Annals of Pharmacotherapy最新文献

{"title":"Comparison of Heart Rates in Patients Initiated on Ticagrelor Versus Other P2Y12 Inhibitors After an Inferior ST Elevation Myocardial Infarction (STEMI).","authors":"Taylor M Law, Kevin M Wohlfarth","doi":"10.1177/10600280241255111","DOIUrl":"10.1177/10600280241255111","url":null,"abstract":"<p><strong>Background: </strong>P2Y12 inhibitors have differing associations of bradyarrhythmias. Ticagrelor has been shown to increase adenosine plasma concentrations leading to increases in bradyarrhythmias. While clopidogrel and prasugrel have not been shown to have any association with bradyarrhythmias.</p><p><strong>Objective: </strong>The objective of this study was to determine heart rates after ticagrelor initiation compared to clopidogrel/prasugrel in inferior ST Elevation Myocardial Infarction (STEMI) patients.</p><p><strong>Methods: </strong>This was a retrospective, multicenter study conducted at 3 primary percutaneous coronary intervention (PCI) centers between January 1, 2017 and September 30, 2022. Adult patients were included if they were diagnosed with an inferior STEMI to the right coronary artery (RCA) and treated with PCI followed by an oral P2Y12 inhibitor. The primary outcome was heart rate at 48 hours or discharge, whichever first, after administration of ticagrelor compared to clopidogrel/prasugrel.</p><p><strong>Results: </strong>This study reviewed 331 patients, 172 in the ticagrelor group and 159 in the clopidogrel/prasugrel group. There were no statistical differences between groups regarding the primary outcome, with a median heart rate of 76 beats per minute (bpm) [67-85] in the ticagrelor group versus 73 bpm [66-84] in the clopidogrel/prasugrel group (<i>P</i> = 0.238). No differences were observed between groups regarding any secondary outcomes.</p><p><strong>Conclusion and relevance: </strong>There were similar heart rates between ticagrelor and clopidogrel/prasugrel. There were also similarities in the ability to tolerate beta-blocker therapy after initiation of a P2Y12 inhibitor. The results of this study suggest that in inferior STEMIs when using ticagrelor as the P2Y12 inhibitor, there are not increased clinical manifestations of bradycardia.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"142-147"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141178977","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":"Buprenorphine in the Intensive Care Unit: Commentary on the Unanswered Questions.","authors":"David J Gagnon, Melody J Glenn, Aurora A Quaye, Brian L Erstad","doi":"10.1177/10600280241254528","DOIUrl":"10.1177/10600280241254528","url":null,"abstract":"<p><p>The removal of the X-waiver in the Mainstreaming Addiction Treatment (MAT) Act of 2023 has substantial implications for buprenorphine prescribing as one of the options to treat opioid use disorder. The purpose of this commentary is to discuss the unanswered questions regarding buprenorphine in the intensive care unit (ICU) including how the passage of the MAT Act will affect ICU providers, which patients should receive buprenorphine, what is the most appropriate route of administration and dose of buprenorphine, what medications interact with buprenorphine, and how can transitions of care be optimized for these patients.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"184-188"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11660430/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955827","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":"Sodium-Glucose Co-Transporter 2 Inhibitors and Severe Urinary Tract Infections: Real-World Meta-Analysis of Cohort Studies.","authors":"Mohammed Aboukaoud, Yocheved Morhi, Ester Osher","doi":"10.1177/10600280241312432","DOIUrl":"https://doi.org/10.1177/10600280241312432","url":null,"abstract":"<p><strong>Objective: </strong>There is limited knowledge about severe urinary tract infections associated with SGLT2i, despite this being the basis for the Food and Drug Administration (FDA) warning. We aim to provide real-world evidence to clarify this relationship further.</p><p><strong>Data source: </strong>A literature review was performed in PubMed and Embase for cohort studies published up to August 2024 using PICO-consistent terms.</p><p><strong>Study selection and data extraction: </strong>Cohort studies in English involving new users of SGLT2i that compare SGLT2i with glucagon-like receptor agonists (GLP-1RA), DPP4i, and other glucose-lowering medications and report severe urinary tract infection (UTI).</p><p><strong>Data synthesis: </strong>The random-effect model determined the odds ratio (OR) and 95% confidence interval (CI) for severe UTI. Subgroup analysis and meta-regression were used to identify sources of heterogeneity. In 11 cohort studies involving 679 617 individuals with type 2 diabetes mellitus and a median age of 64 (interquartile range [IQR] = 56-72) and 42% (IQR = 39%-51%) females, it was found that the use of SGLT2i was associated with a reduced risk of severe UTI compared with both composite glucose-lowering medications (OR = 0.73, 95% CI = 0.60-0.88) and DPP4i (OR = 0.48, 95% CI = 0.43-0.54). There was no significant difference in the risk compared with GLP-1RA (OR = 0.94, 95% CI = 0.78-1.14).</p><p><strong>Relevance to patient care and clinical practice: </strong>The lack of increased risk for severe UTI reassures physicians when assessing benefit-risk to continue SGLT2i after a severe UTI. This may enhance patient adherence and improve diabetes management. Furthermore, our findings show no significant risk increase in chronic kidney disease (CKD) patients who would benefit significantly from SGLT2i.</p><p><strong>Conclusion: </strong>SGLT2i does not appear to pose a greater risk of severe UTI than other oral glucose-lowering medications. This contributes to the existing literature on UTI, accounting for the event's severity. However, more data are needed to assess the potential association between SGLT2i and life-threatening UTI events.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241312432"},"PeriodicalIF":2.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063377","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":"Pharmacist-Directed Transition of Care Services Decrease Readmissions at a Safety-Net Hospital.","authors":"Shannon Carboni, Monika Tawfik, Brooke Menon, Heather Rhodes, Ann Brigino","doi":"10.1177/10600280241310862","DOIUrl":"https://doi.org/10.1177/10600280241310862","url":null,"abstract":"<p><strong>Background: </strong>Limited data exist describing the influence of pharmacist-led transition of care (TOC) services in safety-net hospital settings.</p><p><strong>Objective: </strong>This analysis assessed the impact of pharmacist-led TOC services on hospital readmissions in a high-risk managed Medicaid population impacted by housing instability, substance use disorder (SUD), and mental health issues.</p><p><strong>Methods: </strong>A retrospective evaluation of patients who received safety-net hospital-based TOC pharmacy services between January 1, 2022, and December 31, 2022, was conducted. Patients 18 years and older, insured by a select managed Medicaid plan, and admitted to an inpatient medicine service were included. Patients were excluded if they were admitted from or discharged to a facility or hospice, discharged before medically ready, or died within 30 days of discharge. Interventions included an initial visit, discharge medication delivery and education, and a post-discharge follow-up phone call within 24 to 72 hours. Patients were provided with a number to call for medication-related questions post-discharge. The primary outcome was 30-day hospital readmissions. Secondary outcomes included time to and reason for readmission and a description of TOC services.</p><p><strong>Results: </strong>There were 292 patients engaged in pharmacist-led TOC services. Nearly 1 in 6 patients were experiencing homelessness and almost 40% were struggling with SUD during the index admission. The median readmission performance in the target population 6 months prior to TOC service implementation was 20.2% and fell to 12.3% post-intervention. Substance use disorder was the leading contributor to re-hospitalization, accounting for 58% of readmissions. Six (16.7%) readmissions were medication-related; 5 of 6 were complicated by SUD. There were no preventable medication-related readmissions. There are limitations to this study; not all patients received all TOC program components. Prospective, randomized-controlled studies are needed to show cause and effect.</p><p><strong>Conclusion and relevance: </strong>This evaluation suggests pharmacist-led TOC discharge services may lead to hospital readmission reduction in a socially complex managed Medicaid population in a safety-net hospital setting.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241310862"},"PeriodicalIF":2.3,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035978","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":"https://doi.org/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":"10600280241308212"},"PeriodicalIF":2.3,"publicationDate":"2025-01-17","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":"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":"https://doi.org/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":"10600280241307383"},"PeriodicalIF":2.3,"publicationDate":"2025-01-15","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":"Appropriate Statin Use in Patients With Newly Diagnosed Acute Ischemic Stroke or Myocardial Infarction at a Tertiary County Teaching Hospital.","authors":"Soomin Woo, Charles F Seifert","doi":"10.1177/10600280241305436","DOIUrl":"https://doi.org/10.1177/10600280241305436","url":null,"abstract":"<p><strong>Background: </strong>Statins are the mainstay of therapy in patients suffering an acute ischemic stroke (AIS) or myocardial infarction (MI); however, several studies have shown that prescribing is not optimal.</p><p><strong>Objective: </strong>The main objective of this study was to evaluate the percentage of patients prescribed appropriate statin therapy upon discharge after an AIS or MI.</p><p><strong>Methods: </strong>This is a single-center retrospective cohort study conducted at a tertiary, county, teaching hospital in patients aged 18 to 89 years who were newly diagnosed with AIS or MI, from September 2017 to September 2022.</p><p><strong>Results: </strong>Six hundred thirty-six individuals were hospitalized for AIS or MI according to ICD-10 codes. Of these, 389 patients were excluded, and 247 were included in the analysis. Although 85% of AIS and MI patients were at very high risk of future ASCVD events, over 25% were not discharged on appropriate statin therapy. Patients who had been taking high-intensity statins or were statin-naïve prior to admission (156/194, 80.4%) were significantly more likely to be discharged with appropriate statin therapy compared to those who had been taking low or moderate-intensity statins at home (27/53, 50.9%, p<0.0001, OR = 3.41, 95% CI = 1.71 to 6.79).</p><p><strong>Conclusion and relevance: </strong>The treatment of patients with statin therapy following an AIS and MI remains suboptimal, despite most of these patients being at very high risk for further ASCVD events. Significantly more patients on high-intensity statins or were statin naïve on admission were discharged on appropriate therapy.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241305436"},"PeriodicalIF":2.3,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998831","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":"An Evaluation of Iloperidone for Mania in Bipolar I Disorder.","authors":"Kelen Caskey, Leigh Anne Nelson","doi":"10.1177/10600280241308287","DOIUrl":"https://doi.org/10.1177/10600280241308287","url":null,"abstract":"<p><strong>Objective: </strong>To review the efficacy of iloperidone for mania associated with bipolar I disorder and discuss its safety profile (eg, QTc prolongation, orthostatic hypotension, and metabolic adverse effects).</p><p><strong>Data sources: </strong>Literature was identified using PubMed (1966-September 2024), OVID (1984-November 2024), and clinicaltrials.gov. Search terms included iloperidone, bipolar disorder, and mania.</p><p><strong>Study selection and data extraction: </strong>The study included trials evaluating iloperidone for treating bipolar mania.</p><p><strong>Data synthesis: </strong>In one phase 3 study, iloperidone demonstrated significant improvement in mania symptoms at day 28 on all primary (ie, Young Mania Rating Scale) and secondary outcomes (Clinical Global Impression-Severity/Change scales) compared to placebo. Iloperidone was well tolerated, with tachycardia, dizziness, dry mouth, alanine aminotransferase elevation, nasal congestion, increased weight, and somnolence reported as common adverse effects.</p><p><strong>Relevance to patient care and clinical practice in comparison to existing drugs: </strong>Since there are no head-to-head studies comparing iloperidone with other second-generation antipsychotics for bipolar mania, other treatment considerations drive medication selection. Iloperidone is unavailable in a generic formulation; thus, its use will be associated with higher costs. It is dosed twice daily, which may negatively impact adherence. Iloperidone is associated with a moderate risk of QTc prolongation, metabolic adverse effects, and orthostatic hypotension, which will limit its use in certain patient populations. QTc prolongation is dose related, so drug interactions involving CYP2D6 and CYP3A4 inhibition can have serious consequences.</p><p><strong>Conclusion: </strong>In the pivotal trial, iloperidone was effective in treating adults with an acute manic or mixed episode associated with bipolar I disorder and was safe and well tolerated.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241308287"},"PeriodicalIF":2.3,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969478","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":"https://doi.org/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":"10600280241296841"},"PeriodicalIF":2.3,"publicationDate":"2025-01-12","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":"Evaluation of the Toxicity and Outcomes of the Combination of Midostaurin and CLAG-M in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML): A Multicenter Retrospective Analysis.","authors":"Ashley Chen, Grace Baek, Kathryn Russell, Carole Shaw, Megan Othus, Jonathan Cohen, Shannon Palmer, Jack Rasmussen, Joseph Bubalo, Tenzin Tsomo, Tenley Schwarz, Swathi Namburi, Anna Halpern","doi":"10.1177/10600280241305608","DOIUrl":"https://doi.org/10.1177/10600280241305608","url":null,"abstract":"<p><strong>Background: </strong>Addition of midostaurin to standard \"7+3\" (cytarabine and anthracycline) significantly prolongs overall and event-free survival. At University of Washington/Fred Hutchinson Cancer Center (UW/FHCC), the standard regimen for newly diagnosed (ND) and relapsed/refractory (R/R) AML is cladribine, high-dose cytarabine, GCSF, and mitoxantrone (CLAG-M); midostaurin is added if FLT3-mutated. There is limited data on the use of FLT3-inhibitors with high-dose cytarabine regimens in AML.</p><p><strong>Objective: </strong>This study aimed to evaluate the safety and efficacy of the combination of midostaurin with CLAG-M versus midostaurin plus 7+3 in FLT3-mutated AML patients.</p><p><strong>Methods: </strong>This is a retrospective, multicenter review including FLT3-mutated AML patients undergoing (re)induction chemotherapy with either CLAG-M or 7+3 at UW/FHCC, Oregon Health & Science University, and Swedish Cancer Institute. The primary outcome was incidence of adverse events. Secondary outcomes included disease response per ELN2017 criteria and 28-day mortality. Excluded were patients on clinical trials or who started midostaurin 30 days after chemotherapy.</p><p><strong>Results: </strong>Eighty patients treated from September 2016 to December 2023 were included; 36 patients received CLAG-M, and 44 patients 7+3. Baseline characteristics were similar across all institutions. Adverse event rates were similar between the 2 cohorts, except diarrhea and bleeding which were more common in the 7+3 cohort. The rate of complete remission (CR) plus CR with incomplete blood count recovery did not significantly differ between the 2 cohorts: CLAG-M, 86% versus 7+3, 70% (<i>P</i> = 0.11).</p><p><strong>Conclusion & relevance: </strong>The toxicity profile of CLAG-M combined with midostaurin is comparable with the combination of 7+3 with midostaurin, and induces high remissions rates in adults with FLT3-mutated AML.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241305608"},"PeriodicalIF":2.3,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969451","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}