Annals of Pharmacotherapy最新文献

{"title":"Guselkumab: A New Therapeutic Option for the Treatment of Moderately to Severely Active Ulcerative Colitis.","authors":"Shubha Bhat, David Choi","doi":"10.1177/10600280241305441","DOIUrl":"https://doi.org/10.1177/10600280241305441","url":null,"abstract":"<p><strong>Objective: </strong>To summarize the evidence and pharmacologic profile of guselkumab for moderate to severe ulcerative colitis (UC).</p><p><strong>Data sources: </strong>A PubMed search from inception to end of October 2024 using keywords <i>guselkumab, UC, and interleukin (IL)</i> was conducted. Additional information was obtained from abstracts and package insert.</p><p><strong>Study selection and data extraction: </strong>Phase 2/3 studies plus applicable literature on guselkumab pharmacologic and clinical profile were included.</p><p><strong>Data synthesis: </strong>Approval was based on the QUASAR program, a multicenter, randomized, double-blind, placebo-controlled, phase 2b/3 trial assessing guselkumab's efficacy and safety in adults with moderately to severely active UC who had inadequate response or intolerance to conventional therapies, biologics (excluding IL antagonists), or Janus Kinase inhibitors. Results indicated that guselkumab led to higher clinical remission rates at week 12 and 44 compared to placebo, along with improvements in clinical response, symptomatic remission, endoscopic improvement, and histologic normalization. Common adverse effects included respiratory tract infections, injection site reactions, and arthralgia.</p><p><strong>Relevance to patient care and clinical practice in comparison to existing drugs: </strong>Guselkumab is the fourth IL antagonist approved for UC, and the first to target CD64 (cells involved in IL-23 production). With its dual mechanism, guselkumab is hypothesized to neutralize IL-23 at production and reduce inflammatory response. The QUASAR findings suggest guselkumab can provide durable clinical remission and histologic normalization, addressing a significant gap in UC treatment.</p><p><strong>Conclusion: </strong>As the latest addition to UC therapies, guselkumab presents improved efficacy and dosing flexibility without introducing any new safety concerns compared to existing agents.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241305441"},"PeriodicalIF":2.3,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969454","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":"Doxycycline Versus Vancomycin for the Treatment of Methicillin-Resistant <i>Staphylococcus Aureus-Associated</i> Acute Pulmonary Exacerbations in People With Cystic Fibrosis.","authors":"Kendall H Brickel, Denise Kelley, Theresa Jaso, Hai Quyen Tran, Jason Fullmer, Danielle Beachler, Steven Wulfe","doi":"10.1177/10600280241310595","DOIUrl":"https://doi.org/10.1177/10600280241310595","url":null,"abstract":"<p><strong>Background: </strong>Among people with cystic fibrosis (PwCF), methicillin-resistant <i>Staphylococcus aureus</i> (MRSA)-associated acute pulmonary exacerbations (APEs) have been increasing in prevalence and can cause rapid declines in lung function and increased mortality. Fortunately, since 2019, incidence has started to decline.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate if doxycycline has comparable efficacy to vancomycin for the treatment of APEs in PwCF. Given the potential toxicities and intolerances associated with vancomycin, evaluating alternative therapies such as doxycycline is warranted.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study was conducted in adult and pediatric PwCF who received greater than 48 hours of either vancomycin or doxycycline to treat MRSA-associated APEs between May 1, 2014, and August 31, 2021. The primary outcome was the number of PwCF with a return to ≥90% of baseline forced expiratory volume in the first second (FEV₁).</p><p><strong>Results: </strong>There were 229 PwCF encounters screened, of which 89 met inclusion criteria (n = 26, vancomycin; n = 63, doxycycline). There were no differences between vancomycin and doxycycline for the primary outcome: 18/26 (69.2%) in the vancomycin group vs 51/63 (81.0%) in the doxycycline group (<i>P</i> = 0.23). Secondary outcomes were similar between groups, including no difference in incidence of acute kidney injury (AKI), although a significantly higher incidence of adverse events occurred in the vancomycin arm.</p><p><strong>Conclusion and relevance: </strong>The findings of this study suggest doxycycline may be a reasonable alternative to vancomycin for MRSA-associated APEs, particularly in PwCF who may not tolerate vancomycin or who require concomitant nephrotoxins such as intravenous (IV) aminoglycosides.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241310595"},"PeriodicalIF":2.3,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942880","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":"Evolving Strategies for Respiratory Syncytial Virus (RSV): A Review Article of Preventive Agents and Vaccines for RSV.","authors":"Nick Howard, Edward Pudim","doi":"10.1177/10600280241302085","DOIUrl":"https://doi.org/10.1177/10600280241302085","url":null,"abstract":"<p><strong>Objective: </strong>The objective was to describe the pharmacology, efficacy, safety, and recommendations for the use of newly approved preventive agents and vaccines for respiratory syncytial virus (RSV) and discuss their uptake during the 2023 to 2024 RSV season.</p><p><strong>Data sources: </strong>A literature search of PubMed was performed (January 2020 to February 2024) with the search terms RSV vaccine, preventive antibody, and RSV prevention. Utilization data were collected from TriNetX using the US Collaborative Network (May 2024) using the terms palivizumab, nirsevimab, and RSV prefusion F protein.</p><p><strong>Study selection and data extraction: </strong>Relevant English-language studies assessing the use of Food and Drug Administration (FDA)-approved preventive agents and vaccines for RSV in humans were considered. Population-level utilization data were extracted from TriNetX.</p><p><strong>Data synthesis: </strong>Nirsevimab was observed to have noninferior efficacy and safety compared with palivizumab with less frequent administration. Nirsevimab is recommended to replace palivizumab for RSV prophylaxis in all eligible infants. Arexvy and Abrysvo are effective at reducing the risk of RSV infection in adults aged ≥60 years, and Arexvy is indicated in adults aged ≥50 years. These vaccines are equally recommended for use in the elderly adult population, but only Abrysvo is indicated and recommended for maternal administration. Most infants only require prophylaxis through either maternal RSV vaccination or nirsevimab administration.</p><p><strong>Relevance to patient care and clinical practice: </strong>This review compares the indications for use, guideline recommendations, and clinical trial efficacy and safety data for palivizumab, nirsevimab, Abrysvo, and Arexvy to guide clinical decision-making.</p><p><strong>Conclusions: </strong>Novel RSV preventive agents, including Abrysvo, Arexvy, and nirsevimab, offer less burdensome dosing and administration compared with palivizumab, show promising efficacy and safety data, and expand the populations eligible for RSV prevention. Updated clinical guidance supports immediate adoption of these agents in practice, and population-level data suggest these agents were used during the 2023 to 2024 RSV season.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241302085"},"PeriodicalIF":2.3,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913751","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":"Emergency Medicine Physician Residents' Perceptions of Emergency Medicine Clinical Pharmacists' Involvement in Their Training.","authors":"Francisco Ibarra, Stacy Sawtelle, Mallory Cruz","doi":"10.1177/10600280241253383","DOIUrl":"10.1177/10600280241253383","url":null,"abstract":"<p><strong>Background: </strong>Although the clinical impact of emergency medicine clinical pharmacists (EMCPs) on patient care outcomes is well documented, their educational impact on resident physicians' training is not.</p><p><strong>Objective: </strong>To further highlight the utility of EMCPs, this study evaluated emergency medicine (EM) resident physicians' perceptions of EMCPs' involvement in their training.</p><p><strong>Methods: </strong>A voluntary, anonymous web-based survey was sent by email to all 44 EM resident physicians in July 2022. The survey included multiple choice, 5-point Likert scale, and free response questions derived from Accreditation Council for Graduate Medical Education pharmacotherapy competency-based milestones.</p><p><strong>Results: </strong>Thirty-six of the 44 (82%) residents completed the survey and all 10 PGY-4 class residents completed the survey. Nearly half of the respondents (44.4%) reported they consulted/interacted with the EMCPs 3 to 5 times per week and this number increased with the level of training. Respondents most often consulted the EMCPs to obtain medication indications, antibiotic dosing, pediatric dosing, and contraindications. Overall, respondents primarily reported strongly agree to all survey questions. Nearly all respondents strongly agreed the EMCPs are an important part of the patient care team and provide education that is different from what a supervising physician provides. All respondents who completed the pharmacy elective strongly agreed the elective was valuable and strongly recommended other residents to complete it.</p><p><strong>Conclusion and relevance: </strong>Respondents reported EMCPs are an important part of the patient care team, play a significant role in their training, and provide education that is different from what a supervising physician provides. Our findings encourage other institutions to leverage physicians' views of EMCPs to expand their service line.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"41-46"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178982","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":"Fentanyl Levels May Be Unchanged With Extracorporeal Membrane Oxygenation.","authors":"Jennifer W Chou, Matthew Mueller, Christopher Tainter, Travis Pollema, Cassia Yi, Mazen Odish, E Orestes O'Brien","doi":"10.1177/10600280241249501","DOIUrl":"10.1177/10600280241249501","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"97-98"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141064389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Case of Angioedema to Oral Doxycycline and Cross-Reactivity to Minocycline.","authors":"Jieun Yu, Da Woon Sim","doi":"10.1177/10600280241252542","DOIUrl":"10.1177/10600280241252542","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"95-96"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140915682","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-Time Use of SGLT2i Verified in Pre-dialysis: The RSVP Cross-sectional Study.","authors":"Aylon Wisbaum, Sandrine Gaudreau, Isabelle Cloutier, Pascale Robert, Regina Kolment, Marie-France Beauchesne, Jodianne Couture","doi":"10.1177/10600280241245995","DOIUrl":"10.1177/10600280241245995","url":null,"abstract":"<p><strong>Background: </strong>The use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in nephrology practice is increasingly becoming standard of care in patients with diabetes or those with proteinuria.</p><p><strong>Objectives: </strong>The primary outcome was to identify the proportion of pre-dialysis patients with chronic kidney disease (CKD) G3a, G3b, or G4 prescribed an SGLT2i and describe their characteristics.</p><p><strong>Methods: </strong>This was a retrospective, multicentric, cross-sectional study of patients with CKD followed at 4 pre-dialysis clinics in the province of Quebec, Canada. We collected data of multiple covariates associated with prescribing SGLT2i in patients over 18 years of age with CKD G3a, G3b, or G4. We then performed a multivariate logistic regression to assess their associations.</p><p><strong>Results: </strong>Of the 874 patients included, 22.7% were prescribed an SGLT2i. Factors most strongly associated included male sex (odds ratio [OR] = 4.88, 95% CI = 2.38-10.03), being prescribed metformin (OR = 4.30, 95% CI = 2.23-8.31), having type 2 diabetes (OR = 4.00, 95% CI = 1.86-8.62), or having an albumin-to-creatinine ratio greater than 300 mg/g (OR = 1.84, 95% CI = 1.08-3.14). The majority of patients (60.4%) had their SGLT2i initiated by the pre-dialysis clinic and the most frequent adverse event was an initial increase in serum creatinine 1 week after starting treatment (33.9%).</p><p><strong>Conclusion and relevance: </strong>An increasing number of patients with CKD are being prescribed SGLT2i. Nonetheless, significant disparities in sex, severity of disease, and comorbidities remain. We suggest that specific strategies be put in place to promote prescribing of SGLT2i in women and other at-risk populations, in particular among nephrology teams, to improve patient care.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"13-22"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140910940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Link Between Exogenous Thyroid Hormones and Dementia Symptoms: A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System.","authors":"Jianxing Zhou, Weipeng Lai, Zipeng Wei, Baohua Xu, Maobai Liu, Nanwen Zhang, Xuemei Wu","doi":"10.1177/10600280241252211","DOIUrl":"10.1177/10600280241252211","url":null,"abstract":"<p><strong>Background: </strong>A growing body of evidence indicates a strong association between exogenous thyroid hormone (ETH) and brain health. Establishing the potential relationship between ETH therapy and dementia symptoms is crucial for patients with thyroid disorders.</p><p><strong>Objective: </strong>In this study, we investigate the potential association between ETH therapy and dementia symptoms by exploring the Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Disproportionality analysis (DPA) was conducted using postmarketing data from the FAERS repository (Q1 2004 to Q4 2023). Cases of dementia symptoms associated with ETH therapy were identified and analyzed through DPA using reporting odds ratios and information component methods. Dose and time-to-onset analyses were performed to assess the association between ETH therapy and dementia symptoms.</p><p><strong>Results: </strong>A total of 9889 cases of ETH-associated symptoms were identified in the FAERS database. Dementia accounted for a consistent proportion of adverse drug reactions each year (3.4%-6.3%). The DPA indicated an association between ETH therapy and dementia symptoms, which remained significant even across sex, age, and indications. The median time-to-onset of dementia symptoms was 7.5 days, and the median treatment time was 40.5 days. No significant dose-response relationship was observed.</p><p><strong>Conclusion and relevance: </strong>This study provides evidence for a link between ETH therapy and dementia. Clinicians are therefore advised to exercise vigilance, conduct comprehensive monitoring, and consider individualized dosing to mitigate potential reactions to ETH drug administration.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"23-33"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955829","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":"Low-Dose Valganciclovir Prophylaxis Against Cytomegalovirus in Intermediate-Risk Liver and Dual-Abdominal Transplant Recipients.","authors":"Yihan Li, Dawn M Pluckrose, Roshani Patolia, Serena Arnouk, Yanina Dubrovskaya, John Papadopoulos, Srijana Jonchhe","doi":"10.1177/10600280241255110","DOIUrl":"10.1177/10600280241255110","url":null,"abstract":"<p><strong>Background: </strong>Low-dose valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis post-transplant has been employed due to cost and safety. The incidence of CMV disease in CMV intermediate-risk liver recipients at 1-year after standard-dose prophylaxis is approximately 5%. However, there are limited data on outcomes after using a \"true\" low-dose VGC prophylaxis regimen in liver and dual-abdominal transplant recipients as VGC was not dose-adjusted in all patients with impaired renal function in prior studies.</p><p><strong>Objective: </strong>The objective was to assess the incidence of CMV associated with low-dose VGC prophylaxis in CMV intermediate-risk liver, simultaneous pancreas-kidney (SPK), and simultaneous liver-kidney (SLK) recipients with creatinine clearance (CrCl) >60 mL/min.</p><p><strong>Methods: </strong>This was a retrospective review of CMV intermediate-risk liver, SPK, and SLK recipients with CrCl >60 mL/min transplanted January 2018 to June 2022 who received VGC 450 mg daily for prophylaxis. The primary outcome was incidence of CMV infection 6-months post-transplant.</p><p><strong>Results: </strong>Ninety-nine transplant recipients were included (79 liver, 11 SPK, 9 SLK). The primary outcome occurred in 13% of patients (liver 10%, SPK 36%, SLK 10%), including 1 case of CMV disease and 3 breakthrough infections. In addition, 6 patients experienced CMV infection between 6-months and 1-year. Recurrence occurred in 3 patients. There was no evidence of CMV resistance. Thirty patients experienced neutropenia within 1-year, 32 were prescribed granulocyte-colony stimulating factors, and 5 experienced thrombocytopenia. Two patients died due to graft-vs-host disease.</p><p><strong>Conclusion and relevance: </strong>Low-dose VGC prophylaxis led to comparable CMV infection rates at 6-months in CMV intermediate-risk liver and SLK recipients. However, as SPK recipients displayed higher rates of CMV infection, low-dose VGC should be avoided in this population.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"34-40"},"PeriodicalIF":4.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141154290","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 Use of Protamine for the Management of Postcardiac Surgery Coagulopathy.","authors":"Minlang Lin, Michael Militello, Benjamin Hohlfelder, Kevin Hodges, Jessica Ward","doi":"10.1177/10600280241302324","DOIUrl":"https://doi.org/10.1177/10600280241302324","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241302324"},"PeriodicalIF":2.3,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852216","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}