{"title":"Pharmacotherapy of type 1 diabetes - part 2 Today.","authors":"Marc Rendell","doi":"10.1080/14656566.2025.2479598","DOIUrl":"10.1080/14656566.2025.2479598","url":null,"abstract":"<p><strong>Introduction: </strong>In the 100 years since isolation and administration of animal insulin to sustain life in Type 1 diabetes, there has been increasing progress in the administration of exogenous insulin to lower glucose levels.</p><p><strong>Areas covered: </strong>We reviewed using standard search engines and PubMed present-day techniques of management of type 1 diabetes.</p><p><strong>Expert opinion: </strong>Long-acting insulin formulations have been developed to maintain basal glucose levels in the normal range, while rapid acting insulins have been synthesized to address the sharp rise in glucose levels after a meal. Insulin pumps administer insulin continuously subcutaneously guided by continuous glucose monitoring systems. These almost closed loop systems achieve near normal glucose levels other than at meal times where the rapid glucose rise and then fall pose a significant challenge due to the extended duration of subcutaneous insulin depots. Implanted insulin pumps with intraperitoneal delivery may eventually permit improved post meal glucose control. Type 1 diabetes has now been redefined as an autoimmune disease which may be diagnosed purely from the presence of anti-beta cell antibodies with no abnormality of glucose levels. The future will see an intensification of efforts to combat the immune process which destroys beta cells.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-12"},"PeriodicalIF":2.5,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624004","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}
Stuart H Isaacson, Henry Nasrallah, Rajesh Pahwa, Gustavo Alva, Daniel Kremens, Stephen M Stahl
{"title":"Management of Parkinson's disease psychosis: first-line antipsychotic selection and rationale for continuing, combining, or switching.","authors":"Stuart H Isaacson, Henry Nasrallah, Rajesh Pahwa, Gustavo Alva, Daniel Kremens, Stephen M Stahl","doi":"10.1080/14656566.2025.2481205","DOIUrl":"10.1080/14656566.2025.2481205","url":null,"abstract":"<p><strong>Introduction: </strong>The past decade has seen a paradigm shift in the evaluation and management of Parkinson's disease psychosis (PDP), with the first approval of an antipsychotic in the US in 2016. An evidence-based review by the Movement Disorder Society found pimavanserin and clozapine to be clinically useful, (low-dose) quetiapine to be possibly useful, and all other antipsychotics to be avoided due to motor worsening. Clozapine and quetiapine use can be limited by provoking Parkinson's disease (PD) nonmotor symptoms of somnolence and hypotension. Quetiapine may also be limited by its risk in cognitive impairment. Pimavanserin is not associated with these symptoms. Despite advances in the understanding of PDP and the approval of pimavanserin in the US, clinical questions concerning patient selection, treatment timing, switch strategies, and combination therapy remain.</p><p><strong>Areas covered: </strong>To develop a consensus on first-line and subsequent treatment strategies for PDP, a panel of experts reviewed the clinical presentation and course of PDP, then discussed clinical trial evidence and experience.</p><p><strong>Expert opinion: </strong>PDP is a common but still undertreated sequela of PD progression. Pimavanserin is recommended as a first-line antipsychotic therapy based on its established safety and efficacy. While switching strategies are suggested, further study is needed to assess combination antipsychotic therapy.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-11"},"PeriodicalIF":2.5,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729438","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":"Asciminib: the tyrosine kinase inhibitor with a unique mechanism of action.","authors":"Akriti G Jain, Jorge E Cortes","doi":"10.1080/14656566.2025.2480762","DOIUrl":"10.1080/14656566.2025.2480762","url":null,"abstract":"<p><strong>Introduction: </strong>Management of chronic phase chronic myeloid leukemia (CML-CP) was revolutionized with the development of tyrosine kinase inhibitors (TKIs). Imatinib (first generation), dasatinib, nilotinib and bosutinib (second generation), and ponatinib (third generation) are the five approved TKIs that inhibit BCR::ABL1 by binding to the ATP binding site of ABL1. About half of the resistance to TKIs develops through acquisition of mutations in the ATP binding site, including T315I. Hence, a novel TKI with a distinct mechanism of action that inhibits bcr-abl1 by specifically targeting the ABL1 myristoyl pocket (STAMP inhibitor) was developed.</p><p><strong>Areas covered: </strong>Asciminib was first approved for treatment of CML-CP in the third line setting or beyond and in patients with T315I mutation in October, 2021. More recently, in October, 2024, asciminib was approved for newly diagnosed CML-CP based on ASC4FIRST data showing MMR rate of 67.7% in the asciminib arm compared to 49% in the investigator choice TKI arm (<i>p</i> < 0.001) at 48 weeks. In this review we detail the mechanism of action, preclinical data, clinical data, safety, and tolerability of asciminib.</p><p><strong>Expert opinion: </strong>Due to its mechanism of action, asciminib has fewer off-target effects, resulting in an improved safety and tolerability profile.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-8"},"PeriodicalIF":2.5,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633836","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}
Andy Wang, Uzair Mahmood, Jared Feldman, Stephen Pan, Wilbert S Aronow, Diwakar Jain
{"title":"Amyloidosis of the heart: pathophysiology, diagnosis, and treatment.","authors":"Andy Wang, Uzair Mahmood, Jared Feldman, Stephen Pan, Wilbert S Aronow, Diwakar Jain","doi":"10.1080/14656566.2025.2480254","DOIUrl":"10.1080/14656566.2025.2480254","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiac amyloidosis is characterized by amyloid fibril aggregation due to misfolded circulating proteins and their deposition in the heart, leading to cardiac damage and dysfunction. Given cardiac amyloidosis is associated with a poor prognosis without treatment, early diagnosis and management are critical to increase survival from the disease.</p><p><strong>Areas covered: </strong>This article provides an overview of the disease process, diagnostic modalities, and therapies for cardiac amyloidosis.</p><p><strong>Expert opinion: </strong>Recent technological advances have led to the development of reliable and accurate diagnostic modalities for identifying cardiac amyloidosis. Recent introduction of novel disease-modifying therapies for cardiac amyloidosis has resulted in improvements in the management and prognosis of the disease.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-11"},"PeriodicalIF":2.5,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663115","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}
Vicente Benavides-Córdoba, Mauricio Palacios, Anton Vonk-Noordegraaf
{"title":"Historical milestones and future horizons: exploring the diagnosis and treatment evolution of the pulmonary arterial hypertension in adults.","authors":"Vicente Benavides-Córdoba, Mauricio Palacios, Anton Vonk-Noordegraaf","doi":"10.1080/14656566.2025.2480764","DOIUrl":"10.1080/14656566.2025.2480764","url":null,"abstract":"<p><strong>Introduction: </strong>Pulmonary hypertension is a life-threatening condition characterized by elevated mean pulmonary arterial pressure and vascular resistance. Significant advances in diagnosis and treatment have been achieved over the 20th and 21st centuries, yet challenges remain in improving long-term outcomes.</p><p><strong>Areas covered: </strong>This review discusses the historical milestones in understanding and pharmacotherapy of the pulmonary arterial hypertension (PAH). A comprehensive literature search was conducted to explore the earliest reports of each approved medication for pulmonary hypertension, along with historical papers detailing the pathophysiological and diagnostic development. Additionally, the search aimed to identify novel therapeutic strategies, including repositioned drugs and emerging targets.</p><p><strong>Expert opinion: </strong>While current therapies, such as prostacyclin analogs and PDE5 inhibitors, improve functional capacity and hemodynamics, they face limitations, including costs, administration, and a predominantly vasodilatory approach. Additionally, the limitations of current clinical trial designs for rare diseases like pulmonary arterial hypertension hinder the evaluation of potentially effective drugs. These challenges underscore the urgent need for translational research to optimize trial methodologies, accelerating the development of new therapies. Innovative approaches, such as drug repositioning and the exploration of novel molecular targets, are critical to overcoming these barriers and ensuring timely, effective, and affordable treatment options for patients with PAH.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-11"},"PeriodicalIF":2.5,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647719","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}
Sheena Bhushan, Aalam Sohal, Mazen Noureddin, Kris V Kowdley
{"title":"Resmetirom: the first approved therapy for treating metabolic dysfunction associated steatohepatitis.","authors":"Sheena Bhushan, Aalam Sohal, Mazen Noureddin, Kris V Kowdley","doi":"10.1080/14656566.2025.2478917","DOIUrl":"10.1080/14656566.2025.2478917","url":null,"abstract":"<p><strong>Introduction: </strong>Metabolic dysfunction associated steatohepatitis (MASH), previously referred to as nonalcoholic steatohepatitis (NASH), has emerged as one of the leading indications for liver transplantation in the United States. The disease is associated with increased cardiovascular mortality in patients with early-stage liver fibrosis and a heightened risk of hepatic complications in those with advanced fibrosis. Despite its growing prevalence and significant healthcare burden, there were no approved drugs to treat this chronic disease. In March 2024, Resmetirom, a selective thyroid hormone receptor-beta agonist, became the first drug to receive FDA approval for the treatment of patients with MASH and fibrosis stages F2/F3. This accelerated approval was granted based on significantly higher rates of MASH resolution and fibrosis.</p><p><strong>Areas covered: </strong>This review summarizes the current literature on the mechanism of action, preclinical data, pharmacokinetics, clinical efficacy, indications, and contraindications of resmetirom in the management of patients with MASH.</p><p><strong>Expert opinion: </strong>The approval of resmetirom for patients with MASH and moderate to advanced hepatic fibrosis is a major advance in the management of MASH. The recent positive results of the ESSENCE trial of semaglutide, if associated with conditional approval, may offer clinicians two options to treat MASH in patients with moderate to advanced fibrosis.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1-13"},"PeriodicalIF":2.5,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656648","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":"Will elinzanetant, a neurokinin receptor antagonist, have a role in the treatment of hot flashes?","authors":"Sheila A Doggrell","doi":"10.1080/14656566.2025.2465875","DOIUrl":"10.1080/14656566.2025.2465875","url":null,"abstract":"<p><strong>Introduction: </strong>The use of hormonal treatment for the vasomotor symptoms (VSM) associated with the menopause is back in favor, as the adverse effects reported in the early 2000s have been dispelled. However, many women are still reluctant to use, or have contraindications to, hormonal therapy. Elinzanetant is a combined neurokinin (NK)-1 and -3 receptor antagonist, being trialed for menopausal symptoms.</p><p><strong>Area covered: </strong>A combination of OASIS 1 and 2 in the menopause showed that elinzanetant caused a reduction in the frequency and intensity of VSM and may also independently reduce sleep disturbances. Adverse effects were low with elinzanetant.</p><p><strong>Expert opinion: </strong>Further study is needed to clarify whether elinzanetant reduces sleep disturbance and whether this is due to antagonism at NK-1 receptors. If further studies support OASIS 1 and 2, elinzanetant maybe considered for use in hot flashes associated with the menopause, in subjects where hormonal therapy is contraindicated or not accepted. Fezolinetant, an NK-3 receptor antagonist, has recently been registered for VSM associated with the menopause. Fezolinetant does not have a clear-cut effect on sleep disturbances independent of VMS. Only, if elinzanetant can be shown to independently reduce sleep disturbances, it may have an advantage over fezolinetant.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"349-354"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382076","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":"Efficacy and safety of dutasteride in the treatment of alopecia: a comprehensive review.","authors":"Aditya K Gupta, Mesbah Talukder","doi":"10.1080/14656566.2025.2461169","DOIUrl":"10.1080/14656566.2025.2461169","url":null,"abstract":"<p><strong>Introduction: </strong>Alopecia affects many individuals, with androgenetic alopecia (AGA) being the most common form in both men and women. The exact etiology of AGA is unclear. The systemic treatments of AGA include 5-alpha reductase inhibitors (finasteride, dutasteride) and low-dose oral minoxidil.</p><p><strong>Areas covered: </strong>The article comprehensively reviews dutasteride's pharmacokinetics, pharmacodynamics, clinical efficacy, and side effects to support clinicians in prescribing it for alopecia.</p><p><strong>Expert opinion: </strong>Studies show dutasteride to be more effective than finasteride for AGA, with both drugs having similar safety profiles. In our view, clinicians should consider topical minoxidil and oral finasteride as first-line treatments, as they are well-studied for male and female AGA (finasteride is off label in females and should only be considered in post-menopausal females). If these options are ineffective, oral dutasteride may be considered off-label for greater efficacy in males and post-menopausal females. However, dutasteride can reduce sperm count and motility, potentially affecting fertility in men with preexisting fertility issues. Men whose partners are pregnant should avoid dutasteride.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"367-379"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064726","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":"Have SGLT-2 inhibitors DELIVERed an EMPhatic win in heart failure and chronic kidney disease?","authors":"Awadhesh Kumar Singh, Akriti Singh, Ritu Singh","doi":"10.1080/14656566.2025.2464905","DOIUrl":"10.1080/14656566.2025.2464905","url":null,"abstract":"<p><strong>Introduction: </strong>Major global guidelines currently recommend sodium-glucose co-transporter-2 inhibitors (SGLT-2i) as the first-line agent in people with type 2 diabetes (T2D) who have either established cardiovascular disease (eCVD), heart failure (HF), or chronic kidney disease (CKD), regardless of baseline glycated hemoglobin (HbA1c). Moreover, SGLT-2i are currently included in guideline-directed medical therapy as one of the pillars for people with HF and CKD, regardless of T2D. These recommendations are based on positive cardio-renal outcomes from several randomized controlled trials (RCTs).</p><p><strong>Areas covered: </strong>Following an extensive search in electronic databases of PubMed, Google Scholar, and clinicaltrials.gov, we critically analyzed the RCTs that assessed cardio-renal outcome trials of SGLT-2i and put a perspective on how SGLT-2i delivered an emphatic win for people with HF and CKD, with or without T2D.</p><p><strong>Expert opinion: </strong>From thirteen high-quality RCTs, including five cardiovascular outcome trials, five HF outcome trials, three renal outcome trials, and a pooled meta-analysis, it is evident that SGLT-2i has delivered an emphatic win in people with HF and CKD, with or without T2D, with an acceptable safety profile. Ongoing RCTs shall further enlighten whether SGLT-2i will be effective in polycystic kidney disease, lupus nephritis, vasculitis, end-stage CKD with or without hemodialysis, and renal transplant.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"457-472"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370708","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}
Kazuhiko Tsuruya, Haruko Sugamori, Yusuke Tanaka, Naoko Wakasugi, Yuichiro Ito
{"title":"Real-world safety and effectiveness of roxadustat in patients with anemia of chronic kidney disease: interim results from a post-marketing surveillance study in Japan.","authors":"Kazuhiko Tsuruya, Haruko Sugamori, Yusuke Tanaka, Naoko Wakasugi, Yuichiro Ito","doi":"10.1080/14656566.2025.2462181","DOIUrl":"10.1080/14656566.2025.2462181","url":null,"abstract":"<p><strong>Background: </strong>This planned interim analysis of a mandatory post-marketing surveillance study in Japan evaluated the safety and effectiveness of roxadustat, the first approved hypoxia-inducible factor prolyl hydroxylase inhibitor in the world, in real-world clinical use.</p><p><strong>Research design and methods: </strong>This prospective observational study has a planned 104-week observation period. We report data obtained through 16 December 2023, as a planned interim analysis. Adverse drug reactions (ADRs), mean hemoglobin level change from baseline to 12 weeks of roxadustat treatment, and subgroup analyses stratified by either baseline C-reactive protein or albumin levels were reported.</p><p><strong>Results: </strong>Overall, 2084 patients were treated with roxadustat (total patient-years of exposure: 1579.2). In the non-dialysis-dependent (NDD) group (<i>n</i> = 1075), ADRs and serious ADRs occurred in 209 (19.4%) and 109 (10.1%) patients, respectively. In patients receiving hemodialysis (HD; <i>n</i> = 856), ADRs and serious ADRs occurred in 224 (26.2%) and 142 (16.6%) patients, respectively. In patients receiving peritoneal dialysis (PD; <i>n</i> = 146), ADRs and serious ADRs occurred in 46 (31.5%) and 26 (17.8%) patients, respectively. Mean hemoglobin levels reached target levels at 12 weeks in most patients (NDD: 54.6%; HD: 56.3%; PD: 45.4%).</p><p><strong>Conclusions: </strong>Roxadustat safety was demonstrated in real-world clinical settings. No new safety concerns were identified.<b>Trial Registration:</b> NCT04408820.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"503-517"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122457","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}