Annals of Pharmacotherapy最新文献

{"title":"Live Biotherapeutic Products for the Prevention of Recurrent <i>Clostridioides difficile</i> Infection.","authors":"Natasha N Pettit, Kristy M Shaeer, Elias B Chahine","doi":"10.1177/10600280241239685","DOIUrl":"10.1177/10600280241239685","url":null,"abstract":"<p><strong>Objective: </strong>To review the efficacy, safety, and role of live biotherapeutic products (LBPs) in the prevention of recurrent <i>Clostridioides difficile</i> infection (rCDI).</p><p><strong>Data sources: </strong>A literature search was performed using PubMed and Google Scholar (through February 2024) with search terms RBX2660, SER-109, and fecal microbiota. Other resources included abstracts presented at recent conferences, national clinical practice guidelines, and manufacturers' websites.</p><p><strong>Study selection and data extraction: </strong>All relevant studies, trial updates, conference abstracts, and guidelines in the English language were included.</p><p><strong>Data synthesis: </strong>Two LBPs were recently approved by the Food and Drug Administration for the prevention of recurrence in adults following antibiotic treatment for rCDI. Fecal microbiota, live-jslm is administered rectally as a retention enema, whereas fecal microbiota spores, live-brpk is given orally after bowel preparation. Several phase 2 and phase 3 clinical trials have established the safety and efficacy of these LBPs in reducing rates of rCDI compared with placebo. Patients with severe immunosuppression and those with inflammatory bowel disease were largely excluded from these trials.</p><p><strong>Relevance to patient care and clinical practice in comparison with existing drugs: </strong>Live biotherapeutic products offer a similar mechanism to conventional fecal microbiota transplant (FMT) in preventing rCDI through microbiota restoration. The primary advantages of LBPs over FMT are their standardized composition and donor stool screening processes for transmissible pathogens. Bezlotoxumab is also available for the prevention of <i>Clostridioides difficile</i> infection; however, there are no clinical data available to compare the efficacy of LBPs with bezlotoxumab, and the benefit of simultaneous use of these preventative therapies is unclear.</p><p><strong>Conclusions: </strong>Live biotherapeutic products provide a safe and effective option for the prevention of rCDI and represent an improvement over conventional FMT. Additional studies are needed to further determine their place in therapy relative to bezlotoxumab and in the setting of immunosuppression and inflammatory bowel disease.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1204-1217"},"PeriodicalIF":2.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140304443","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":"Vaccines for Respiratory Syncytial Virus Prevention in Older Adults.","authors":"Daniel Wroblewski, Lindsay A Brust-Sisti, Matthew Bridgeman, Mary Barna Bridgeman","doi":"10.1177/10600280241241049","DOIUrl":"10.1177/10600280241241049","url":null,"abstract":"<p><strong>Objective: </strong>This review evaluates the efficacy and safety of novel respiratory syncytial virus (RSV) vaccines approved for adults aged 60 years and older.</p><p><strong>Data sources: </strong>A literature search through February 27, 2024 was conducted using search terms, such as RSV, viral respiratory illness, vaccine, RSVpreF, RSVpreF3, Prefusion F, Abrysvo, and Arexvy.</p><p><strong>Study selection and data extraction: </strong>Data from primary literature and vaccine prescribing information were reviewed, encompassing evaluations of clinical pharmacology, efficacy, safety, adverse events, warnings, and precautions.</p><p><strong>Data synthesis: </strong>The literature review process resulted in 10 articles included within this article's scope, including the results of 2 major phase III trials presented in detail. Two RSV vaccines, Respiratory Syncytial Virus Vaccine (recombinant [adjuvanted]; RSVpreF3-ASO1E, Arexvy) and Respiratory Syncytial Virus Vaccine (recombinant; RSVpreF, Abrysvo), approved for preventing RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 years or older in the United States are discussed. Results from Phase III trials have demonstrated the efficacy of 1 dose of these vaccines in preventing RSV-associated LRTD across 2 RSV seasons.</p><p><strong>Relevance to patient care and clinical practice: </strong>The Advisory Committee on Immunization Practices currently recommends use of these vaccines under shared clinical decision-making for adults aged 60 years or older. Most common adverse effects include injection site reactions (eg, site pain, redness, and swelling). Administration requires a single intramuscular injection of 0.5 mL, reconstituted prior to administration.</p><p><strong>Conclusions: </strong>The RSVpreF3-ASO1E and RSVpreF vaccines effectively prevent RSV-associated LRTD in adults aged 60 years and older.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1218-1228"},"PeriodicalIF":2.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140334461","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 Clinical Outcomes Associated With Phenobarbital With Taper Compared to No Taper for the Management of Alcohol Withdrawal Syndrome.","authors":"Matthew Thaller, Adrian Wong, Tuyen Yankama, Ifeoma Mary Eche, Pansy Elsamadisi","doi":"10.1177/10600280241236412","DOIUrl":"10.1177/10600280241236412","url":null,"abstract":"<p><strong>Background: </strong>Phenobarbital (PHB) has been shown to be an effective treatment of alcohol withdrawal syndrome (AWS), with multiple dosing strategies used (e.g., single-dose and symptom-triggered). Studies have often used tapered doses, typically following a front-loaded dose, despite PHB's long half-life which should lead to an ability to auto-taper.</p><p><strong>Objective: </strong>The purpose of this study was to compare clinical outcomes associated with two PHB dosing strategies (taper [T], no taper [NT]) for AWS.</p><p><strong>Methods: </strong>This retrospective cohort study compared adult patients admitted to the ICU from October 2017 to May 2019 who received an initial loading dose of PHB for AWS. The use of PHB was at the discretion of the clinician per our institutional guidelines. Prior to November 2018, patients were prescribed a PHB taper, while after this period, the taper was no longer recommended. The primary outcome was the proportion of patients requiring rescue PHB or adjunctive medications for AWS. Secondary outcomes included number of adjunctive agents used, prevalence of severe manifestations of AWS, ICU and hospital lengths of stay, and incidence of potentially significant drug interactions.</p><p><strong>Results: </strong>A total of 172 patients were included (T: n = 81, NT: n = 91). Baseline characteristics were similar between groups, including history of severe AWS and cumulative benzodiazepine dose pre-PHB. There was no difference in the primary outcome between groups (T: 70.4% vs NT: 59.3%, <i>P</i> = 0.152). The median number of adjunctive agents per patient, severe manifestations, and ICU and hospital length of stay did not differ between groups. Twenty-five patients (14.5%) had potentially significant drug interactions.</p><p><strong>Conclusion and relevance: </strong>The use of a PHB loading dose without a taper may be comparable to a taper strategy on clinical outcomes. Prospective studies are needed to further delineate the optimal dose of PHB for AWS.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1170-1178"},"PeriodicalIF":2.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157433","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":"The Effect of Albumin Replacement on Vasopressor Duration in Septic Shock in Patients With Hypoalbuminemia.","authors":"Jacob P Counts, Joshua Arnold, Sara Atyia, Stella Ogake, Rachel M Smith, Bruce Doepker","doi":"10.1177/10600280241236507","DOIUrl":"10.1177/10600280241236507","url":null,"abstract":"<p><strong>Background: </strong>The use of albumin resuscitation in septic shock is only recommended in patients who have received large volumes of crystalloid resuscitation regardless of serum albumin concentration. The role of albumin is still largely debated and evidence to support its use still lacking.</p><p><strong>Objective: </strong>The objective of this study was to evaluate whether albumin replacement increases the number of vasopressor-free days in patients with septic shock and hypoalbuminemia.</p><p><strong>Methods: </strong>A retrospective analysis was conducted to assess the effect of albumin replacement in septic shock. Hypoalbuminemic patients with septic shock who received albumin were retrospectively compared with a cohort who did not. The primary outcome was number of vasopressor-free days at day 14 from shock presentation, which was analyzed using an adjusted linear regression model to adjust for confounders.</p><p><strong>Results: </strong>There was no difference in vasopressor-free days at day 14 in patients who received albumin versus those who did not, after adjusting for confounders of exposure (0.50, 95% CI = -0.97 to 1.97; <i>P</i> = 0.502). There also was no difference in secondary outcomes except for need for invasive mechanical ventilation (MV), which was significantly lower in patients who received albumin (61 [54.4%] vs 88 [67.7%]; <i>P</i> = 0.035).</p><p><strong>Conclusions and relevance: </strong>We observed no difference in vasopressor-free days at day 14 in patients with hypoalbuminemia who received albumin compared with those who did not. However, patients who received albumin required significantly less MV although further studies are warranted to assess this effect.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1179-1186"},"PeriodicalIF":2.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140130501","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 \"Impact of Dexmedetomidine Dosing and Timing on Acute Kidney Injury and Renal Outcomes After Cardiac Surgery: A Meta-Analytic Approach\".","authors":"Akshaya Upadhyay, Muhammed Shabil, Sanjit Sah","doi":"10.1177/10600280241292048","DOIUrl":"https://doi.org/10.1177/10600280241292048","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241292048"},"PeriodicalIF":2.3,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724826","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 Door-to-Needle Times Between Alteplase and Tenecteplase for Acute Ischemic Stroke at Two Academic Medical Centers.","authors":"Nicholas J Monkemeyer, Kaylee K Marino, Melanie Z Goodberlet, Christopher Anderson, Linda Bresette, Andrew J Webb, Aneesh Singhal, Lydia R Ware","doi":"10.1177/10600280241300230","DOIUrl":"https://doi.org/10.1177/10600280241300230","url":null,"abstract":"<p><strong>Background: </strong>Off-label tenecteplase use for acute ischemic stroke (AIS) has increased due to ease of administration and comparable efficacy and safety to alteplase.</p><p><strong>Objective: </strong>This study aimed to evaluate time to thrombolysis before and after transition from alteplase to tenecteplase for treatment of AIS at 2 institutions.</p><p><strong>Methods: </strong>This retrospective cohort study included adult patients receiving thrombolysis for AIS before and after transition from alteplase to tenecteplase at 2 academic medical centers from January 1, 2020 to January 31, 2024. The primary endpoint was door-to-needle (DTN) time, defined as minutes from hospital arrival to thrombolysis administration. Notable secondary endpoints included time from last known well (LKW) to thrombolysis, time from brain imaging to thrombolysis, hospital length of stay (LOS), and incidence of symptomatic intracranial hemorrhage (sICH).</p><p><strong>Results: </strong>A total of 328 patients (168 tenecteplase and 160 alteplase) were included. Patients were 51.5% female with a median (interquartile range [IQR]) age of 70 [58-80] years and initial National Institutes of Health Stroke Scale (NIHSS) score of 8 [5-14]. There was no statistically significant difference in DTN time (60 vs 56 minutes), time from LKW to thrombolysis (134 vs 147.5 minutes), or time from brain imaging to thrombolysis (32 vs 31 minutes) between tenecteplase and alteplase. Hospital LOS (5.7 vs 4.9 days) and the rates of sICH (3% vs 3.8%) were similar between groups.</p><p><strong>Conclusion and relevance: </strong>Tenecteplase and alteplase had comparable DTN times for treatment of AIS and similar safety endpoints. Further studies are warranted to identify opportunities to streamline DTN times with tenecteplase.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241300230"},"PeriodicalIF":2.3,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724831","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":"SGLT2 Inhibitor-Induced Euglycemic Diabetic Ketoacidosis (EDKA) in Patients With Underlying Risk Factors.","authors":"Paul Joseph Solinsky, Amy Holstege, Glen Burnie","doi":"10.1177/10600280241294060","DOIUrl":"https://doi.org/10.1177/10600280241294060","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241294060"},"PeriodicalIF":2.3,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724836","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 Disproportionality Analysis of Treprostinil Based on FDA Adverse Event Reporting System Database.","authors":"Lingling Li","doi":"10.1177/10600280241299114","DOIUrl":"https://doi.org/10.1177/10600280241299114","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241299114"},"PeriodicalIF":2.3,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724812","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":"Utilizing Theoretical Domains Framework to Determine Barriers to Evidence-Based Recommendations in Non-Valvular Atrial Fibrillation.","authors":"Evan White, Sandra L Kane-Gill, Sandeep Jain, Charles Medico, Nicole Ansani, James C Coons","doi":"10.1177/10600280241298947","DOIUrl":"https://doi.org/10.1177/10600280241298947","url":null,"abstract":"<p><strong>Background: </strong>Implementation of evidence-based guidelines in patient care is inefficient. Only 14% of new research are routinely adopted into clinical practice. The atrial fibrillation (AF) practice guidelines recommend anticoagulation in men with a CHA₂DS₂-VASc score greater than or equal to 2 and in women with a CHA₂DS₂-VASc score greater than or equal to 3. Despite these recommendations, oral anticoagulation prescribing rates were found to be as low as 51%. Existing frameworks, such as the Theoretical Domain Framework (TDF), are used in implementation science to identify behavior changes to overcome barriers to guideline adoption.</p><p><strong>Objective: </strong>In this project, we explored behavioral themes and barriers that prevented clinician adherence to evidence-based recommendations for patients with non-valvular atrial fibrillation (NVAF) and developed interventions to overcome those barriers.</p><p><strong>Methods: </strong>Nine focused interviews were conducted with stakeholders across multiple disciplines involved with NVAF care. Interview questions were based on the TDF and designed to determine behavior changes necessary to increase appropriate anticoagulation prescribing and decrease unnecessary NVAF hospital admissions. The interviews were transcribed and coded using NVivo 12 qualitative data analysis software (released 2018). Themes were documented, and interventions were then developed to address the barriers.</p><p><strong>Results: </strong>TDF interviews yielded 4 main barrier themes regarding appropriate NVAF management in 2 theoretical domains. These themes were lack of knowledge, cost of anticoagulation, patient refusal to take anticoagulation, and social determinants of health. The theoretical domains were knowledge and environmental context and resources.</p><p><strong>Conclusion and relevance: </strong>Based on our limited interviews, the TDF framework informed potential barriers contributing to the underutilization of appropriate anticoagulation in patients with NVAF. Techniques for behavior change interventions may be applied to overcome the identified barriers.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241298947"},"PeriodicalIF":2.3,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724839","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":"Incidence of Venous Thromboembolism Post-Oral Anticoagulation Reversal in Intracranial Hemorrhage Patients.","authors":"Aliya Abdulla, Kevin R Donahue, Courtney Hall, Lauren G Culver, Celia Morton","doi":"10.1177/10600280241297701","DOIUrl":"https://doi.org/10.1177/10600280241297701","url":null,"abstract":"<p><strong>Background: </strong>Rates of in-hospital venous thromboembolism (VTE) in the intracranial hemorrhage (ICH) population post oral anticoagulation (AC) reversal are as high as 10%. Guidelines recommend the initiation of prophylactic AC 24 to 48 hours post ICH; however, there is no guidance regarding optimal VTE prophylaxis post-reversal.</p><p><strong>Objective: </strong>This study aimed to identify the incidence of thromboembolism post oral AC reversal in patients presenting with ICH and describe VTE prophylaxis timing and agent selection.</p><p><strong>Methods: </strong>This was a retrospective, descriptive study conducted within a single health system. Patients on AC who received reversal agents 4-factor prothrombin complex concentrate (4F-PCC) with or without vitamin K, andexanet alfa, and/or idarucizumab for AC-associated ICH were included. The primary endpoint was incidence of in-hospital VTE post-reversal. Secondary endpoints included AC utilization specifications, length of stay, and in-hospital mortality.</p><p><strong>Results: </strong>There were 118 patients (57%) who received 4F-PCC and 89 patients (43%) who received andexanet alfa for reversal post-ICH. Overall, 195 patients (94.2%) achieved hemostasis. Eight patients had incidence of VTE (3.9%), and of those, 6 patients (75%) were reinitiated on AC, all of which utilized prophylactic heparin. The median time from reversal to VTE was 55.9 days (interquartile range [IQR] = 21.2-72.4). For all patients on AC, the median time to initiation from reversal was 3.98 days (IQR = 2.5-6.01), and for those with incidence of thrombosis, the median time to AC initiation was 6.4 days (IQR = 2.6-13.1). Mortality occurred in 13 patients (6.3%).</p><p><strong>Conclusion and relevance: </strong>This patient population is complex in that the need to achieve hemostasis with AC reversal must be balanced with the risk of VTE. Further studies are needed to determine the ideal timing and agent selection for VTE prophylaxis initiation post ICH reversal.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241297701"},"PeriodicalIF":2.3,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674946","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}