Annals of Pharmacotherapy最新文献

{"title":"Biologic Treatments in Adolescents With Moderate-to-Severe Atopic Dermatitis: A Systematic Literature Review and Network Meta-analysis.","authors":"Kevin H Li, Emily K Duffy, Jonathan Luong, Beth Devine","doi":"10.1177/10600280251415369","DOIUrl":"https://doi.org/10.1177/10600280251415369","url":null,"abstract":"<p><strong>Background: </strong>Novel interventions, particularly biologic therapies, have been shown to be efficacious and safe in treating atopic dermatitis (AD) in adolescents. However, the comparative efficacy and safety of biologic interventions in adolescents with moderate-to-severe AD have not been explored.</p><p><strong>Objective: </strong>To compare efficacy and safety measures in clinical trials of biologic interventions in adolescents aged 12 to 17 with moderate-to-severe AD.</p><p><strong>Methods: </strong>MEDLINE, Embase, and trial registries were searched for double-blind, randomized placebo-controlled clinical trials assessing the efficacy of biologic therapies in adolescents with moderate-to-severe AD. Arm-level Bayesian network meta-analyses (NMAs) were performed and certainty of evidence was assessed through the Confidence in Network Meta-Analysis grading tool. Primary outcomes included the proportion of participants who achieved 75% improvement in Eczema Area and Severity Index score (EASI-75) and the proportion of participants who achieved 0 (clear) or 1 (almost clear) value on the Investigators' Global Assessment (IGA 0/1) at week 16.</p><p><strong>Results: </strong>Four trials evaluating 3 drugs, dupilumab, lebrikizumab, and tralokinumab, representing 642 study participants were analyzed. Two dosing options were assessed for dupilumab and tralokinumab. Compared with placebo, the greatest effect was observed with dupilumab 200/300 mg every 2 weeks in both EASI-75 (risk ratio [RR]: 5.2; 95% credible interval [CrI]: 2.6, 12.0) and IGA 0/1 (RR: 12.0; 95% CrI: 3.3, 78.0). No differences were found between treatments. Certainty of the evidence was low.</p><p><strong>Conclusion and relevance: </strong>Although there is some evidence that dupilumab may be more efficacious than lebrikizumab or tralokinumab, our findings suggest that there is no strong evidence of superiority of one treatment over another.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251415369"},"PeriodicalIF":2.3,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146111885","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":"Tofersen: A Novel Option for the Treatment of Amyotrophic Lateral Sclerosis.","authors":"Michael Karros, Marissa DiFulco, Anna Nogid","doi":"10.1177/10600280251408862","DOIUrl":"https://doi.org/10.1177/10600280251408862","url":null,"abstract":"<p><strong>Objective: </strong>This review summarizes current evidence on the efficacy and safety of tofersen (Qalsody) in treating amyotrophic lateral sclerosis (ALS).</p><p><strong>Data sources: </strong>PubMed, MEDLINE, Google Scholar, and ClinicalTrials.gov were searched using the keywords: <i>Qalsody</i>, <i>BIIB067</i>, <i>antisense oligonucleotides</i>, <i>SOD1</i>, and <i>amyotrophic lateral sclerosis</i>. Articles published from inception to November 2025 were included.</p><p><strong>Study selection and data extraction: </strong>English-language studies assessing the pharmacokinetics, pharmacology, efficacy, and safety of tofersen were included. Prescribing information and real-world evidence were also reviewed.</p><p><strong>Data synthesis: </strong>Tofersen is an intrathecally administered antisense oligonucleotide targeting superoxide dismutase 1 (SOD1) mRNA. Early trials demonstrate dose-dependent reductions in cerebrospinal fluid (CSF) SOD1 protein levels of -33% and slower ALS Functional Rating Scale (ALSFRS-R) decline compared to placebo (-1.19 vs -5.63 points). In Phase 3 trials, tofersen reduced CSF SOD1 by 29% and plasma neurofilament light chain (NfL) by 60%, while biomarkers increased in the placebo group. There was no significant difference in ALSFRS-R decline between tofersen and placebo (-6.98 vs -8.14; <i>P</i> = 0.97). Real-world data show favorable patient-related outcomes and improvement in ALSFRS-R. Adverse effects are primarily lumbar puncture related with serious neurologic events documented in 7% of tofersen recipients.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:As the first Food and Drug Administration (FDA)-approved gene-directed therapy for SOD1 ALS, tofersen directly targets the underlying genetic cause. Barriers include the need for genetic confirmation and intrathecal administration.</p><p><strong>Conclusion: </strong>Tofersen provides a promising targeted treatment option for pathogenic SOD1 ALS. Ongoing studies will clarify its long-term clinical impact.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251408862"},"PeriodicalIF":2.3,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146117646","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":"Melatonin: Helpful or Harmful?","authors":"Lauren M Hynicka, Jessica Battaglia","doi":"10.1177/10600280261418736","DOIUrl":"https://doi.org/10.1177/10600280261418736","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261418736"},"PeriodicalIF":2.3,"publicationDate":"2026-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146117649","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":"Effect of Conversion From Intravenous to Oral Administration on Cyclosporine Exposure in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation.","authors":"Junyan Wang, Meng Zhang, Lingkun Wang, Jufei Yang, Lingfei Huang, Jing Miao","doi":"10.1177/10600280251414685","DOIUrl":"https://doi.org/10.1177/10600280251414685","url":null,"abstract":"<p><strong>Background: </strong>Cyclosporine is an immunosuppressant extensively used for the prevention and treatment of graft-vs-host disease (GvHD) in pediatric allogeneic hematopoietic stem cell transplantation (allo-HSCT). Converting the administration route of cyclosporine from intravenous to oral is common in the early period of allo-HSCT. Various factors may have an impact on the conversion ratio of cyclosporine.</p><p><strong>Objective: </strong>To evaluate the effect of converting administration route from intravenous to oral on cyclosporine exposure in pediatric allo-HSCT recipients.</p><p><strong>Methods: </strong>Children who underwent allo-HSCT and were administered with cyclosporine for the prevention of GvHD were included. The cyclosporine trough concentration (C0), the trough concentration-dose ratio (CDR), and the conversion ratio were evaluated. Meanwhile, factors related to the bioavailability of cyclosporine were also investigated.</p><p><strong>Results: </strong>A total of 67 children with 280 concentrations were involved. The conversion ratio used in the study was approximately 1:2, and a significant decrease in cyclosporine CDR (110.5 vs 41.4 mg/kg per μg/L, <i>P</i> < 0.001) was observed. The overall bioavailability of cyclosporine was approximately 35%. Age younger than 3 years old (β = -10.70, 95% CI = -18.45 to -2.96, <i>P</i> = 0.007) and moderately increased transaminases (β = -17.95, 95% CI = -25.42 to -10.48, <i>P</i> < 0.001) had a significant impact on cyclosporine bioavailability.</p><p><strong>Conclusions and relevance: </strong>A conversion ratio of 1:3 was found to be more appropriate for pediatric allo-HSCT recipients when switching cyclosporine from intravenous to oral administration. Children younger than 3 years old or with moderately increased transaminases had significant lower cyclosporine bioavailability. These results can assist in an individualized approach for patients undergoing cyclosporine formulation switching.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251414685"},"PeriodicalIF":2.3,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103611","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":"Comparison of Train-of-Four Versus No Train-of-Four Monitoring of Neuromuscular Blockade on Drug Consumption for Acute Respiratory Distress Syndrome.","authors":"Kayleigh N Yaeger, Ryan M Rivosecchi, Julie N Clarkson, Phillip E Lamberty, Lara M Groetzinger","doi":"10.1177/10600280251414669","DOIUrl":"https://doi.org/10.1177/10600280251414669","url":null,"abstract":"<p><strong>Background: </strong>There is limited data regarding the use of clinical assessment alone for neuromuscular blockade (NMB) titrations in the setting of acute respiratory distress syndrome (ARDS).</p><p><strong>Objective: </strong>To compare the amount of cisatracurium (CIS) consumed when utilizing train-of-four (TOF)-guided NMB titrations or clinical assessment alone without TOF for continuous infusion (CI) administration.</p><p><strong>Methods: </strong>A retrospective analysis was performed evaluating TOF-guided titrations compared with clinical assessment alone (non-TOF) for CI NMB with CIS. Individuals within the TOF group were assessed from January 2013 to December 2018 while those within the clinical assessment alone group were assessed from January 2021 to December 2024. Patients were excluded if they were less than 18 years old, had documentation of COVID-19 infection, were receiving extracorporeal membrane oxygenation, or had NMB initiated at an outside hospital. The primary objective was assessing drug utilization between groups.</p><p><strong>Results: </strong>A total of 1047 and 553 individuals were screened resulting in 99 and 65 included for analysis in the TOF and non-TOF groups, respectively. The median cumulative CIS dose was 665 (472, 927) mg in the TOF group and 536 (400, 699) mg in the clinical assessment alone group, <i>P</i> = 0.011. The median infusion rate was 32% higher in the TOF group: 2.5 (1.8, 3.6) versus 1.9 (1.8, 2.4) µg/kg/min, <i>P</i> < 0.001, despite similar starting rates. Median drug costs were also significantly reduced when comparing the TOF group with the non-TOF group: $178 (126, 247) versus $143 (107, 187), <i>P</i> = 0.011.</p><p><strong>Conclusion and relevance: </strong>This study assesses drug utilization when comparing TOF-guided NMB titration with clinical assessment alone in the modern ARDS era. Utilization of clinical assessment alone without TOF monitoring for CI CIS resulted in significantly reduced drug utilization and costs. Further studies are needed to assess the impact of clinical assessment alone on improvement of oxygenation.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251414669"},"PeriodicalIF":2.3,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103571","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":"Safety of Intravenous Push Administration of High-Dose (≥3 g) Levetiracetam.","authors":"Ming May Zhang, Nicole A Leshko, Gerald C Elliott","doi":"10.1177/10600280251345079","DOIUrl":"10.1177/10600280251345079","url":null,"abstract":"<p><strong>Background: </strong>Levetiracetam administration via intravenous push (IVP) may improve outcomes in status epilepticus (SE) by decreasing time to administration. However, there is a paucity of literature describing the safety of IVP administration of higher loading doses used for early management of SE.</p><p><strong>Objective: </strong>The purpose of this evaluation was to investigate the safety of high-dose IVP levetiracetam.</p><p><strong>Methods: </strong>This was a retrospective, single-arm cohort study conducted at an academic medical center. Patients were included if they received IVP levetiracetam ≥3000 mg. The primary outcome was a composite of clinically significant adverse events (AEs) within 1-hour post-administration of levetiracetam: hypotension, hypertension, bradycardia, tachycardia, arrhythmia, and/or injection site reaction.</p><p><strong>Results: </strong>A total of 140 patients met inclusion criteria, receiving a median levetiracetam dose of 4000 mg (interquartile range [IQR] = 3000, 4500). Seventeen (12.1%) patients experienced a clinically significant AE. The most common clinically significant AE was hypotension (9.2% [10/109]), followed by tachycardia (3.6% [4/112]), arrhythmia (1.8% [2/112]), hypertension (0.9% [1/109]), and injection site reaction (0.7% [1/140]). Eighty percent [8/10] of patients who experienced clinically significant hypotension were on at least 1 medication with potential confounding hemodynamic effects.</p><p><strong>Conclusion and relevance: </strong>In this retrospective, single-arm analysis, high-dose (≥3000 mg) IVP levetiracetam was relatively well-tolerated but associated with a higher rate of clinically significant hypotension than has been reported in the previous literature, although several confounding factors may have contributed to this outcome. Our findings support the continued use of high-dose IVP levetiracetam with appropriate hemodynamic monitoring; hemodynamic effects should be further explored in future studies.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"149-155"},"PeriodicalIF":2.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301051","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":"Reply: Impact of Remdesivir on Heart Rate and Bradycardia Incidence Among Hospitalized Adults With COVID-19.","authors":"Wesley D Kufel, Robert W Seabury, Sarah A Spinler","doi":"10.1177/10600280251354862","DOIUrl":"10.1177/10600280251354862","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"205-206"},"PeriodicalIF":2.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567004","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 Symptom-Triggered Benzodiazepines Versus Phenobarbital for Alcohol Withdrawal Syndrome in Trauma-Surgical Intensive Care Patients.","authors":"Taylor M Law, Spencer L Roper, Amanda McKinney, Cassey Starnes, Joshua Rains, Ji-Ming Yune, Nathan Hieb, Reagan Bollig, Brian Daley, A Shaun Rowe","doi":"10.1177/10600280251340164","DOIUrl":"10.1177/10600280251340164","url":null,"abstract":"<p><strong>Background: </strong>The standard of care for alcohol withdrawal syndrome (AWS) is symptom-triggered benzodiazepines. There is an interest in utilizing phenobarbital first line for AWS in trauma-surgical patients.</p><p><strong>Objective: </strong>The objective of this study was to compare a preemptive phenobarbital monotherapy protocol to symptom-triggered benzodiazepines for the prevention or treatment of AWS in the trauma-surgical patients.</p><p><strong>Methods: </strong>This was a single-center, retrospective study to evaluate the AWS standard of care for the Trauma Surgical Critical Care Service. Patients were divided into groups based on AWS protocol. The primary outcome was intensive care unit (ICU) length of stay (LOS). Secondary outcomes included: hospital mortality, hospital LOS, use of adjunctive agents for sedation, and incidence of mechanical ventilation rates.</p><p><strong>Results: </strong>A total of 514 patients were screened for eligibility, and 200 patients met inclusion criteria, with 100 patients being in each group. Patients who received the symptom-triggered benzodiazepine protocol had similar ICU LOS (median [IQR], 2.6 days [1.4-5.6 days] vs 2.9 days [1.8-4.7 days]; <i>P</i> = 0.4) and hospital LOS (8.1 days [3.9-16.9 days] vs 7.1 days [3.9-11.2 days]; <i>P</i> = 0.05) compared with the phenobarbital protocol. Hospital mortality was significantly lower in those who received phenobarbital (4% vs 14%; <i>P</i> = 0.02), as was use of adjunctive sedative agents (22% vs 46%; <i>P</i> < 0.001), and mechanical ventilation rates (9% vs 31%; <i>P</i> < 0.001) when compared with symptom-triggered benzodiazepines.</p><p><strong>Conclusion and relevance: </strong>Trauma-surgical patients receiving phenobarbital for prevention or treatment of AWS had similar ICU and hospital LOS compared with symptom-triggered benzodiazepines. The use of a phenobarbital protocol was associated with lower mortality, mechanical ventilation, and adjunctive sedative medication use.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"105-114"},"PeriodicalIF":2.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172474","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 \"Association Between Rocuronium Administration and Clinical Outcomes in Patients With Moderate-To-Severe Acute Respiratory Distress Syndrome: A Retrospective Cohort Study\".","authors":"Venkata Dileep Kumar Veldi, Ranjana Sah","doi":"10.1177/10600280251338172","DOIUrl":"10.1177/10600280251338172","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"202-203"},"PeriodicalIF":2.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967118","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":"Eco-Responsible Awareness Raising interventions To reduce the Use of Long-Acting MDIs and Carbon Footprint in a University Hospital Center (EARTH).","authors":"Sophia Groguhé, Olivier Landry, Christine Sirmalis, David Williamson, Alessandra Stortini, Maude Fortier","doi":"10.1177/10600280251343947","DOIUrl":"10.1177/10600280251343947","url":null,"abstract":"<p><strong>Background: </strong>There are very limited data studying strategies designed to enhance environmentally conscious MDI prescribing habits. This study aimed to evaluate the impact of a multicomponent strategy promoting more environmentally responsible inhaler prescribing practices on the use of long-acting MDIs.</p><p><strong>Objectives: </strong>What is the impact of a multicomponent eco-responsible inhaled medication prescribing awareness program on the prescription rate of long-acting MDIs in hospitalized patients?</p><p><strong>Methods: </strong>This interrupted time series was conducted by retrospectively collecting long-acting inhaler metrics from digitalized records before and after awareness raising interventions. The primary outcome was to assess the impact of the multicomponent awareness campaign on the proportion of long-acting MDIs relative to the total number of long-acting inhalers prescribed on all in-patient hospital wards. The secondary endpoint was to evaluate the difference in proportion of long-acting MDI prescriptions between hospital admission and discharge in selected wards.</p><p><strong>Results: </strong>A total of 7452 inhalers was collected. A significant relative decrease in level of 20.1% (<i>P</i> = 0.017) was observed between the preintervention and postintervention periods (27.9% and 22.3%, respectively). The slope of the proportion of long-acting MDIs was not significantly different (-0.2%, <i>P</i> = 0.319). There was no significant difference in the level or slope between admission and discharge for the secondary outcome.</p><p><strong>Conclusion and relevance: </strong>A 20.1% reduction in the prescription rate of MDIs could be observed following awareness interventions focused on eco-responsible inhaler prescribing in a hospital setting. This is explained mainly by an initial decrease in the number of prescriptions postintervention and that change remained stable over time.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"156-162"},"PeriodicalIF":2.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214656","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}