{"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}
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}
{"title":"Weighing up GnRH agonist therapy for endometriosis: outcomes and the treatment paradigm.","authors":"Márcia Mendonça Carneiro","doi":"10.1080/14656566.2025.2459783","DOIUrl":"10.1080/14656566.2025.2459783","url":null,"abstract":"<p><strong>Introduction: </strong>Endometriosis is a chronic inflammatory estrogen-dependent disease affecting 10% of women worldwide leading to chronic pelvic pain and infertility which may be treated clinically or surgically.</p><p><strong>Areas covered: </strong>Current literature was reviewed using the keywords 'gonadotropin releasing hormone agonists (GnRHa),' 'endometriosis,' 'infertility' and 'chronic pelvic pain.' Relevant papers prioritizing randomized controlled clinical trials (RCT), systematic reviews, meta-analyses, as well as international guidelines were evaluated.</p><p><strong>Expert opinion: </strong>Available options for relieving endometriosis-associated pain include GnRHa, progestagens, and combined oral contraceptives, all of which block menstruation to control symptoms without curing the disease. GnRHa administration decreases pain and symptom recurrence after surgical treatment, but side effects and costs limit its use. Published studies to test its effectiveness in easing endometriosis-associated pain are heterogeneous, consider different outcomes with no long-term results. Drug choice should be individualized considering the side-effect profile, tolerability, costs, risks, and benefits as one size does not fit all. As we wait for the development of an ideal pharmacological agents, GnRHa with an add-back regimen remains a second-line option to alleviate the painful symptoms in women with endometriosis. Endometriosis management should consider the systemic nature of the disease and the complexity involved in the pathogenesis of symptoms.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"355-365"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143037736","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}
{"title":"Controversies and challenges of anticoagulation therapy in obesity.","authors":"Thomas Salmon, Gregory Y H Lip","doi":"10.1080/14656566.2025.2462766","DOIUrl":"10.1080/14656566.2025.2462766","url":null,"abstract":"<p><strong>Introduction: </strong>The relationship between anticoagulation efficacy and safety in obesity is complex and can vary between degrees of obesity and anticoagulant choice. Indeed, patients at extremes of body weight were under-represented in randomized trials. Additionally, the possibility of an 'obesity paradox' has been raised in atrial fibrillation, describing decreased thromboembolic risk in obese patients.</p><p><strong>Areas covered: </strong>We explore the current literature on anticoagulation in obesity, specifically with regard to efficacy in atrial fibrillation, efficacy in venous thromboembolism, and bleeding risk. Pharmacodynamic and pharmacokinetic considerations are also discussed.</p><p><strong>Expert opinion: </strong>As a class, direct oral anticoagulants are comparable to vitamin-K antagonists in preventing and treating thromboembolism in overweight and obese patients, whilst not increasing bleeding risk.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"381-431"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143079172","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}
Claudia Elera-Fitzcarrald, Graciela S Alarcón, Manuel F Ugarte-Gil
{"title":"Challenges in the care of patients with systemic lupus erythematosus and lupus nephritis in Latin America.","authors":"Claudia Elera-Fitzcarrald, Graciela S Alarcón, Manuel F Ugarte-Gil","doi":"10.1080/14656566.2025.2464913","DOIUrl":"10.1080/14656566.2025.2464913","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic lupus erythematosus is a rare disease; however, it is one of the leading causes of death in young women, in particular those with a larger percentage of Amerindian ancestry.</p><p><strong>Areas covered: </strong>This article provides a review of the epidemiology of systemic lupus erythematosus and lupus nephritis in the Latin American population, as well as the challenges for the appropriate management of these patients, including delays in diagnosis, healthcare access, and access to new drugs in the region. We propose potential solutions to these problems, including activities to be done by governments, healthcare systems, and healthcare professionals.</p><p><strong>Expert opinion: </strong>Systemic lupus erythematosus, in particular lupus nephritis, is more severe in patients with a larger percentage of Amerindian ancestry; this is influenced not only by their ancestry but also by their sociodemographic characteristics, including access to healthcare and the availability of new drugs. Several strategies to improve diagnosis, management, and access to medication need to be done to reduce these disparities.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"447-455"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364169","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}
Joanna Mazgaj, Magdalena Kotewicz, Andrzej Jaworek, Jacek C Szepietowski
{"title":"The future of topical JAK inhibitors in the treatment of atopic dermatitis.","authors":"Joanna Mazgaj, Magdalena Kotewicz, Andrzej Jaworek, Jacek C Szepietowski","doi":"10.1080/14656566.2025.2465869","DOIUrl":"10.1080/14656566.2025.2465869","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin condition, rising in prevalence and significantly impacting quality of life. Janus kinase (JAK) inhibitors are small molecules targeting the JAK-STAT signaling pathway, responsible for immune response and cell proliferation. Therapy with topical JAK inhibitors (JAKinibs) improves AD itch and skin lesions and is well tolerated with no major side effects, making it an interesting novel therapy for AD.</p><p><strong>Areas covered: </strong>This review provides a comprehensive look at the available research on topical JAK inhibitors, primarily for atopic dermatitis, based on clinical trial outcomes.</p><p><strong>Expert opinion: </strong>In this review, we summarize research on topical JAKinibs, including ruxolitinib, tofacitinib, delgocitinib, cerdulatinib, and bredocitinib, which target multiple cytokine pathways and have been shown to reduce the itch and inflammation. Their low bioavailability contributes to infrequent and mild side effects. The main limitation of predominantly short-term studies is that the long-term effects of JAK inhibitor therapy are not yet fully known. The body of research is growing, and more information about their effectiveness and safety is being added each year.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"473-480"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382073","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}
Davide Santagata, Eleonora Tamborini Permurian, Lucia Maria Caiano, Alessandro Squizzato, Walter Ageno, Marco Paolo Donadini
{"title":"Pharmacotherapeutic management of venous thromboembolism during pregnancy and cesarean section.","authors":"Davide Santagata, Eleonora Tamborini Permurian, Lucia Maria Caiano, Alessandro Squizzato, Walter Ageno, Marco Paolo Donadini","doi":"10.1080/14656566.2025.2464100","DOIUrl":"10.1080/14656566.2025.2464100","url":null,"abstract":"<p><strong>Introduction: </strong>Venous thromboembolism (VTE) pharmacological management during pregnancy can be challenging due to concerns for both maternal and fetal safety.</p><p><strong>Areas covered: </strong>We performed a narrative review to evaluate the most updated therapeutic options for pregnancy-related VTE treatment, also assessing peri-partum management in the case of cesarean section.</p><p><strong>Expert opinion: </strong>The correct management of acute VTE in pregnancy starts with an accurate diagnosis followed by anticoagulant therapy, with low-molecular-weight heparin (LMWH) at therapeutic dose being the preferred option. Similar to the non-pregnant population, thrombolytic therapy is reserved to life-threatening pulmonary embolism. Secondary prophylaxis with LMWH at a prophylactic dose during pregnancy is recommended in women with a history of unprovoked or hormone-associated VTE, while postpartum prophylaxis is recommended for all women with a previous VTE. Primary prophylaxis remains more controversial. Peripartum management of women receiving anticoagulants requires collaboration among multiple specialists, especially in cases of unscheduled cesarean section, where both thrombotic and hemorrhagic risks are elevated.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"433-445"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373951","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":"Selecting optimal therapy for higher-risk myelodysplastic syndromes: present and future projections.","authors":"Farzad Teymouri, Constantin A Dasanu","doi":"10.1080/14656566.2025.2468467","DOIUrl":"10.1080/14656566.2025.2468467","url":null,"abstract":"","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"345-347"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432694","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":"Investigating osimertinib plus chemotherapy in EGFR-mutated advanced non-small cell lung cancer.","authors":"Alessia Spagnuolo, Cesare Gridelli","doi":"10.1080/14656566.2025.2464903","DOIUrl":"10.1080/14656566.2025.2464903","url":null,"abstract":"<p><strong>Introduction: </strong>Worldwide, 15-40% of advanced-stage non-small cell lung cancers (NSCLCs) have an activating EGFR mutation, treatable with tyrosine-kinase inhibitors (TKIs) such as osimertinib, recommended as front-line therapy. Despite the efficacy of first-line osimertinib, most patients will experience disease progression. Therefore, combining it with chemotherapy has become an area of interest.</p><p><strong>Areas covered: </strong>Osimertinib is a third-generation EGFR-TKI that has extended survival in NSCLC patients with EGFR mutation. However, resistance eventually leads to treatment failure. This has driven the advancement of strategies to overcome resistance to osimertinib. In this setting, the FLAURA2 trial yielded positive results by combining osimertinib with chemotherapy. Additionally, a range of other approaches, including the use of bispecific antibodies and antibody-drug conjugates alongside third-generation EGFR-TKIs or chemotherapy, support the development of novel therapeutic combinations, some of which have already been approved for EGFR-mutated advanced NSCLC.</p><p><strong>Expert opinion: </strong>Next to osimertinib monotherapy, expanded upfront treatment options for patients with EGFR-mutated advanced NSCLC require patient selection considering disease extent, toxicity and tolerability, dosing schedule and what the patient can expect through shared decision-making. Further studies are needed to identify the patients who will benefit the most from combination therapies and to sequence the new drugs into the treatment algorithm.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"491-501"},"PeriodicalIF":2.5,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398866","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}