Annals of Pharmacotherapy最新文献

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Enlicitide: The First Oral PCSK9i for Lowering Low-Density Lipoprotein Cholesterol. enlicicitide:第一个口服PCSK9i用于降低低密度脂蛋白胆固醇。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-14 DOI: 10.1177/10600280261494015
Rachel C Lucas, Mia E Lussier, Azadeh Nasuhidehnavi, Taylor M Clark
{"title":"Enlicitide: The First Oral PCSK9i for Lowering Low-Density Lipoprotein Cholesterol.","authors":"Rachel C Lucas, Mia E Lussier, Azadeh Nasuhidehnavi, Taylor M Clark","doi":"10.1177/10600280261494015","DOIUrl":"https://doi.org/10.1177/10600280261494015","url":null,"abstract":"<p><strong>Objective: </strong>This article describes pharmacology, pharmacokinetics, safety, and efficacy data of enlicitide, the first Food and Drug Administration (FDA)-approved oral proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i).</p><p><strong>Data sources: </strong>PubMed, Embase, Web of Science, and Cochrane were searched through July 17, 2026.</p><p><strong>Study selection and data extraction: </strong>Clinical trials published in English were included. Relevant information from the methodology and results was extracted.</p><p><strong>Data synthesis: </strong>Enlicitide received FDA approval on July 16, 2026, based on results from phase 2 and 3 trials showing a 57.1% to 64.6% reduction in low-density lipoprotein-cholesterol (LDL-C) and reduced other atherogenic lipid particles at 24 weeks in patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia, while maintaining a favorable adverse effect profile. Enlicitide represents the fifth FDA-approved agent targeting PCSK9, having similar efficacy to other agents in class while having a novel macrocyclic peptide formulation with permeation enhancers, allowing for oral administration.Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:As PCSK9is continue to be at the forefront of dyslipidemia guidelines, the approval of an oral agent is paramount in ensuring patient access. Enlicitide mirrors LDL-C lowering compared with existing PCSK9is and surpasses LDL-C lowering compared with non-statin options such as bempedoic acid and ezetimibe. Confirmation of cardiovascular outcomes data with enlicitide will solidify its role in reducing atherosclerotic cardiovascular disease risk.</p><p><strong>Conclusion: </strong>Enlicitide significantly lowered LDL-C similar to existing PCSK9is with few adverse effects. The oral formulation provides an essential option for LDL-C lowering, especially in patients adverse to injections.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261494015"},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178941","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}
引用次数: 0
Manufacturing Quality Issues in Healthcare and Cosmetics: An Analysis of FDA Surveillance Data. 医疗保健和化妆品生产质量问题:FDA监测数据分析。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-13 DOI: 10.1177/10600280261492707
Ethan M Coleman, C Michael White
{"title":"Manufacturing Quality Issues in Healthcare and Cosmetics: An Analysis of FDA Surveillance Data.","authors":"Ethan M Coleman, C Michael White","doi":"10.1177/10600280261492707","DOIUrl":"https://doi.org/10.1177/10600280261492707","url":null,"abstract":"<p><strong>Background: </strong>Poor manufacturing quality in healthcare and cosmetic products expose people to danger and needs further categorization and assessment.</p><p><strong>Objective: </strong>This study reviewed Food and Drug Administration (FDA) records to identify major types of quality issues, the type of products involved, and patterns occurring over time.</p><p><strong>Methods: </strong>The \"FDA Health Fraud Product\" and \"FDA Recalls, Market Withdrawals, and Safety Alerts\" databases were assessed from June 4, 2010, through May 30, 2026. Drugs, cosmetics, and dietary supplements/quasi-legal products with verified manufacturing quality issues were included. Products were sorted by product type and FDA warning letters or official reports were reviewed and categorized.</p><p><strong>Results: </strong>Of 266 reviewed entries, 195 manufacturing quality issues were elucidated from 184 unique products. Drugs accounted for 70% of issues, cosmetics for 21%, and dietary supplement/quasi-legal products for 9%, respectively. Overall, chemical contamination (30%), procedural or testing issues (29%), and microbial contamination (19%) comprised 78% of identified issues. Drug issues were primarily procedural/testing, chemical contamination, and microbial contamination; cosmetic issues were predominantly elemental impurities and chemical contamination; and dietary supplement/quasi-legal issues were mainly microbial contamination, procedural/testing, and elemental impurities. Particulate contamination occurred only in drugs. The number of issues per year showed no consistent trend, but spiked in 2020, 2022, 2024, and 2025.</p><p><strong>Conclusion and relevance: </strong>Manufacturing quality problems varied substantially by product category and occurred in irregular clusters. Inconsistent FDA reporting practices and fluctuations in agency surveillance may have contributed to these patterns. Budgetary cuts to the FDA could increase consumer exposure to manufacturing issues.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261492707"},"PeriodicalIF":2.5,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178932","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}
引用次数: 0
Ritlecitinib in Nonsegmental Vitiligo: A Systematic Review and Comprehensive Program Synthesis of Clinical Efficacy, Safety, and Biomarker Outcomes. 利来替尼治疗非节段性白癜风:临床疗效、安全性和生物标志物结果的系统评价和综合程序综合。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-13 DOI: 10.1177/10600280261493131
Aya Mamdouh Fayoud, Eslam Abady, Khloud Shendy, Hanin Abdelhamied Rabea, Alaa A Al-Laithy, Marim A Alnahas, Reem Romaih, Ahmed A Algamal, Asmaa Ahmed Elrashedy, Fawzy Elbarbry
{"title":"Ritlecitinib in Nonsegmental Vitiligo: A Systematic Review and Comprehensive Program Synthesis of Clinical Efficacy, Safety, and Biomarker Outcomes.","authors":"Aya Mamdouh Fayoud, Eslam Abady, Khloud Shendy, Hanin Abdelhamied Rabea, Alaa A Al-Laithy, Marim A Alnahas, Reem Romaih, Ahmed A Algamal, Asmaa Ahmed Elrashedy, Fawzy Elbarbry","doi":"10.1177/10600280261493131","DOIUrl":"https://doi.org/10.1177/10600280261493131","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical efficacy and safety of oral ritlecitinib, a selective Janus kinase 3 (JAK3) and tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, for the treatment of nonsegmental vitiligo (NSV).</p><p><strong>Data sources: </strong>A systematic literature search was conducted across PubMed, Web of Science, Scopus, ClinicalTrials.gov, and the Cochrane Library from inception through August 31, 2026. Search terms included combinations of \"ritlecitinib,\" \"JAK inhibitor,\" and \"vitiligo..\"</p><p><strong>Study selection and data extraction: </strong>Included studies were clinical trials evaluating ritlecitinib, monotherapy, or with narrowband ultraviolet B (nbUVB), in adults with NSV. Five interrelated studies from the ritlecitinib phase 2b program involving 364 participants were identified for qualitative synthesis. Data extraction included study design, participant demographics, efficacy indices (F-VASI[Facial Vitiligo Area Scoring Index], T-VASI [Total Vitiligo Area Scoring Index], and PGIC-V [Patient Global Impression of Change-Vitiligo]), biomarker changes, and safety outcomes. Quality was assessed using the Cochrane Risk-of-Bias 2 tool.</p><p><strong>Data synthesis: </strong>Ritlecitinib 50 mg daily demonstrated significant facial repigmentation at week 24, achieving a percent change from baseline (%CFB) in F-VASI of -18.5% to -21.2% compared with +2.1% for placebo. Adding nbUVB significantly enhanced efficacy (F-VASI %CFB: -69.6% vs -55.1%; <i>P</i> = .009) and total-body repigmentation. Darker skin phototypes (FST IV-VI) showed earlier and more robust responses (-37.4%) than lighter skin types (FST I-III; -15.2%). Safety outcomes were comparable with placebo, with overall adverse event rates between 60.0% and 86.2% and rare serious adverse events (≤2%). Biomarker analysis confirmed the downregulation of Th1-associated markers (CXCL9 and IFNG) and restoration of melanocyte markers like tyrosinase and Melan-A.Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:Ritlecitinib 50 mg daily provides a well-tolerated oral systemic option for active NSV. Efficacy is optimized when combined with nbUVB, and baseline skin phototype is a key predictor of the speed and extent of repigmentation.</p><p><strong>Conclusions: </strong>Oral ritlecitinib 50 mg daily is an effective systemic treatment for active NSV, demonstrating continuous repigmentation through 48 weeks with a favorable safety profile.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261493131"},"PeriodicalIF":2.5,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149178978","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}
引用次数: 0
Low-Dose Buprenorphine Initiation Strategies for Pain. 小剂量丁丙诺啡治疗疼痛的起始策略。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-13 DOI: 10.1177/10600280261491998
Jeremiah J Jean, Michael A Smith
{"title":"Low-Dose Buprenorphine Initiation Strategies for Pain.","authors":"Jeremiah J Jean, Michael A Smith","doi":"10.1177/10600280261491998","DOIUrl":"https://doi.org/10.1177/10600280261491998","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this review is to describe the common benefits and pitfalls of various low-dose buprenorphine initiation strategies for patients experiencing long-term pain without opioid use disorder (OUD).</p><p><strong>Data sources: </strong>A search of the primary literature was performed in PubMed using the following keywords: \"Buprenorphine OR Buprenorphine-naloxone OR Belbuca OR Suboxone, Primary care OR Outpatient, Pain OR Pain management,\" from January 1980 to August 2, 2026.</p><p><strong>Study selection and data extraction: </strong>Case reports involving the use of sublingual/buccal buprenorphine in outpatients for pain without OUD were included.</p><p><strong>Data synthesis: </strong>Three low-dose buprenorphine initiation methods were evaluated, titrating buprenorphine from once to thrice-daily up to a total of 7 days. Two studies abruptly discontinued full μ-agonists prior to initiating buprenorphine, whereas 1 study tapered full μ-agonists by 25% weekly after day 7. Tapering full-agonist opioids after attainment of target buprenorphine dosing was well tolerated and potentially unneeded after steady-state levels were achieved; bridging analgesia with sufficient pharmacokinetic overlap between buprenorphine and full μ-agonist opioids appears tantamount to mitigating withdrawal symptoms.</p><p><strong>Relevance to patient care and clinical practice: </strong>The ideal buprenorphine initiation method considers desired duration, whether to perform cross-titration, product pharmacokinetics, patient-specific factors, and goals of care.</p><p><strong>Conclusions: </strong>No data exist to support one low-dose buprenorphine initiation method over another. All methods discussed were highly successful at rotating patients to buprenorphine, that is, with equivalent or improved pain control with minimal to no withdrawal symptoms and may be used to build a methodology for starting buprenorphine in outpatients with sub-optimal pain regimens.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261491998"},"PeriodicalIF":2.5,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179011","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}
引用次数: 0
Objective Limitations of Qualitative TOF Monitoring in ARDS. 目的:ARDS TOF定性监测的局限性。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-12 DOI: 10.1177/10600280261495089
Dustin D Linn, Kendra J Schomer
{"title":"Objective Limitations of Qualitative TOF Monitoring in ARDS.","authors":"Dustin D Linn, Kendra J Schomer","doi":"10.1177/10600280261495089","DOIUrl":"https://doi.org/10.1177/10600280261495089","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261495089"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164628","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}
引用次数: 0
Reply: Comparison of Train-of-Four Versus No Train-of-Four Monitoring of Neuromuscular Blockade on Drug Consumption for Acute Respiratory Distress Syndrome. 答复:四列训练与非四列训练监测神经肌肉阻断对急性呼吸窘迫综合征药物消耗的比较。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-12 DOI: 10.1177/10600280261495097
Kayleigh Yaeger, Ryan Rivosecchi, Lara M Groetzinger
{"title":"Reply: Comparison of Train-of-Four Versus No Train-of-Four Monitoring of Neuromuscular Blockade on Drug Consumption for Acute Respiratory Distress Syndrome.","authors":"Kayleigh Yaeger, Ryan Rivosecchi, Lara M Groetzinger","doi":"10.1177/10600280261495097","DOIUrl":"https://doi.org/10.1177/10600280261495097","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261495097"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164131","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}
引用次数: 0
Retrospective Evaluation of the Association of Hypoalbuminemia With Acute Treatment Outcomes in Methicillin-Susceptible Staphylococcus Aureus Bacteremia. 低白蛋白血症与甲氧西林敏感金黄色葡萄球菌血症急性治疗结果的回顾性评价
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-11 DOI: 10.1177/10600280261491400
Ryan W Stevens, Daniel C DeSimone, Kyle A Hess, Joya-Rita Hindy, Kristin Cole, Kirstin Kooda, John C Robinson, Larry M Baddour, Dan Ilges
{"title":"Retrospective Evaluation of the Association of Hypoalbuminemia With Acute Treatment Outcomes in Methicillin-Susceptible <i>Staphylococcus Aureus</i> Bacteremia.","authors":"Ryan W Stevens, Daniel C DeSimone, Kyle A Hess, Joya-Rita Hindy, Kristin Cole, Kirstin Kooda, John C Robinson, Larry M Baddour, Dan Ilges","doi":"10.1177/10600280261491400","DOIUrl":"https://doi.org/10.1177/10600280261491400","url":null,"abstract":"<p><strong>Background: </strong>Cefazolin and antistaphylococcal penicillins (ASP) are first-line agents for methicillin-susceptible <i>Staphylococcus aureus</i> (MSSA) bacteremia. These agents are substantially protein-bound; however, scant data exist evaluating the impact of hypoalbuminemia on microbiologic and patient outcomes for this indication.</p><p><strong>Objective: </strong>The purpose of this study was to assess whether hypoalbuminemia is associated with delayed blood culture clearance in patients with MSSA bacteremia being treated with cefazolin or ASPs as definitive therapy.</p><p><strong>Methods: </strong>This retrospective cohort study included patients admitted for MSSA bacteremia between January 1, 2006 and December 31, 2019, with a serum albumin obtained between the date of an initial positive blood culture result and 72 hours following initiation of definitive therapy with cefazolin or an ASP. The primary outcome was the rate of persistently positive blood cultures, defined as failure to clear blood cultures within 72 hours of definitive therapy initiation. Patients with a serum albumin ≤2.5 g/dL were compared with those with an albumin >2.5 g/dL. Propensity score weighting was used to account for differences in cohort characteristics.</p><p><strong>Results: </strong>A total of 123 patients were included. After propensity score weighting, patients with hypoalbuminemia had a higher rate of persistently positive blood cultures, both in the overall cohort (45.0% vs 13.2%, <i>P</i> < .001) and in the subgroups of cefazolin (33.0% vs 9.1%, <i>P</i> = .015) and ASP (60.1% vs 18.3%, <i>P</i> = .001) when analyzed separately. After propensity weighting in the combined cohort, the length of stay was longer in the hypoalbuminemic cohort, but no differences in mortality were observed.</p><p><strong>Conclusions and relevance: </strong>Hypoalbuminemia was associated with a delayed 72-hour blood culture clearance in patients with MSSA bacteremia treated with either cefazolin or ASPs.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280261491400"},"PeriodicalIF":2.5,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164738","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}
引用次数: 0
Efficacy and Safety of GLP-1 Receptor Agonists for the Management of Antipsychotic-Induced Weight Gain. GLP-1受体激动剂治疗抗精神病药致体重增加的有效性和安全性。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-01 Epub Date: 2026-02-21 DOI: 10.1177/10600280251414107
Sarah Pascale, Justin P Reinert
{"title":"Efficacy and Safety of GLP-1 Receptor Agonists for the Management of Antipsychotic-Induced Weight Gain.","authors":"Sarah Pascale, Justin P Reinert","doi":"10.1177/10600280251414107","DOIUrl":"10.1177/10600280251414107","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this systematic review and meta-analysis was to compare the efficacy and safety of glucagon-like peptide-1 (GLP-1) receptor agonists for the management of antipsychotic-induced weight gain.</p><p><strong>Data sources: </strong>A systematic review was conducted following PRISMA methodology through July 2025 that evaluated the efficacy and safety of GLP-1 agonists for the management of antipsychotic-induced weight gain.</p><p><strong>Study selection and data extraction: </strong>Efficacy endpoints were change in body weight (kg), change in body mass index (BMI) (kg/m<sup>2</sup>), and change in HbA<sub>1c</sub> (%). The safety endpoint was gastrointestinal (GI) adverse effects. A <i>P</i>-value of 0.05 was considered statistically significant, and heterogeneity was reported as I<sup>2</sup>.</p><p><strong>Data synthesis: </strong>Six studies were included in this systematic review, of which 4 trials were included in the meta-analysis. The difference found between GLP-1 agonists and placebo was a change in weight of -5.85 kg (<i>P</i> = 0.0622, 95% CI = -9.72 to -1.97), a change in BMI of -2.11 kg/m<sup>2</sup> (<i>P</i> = 0.7692, 95% CI = -5.51 to 1.29), and a change in HbA<sub>1c</sub> of -1.58 (<i>P</i> = 0.6659, 95% CI = -4.75 to 1.58). The overall risk ratio for a patient to experience a GI-related adverse effect when taking a GLP-1 agonist compared to placebo was 1.83 (95% CI = 1.42 to 2.37).</p><p><strong>Relevance to patient care and clinical practice: </strong>While the efficacy endpoints did not reach significance, this meta-analysis shows that select GLP-1 receptor agonists may be used to promote weight loss in patients taking antipsychotics. Controlling antipsychotic-induced weight gain helps patients remain adherent to therapeutic doses of their antipsychotic medications.</p><p><strong>Conclusion: </strong>The use of certain GLP-1 agonists may be considered to help promote weight loss in patients experiencing antipsychotic-induced weight gain.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"991-1001"},"PeriodicalIF":2.5,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146775879","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}
引用次数: 0
Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea. 吉波达肽治疗无并发症泌尿生殖道淋病。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-01 Epub Date: 2026-04-10 DOI: 10.1177/10600280261435593
Spencer H Durham, Amanda K McAllister, Elias B Chahine
{"title":"Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea.","authors":"Spencer H Durham, Amanda K McAllister, Elias B Chahine","doi":"10.1177/10600280261435593","DOIUrl":"10.1177/10600280261435593","url":null,"abstract":"<p><strong>Objective: </strong>To review the efficacy and safety of gepotidacin for the treatment of uncomplicated urogenital gonorrhea (uUGG).</p><p><strong>Data sources: </strong>A literature search of PubMed and Google Scholar (January 2010 to January 2026) was conducted using the terms gepotidacin and GSK2140944. Additional sources included conference abstracts, the manufacturer's website, and prescribing information.</p><p><strong>Study selection and data extraction: </strong>Relevant English-language studies evaluating the efficacy and safety of gepotidacin for uUGG were included.</p><p><strong>Data synthesis: </strong>Gepotidacin is a first-in-class triazaacenaphthylene antibiotic with a novel mechanism of action and potent activity against <i>Neisseria gonorrhoeae</i>. In the phase 3 EAGLE-1 trial, gepotidacin demonstrated noninferiority to ceftriaxone plus azithromycin for uUGG treatment. It was generally well tolerated, with gastrointestinal adverse effects most commonly reported. Gepotidacin is administered as 3000 mg orally every 12 hours for 2 doses and is approved for adults and pediatric patients aged ≥12 years weighing ≥45 kg with limited or no alternative treatment options. Administration with food is recommended to reduce gastrointestinal adverse effects.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Gepotidacin provides a new 2-dose oral option for uUGG treatment. Compared with ceftriaxone, the current drug of choice, oral administration may improve convenience and access. Similar to cefixime and zoliflodacin, its oral formulation may facilitate treatment while potentially reducing microbiome disruption compared with ceftriaxone.</p><p><strong>Conclusions: </strong>Gepotidacin is a promising oral antibiotic with a novel mechanism of action and demonstrated efficacy for uUGG treatment.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1012-1018"},"PeriodicalIF":2.5,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147653680","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}
引用次数: 0
Effect of Conversion From Intravenous to Oral Administration on Cyclosporine Exposure in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation. 儿童异基因造血干细胞移植中由静脉给药转为口服给药对环孢素暴露的影响。
IF 2.5 4区 医学
Annals of Pharmacotherapy Pub Date : 2026-10-01 Epub Date: 2026-02-02 DOI: 10.1177/10600280251414685
Junyan Wang, Meng Zhang, Lingkun Wang, Jufei Yang, Lingfei Huang, Jing Miao
{"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":"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":"962-969"},"PeriodicalIF":2.5,"publicationDate":"2026-10-01","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}
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