N</em> = 42) were randomized to BGF with HFA-134a with a spacer (reference), HFO-1234ze with a spacer (test), and HFO-1234ze without a spacer (descriptive treatment) over 3 treatment periods in 1 of 6 sequences. As spacer devices help to increase exposure, the upper limit of the 90% confidence interval (CI) of geometric mean ratios (GMRs) was of interest, and bioequivalence was not included as a study objective.</div></div><div><h3>Findings</h3><div>Analyses demonstrated the upper 90% CI of the GMRs for maximum observed plasma concentration (Cmax) and area under the plasma concentration curve from time zero to the time of the last quantifiable concentration (AUClast) were &lt;125% for all BGF components for HFO-1234ze versus HFA-134a when using a spacer, indicating exposure with HFO-1234ze did not exceed exposure with HFA-134a. Additionally, Cmax was increased for all BGF components with HFO-1234ze when using versus not using a spacer, with the largest increases observed among participants with the lowest exposure when not using a spacer, likely due to poor inhalation technique. No new safety findings, and no deaths or serious adverse events, occurred during the study.</div></div><div><h3>Implications</h3><div>These findings provide evidence that may help to support the future use of HFO-1234ze propellant in BGF pMDIs.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 73-80"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676351","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":"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","authors":"Emmanuelle Kaltenbach PharmD, MSc ,&nbsp;Virginie Jacquemin PhD ,&nbsp;Luis Briseño-Roa PhD ,&nbsp;Andres Gomez-Lievano PhD ,&nbsp;Marie-Cécile Fournier PhD ,&nbsp;Fatine Elaraki MD","doi":"10.1016/j.clinthera.2025.10.014","DOIUrl":"10.1016/j.clinthera.2025.10.014","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 127-128"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631082","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":"Corrigendum to “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” (Clin Ther. 2025 Oct 28. [Epub ahead of print])","authors":"Jinho Shin MD, PhD ,&nbsp;Seong Hwan Kim MD, PhD ,&nbsp;Ki Hoon Han MD, PhD ,&nbsp;Moo Hyun Kim MD, PhD ,&nbsp;Young Keun Ahn MD, PhD ,&nbsp;Il Suk Sohn MD, PhD ,&nbsp;Kwang Il Kim MD, PhD ,&nbsp;Dong Hun Cha MD, PhD ,&nbsp;Soon Jun Hong MD, PhD ,&nbsp;Eun Joo Cho MD, PhD ,&nbsp;Hae Young Lee MD, PhD ,&nbsp;Wook Bum Pyun MD, PhD ,&nbsp;Ho Joong Youn MD, PhD ,&nbsp;Woo Shik Kim MD, PhD ,&nbsp;Moo Yong Rhee MD, PhD ,&nbsp;Jun Hee Lee MD, PhD ,&nbsp;Jong Won Ha MD, PhD ,&nbsp;Ji Yong Choi MD, PhD ,&nbsp;Byung Su Yoo MD, PhD ,&nbsp;Jin Ok Jeong MD, PhD ,&nbsp;Chong Jin Kim MD, PhD","doi":"10.1016/j.clinthera.2025.11.011","DOIUrl":"10.1016/j.clinthera.2025.11.011","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Page 131"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145767421","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":"Evaluation of the Application of Antimicrobial Stewardship on the Rational Use of Antibiotics and Overcoming Antimicrobial Resistance in Tertiary Hospitals: A Point Prevalence Survey","authors":"Sara Youssif Ibrahim PhD ,&nbsp;Yara Ali BSc ,&nbsp;Zohra Abdelfattah BSc ,&nbsp;Amany Gad BSc ,&nbsp;Nada Mohamed BSc ,&nbsp;Nancy Mortada BSc ,&nbsp;Omar Ahmed BSc ,&nbsp;Ahmed Nabil BSc ,&nbsp;Mahmoud Refay BSc ,&nbsp;Ahmed Mohamed BSc ,&nbsp;Mohamed Goda BSc ,&nbsp;Ahmed Essam Abou Warda PhD ,&nbsp;Salwa Selim Abougalambou PhD ,&nbsp;Hadeer Ehab Barakat PhD","doi":"10.1016/j.clinthera.2025.10.008","DOIUrl":"10.1016/j.clinthera.2025.10.008","url":null,"abstract":"<div><h3>Purpose</h3><div>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.</div></div><div><h3>Methods</h3><div>A prospective, multicentric, quasi-experimental study was conducted in various departments over a period of 12 weeks. Inpatients receiving antibiotics were surveyed before and after the implementation of ASP. These interventions included customizing ASP guidelines, training healthcare team, and auditing prescribing behaviors. Data was analyzed using SPSS, and outcomes evaluated included adherence to guidelines, prevalence of antibiotic use, and appropriateness of prescriptions.</div></div><div><h3>Results</h3><div>Of the 174 patients were surveyed across PPS. <em>Escherichia coli</em> showed the highest prevalence in PPS-1 (26%), while <em>Klebsiella pneumoniae</em> and <em>Staphylococcus aureus</em> showed the highest in PPS-2 (18%). Carbapenem-resistant Enterobacteriaceae decreased from 25% in PPS-1 to 8% in PPS-2. Guideline-inappropriate prescriptions and missing documentation of preparation or administration method declined from 27.3% to 5.2% (<em>P</em> = 0.000042) and from 78.5% to 56.2% (<em>P</em> = 0.002) respectively, reflecting improved prescribing quality and record-keeping. Although the proportion of prescriptions with improper antibiotic duration increased from 32.1% to 42.7% (<em>P</em> = 0.145), this trend may reflect evolving clinical decision-making rather than a decline in care quality.</div></div><div><h3>Conclusion</h3><div>The study suggests that ASP interventions were associated with improved antibiotic prescribing practices and adherence to guidelines in ICU settings, contributing to the fight against AMR. Given the study design and sample size, findings are exploratory and suggestive. Future work includes expanding ASP monitoring and education strategies with solutions focusing on antibiotic duration.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages e1-e9"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145602763","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":"Corrigendum to “Evaluating the Clinical and Economic Impact of Ceramide-Infused Skin Barriers in Patients With Intestinal and Urinary Stomas: A Systematic Review and Meta-Analysis” [Clin Ther. 2025;47:e21–e32]","authors":"Rosario Caruso PhD, RN, FESNO, FAAN,&nbsp;Silvia Belloni PhD, RN,&nbsp;Beniamino Schiavone MD,&nbsp;Gianluca Conte PhD, RN,&nbsp;Cristina Di Pasquale RN,&nbsp;Arianna Magon PhD, RN,&nbsp;Cristina Arrigoni RN, MSc,&nbsp;Giuseppe Candilio MD,&nbsp;Francesco Stanzione MD,&nbsp;Alessandro Stievano PhD, MSN, MEd, FAAN, FEANS, FESNO, FFNMRCSI, FTNSS,&nbsp;Gennaro Rocco PhD, RN, FFNMRCSI, FESNO, FAAN,&nbsp;Maddalena De Maria PhD, RN, FESNO","doi":"10.1016/j.clinthera.2025.12.004","DOIUrl":"10.1016/j.clinthera.2025.12.004","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 132-133"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800057","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":"Impact of CRRT Timing on Mortality in Oliguric Sepsis-Associated Acute Kidney Injury: A Propensity Score Matching Cohort Study","authors":"Jing Li MM ,&nbsp;Caiyun Xu MM ,&nbsp;Zhe Huang MM ,&nbsp;Lan Yao MM ,&nbsp;Huayun Liu MM ,&nbsp;Fuxing Deng MD ,&nbsp;Can Zhu MM ,&nbsp;Qinjuan Jiang MM","doi":"10.1016/j.clinthera.2025.10.012","DOIUrl":"10.1016/j.clinthera.2025.10.012","url":null,"abstract":"<div><h3>Purpose</h3><div>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).</div></div><div><h3>Methods</h3><div>Using the MIMIC-IV database, we conducted a retrospective analysis of 2,131 ICU patients with oliguric S-AKI who had CRRT records. Patients were categorized into 2 groups according to the timing of CRRT initiation: early initiation within 48 hours (<em>n</em> = 1,222) and delayed initiation after 48 hours (<em>n</em> = 909) following the onset of oliguria. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were applied to adjust for confounding factors. Baseline characteristics, physiological parameters, and laboratory findings were compared between the 2 groups. Survival outcomes were analyzed using Kaplan-Meier curves and log-rank tests, with a primary focus on 90-day mortality.</div></div><div><h3>Findings</h3><div>Patients who initiated CRRT more than 48 hours after oliguria onset had significantly longer ICU stays compared to those who received early CRRT (17.6 vs. 11.5 days, <em>P</em> &lt; 0.001) and exhibited higher SOFA scores (11.5 vs. 9.14, <em>P</em> &lt; 0.001). After PSM, delayed CRRT was associated with decreased 90-day survival among patients with oliguria, as demonstrated by Kaplan-Meier analysis (<em>P</em> &lt; 0.05). Causal inference showed a 10% increase in the 90-day mortality rate for patients who started CRRT after 48 hours (ATE 0.11, 95% CI: 0.02 - 0.19, <em>P</em> = 0.01).</div></div><div><h3>Implications</h3><div>Early initiation of CRRT, within 48 hours of oliguria onset, in S-AKI patients is associated with improved 90-day survival. These findings suggest that earlier CRRT initiation may be beneficial for improving survival outcomes in this patient population.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 65-72"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573429","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":"LYNKUET® (elinzanetant).","authors":"Paul Beninger","doi":"10.1016/j.clinthera.2025.12.006","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.12.006","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145849042","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":"Implementing CYP2C19 Pharmacogenetic Testing for Personalized Antiplatelet Therapy: Findings From the QPGx-CARES Initiative.","authors":"Rania Abdel-Latif, Wadha Al Muftah, Shaban Mohammed, Toka AlHsson, Daoud Al-Badriyeh, Radja Badji, Awad Al-Qahtani, Abdul Rahman Arabi, Said Ismail, Moza Al Hail, Jassim Al Suwaidi","doi":"10.1016/j.clinthera.2025.12.003","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.12.003","url":null,"abstract":"<p><strong>Purpose: </strong>CYP2C19 loss-of-function (LoF) alleles are associated with increased cardiovascular risk in clopidogrel-treated percutaneous coronary intervention (PCI) patients. Despite the guidelines recommendation for newer P2Y12 inhibitors, clopidogrel remains widely prescribed. The study the potential impact and feasibility of implementing pharmacogenetics (PGx) testing to guide antiplatelet therapy and develop strategies for its clinical integration to improve patient management.</p><p><strong>Methods: </strong>A pilot study following a prospective cohort design was conducted within the largest community healthcare provider in Qatar using point-of-care (POC) CYP2C19 genotyping in tailoring antiplatelet therapy for PCI patients. Eligible patients underwent CYP2C19 genotyping, and P2Y12 inhibitor prescriptions were adjusted based on genetic results. The study measured antiplatelet prescribing patterns and identified clinically significant gene-drug interactions.</p><p><strong>Findings: </strong>Out of 376 patients tested, 283 patients received PGx-guided recommendations for anti-platelet therapy. Actionable CYP2C19 alleles were detected in 22% of those patients, prompting a change in drug therapy. PGx-guided recommendations were adopted at a rate of 80%, and CYP2C19 genotyping was a significant predictor of antiplatelet therapy adjustments. A sub-analysis of the cost impact revealed an estimated reduction of 300 QR (82.41 $) per patient annually for ACS patients who underwent PCI with stent placement.</p><p><strong>Implications: </strong>This real-world study highlights the feasibility and clinical impact of CYP2C19 genotyping in guiding antiplatelet therapy for ACS and PCI patients, supporting broader PGx testing implementation in routine cardiovascular care.</p><p><strong>Trail registration: </strong>HMC-IRB Registration: IRB-HMC-2021-011, IRB-MoPH Assurance: IRB-A-HMC-2019-0014. ISRCTN registration: ISRCTN15110009, https://www.isrctn.com/ISRCTN15110009.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846586","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":"Comment on \"Pharmacists' Knowledge and Perceptions of Buprenorphine at New York State Pharmacies: Identifying the Extent of Pharmacy-Level Barriers to Access Buprenorphine\".","authors":"Siyi Liu","doi":"10.1016/j.clinthera.2025.11.013","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.11.013","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773897","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}