Esposito N, Buonomo AR, Di Filippo I
… +4 more, Forte E, Trucillo E, Gentile I, Schiano Moriello N
Expert Opin Drug Saf
· 2026 Mar · PMID 41800523
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INTRODUCTION: Pregnant women represent a vulnerable population during the COVID-19 pandemic, facing increased risks of severe disease and adverse obstetric outcomes, yet they have been largely excluded from pivotal thera...INTRODUCTION: Pregnant women represent a vulnerable population during the COVID-19 pandemic, facing increased risks of severe disease and adverse obstetric outcomes, yet they have been largely excluded from pivotal therapeutic clinical trials, leaving a critical evidence gap for treatment decisions. AREAS COVERED: This review examines the available evidence on the safety and efficacy of COVID-19 therapies during pregnancy, including oral antivirals (nirmatrelvir/ritonavir, molnupiravir), intravenous remdesivir, monoclonal antibodies, corticosteroids, and immunomodulators (tocilizumab, baricitinib). A literature search was conducted using MEDLINE/PubMed for English-language articles published from March 2020 to December 2023, including studies of any design reporting maternal and neonatal outcomes. EXPERT OPINION: The COVID-19 pandemic exposed a critical gap in clinical research through the systematic exclusion of pregnant women from therapeutic trials. Current evidence, though largely observational, supports vaccination as the primary preventive strategy, nirmatrelvir/ritonavir for outpatients at risk of progression, and remdesivir plus corticosteroids for hospitalized patients requiring oxygen supplementation.
Okoli GN, Cowling BJ, Askin N
… +2 more, Harper DM, Van Caeseele P
Expert Opin Drug Saf
· 2026 Mar · PMID 41790560
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INTRODUCTION: To thoroughly examine the risk of active tuberculosis and herpes zoster infections with tumor necrosis factor (TNF) inhibitor treatment in adults (≥18-year-olds) with autoimmune disease conditions. METHODS:...INTRODUCTION: To thoroughly examine the risk of active tuberculosis and herpes zoster infections with tumor necrosis factor (TNF) inhibitor treatment in adults (≥18-year-olds) with autoimmune disease conditions. METHODS: A trial sequential analysis (TSA) informed by a high-quality systematic review and meta-analysis of evidence from published randomized placebo-controlled trials. We pooled appropriate trial data using an inverse variance, random-effects model and expressed the results as relative risk and associated 95% confidence intervals. Statistical heterogeneity was calculated using the I2 statistic. Further, we assessed the strength/quality of the pooled evidence. RESULTS: We included 49 trials. Irrespective of autoimmune disease condition type and TNF inhibitor treatment dosage, while we observed a marginally increased risk of active tuberculosis with infliximab (3.66 [1.13-11.90], I2 = 0%, 7 pooled estimates, moderate certainty), there was no increased risk of active tuberculosis or herpes zoster with other evaluated TNF inhibitors. However, TSA suggested that pooled sample sizes were not enough to support definitive conclusions on all the analyses. CONCLUSIONS: The available evidence from randomized placebo-controlled clinical trials in adults with autoimmune disease conditions does not support the risk of active tuberculosis or herpes zoster with TNF inhibitors. However, the evidence is insufficient for strong conclusions. PROTOCOL REGISTRATION: www.crd.york.ac.uk/prospero identifier is CRD42024614017.
Omrani MA, Baskaran BS, Sadeghi H
… +4 more, Ahmadi F, Ez Eddin L, Jafari A, Muanda FT
Expert Opin Drug Saf
· 2026 Mar · PMID 41784948
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INTRODUCTION: SGLT-2 inhibitors improve type 2 diabetes and heart failure outcomes, yet representation of key demographic and clinical subgroups remains unclear. We aimed to quantify their representation in phase 3/4 tri...INTRODUCTION: SGLT-2 inhibitors improve type 2 diabetes and heart failure outcomes, yet representation of key demographic and clinical subgroups remains unclear. We aimed to quantify their representation in phase 3/4 trials. METHODS: We searched CENTRAL, MEDLINE, and Embase (inception-5 May 2025) for trials (≥300 participants) reporting subgroup enrollment. We estimated pooled prevalence using random-effects meta-analyses and calculated exploratory Participation-to-Prevalence Ratios (PPRs) against real-world U.S. disease burden. RESULTS: Across 91 RCTs, type 2 diabetes prevalence was: females 43.8% (95% CI 42.0%-45.7%), eGFR < 60 32.5% (13.1%-55.6%), older adults 31.8% (25.7%-38.2%), and Black participants 4.9% (4.3%-5.6%). In heart failure, prevalence was: older adults 68.7% (59.9%-76.8%), females 34.1% (27.8%-40.7%), and Black participants 7.6% (5.7%-9.7%). Exploratory PPRs indicated underrepresentation of Black participants (0.3 diabetes; 0.5 heart failure), older adults in diabetes (0.7), and females in heart failure (0.7). Data for liver disease and children/adolescents were insufficient. CONCLUSIONS: Prevalence was low for Black participants in both populations, older adults in diabetes trials, and females in heart failure trials. These disparities, alongside the exclusion of children and adolescents, may limit safety data generalizability, underscoring the need for inclusive recruitment. PROTOCOL REGISTRATION: www.crd.york.ac.uk/prospero identifier is CRD42024561154.
Kilic Konte E, Gul U, Aslan E
… +6 more, Akay N, Yildiz M, Adrovic A, Sahin S, Barut K, Kasapçopur O
Expert Opin Drug Saf
· 2026 Mar · PMID 41773958
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INTRODUCTION: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, with varying clinical and immunological features. Over the last 20 years, treatment options for JIA have signifi...INTRODUCTION: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, with varying clinical and immunological features. Over the last 20 years, treatment options for JIA have significantly expanded, with the development of biologic and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs), which have substantially improved clinical outcomes. AREAS COVERED: This review provides a comprehensive assessment of bDMARDs and tsDMARDs in the management of JIA, focusing on their therapeutic efficacy, long-term safety profiles, and evolving role in personalized treatment strategies. It integrates comparative data on safety and effectiveness from randomized controlled trials, observational cohorts, and large registry studies. EXPERT OPINION: Despite substantial therapeutic progress, achieving sustained, drug-free remission remains a challenge for many JIA patients. Precision medicine - guided by predictive biomarkers, pharmacovigilance data, and real-world evidence - is essential for optimizing individualized care. Future efforts should prioritize the development of safer, more tolerable, and accessible therapies tailored to the unique needs of pediatric populations.
Expert Opin Drug Saf
· 2026 Mar · PMID 41773040
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INTRODUCTION: GLP-1 receptor agonists (GLP-1RA) are glucose- and body weight-lowering therapies provided with cardio-renal benefits. Use of GLP-1RA in older adults with type 2 diabetes mellitus (T2DM) is increasing but c...INTRODUCTION: GLP-1 receptor agonists (GLP-1RA) are glucose- and body weight-lowering therapies provided with cardio-renal benefits. Use of GLP-1RA in older adults with type 2 diabetes mellitus (T2DM) is increasing but concerns remain about their safety in this age group, particularly in light of multimorbidity, frailty, and polypharmacy, as well as age-related vulnerability to adverse events (AEs). AREAS COVERED: We discuss the opportunities and challenges of GLP-1RA in older people with T2DM, focusing on real-world (RW) safety evidence. Available RW studies confirm the established GLP-1RA safety profile, with AEs in 10-30% of older users, predominantly gastrointestinal and mild-to-moderate in severity. Age-stratified analyses provide mixed results on AE susceptibility, but discontinuation due to intolerance appears more frequent in older adults. Weight loss is preserved across age groups, with no consistent evidence of harmful unintended reductions. However, the effects on muscle mass and sarcopenia risk remain largely unexplored. EXPERT OPINION: Current RW evidence supports GLP-1RA as a safe therapeutic option for older individuals with T2DM, without age-specific safety signals. Clinical phenotype-driven selection is essential to balance benefits and risks, particularly regarding nutritional status and frailty. Prospective, phenotype-stratified studies with body composition assessment are needed to guide optimal, individualized use in aging populations.
Ngo S, Rong J, Menon R
… +17 more, Colli Cruz C, Chatterjee A, Mortan R, Salim H, Urias Rivera A, Jafri FI, Garza D, Kim S, Funchain P, Zhang HC, Sheshadri A, Ernstoff M, Neilan T, Oo TH, Roeland E, Moshiri A, Wang Y
Expert Opin Drug Saf
· 2026 Mar · PMID 41729184
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INTRODUCTION: Immune checkpoint inhibitors have become an increasingly effective treatment for various malignancies, although their use is associated with a range of organ toxicities. As these therapies become more preva...INTRODUCTION: Immune checkpoint inhibitors have become an increasingly effective treatment for various malignancies, although their use is associated with a range of organ toxicities. As these therapies become more prevalent, it is critical to establish appropriate management and long-term surveillance strategies for patients who develop immune-related adverse events. AREAS COVERED: This review explores the chronic sequelae that may result from immune-related adverse events and focuses specifically on their persistence, outcomes, and implications for future research. A literature review was conducted using PubMed to identify relevant articles from within the last 10 years. EXPERT OPINION: While acute management of irAEs has improved over the past decade, there is a major gap in understanding and addressing their chronic sequelae. Challenges in studying these sequelae include the complexity of cancer care, overlapping clinical presentations, and previously, a lack of long-term data. Continued research from large multicenter studies and dedicated databases can identify high-risk patients, inform risk-benefit discussions, refine management strategies, and pave the way for evidence-based, long-term care.
Rong J, Jafri F, Ngo S
… +17 more, Chatterjee A, Moura Nascimento Santos MJ, Garza D, Salim H, Menon R, Mortan R, Urias Rivera AC, Zhang HC, Patel A, Rojas Hernandez C, Jeff Li Y, Sheshadri A, Aaroe A, Shariff A, Schneider B, Thomas A, Wang Y
Expert Opin Drug Saf
· 2026 Feb · PMID 41664562
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INTRODUCTION: Immune checkpoint inhibitors (ICIs), although revolutionary in the field of oncology, have been associated with immune-related adverse events (irAEs) that affect nearly every organ of the body. Many common...INTRODUCTION: Immune checkpoint inhibitors (ICIs), although revolutionary in the field of oncology, have been associated with immune-related adverse events (irAEs) that affect nearly every organ of the body. Many common AEs are well documented, but in this review, we highlight some rare irAEs that are mostly limited to reports of observational or case studies. Although these irAEs can be difficult to associate with ICI use due to their scarcity and often delayed onset, understanding and characterizing these rare irAEs is crucial to refining treatment strategies and improving outcomes for patients with cancer receiving ICIs. AREAS COVERED: This review covers the rare irAEs affecting various organ systems, including cardiac, dermatological, endocrine, gastrointestinal, hematological, hepatobiliary, neurological, ocular, pancreatic, renal, and rheumatological. Information regarding irAEs compiled in this review are largely derived from case reports and case series and includes discussion surrounding proposed etiology, phenotype, and treatment of AEs. EXPERT OPINION: Rare irAEs can occur in nearly all organ systems. Although it is difficult to attribute causation of an AE to ICIs, it is important for clinicians to be aware of possible AEs to rapidly diagnose and treat potential symptoms. Further research should focus on strategies to improve recognition of rare irAEs.
Expert Opin Drug Saf
· 2026 Jul · PMID 41649239
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INTRODUCTION: Pharmacovigilance (PV) plays a vital role in post-marketing surveillance of drug safety; however, traditional methods are hindered by underreporting, data heterogeneity, and delayed signal detection. Artifi...INTRODUCTION: Pharmacovigilance (PV) plays a vital role in post-marketing surveillance of drug safety; however, traditional methods are hindered by underreporting, data heterogeneity, and delayed signal detection. Artificial Intelligence (AI) has been increasingly employed to overcome these shortcomings through automation, advanced pattern recognition, and multimodal fusion of patient data. AREAS COVERED: The regulatory acceptance of these systems rests on explainability, transparency, and auditability, which necessitate the inclusion of explainable AI (XAI) methods. This review thoroughly examines the international regulatory environment for AI in PV and suggests using Shapley Additive Explanations (SHAP) and Local Interpretable Model-Agnostic Explanations (LIME) to build regulatory trust. Research materials, including official guidelines and publications, were systematically sourced from authoritative regulatory websites in the US, Europe, and India, as well as from major academic databases such as Google Scholar, ScienceDirect, and PubMed. EXPERT GUIDANCE: The EU AI Act classifies PV algorithms as 'high-risk,' imposing strict requirements for human oversight and transparency, aligning with the FDA's GMLP and India's Responsible AI principles. The review emphasizes traceability and governance, recommending convergence with human oversight into a regulatory-fit XAI framework to maximize safety signal detection and foster international trust in AI-based decision-making.
Perrone U, Barra F, Evangelisti G
… +5 more, Izzotti A, Gustavino C, Antonelli A, Leone Roberti Maggiore U, Ferrero S
Expert Opin Drug Saf
· 2026 Feb · PMID 41630559
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INTRODUCTION: Hormonal therapy is the cornerstone of long-term endometriosis management, especially for women deferring surgery. In patients with comorbid migraine - a common, disabling condition - therapeutic choices mu...INTRODUCTION: Hormonal therapy is the cornerstone of long-term endometriosis management, especially for women deferring surgery. In patients with comorbid migraine - a common, disabling condition - therapeutic choices must balance efficacy with neurological and vascular safety. AREAS COVERED: This review summarizes hormonal therapies for endometriosis with a focus on safety in migraineurs. A comprehensive literature search was conducted using MEDLINE, EMBASE, and the Cochrane Library up to March 2025. EXPERT OPINION: Combined hormonal contraceptives (CHCs) and progestins remain first-line options for treating endometriosis-related pain. CHCs are contraindicated in patients with migraine with aura because of the increased risk of ischemic stroke, while their prescription in migraine without aura should be individualized, considering also the fact that evidence in women with concomitant endometriosis is still limited. Progestins generally show better tolerability and may improve migraine outcomes, despite the occurrence of breakthrough bleeding or mood changes. Gonadotropin-releasing hormone (GnRH) agonists and antagonists are second-line options, providing effective pain control, although their effects on migraine are variable and headaches are a frequent adverse event. Add-back therapy is essential to mitigate hypoestrogenic sequelae, particularly about bone health. Overall, treatment should be individualized according to migraine subtype and vascular risk profile to ensure long-term safety, adherence, and therapeutic effectiveness.
Expert Opin Drug Saf
· 2026 Jan · PMID 41565246
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OBJECTIVE: To analyze adverse events signals linked to dipyridamole using the FDA Adverse Event Reporting System, informing safety protocols for clinical use. METHODS: We retrospectively extracted AE reports linked to di...OBJECTIVE: To analyze adverse events signals linked to dipyridamole using the FDA Adverse Event Reporting System, informing safety protocols for clinical use. METHODS: We retrospectively extracted AE reports linked to dipyridamole from the FAERS database, covering the period from Q1 2004 to Q4 2024. Signal detection was rigorously performed using a combination of statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). RESULTS: A total of 1235 patients experienced adverse events related to dipyridamole, with these events occurring 3371 times in total. The signal for Acquired von Willebrand's Disease emerged as particularly prominent, followed by Steal syndrome and Peritoneal hematoma. Additionally, signals indicating increased risks of pulmonary edema, myocardial ischemia and ischemic stroke were detected. Adverse events were common in patients aged ≥65 years, with the most prominent signal being Catheter site hematoma and Blood creatine phosphokinase MB increased. The combination of dipyridamole and other drugs was prone to bleeding adverse events, suggesting a multifaceted safety profile that warrants careful clinical consideration. CONCLUSIONS: These findings underscore the need for tailored safety monitoring strategies and more nuanced risk-benefit assessments in the clinical use of dipyridamole.
Nguyen UT, Nguyen MH, Duong KNC
… +5 more, Nguyen PTL, Cao HTT, Nguyen QN, Vu HD, Nguyen HA
Expert Opin Drug Saf
· 2026 Jan · PMID 41557588
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OBJECTIVE: This systematic review and meta-analysis aimed to identify and evaluate risk factors for bleeding in hospitalized patients receiving anticoagulation therapy. METHODS: Cochrane, Embase, and PubMed were searched...OBJECTIVE: This systematic review and meta-analysis aimed to identify and evaluate risk factors for bleeding in hospitalized patients receiving anticoagulation therapy. METHODS: Cochrane, Embase, and PubMed were searched from database inception until 20 November 2024, to identify studies exploring associations between risk factors and anticoagulation-related bleeding. Study quality was assessed using the PROBAST for risk assessment model studies and the QUIPS for prognostic factor studies. We rated the certainty of evidence for each factor using the GRADE framework. We calculated pooled odd ratios (ORs) with 95% Confidence interval [CI] using random-effects meta-analyses. RESULTS: This review included 29 studies, assessing 93 factors, 37 of which were associated with bleeding. We found high certainty evidence of an association between the bleeding risk and the following factors: gastrointestinal ulcers (OR 4.21, 95% CI 2.82-6.28), anemia (OR 3.24, 95% CI 2.08-5.06), medical procedures (OR 2.20, 95% CI 1.53-3.17), renal failure (OR 1.81, 95% CI 1.40-2.35), co-administration of antiplatelet agents (OR 1.78, 95% CI 1.48-2.14), concomitant use of bleeding-related drugs such as nonsteroidal anti-inflammatory drugs and corticosteroids (OR 2.67, 95% CI 2.13-3.33). CONCLUSION: Our results highlight comorbidity and medication factors associated with in-hospital bleeding related to anticoagulants. STUDY REGISTRATION: PROSPERO CRD42025648123.
Expert Opin Drug Saf
· 2026 Jan · PMID 41549983
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BACKGROUND: Immune checkpoint inhibitors (ICIs) are widely used in cancer treatment but can induce thyroid dysfunction. While the incidence of ICI-induced thyroid dysfunction (ICI-TD) has been studied, the timing of onse...BACKGROUND: Immune checkpoint inhibitors (ICIs) are widely used in cancer treatment but can induce thyroid dysfunction. While the incidence of ICI-induced thyroid dysfunction (ICI-TD) has been studied, the timing of onset, particularly in relation to sex differences, remains underexplored. RESEARCH DESIGN AND METHODS: We assessed time to onset of thyroid dysfunction caused by nivolumab, pembrolizumab, and ipilimumab using the Japanese Adverse Drug Event Report (JADER) database. Cases were identified using standardized MedDRA queries. Reporting odds ratios and 95% confidence intervals were calculated. Time-to-onset analysis used the Weibull shape parameter and Mann-Whitney U-test, stratified by sex. RESULTS: Among 914,713 reports, 2468 nivolumab, 3030 pembrolizumab, and 1457 ipilimumab cases of suspected ICI-TD were found. All ICIs detected positive signals. Median onset times for hyperthyroidism were 42, 33 and 44.5 days, for nivolumab, pembrolizumab, and ipilimumab, respectively; hypothyroidism onset times were 85, 60 and 65 days, respectively. Onset time was consistently shorter in females than males. The Weibull analysis indicated a wear-out failure type, except for pembrolizumab-induced hypothyroidism, which showed a random failure type. CONCLUSIONS: ICI-TD occurs earlier in female patients. This finding highlights the need for sex-specific monitoring to optimize early detection and management of thyroid-related adverse events in patients receiving ICIs.
Bai L, Lin S, Liu D
… +3 more, Zhang B, Liu L, Zhao G
Expert Opin Drug Saf
· 2026 Mar · PMID 41469030
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INTRODUCTION: The study aimed to comprehensively evaluate the role of direct oral anticoagulants (DOACs) combined with antiplatelet therapy (APT) in acute coronary syndrome (ACS) patients and those with atrial fibrillati...INTRODUCTION: The study aimed to comprehensively evaluate the role of direct oral anticoagulants (DOACs) combined with antiplatelet therapy (APT) in acute coronary syndrome (ACS) patients and those with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) or complicating ACS. METHODS: Data were pooled using the Mantel - Haenszel random-effect models. The risk ratio (RR) value and 95% confidence intervals (CI) calculated were applied to dichotomous outcomes. RESULTS: In 38,170 ACS patients from 11 studies, DOACs combined with APT significantly reduced major adverse cardiovascular events (MACEs), stent thrombosis (ST), ischemic stroke and all-cause death, accompanied by increased bleeding risks compared with control groups. Among 11,175 participants from 6 studies involving AF patients undergoing PCI or complicating ACS, DOACs plus APT markedly reduced bleeding risksin various definitions, with no significant difference in efficacy outcomes compared with control groups. CONCLUSIONS: The combination of DOACs and APT requires a tailored approach. For ACS patients, therapy should center on balancing ischemic and bleeding risks, favoring those at high ischemic risk but low or manageable bleeding risk. In contrast, for AF patients undergoing PCI or complicating ACS, the regimen is aimed at risk minimization and is most suitable for patients in whom this is the primary concern. www.crd.york.ac.uk/prospero identifier is CRD42025645639.
Expert Opin Drug Saf
· 2026 Jan · PMID 41445423
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INTRODUCTION: This meta-analysis evaluated the efficacy and safety of naldemedine for treating opioid-induced constipation (OIC) in non-cancer patients, focusing on SBM, serious TEAEs, GI side effects, opioid withdrawal,...INTRODUCTION: This meta-analysis evaluated the efficacy and safety of naldemedine for treating opioid-induced constipation (OIC) in non-cancer patients, focusing on SBM, serious TEAEs, GI side effects, opioid withdrawal, and other adverse events (AEs). METHODS: A systematic review was conducted using PubMed, ScienceDirect, CINAHL, and the Cochrane Library. Two reviewers independently screened studies, extracted data, and assess methodological quality. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. A random-effects model was applied to analyze outcomes using Review Manager 5.3. RESULTS: Eight RCTs from six studies were included, with 3879 patients in the intervention group and 3868 in the control group. Naldemedine significantly increased the incidence of serious TEAEs (RR = 1.07; 95% CI: 1.00-1.14, < 0.05), drug-related adverse events (RR = 1.44, 95% CI: 1.26-1.65, < 0.05), GI adverse events (RR = 1.61, 95% CI: 1.40-1.86, < 0.0), and opioid withdrawal-related events (RR = 1.65, 95% CI: 1.42-1.91, < 0.05). Specific AEs include abdominal pain (RR = 3.71, CI: 2.87-3.71, < 0.01), nausea (RR = 1.51, CI: 1.38-1.65, < 0.01), and diarrhea (RR = 2.57, CI: 2.08-3.16, < 0.01) were also significantly higher in the naldemedine group. CONCLUSIONS: Naldemedine 0.2 mg is effective for treating OIC in non-cancer patients and is generally well tolerated, with primarily mild-moderate AEs. Further studies should explore long-term safety and comparisons with other PAMORAs.This review was registered in the PROSPERO databases (CRD42023472575).
Desai MY, Michaud V, Thacker D
… +6 more, Arwood M, Dow P, Martinez M, Michels M, Owens AT, Turgeon J
Expert Opin Drug Saf
· 2026 May · PMID 41313044
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INTRODUCTION: Several sarcomeric gene abnormalities associated with left ventricular thickening, hypercontractility, and high left ventricular ejection fraction define hypertrophic cardiomyopathy (HCM). Standard treatmen...INTRODUCTION: Several sarcomeric gene abnormalities associated with left ventricular thickening, hypercontractility, and high left ventricular ejection fraction define hypertrophic cardiomyopathy (HCM). Standard treatment options such as beta-adrenergic blockers, calcium channel blockers, and/or disopyramide improve symptoms in many patients, but have limited ability to modify disease progression. Two new cardiac myosin inhibitors (CMIs), mavacamten and aficamten, reduce the intensity of myosin - actin cross-bridge formation and could treat causes of HCM. AREAS COVERED: Drug clearance concepts, relevant information pertaining to cytochrome P450 (CYP450) isoenzymes involved in the disposition of mavacamten and aficamten, genetic polymorphisms associated with CYP450 isoenzymes, and relevance of multi-drug interactions leading to changes in the systemic exposure of CMIs. EXPERT OPINION: Both mavacamten and aficamten exhibit complex disposition and are extensively metabolized by CYP450 isoenzymes including CYP2C9, CYP2C19, and CYP2D6, which exhibit genetic polymorphisms. CYP3A4 contributes less to the metabolism of mavacamten and aficamten. However, CYP3A4 can influence the disposition of these CMIs and other drugs, as CYP3A4 is subjected to induction and inhibition, and modulation by inflammatory factors. Therefore, multi-drug interactions due to changes in the metabolic clearances of CMIs are expected in HCM patients with other chronic conditions and polypharmacy.
Xiong L, Li K, Feng X
… +3 more, Wu J, Yang Y, Zhong T
Expert Opin Drug Saf
· 2026 Mar · PMID 41306055
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BACKGROUND AND AIMS: Ciprofol (HSK3486), a novel intravenous anesthetic with a chemical structure similar to propofol, is not inferior to propofol in terms of its effectiveness. We compared the effects of ciprofol and pr...BACKGROUND AND AIMS: Ciprofol (HSK3486), a novel intravenous anesthetic with a chemical structure similar to propofol, is not inferior to propofol in terms of its effectiveness. We compared the effects of ciprofol and propofol on dreams and emotional states in patients following painless gastroscopy. RESEARCH DESIGN AND METHODS: This was a single-center, randomized controlled trial. The primary outcome was the proportion of positive dreams during sedation. RESULTS: A total of 110 outpatients were included, with 55 in each group. The proportion of positive dreams among dreamers was significantly greater in the propofol group than in the ciprofol group (60.9% vs 20.0%; = 0.020). Additionally, the propofol group exhibited significantly higher positive emotion scores compared to the ciprofol group (19 [15,25] vs 17 [12,21]; = 0.021). No significant differences were observed in vital signs, BIS values, or satisfaction with the procedure between the two groups. As for the adverse drug reactions, the incidence of injection pain of propofol was significantly higher than that of ciprofol (12.7% vs 0%; = 0.013). CONCLUSIONS: Compared to propofol, ciprofol demonstrated a weaker capacity to induce positive dreams and emotions during painless gastroscopy. However, this does not impact patient satisfaction with the procedure. CLINICAL TRIAL REGISTRATION: www.chictr.org.cn; identifier: ChiCTR2400082655.
Irlik K, Kwiendacz H, Ignacy W
… +4 more, Grabska A, Gumprecht J, Lip GYH, Nabrdalik K
Expert Opin Drug Saf
· 2026 Mar · PMID 41292445
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INTRODUCTION: Advanced chronic kidney disease (CKD), defined as an estimated glomerular filtration rate < 30 ml/min/1.73 m, significantly amplifies the challenges of managing atrial fibrillation (AF), highly prevalent in...INTRODUCTION: Advanced chronic kidney disease (CKD), defined as an estimated glomerular filtration rate < 30 ml/min/1.73 m, significantly amplifies the challenges of managing atrial fibrillation (AF), highly prevalent in this population. People with advanced CKD besides increased cardiovascular risk are also at increased risk of both thromboembolic events and bleeding complications. Evidence regarding optimal anticoagulant use in this specific population remains limited, as most pivotal trials exclude people with advanced CKD, also those on maintenance dialysis. AREAS COVERED: This review examines the safety and efficacy of anticoagulation strategies, namely vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) in people with AF and advanced CKD. It highlights the shortcomings of existing thromboembolism risk stratification tools and explores the off-target effects of anticoagulants. The literature search utilized PubMed, Embase, and Web of Science. EXPERT OPINION: Some emerging data suggest that DOACs, particularly rivaroxaban and apixaban, may offer improved safety profiles compared to VKAs in advanced CKD, with comparable efficacy. Observational studies indicate a potential advantage of DOACs in preventing stroke or systemic embolism (SSE) over VKAs. Large clinical trials including a no-anticoagulation arm and validation of risk stratification tools specific to advanced CKD are urgently needed.