{"title":"A review of pharmacokinetic data describing long-acting injectable cabotegravir during pregnancy.","authors":"Shawnalyn W Sunagawa, Kimberly K Scarsi","doi":"10.1080/14656566.2025.2499151","DOIUrl":"10.1080/14656566.2025.2499151","url":null,"abstract":"<p><strong>Introduction: </strong>Eliminating vertical human immunodeficiency virus (HIV) transmission is a global health objective. Significant progress has been accomplished through advancements in antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). Long-acting cabotegravir (CAB-LA) is a novel strategy addressing daily oral adherence challenges for both treatment and prevention of HIV. For treatment, CAB-LA is currently approved in combination with long-acting rilpivirine (RPV-LA). Despite its promise, there are limited data surrounding the utilization of CAB-LA in pregnancy. Understanding potential CAB-LA pharmacokinetic (PK) changes during pregnancy is necessary to ensure effectiveness and safety.</p><p><strong>Areas covered: </strong>Current PK data for CAB-LA in pregnant individuals, including physiological changes affecting PK, physiologically based PK modeling, and clinical PK data.</p><p><strong>Expert opinion: </strong>Long-acting therapies represent the future of HIV treatment and prevention. Available data demonstrate no clinically significant change in CAB PK, supporting CAB-LA for PrEP in pregnant individuals. However, available data for oral RPV and RPV-LA during pregnancy demonstrate lower drug concentrations, which limit CAB-LA utilization for HIV treatment until alternative partner drugs are available. Other long-acting prevention and treatment strategies are in development. Future studies assessing long-acting strategies are necessary during drug development to ensure equitable and timely access to novel therapies for all individuals.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"961-968"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Moza Hamoud, Ruba Alchaikh Hassan, Constantin A Dasanu
{"title":"Selecting optimal therapy for Langerhans cell histiocytosis: current state and future directions.","authors":"Moza Hamoud, Ruba Alchaikh Hassan, Constantin A Dasanu","doi":"10.1080/14656566.2025.2508276","DOIUrl":"10.1080/14656566.2025.2508276","url":null,"abstract":"","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1005-1008"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lucas W Rowe, Christian Akotoye, Alon Harris, Thomas A Ciulla
{"title":"Beyond the injection: delivery systems reshaping retinal disease management.","authors":"Lucas W Rowe, Christian Akotoye, Alon Harris, Thomas A Ciulla","doi":"10.1080/14656566.2025.2496424","DOIUrl":"10.1080/14656566.2025.2496424","url":null,"abstract":"<p><strong>Introduction: </strong>Intravitreal injections remain the standard for treating common retinal diseases including age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy. However, frequent administration creates significant treatment burden due to limited drug half-life and the chronic nature of these conditions.</p><p><strong>Areas covered: </strong>This review summarizes emerging drug delivery techniques and therapies for retinal disease that have achieved FDA approval within the past five years or have advanced to Phase 3 development, including intravitreal sustained-release platforms and alternative delivery routes (suprachoroidal, subretinal, topical, and subcutaneous). Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone).</p><p><strong>Expert opinion: </strong>Promising innovations include sustained-release intravitreal implants, topical and subcutaneous delivery systems, and targeted methods like suprachoroidal and subretinal injections, each with unique advantages and limitations. Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"939-952"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12360407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Valeria Mammarella, Ludovico Randazzo, Sara Romano, Maria Breda, Oliviero Bruni
{"title":"Pharmacological management for insomnia in children and adolescents with autism and attention deficit and hyperactivity disorder.","authors":"Valeria Mammarella, Ludovico Randazzo, Sara Romano, Maria Breda, Oliviero Bruni","doi":"10.1080/14656566.2025.2508277","DOIUrl":"10.1080/14656566.2025.2508277","url":null,"abstract":"<p><strong>Introduction: </strong>Insomnia is common in children and adolescents with autism spectrum disorder (ASD) and/or attention deficit and hyperactivity disorder (ADHD), with significant implications for quality of life and prognosis. Although non-pharmacological interventions represent the first-line approach, they are not always effective. Therefore, it is important to determine when a pharmacological treatment can be indicated and which compound to prefer based on evidence of efficacy and safety.</p><p><strong>Areas covered: </strong>The literature evidence related to the pharmacological treatment of insomnia in ASD and/or ADHD is discussed. We present data on drugs and supplements used and considerations about the choice of starting a pharmacological therapy, suggesting clinical advice that may guide clinicians.</p><p><strong>Expert opinion: </strong>Untreated insomnia can worsen ASD and ADHD symptoms, impair cognitive function, and reduce quality of life. Targeted interventions are essential. Behavioral strategies, with or without melatonin, are recommended after evaluating comorbidities and medications. Off-label treatments for children with ASD include antihistamines, alpha-adrenergics, trazodone, antidepressants, antipsychotics, anticonvulsants, and hypnotics. For ADHD, options include iron supplementation for restlessness and low ferritin levels, and alpha2-adrenergics like guanfacine and clonidine for their sedative effects.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1079-1098"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Klaus Rose, Tomoko Maeda-Chubachi, Jane M Grant-Kels
{"title":"Drug development in dermatology: challenges in treating young patients.","authors":"Klaus Rose, Tomoko Maeda-Chubachi, Jane M Grant-Kels","doi":"10.1080/14656566.2025.2496425","DOIUrl":"10.1080/14656566.2025.2496425","url":null,"abstract":"<p><strong>Introduction: </strong>Drug development for skin disorders is influenced by the concept of children as 'therapeutic orphans' and is subject to pediatric requirements of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The EMA requires a 'pediatric investigation plan' (PIP) early in development. Healthy newborns' skin is as thick as that of adults. For crisaborole for atopic dermatitis, the FDA accepted pivotal trials involving patients 2-79 years; the EMA accepted this as part of its PIP. In contrast, for psoriasis, PIPs require separate evidence of efficacy and safety in children aged 6-17 years.</p><p><strong>Areas covered: </strong>Adolescents' skin does not change overnight on their 18th birthday, only the legal status. Most FDA pediatric requirements are grounded in commonsense and reflect current scientific understanding. The EMA, however, continues to take rigid stance in its pediatric demands. PIP negotiations are often lengthy, complex, and frustrating.</p><p><strong>Expert opinion: </strong>Companies must possess a deep understanding of the clinical landscape, considerable patience, and sometimes seek external experts' support. A gap has become wider between US and EU, with the EU increasingly falling behind in drug development.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"953-960"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143992956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kareem Malas, Salman Kazmi, Yu Mi Kang, Darren K McGuire
{"title":"The contemporary landscape of cardiovascular optimization in type 2 diabetes: overcoming barriers to evidence-based use of newer antihyperglycemic agents.","authors":"Kareem Malas, Salman Kazmi, Yu Mi Kang, Darren K McGuire","doi":"10.1080/14656566.2025.2504702","DOIUrl":"10.1080/14656566.2025.2504702","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiometabolic diseases, particularly type 2 diabetes (T2D) and cardiovascular disease (CVD), represent leading global health challenges with rising incidence and prevalence. Despite strong evidence supporting the benefits of sodium-glucose cotransporter inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) in managing CVD risk in T2D, these therapies remain underutilized.</p><p><strong>Areas covered: </strong>This review discusses the present state of SGLT2i and GLP-1 RA usage, emphasizing barriers to their adoption, including clinical inertia, high costs, and misconceptions about injectable therapies. The literature search was conducted using PubMed, UpToDate, major society journals, and clinical guidelines. Information was gathered from cohort studies, survey reports, randomized controlled trials, and meta-analyses that examine the effectiveness and challenges surrounding these treatments.</p><p><strong>Expert opinion: </strong>Addressing the underuse of SGLT2i and GLP-1 RA requires a multifaceted approach. Key strategies include improving prescriber awareness, reducing out-of-pocket costs, fostering interdisciplinary collaboration, and leveraging digital health tools. Implementation science has shown promise in enhancing therapy uptake. Future efforts must integrate these therapies into value-based care models to ensure timely, equitable access, ultimately reducing cardiovascular (CV) morbidity and mortality in high-risk T2D populations.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1009-1020"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Darshilkumar Maheta, Siddharth Pravin Agrawal, Wilbert S Aronow
{"title":"Advances in the management of obstructive hypertrophic cardiomyopathy: The role of mavacamten.","authors":"Darshilkumar Maheta, Siddharth Pravin Agrawal, Wilbert S Aronow","doi":"10.1080/14656566.2025.2498479","DOIUrl":"10.1080/14656566.2025.2498479","url":null,"abstract":"<p><strong>Introduction: </strong>Hypertrophic cardiomyopathy (HCM) is a common inherited cardiovascular disorder characterized by asymmetric left ventricular hypertrophy and increased risk of sudden cardiac death. While current treatments like beta-blockers, calcium channel blockers, and invasive procedures provide symptom relief, they do not prevent disease progression. Mavacamten, a first-in-class cardiac myosin inhibitor, offers a promising alternative by directly targeting the underlying cause of left ventricular outflow tract (LVOT) obstruction in obstructive HCM. This drug reduces myosin ATPase activity, decreasing myocardial contractility and alleviating symptoms such as shortness of breath, fatigue, and chest pain. Clinical trials, including EXPLORER-HCM and VALOR-HCM, have demonstrated significant improvements in LVOT obstruction, exercise capacity, and overall quality of life while reducing the need for invasive procedures.</p><p><strong>Areas covered: </strong>This review discusses mavacamten's mechanism of action, pharmacokinetics, clinical efficacy, safety, and integration into clinical practice, highlighting its role as a key treatment for patients who do not respond to conventional therapies.</p><p><strong>Expert opinion: </strong>Mavacamten is generally well tolerated, although it requires careful monitoring of left ventricular ejection fraction (LVEF) and genetic factors such as CYP2C19 variations. The drug represents a significant advancement in the management of symptomatic obstructive HCM, offering a noninvasive, disease-modifying option.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"927-931"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stephanie K A Wong, Simone Appenzeller, Marinka Twilt
{"title":"Advances in pharmacotherapy of juvenile idiopathic arthritis.","authors":"Stephanie K A Wong, Simone Appenzeller, Marinka Twilt","doi":"10.1080/14656566.2025.2501146","DOIUrl":"10.1080/14656566.2025.2501146","url":null,"abstract":"<p><strong>Introduction: </strong>Juvenile Idiopathic Arthritis (JIA) is the most common chronic rheumatic disease in childhood. More therapeutic options are available for the treatment of JIA with more children achieving minimal active disease or inactive disease status.</p><p><strong>Areas covered: </strong>This review summarizes the major novel treatment options for children with non-systemic JIA, including current evidence supporting the safety and efficacy of biologic treatments.</p><p><strong>Expert opinion: </strong>With all the advances in treatment targets, the disease trajectory of patients with JIA have changed significantly and remission is the goal of today's treatment. New treatment trials show the pharmacokinetic, immunogenicity, efficacy and safety for these medications in children with JIA. Future studies will need to incorporate patient and family preferences, in addition to novel biomarkers and artificial intelligence-based diagnostic systems into head-to-head international multicenter trials to better assess the treatment algorithm for individual patients.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"969-978"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Satoru Hashimoto, Yoshihiro Motozawa, Toshiki Mano
{"title":"The effectiveness of the current lipid-lowering therapy for refractory dyslipidaemia in patients with coronary artery disease: the price of 'the lower, the better' - results of a survey by Japanese cardiologists.","authors":"Satoru Hashimoto, Yoshihiro Motozawa, Toshiki Mano","doi":"10.1080/14656566.2025.2503853","DOIUrl":"10.1080/14656566.2025.2503853","url":null,"abstract":"<p><strong>Background: </strong>Optimal medical therapy plays a critical role in improving the prognosis of patients with coronary artery disease (CAD), particularly through the management of dyslipidaemia. This study investigated treatment practices for patients with dyslipidaemia-complicated CAD (DL-CAD) in Japan, focusing on cases considered refractory to standard management.</p><p><strong>Research design and methods: </strong>A web-based survey was conducted from 10 November 2023 to 1 December 2023 among cardiologists. Responses from 202 participants were analysed and divided into two groups based on the proportion of patients with refractory DL-CAD: <10% (<i>n</i> = 102) and ≥ 10% (<i>n</i> = 100).</p><p><strong>Results: </strong>There was no significant difference in the use of maximally tolerated statins between groups. However, ezetimibe, EPA, and omega-3-acid ethyl esters were used more frequently in the group with a higher proportion of refractory patients. Logistic regression analysis revealed that the use of ezetimibe was the only factor affecting the proportion of patients with refractory DL-CAD (odds ratio: 1.26, p = 0.0499).</p><p><strong>Conclusions: </strong>Japanese cardiologists tend to prescribe ezetimibe in addition to maximally tolerated statin for patients with refractory DL-CAD. Furthermore, they are increasingly targeting elevated triglycerides using polyunsaturated fatty acids as a strategy to reduce residual cardiovascular risk when LDL-C targets are unmet.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"991-998"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Time to reconsider the way of selecting antihypertensives for hypertensive left ventricular hypertrophy.","authors":"Goran Koraćević, Milovan Stojanović, Marija Zdravković, Ruzica Janković Tomasević, Snežana Ćirić Zdravković, Nenad Božinović, Predrag Cvetković, Milorad Pavlović, Dimitrije Pavlović","doi":"10.1080/14656566.2025.2508282","DOIUrl":"10.1080/14656566.2025.2508282","url":null,"abstract":"<p><strong>Introduction: </strong>Hypertensive left ventricular hypertrophy (HTN LVH) is a highly prevalent high-risk condition, and the recommendations for HTN LVH treatment are essentially unchanged for several decades.</p><p><strong>Areas covered: </strong>The current therapeutic approach to HTN LVH is to choose antihypertensive drugs according to their ability to reverse left ventricular (LV) remodeling. On the other hand, for the majority arterial hypertension (HTN) patients we should start treatment with a combination of different antihypertensive drugs. Therefore, the goal of antihypertensive treatment of HTN LVH should be adapted to the current recommendation in other parts of guidelines. The recommendation we need is not only which individual drug, but rather which combination of two antihypertensive agents is optimal for reversed LV remodeling.</p><p><strong>Expert opinion: </strong>In this paper, we pointed out that treatment recommendation for HTN LVH can be updated in a similar way as therapy for the whole HTN population - by recommending a combination of two or three antihypertensives in a single pill. Clinicians should be directly advised what is the first- and what the second-line combination of antihypertensives for HTN LVH in evidence-based medicine. Therefore, we suggest that combination treatment should be studied, compared and then recommended also for very prevalent higher-risk HTN LVH patients.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1071-1077"},"PeriodicalIF":2.5,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}