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":"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.Relevance to patient care and clinical practice in comparison to existing drugs: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":"862-867"},"PeriodicalIF":2.3,"publicationDate":"2025-09-01","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":"Travoprost Intracameral Implant: A Review on the Novel Treatment Modality for Open-Angle Glaucoma and Ocular Hypertension.","authors":"Jessica Huston, Mark Paauw, Dontia Orey, Aliya Centner, Azeem Hasan, Rajesh Shetty, Kathryn Freidl, Rebecca Goldfaden","doi":"10.1177/10600280241291911","DOIUrl":"10.1177/10600280241291911","url":null,"abstract":"<p><strong>Objective: </strong>This article reviews the published data encompassing the development, pharmacology, efficacy, and safety of travoprost, intracameral implant, a treatment for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.</p><p><strong>Data sources: </strong>A literature search was conducted from drug discovery until September 2024 through PubMed, MEDLINE, and National Institutes of Health Clinical Trials Registry utilizing the following search terms: iDose, travoprost, intracameral implant, OTX-TIC, open-angle glaucoma, and ocular hypertension.</p><p><strong>Study selection and data extraction: </strong>All relevant English-language studies, or studies that could be appropriately translated into English, containing the pharmacology, pharmacokinetics, safety, and efficacy of travoprost intracameral implant were selected for review.</p><p><strong>Data synthesis: </strong>Travoprost implants showed significant reductions in IOP compared with other treatment options with fewer limitations often associated with topical medications resulting in travoprost implant patients favoring reduced concomitant use of topical IOP-lowering medications (with 81% of patients being medication free).Relevance to Patient Care and Clinical Practice in Comparison with Existing Drugs:Due to limited compliance with topical treatment modalities, the travoprost implant presents a promising alternative pathway for drug delivery. With a duration of 3 years and removal of the need for patient dexterity and application compliance, the travoprost implant serves an unmet need for patients and prescribers.</p><p><strong>Conclusion: </strong>Travoprost intracameral implant is a safe and effective delivery system for intracameral travoprost administration for patients with OAG or ocular hypertension.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"767-772"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806055","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":"10.1177/10600280241302324","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"773-775"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","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}

{"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":"10.1177/10600280241292048","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"778"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","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":"Utility Assessment of a Pharmacy to Dose Daptomycin Protocol: A Retrospective Cohort Study.","authors":"Kevin Burnham, Stefanie Henley, Matthew P Crotty, Ronda L Akins","doi":"10.1177/10600280241308212","DOIUrl":"10.1177/10600280241308212","url":null,"abstract":"<p><strong>Background: </strong>Pharmacy-to-dose (PTD) services describe an established practice where providers consult pharmacists for various medication dosing. In 2019, several institutions approved a daptomycin protocol, which allowed pharmacists to select doses based on provider-selected indications, renal function, and body mass index (BMI).</p><p><strong>Objective: </strong>This study aims to determine the utility of a daptomycin PTD consult service.</p><p><strong>Methods: </strong>A retrospective analysis was conducted using data from 4 community hospitals between July 19, 2019 and October 31, 2021. The 2 comparative cohorts included patients who started on daptomycin with and without PTD services. The primary endpoint was the proportion of patients receiving appropriate initial dosing of daptomycin.</p><p><strong>Results: </strong>A total of 297 patients met the inclusion criteria, with 128 (43.1%) in the PTD group and 169 (56.9%) in the non-PTD group. The primary endpoint of appropriate initial dosing occurred significantly more in the PTD group (92.2% vs 82.8%, <i>P</i> = 0.02). Baseline creatine phosphokinase (CPK) was ordered significantly more in the PTD group (88.3% vs 77.5%, <i>P</i> = 0.02). A nonsignificant trend was seen in favor of the PTD arm (80% vs 58.3%, <i>P</i> = 0.22) for dose adjustments required within the first 24 hours.</p><p><strong>Conclusion and relevance: </strong>The use of a PTD daptomycin protocol was associated with a significant increase in appropriate initial dosing and baseline CPK monitoring compared with traditional provider order entry.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"714-723"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998833","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":"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":"685-693"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","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":"Pivmecillinam for Uncomplicated Acute Cystitis: A Contemporary Review.","authors":"Jessica E Burchette, Kelly Covert, Patrick Tu, Bryan P White, Daniel B Chastain, David B Cluck","doi":"10.1177/10600280241288554","DOIUrl":"10.1177/10600280241288554","url":null,"abstract":"<p><strong>Objective: </strong>To review the evidence and discuss use of pivmecillinam in uncomplicated acute cystitis.</p><p><strong>Data sources: </strong>A literature search was conducted utilizing PubMed (from 2000 through August 2024) and ClinicalTrials.gov. Medical Subject Headings (MeSH) terms, such as mecillinam or pivmecillinam and urinary tract infections, were utilized. Additional references were identified by reviewing literature citations.</p><p><strong>Study selection and data extraction: </strong>Articles were limited to English language publications evaluating the efficacy or safety of pivmecillinam for urinary tract infections (UTIs) in adult populations.</p><p><strong>Data synthesis: </strong>Data from 6 randomized controlled trials support pivmecillinam for acute uncomplicated cystitis at doses of 200 to 400 mg 3 times daily for 3 to 7 days, with more consistent clinical and bacteriologic cure observed with 400 mg doses and longer therapy durations. Clinical evaluation of 400 mg 2 to 3 times daily is available with use more common in non-US Food and Drug Administration (FDA)-approved populations, such as men, pregnancy, and multidrug resistant infections. There are limited data supporting pivmecillinam for pyelonephritis; routine use is cautioned until further clinical data are available.Relevance to patient care and clinical practice in comparison with existing drugs:As resistance to first-line antimicrobials rises, the need for safe and effective treatment options remains high. Pivmecillinam represents a new therapeutic option available in the United States for outpatient management of uncomplicated acute cystitis.</p><p><strong>Conclusion: </strong>Pivmecillinam could be a key agent for uncomplicated acute cystitis. Utilization will likely be cost driven, but the promise of low resistance encourages the place in therapy when other agents are not susceptible to infecting uropathogens.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"743-757"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791036","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 Management of Linezolid-Induced Adverse Events in Shorter and Longer Treatment of Rifampicin-Resistant Tuberculosis.","authors":"Hakob Atshemyan, Naira Khachatryan, Anush Khachatryan, Narine Mirzoyan","doi":"10.1177/10600280241296841","DOIUrl":"10.1177/10600280241296841","url":null,"abstract":"<p><strong>Background: </strong>Linezolid is included in most of the regimens for treatment of rifampicin-resistant tuberculosis. The prior publications presented the safety profile and clinical effectiveness of linezolid.</p><p><strong>Objectives: </strong>The research objectives of this study include: description of cumulative incidence rates of linezolid-induced adverse events, assessment of associations of those events with different variables, evaluation of the adverse event management and impacts of the unfavorable events on the effectiveness of treatment for rifampicin-resistant tuberculosis.</p><p><strong>Methods: </strong>We analyzed and compared the data of 2 cohorts: the retrospective cohort of the longer treatment regimens, and the prospective longitudinal cohort consisting of patients on the shorter regimens. Systematic collection of data on adverse events was conducted according to the principles of active pharmacovigilance.</p><p><strong>Results: </strong>The most common linezolid-induced adverse event was peripheral neuropathy (17.5%, 95% confidence interval [CI]: 9.2-25.8). Developing peripheral neuropathy was associated with comorbidities (HIV and endocrine disorders) and the age above 56. The patients exposed to the combination of linezolid and cycloserine were at higher risk of peripheral neuropathy compared with the patients receiving only one of those drugs. The mean time to recovery from peripheral neuropathy was 5.5 months. Myelosuppression and optic nerve disorders were observed at a relatively low frequency.</p><p><strong>Conclusion and relevance: </strong>The rational management of linezolid-induced adverse events minimizes their impact on the effectiveness of treatment. The timely withdrawal of linezolid is the most rational way to prevent delayed recovery from peripheral neuropathy. The withdrawal of linezolid during the first 4 months of chemotherapy was associated with the failure to complete the shorter regimens in 9 months because of slow radiological dynamics. In our research, we are the first to assess the safety and effectiveness of the mSTR regimens in the context of linezolid-induced adverse events by comparing the findings with the data of conventional treatment.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"724-729"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969458","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 UW Experience: Feasibility of De Novo Letermovir for Primary Prophylaxis After Abdominal Solid Organ Transplant.","authors":"Jillian L Descourouez, Hanna Kleiboeker, Christopher M Saddler, Jeannina A Smith, John P Rice, Didier A Mandelbrot, Jon S Odorico, Margaret R Jorgenson","doi":"10.1177/10600280241307383","DOIUrl":"10.1177/10600280241307383","url":null,"abstract":"<p><strong>Background: </strong>Letermovir is approved for primary prophylaxis of cytomegalovirus (CMV) in high-risk kidney transplant recipients. However, many experts suggest the drug be reserved as a second-line agent when valganciclovir is not tolerated or fails.</p><p><strong>Objective: </strong>The purpose of this study was to describe the feasibility of a de novo letermovir prophylactic approach for CMV high-risk and seropositive abdominal solid organ transplant patients.</p><p><strong>Methods: </strong>Retrospective review of abdominal transplant recipients who required CMV prophylaxis between June 6, 2023, and June 6, 2024. The purpose was to evaluate feasibility of universal letermovir prophylaxis and prophylaxis success.</p><p><strong>Results: </strong>278 patients required CMV prophylaxis and 207 obtained letermovir (74% success). Mean time from transplant to drug approval was 10.5 ± 27 days. Mean out of pocket patient cost was $10.19 ± $36.06 per 28-day supply of letermovir and $55.69 ± $311.48 per 30-day supply of valganciclovir (<i>P</i> = 0.0419). For patients who obtained letermovir, 107 (52%) required prior authorization; 32 (16%) required insurance appeal after denial of prior authorization. Forty-two patients (20%) used Merck copay assistance program while 23 (11%) used the Merck Access patient assistance program to obtain drug. There were no episodes of prophylaxis failure due to breakthrough replication necessitating termination.</p><p><strong>Conclusion and relevance: </strong>De novo use of letermovir for CMV primary prophylaxis after abdominal transplant was found to be feasible with a high rate of success in obtaining the drug in a timely manner posttransplant and without significant out-of-pocket cost to the patient.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"730-735"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998832","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":"Maternal RSVpreF Vaccine: A Novel Agent for Respiratory Syncytial Virus Prevention in Infants.","authors":"J Hunter Fly, Jeremy S Stultz, Lea S Eiland","doi":"10.1177/10600280241302775","DOIUrl":"https://doi.org/10.1177/10600280241302775","url":null,"abstract":"<p><strong>Objective: </strong>The objective was to summarize available data regarding the safety and efficacy of RSVpreF in the setting of maternal administration for infant protection against respiratory syncytial virus (RSV) while comparing RSVpreF to other RSV prevention strategies.</p><p><strong>Data sources: </strong>A literature search of PubMed was conducted utilizing the phrases \"RSVpreF\" and \"pregnancy.\" Additional references were identified through found sources of information. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.</p><p><strong>Study selection and data extraction: </strong>Clinical trials investigating RSVpreF administration to pregnant women were included as well as other references on pharmacology, pharmacokinetics, and vaccine uptake.</p><p><strong>Data synthesis: </strong>RSVpreF vaccine, administered once to pregnant women, demonstrated a 69.4% (97.58% confidence interval [CI] = 44.3 to 84.1) lower incidence of severe medically attended RSV lower respiratory tract infection (MA RSV-LRTI) and 51.3% (97.58% CI = 29.4 to 66.8) lower incidence of MA-RSV-LRTI at 180 days post birth in 1 placebo-controlled study. The RSVpreF vaccine administered at 24 to 36 weeks did not have a statistically significant higher rate of preterm births (relative risk = 1.20; 95% CI = 0.99 to 1.46) across two studies and in postmarketing data.Relevance to patient care and clinical practice in comparison with existing agents:The RSVpreF vaccine is the first maternal vaccine approved by the US Food and Drug administration for prevention of RSV in all infants. When compared with other agents, the optimal prophylaxis agent is unclear.</p><p><strong>Conclusions: </strong>Maternal immunization with RSVpreF demonstrated a reduction in MA RSV-LRTI, severe MA RSV-LRTI, and RSV-associated hospitalizations for infants. The vaccine is well tolerated, and adverse events continue to be evaluated.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":"59 8","pages":"758-766"},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144504671","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}