Current Medical Research and Opinion最新文献

{"title":"Indirect comparison of the relative vaccine effectiveness of mRNA-1283 vs. BNT162b2 vaccines against symptomatic COVID-19 among US adults.","authors":"Ekkehard Beck, Mihaela Georgieva, Wei-Jhih Wang, Andres Gomez-Lievano, Hongjue Wang, Yipeng Gao, Hagit Kopel, Mary Bausch-Jurken, Oscar Patterson-Lomba, Fan Mu, Eric Wu, Nicolas VandeVelde","doi":"10.1080/03007995.2025.2466726","DOIUrl":"https://doi.org/10.1080/03007995.2025.2466726","url":null,"abstract":"<p><strong>Background: </strong>COVID-19 continues to pose a significant health burden, particularly among older adults. mRNA-1283 is a next-generation COVID-19 mRNA vaccine developed to enhance immune response. Findings from the Phase 3 NextCOVE trial comparing bivalent versions of mRNA-1273 and mRNA-1283 vaccines have recently become available. However, there are no head-to-head trials comparing mRNA-1283 and the BNT162b2 vaccine.</p><p><strong>Objective: </strong>To indirectly compare the effectiveness of mRNA-1283 and BNT162b2 against symptomatic COVID-19 among adults in the U.S.</p><p><strong>Methods: </strong>A targeted literature review was conducted to identify relevant studies comparing the mRNA-1273 and BNT162b2 bivalent vaccines. A real-world evidence (RWE) study by Kopel et al. (2023) assessing the relative vaccine effectiveness (rVE) of mRNA-1273 vs. BNT162b2, was selected for an indirect treatment comparison (ITC) against the NextCOVE trial using the Bucher method. Analyses were stratified by age group, and sensitivity analyses were conducted using alternative outcome definitions.</p><p><strong>Results: </strong>Despite differences between NextCOVE and the Kopel study, comparability assessments supported a robust ITC. Among participants ≥18 years of age, the indirect rVE of mRNA-1283 vs. BNT162b2 against symptomatic COVID-19 was 15.3% (95% CI: 4.7-24.8%, p = 0.006). For adults ≥65 years of age, the rVE was 22.8% (95% CI: 3.7-38.1%, p = 0.022). Sensitivity analyses with alternative outcome definitions supported these estimates.</p><p><strong>Conclusion: </strong>This analysis provides consistent and statistically significant evidence indicating the next-generation mRNA-1283 vaccine is more effective in preventing symptomatic COVID-19 than BNT162b2, with the largest effect in individuals aged ≥65. Consistent results across sensitivity analyses underscore the robustness of the findings, offering important evidence to inform vaccination decisions by policymakers, providers, and payers.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-21"},"PeriodicalIF":2.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457210","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-world prevalence of potential drug-drug interactions associated with oral advanced therapies indicated for ulcerative colitis.","authors":"Maryia Zhdanava, Sabree Burbage, Todor I Totev, Sumesh Kachroo, Lilian Diaz, Bridget Godwin, Patrick Lefebvre, Dominic Pilon","doi":"10.1080/03007995.2025.2465649","DOIUrl":"10.1080/03007995.2025.2465649","url":null,"abstract":"<p><strong>Objective: </strong>To describe potential drug-drug interactions (DDIs) with oral advanced therapies among patients with ulcerative colitis (UC) and characterize clinical assessments before ozanimod initiation.</p><p><strong>Methods: </strong>Adults with UC were selected from the Merative MarketScan Commercial Database (01 January 2018-31 January 2023); the index date was the most recent UC diagnosis. Patients had no other immune conditions in the 12-month baseline period before the index date. Those with moderate-to-severe UC were analyzed separately. Potential baseline DDIs were identified as claims for medications that may cause a moderate/severe DDI with Janus kinase (JAK) inhibitors (tofacitinib/upadacitinib) or ozanimod according to the Merative Micromedex Complete Drug Interactions Tool. Clinical assessments before ozanimod initiation were characterized.</p><p><strong>Results: </strong>Of 58,870 patients with UC, 24,654 (41.9%) had moderate-to-severe UC. All potential DDIs with ozanimod were severe, while JAK inhibitors had moderate and severe potential DDIs. Among patients with UC, mean (standard deviation) number of severe DDIs was 2.0 (2.4) for ozanimod and 0.2 (0.5) for JAK inhibitors; in moderate-to-severe UC, it was 2.3 (2.6) for ozanimod and 0.4 (0.6) for JAK inhibitors. The most common potential DDIs for ozanimod in UC and moderate-to-severe UC were ondansetron (18.6% and 22.7%), azithromycin (11.9% and 12.8%), as well as hydrocodone, fentanyl, albuterol, ciprofloxacin, and metronidazole (9.0%-11.0% each). For JAK inhibitors, these were COVID-19 vaccines (30.7% and 31.4%), infliximab (8.5% and 20.2%), fluconazole (6.1% and 6.8%), and azathioprine (5.5% and 13.0%). Among patients initiating ozanimod, the first claim for a required clinical assessment was on average, 8 months before initiation.</p><p><strong>Conclusion: </strong>Comorbidities and polypharmacy among patients with UC pose a high risk of DDIs for oral advanced therapies and required pre-treatment clinical assessments can be complicated. This justifies a thorough review of patient profiles for prescribers considering novel treatment options.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"329-338"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406119","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":"Methodological challenges and clinical perspectives in evaluating new treatments for ultra rare cancers.","authors":"Stefania Bellino, Anna La Salvia","doi":"10.1080/03007995.2025.2470735","DOIUrl":"10.1080/03007995.2025.2470735","url":null,"abstract":"<p><p>Patients with ultra rare cancers have a high unmet medical need for the development of safe and effective treatments. To advance cancer drug development is often considered economically unattractive, and usually infeasible with the use of traditional paradigms. Compounding the challenges, evolving scientific understanding of the molecular biology of cancers has resulted in further subdivision of rare cancers into small molecularly defined subsets that may be eligible for targeted therapies. Indeed, research in oncology has undergone an evolution due to advances in biomarker discovery and drug target innovation moving towards a more personalized medicine and effective approach to cancer treatment. These therapies have shown remarkable efficacy with better disease management and brought a higher quality of life for cancer patients. Given the rarity of the diseases, standard randomized controlled trials may not be feasible, and innovative study designs and statistical methods should be applied to evaluate new treatments. To this aim, regulatory agencies have developed guidelines to introduce flexibility in planning of clinical trials, including new adaptive designs, use of real-world data, and surrogate endpoints. This commentary aims at reporting challenges on the evaluation of new treatments for ultra rare cancers with a focus on innovative trial designs, statistical methods, and managing of patients as these cancers are often poorly understood, have limited clinical data, and may require specialized treatment approaches.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"369-373"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467103","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":"Improving the management of Polycythemia Vera patients eligible for cytoreduction: report of a multidisciplinary advisory board.","authors":"Francesco Ramundo, Elena Rossi, Ketty Peris, Alfredo Pontecorvi, Gabriele Sani, Silvia Betti, Marco Marietta, Valerio De Stefano","doi":"10.1080/03007995.2025.2458531","DOIUrl":"10.1080/03007995.2025.2458531","url":null,"abstract":"<p><strong>Introduction: </strong>The management of patients with Polycythemia Vera (PV) traditionally includes low-dose aspirin, phlebotomy, and cytoreductive therapy for high-risk individuals. Recent evidence suggests that cytoreductive treatment may be warranted for patients with additional risk factors beyond the traditional criteria of a history of thrombosis and age over 60 years. Introducing new therapeutic agents, including ropeginterferon alfa-2b and ruxolitinib, enables a more personalized treatment approach tailored to individual patient characteristics.</p><p><strong>Case report: </strong>This report presents three complex clinical scenarios involving patients with PV who required cytoreductive therapy, which were discussed by a multidisciplinary advisory board. Each case is accompanied by a concise literature review and recommendations from non-hematologist specialists on managing adverse events associated with cytoreductive treatment. A multidisciplinary expert panel has identified three conceptual pathways to guide clinicians in selecting cytoreductive therapies and managing their associated complications.</p><p><strong>Conclusion: </strong>The advent of new criteria for starting cytoreduction and the approval of novel drugs for PV has increased the complexity of selecting appropriate cytoreductive therapies. A multidisciplinary approach is increasingly essential to ensure personalized care that maximizes tolerability and minimizes adverse events, particularly given the often chronic nature of the treatment.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"239-245"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063887","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 impact of oral anticoagulants on mortality from pneumonia: a propensity score matching analysis.","authors":"Martin J Ryll, Isabell Aster, Aurelia Zodl, Sarah Thaler, Clemens Rieder, Roland Tomasi, Philipp Groene","doi":"10.1080/03007995.2025.2471498","DOIUrl":"10.1080/03007995.2025.2471498","url":null,"abstract":"<p><strong>Objective: </strong>Pneumonia continues to be one of the leading causes of death. During the COVID pandemic, pre-existing anticoagulant therapy with direct oral anticoagulants (DOACs) appeared to be beneficial. The present study aimed to investigate the impact of pre-existing DOAC therapy on mortality from community-acquired, non-COVID pneumonia.</p><p><strong>Methods: </strong>The study utilized data from the eICU Collaborative Research Database, a comprehensive, multi-institutional critical care database. We included all adult patients with community-acquired pneumonia, selecting for patients with a primary admission diagnosis of pneumonia or pulmonary sepsis who were admitted to the ICU <24 h after admission to the hospital. To adjust for confounders, we performed propensity score matching, matching patients receiving DOACs to an equivalent cohort of patients not receiving DOAC therapy. Our primary outcome was overall survival. Secondary outcomes included all-cause in-hospital mortality, all-cause in-ICU mortality, intubation within 24 h following ICU admission, incidence of acute kidney injury and renal replacement therapy, vasopressor administration, and mechanical ventilation days.</p><p><strong>Results: </strong>Our final matched cohort included 198 DOAC patients matched to 594 patients without DOAC therapy. Survival was significantly higher in DOAC patients with a hazard ratio of 0.56 [95% CI = 0.36-088]. Both all-cause in-unit mortality (6.1% [95% CI = 2.7-9.4%] vs. 13.3% [95% CI = 10.6-16.0%], <i>p</i> = 0.008) and all-cause in-hospital mortality (11.6% [95% CI = 7.2-16.1%] vs. 19.7% [95% CI = 16.5-22.9%], <i>p</i> = 0.013) were significantly lower in patients receiving DOACs.</p><p><strong>Conclusion: </strong>This study demonstrates a positive association between the pre-existing intake of direct oral anticoagulants and the survival of community acquired pneumonia. Future prospective studies should evaluate supportive therapy with DOACs.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"339-346"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522851","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":"US general population food allergy treatment preferences: a discrete choice experiment.","authors":"Alexis T Mickle, Christina E Ciaccio, Arpamas Seetasith, Karissa M Johnston, Jessica S Dunne, Stacey Kowal, Andrea Bever, Stella Ko, Vincent Garmo, Sachin Gupta, Andrew Lloyd, Christopher M Warren","doi":"10.1080/03007995.2025.2459784","DOIUrl":"10.1080/03007995.2025.2459784","url":null,"abstract":"<p><strong>Objective: </strong>To quantify treatment preferences for food allergy management options (oral immunotherapy, biologic therapy, and allergen avoidance), overall and by sociodemographic strata.</p><p><strong>Methods: </strong>A US general population (≥13 years) discrete choice experiment (DCE) was conducted, including the Intolerance of Uncertainty-12 Scale and clinical/demographic questions. Conditional logistic regression analyses were conducted overall and by sociodemographic factors. DCE results were presented as odds ratios (ORs) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Participants (<i>n</i> = 294) mean (standard deviation) age was 47 (19.7) years; 48.6% were male. A 1% reduction in risk of having an exposure resulting in a moderate-to-severe reaction was statistically significantly associated with treatment preference (OR: 1.10; CI:1.04-1.16; <i>p</i> < 0.01). Features significantly associated with reduced preference included: a 1% increase in risk of treatment-related, severe anaphylaxis (0.85; 0.74-0.97; <i>p</i>=0.02); a 1% increase in risk of gastrointestinal symptoms (0.99; 0.99-0.99; <i>p</i> < 0.01); daily treatment (<i>vs.</i> every 2-4 weeks; 0.81; 0.72-0.91; <i>p</i> < 0.01); in-clinic administration (<i>vs.</i> at-home; 0.76; 0.66-0.87; <i>p</i> < 0.01); subcutaneous administration (<i>vs.</i> oral; 0.69; 0.61-0.78; <i>p</i> < 0.01); three-hour post-treatment physical activity limitation (0.84; 0.77-0.93; <i>p</i> < 0.01); and one-year life expectancy reduction (0.87; 0.85-0.89; <i>p</i> < 0.01). Rural dwellers favoured at-home use and no activity limits; lower-income respondents preferred convenience (oral, less frequent, and at-home administration). Teens strongly preferred being bite-safe (<i>vs.</i> fully allergic; 2.75; 1.09-6.90; <i>p</i> = 0.03).</p><p><strong>Conclusion: </strong>When making food allergy management decisions, US general population respondents had strong preferences for features related to safety and convenience; however, the magnitude of preferences varied by sociodemographic factors. These findings may be pertinent for population-level health decision makers.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"269-279"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063888","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":"Patient and caregiver insights into lung cancer treatment decision-making: an exploratory focus group.","authors":"Julie Vanderpoel, Nida Imran, Andy L Johnson, Susan Hutter, Karen Fixler, Christine Holcomb, Wesley Peters, Lisa Shea","doi":"10.1080/03007995.2025.2456009","DOIUrl":"10.1080/03007995.2025.2456009","url":null,"abstract":"<p><strong>Objective: </strong>We describe discussions about the lung cancer treatment decision-making process across the patient journey from the perspective of patients and caregivers with diverse experiences of living with lung cancer.</p><p><strong>Methods: </strong>Patient preference studies show individuals with lung cancer usually favor more aggressive treatments despite adverse events (AEs), in pursuit of better survival. However, patients are frequently passive in treatment decisions, suggesting there are barriers impairing patients' abilities to engage in shared decision-making. To explore this further, we asked patients with epidermal growth factor receptor-positive lung cancer and their caregivers to complete surveys and participate in focus group discussions facilitated by research specialists.</p><p><strong>Results: </strong>US patients with lung cancer (<i>n</i> = 11) and caregivers (<i>n</i> = 4) took part in exploratory focus groups. While initial treatment decisions were mostly led by healthcare providers, participants became more engaged in their treatment over time. As in other studies, participants prioritized survival over AEs when selecting treatments and shared fears of being switched to less efficacious treatments or reduced dose if they disclosed AEs. Participants emphasized the importance of shared decision-making, early discussions about AEs, and access to patient advocates.</p><p><strong>Conclusion: </strong>Healthcare providers should distribute reliable educational materials and have early conversations with patients on individual lung cancer treatment, health-related quality of life goals, potential AEs, and distinguishing AEs from disease progression symptoms.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"297-306"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406114","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 response to pericapsular soft tissue and pelvic realignment therapy may be partially predicted by the relevant factors influencing the program's response of the candidates with hip osteoarthritis for joint replacement.","authors":"Kazuo Hayashi, Shoji Tokunaga, Toshiharu Tsunoda, Ken Toyota","doi":"10.1080/03007995.2025.2454508","DOIUrl":"10.1080/03007995.2025.2454508","url":null,"abstract":"<p><strong>Objective: </strong>To explore the risk factors for discontinuation of pericapsular soft tissue and pelvic realignment (PSTP-R) therapy derived from Shiatsu in the candidates with osteoarthritis for total hip replacement (THR) (i.e. candidates for total hip replacement) treated from 2017 to 2020, and to identify the effect modifiers of PSTP-R therapy for patients who continued therapy for 6 months.</p><p><strong>Methods: </strong>Exploratory analyses of data from the clinical trial for PSTP-R therapy in a prospective observational study in which the PSPT-R therapies for 6 months improved Harris Hip Score (HHS) in 193 patients with an HHS below 60 points in two study centers, even in 130 patients with complete loss of cartilage on radiography among those 193 ones. The risk factors for the discontinuation of PSTP-R therapy and the effect modifiers for PSTP-R therapy were explored statistically.</p><p><strong>Results: </strong>The risk of discontinuation of PSTP-R therapy increased as the frequency of buttock pain at baseline increased, and was mitigated as the baseline opening angle of the hip according to the modified Patrick's test increased. Cartilage loss on radiography was not a risk factor for withdrawal from PSPT-R therapy. Among patients who continued PSTP-R therapy for 6 months, a lower Kellgren-Lawrence grade at baseline was associated with an increase in the total score of HHS.</p><p><strong>Conclusion: </strong>Buttock pain at baseline was most associated with discontinuation of PSPT-R therapy. The patients that can improve with PSPT-R therapy should be selected to avoid inappropriate surgery by the detailed analysis of relevant clinical factors influencing the response for this program as well as image findings such as cartilage loss on radiography at baseline. <b>Trial registration:</b> Registered in the Clinical Trials Registry on 20 July 2017 (UMIN000028277).</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"281-296"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001594","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":"Resistance to conventional drug therapy and good response to lomitapide allowed the identification of a novel bi-allelic semi-dominant monogenic HoFH: a case report.","authors":"Paolo Fornengo, Simone Mattivi, Elisa Rinaudo, Federica Lepore, Ileana Iemmolo, Valeria Bracciamà, Giulia Margherita Brach Del Prever, Angelo Corso Faini, Marilena Durazzo, Silvia Deaglio","doi":"10.1080/03007995.2025.2465615","DOIUrl":"10.1080/03007995.2025.2465615","url":null,"abstract":"<p><strong>Introduction: </strong>Familial hypercholesterolaemia (FH) is a genetic disorder associated with high cholesterol levels and an increased risk of premature cardiovascular events. Rare forms, such as semi-dominant bi-allelic mutations, pose diagnostic and therapeutic challenges. Misdiagnosis of FH is a significant concern, as highlighted by both this case and a review of the literature.</p><p><strong>Case report: </strong>We report the case of a 54-year-old woman with an acute myocardial infarction at the age of 43 years. She had a positive family history of early cardiovascular events and was diagnosed with familial hypercholesterolaemia at the age of 33 years. She tried statins with no benefit. In 2017, evolocumab was introduced but was insufficient to control cholesterol values (low-density lipoprotein cholesterol 324 mg/dL). She started lomitapide, and next-generation sequencing screening was performed in consideration of the different pharmacological effects and clinical trends compared to other family members. A bi-allelic semi-dominant mutation (c.241C > T in exon 3 of the LDLR gene) was found in addition to the previously identified mutation. She is now in good clinical condition and laboratory response with lomitapide, evolocumab, statin, and ezetimibe. A literature review was conducted to explore the clinical and diagnostic challenges of FH, with a focus on the risk of misdiagnosis.</p><p><strong>Conclusion: </strong>This case underscores the importance of genetic testing in diagnosing rare forms of FH, such as semi-dominant bi-allelic mutations, which may lead to misdiagnosis. Lomitapide proved effective in controlling cholesterol levels, highlighting its value in managing complex FH cases. The literature review further emphasizes the critical need for improved diagnostic approaches to minimize the risk of misdiagnosis.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"209-217"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of clinical applications of pharmacokinetic simulations for a 2-month long-acting injectable formulation of aripiprazole.","authors":"Andrea Fagiolini, Yanlin Wang, Miquel Bioque, Matthew Harlin, Frank Larsen, Xiaofeng Wang, Wansu Park, Benjamin Rich, Jogarao V Gobburu, Arash Raoufinia","doi":"10.1080/03007995.2025.2456014","DOIUrl":"10.1080/03007995.2025.2456014","url":null,"abstract":"<p><p>Aripiprazole 2-month ready-to-use (Ari 2MRTU) is a long-acting injectable antipsychotic that was approved for use in Europe in March 2024, for the maintenance treatment of schizophrenia in adult patients stabilized with aripiprazole; it is administered <i>via</i> gluteal intramuscular injection once every two months. This review examines population pharmacokinetic model-based simulations relevant to the use of Ari 2MRTU in Europe, accompanied by expert commentary that contextualizes the simulations and highlights the potential implications of the availability of Ari 2MRTU for patients, caregivers, and clinicians. Various simulations conducted across 8 weeks (representing the first dosing interval), or 32 weeks (representing maintenance dosing) demonstrated an aripiprazole exposure profile for Ari 2MRTU that was similar to aripiprazole once-monthly (AOM), but with an extended dosing interval. In treatment initiation scenarios consistent with the European label, therapeutic levels of aripiprazole (i.e. ≥95 ng/mL) were maintained when transitioning from either AOM or oral aripiprazole, including with a two-injection start regimen with no requirement for 14 days of oral aripiprazole supplementation. Therapeutic levels of aripiprazole were also observed for treatment maintenance scenarios, except when dosing of Ari 2MRTU was delayed by 8 weeks. The availability of Ari 2MRTU extends the range of options for the maintenance treatment of schizophrenia in Europe. Ari 2MRTU may provide adherence benefits due to its extended dosing interval and the option to initiate treatment using a two-injection start regimen, which does not require 14 days of overlapping oral supplementation.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"317-327"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051897","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}