Expert Opinion on Drug Safety最新文献_第3页

The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study. 用药方案复杂性评分对危重患者多器官功能障碍和临床结局的影响：一项队列研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-04-30 DOI: 10.1080/14740338.2025.2497395

Kholoud Al Aamer, Khalid Al Sulaiman, Ohoud Aljuhani, Sarah Alshehri, Abdulmajeed M Alshehri, Lina Aldawood, Asmahan AlQurashi, Khuld Aloufi, Lamyaa Kassem, Shahad Nazel, Khalid Albarqi, Alawi S Alsaeedi, Shaden Alonazi, Afnan Alqahtani, Munirah Alhmoud, Majidah Aljohani, Qasem A Bahri, Abdulaziz Alanazi, Saud Jassar, Bader Alnasser, Razan Alqadi, Amal Alqumia, Hasan M Al-Dorzi

{"title":"The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study.","authors":"Kholoud Al Aamer, Khalid Al Sulaiman, Ohoud Aljuhani, Sarah Alshehri, Abdulmajeed M Alshehri, Lina Aldawood, Asmahan AlQurashi, Khuld Aloufi, Lamyaa Kassem, Shahad Nazel, Khalid Albarqi, Alawi S Alsaeedi, Shaden Alonazi, Afnan Alqahtani, Munirah Alhmoud, Majidah Aljohani, Qasem A Bahri, Abdulaziz Alanazi, Saud Jassar, Bader Alnasser, Razan Alqadi, Amal Alqumia, Hasan M Al-Dorzi","doi":"10.1080/14740338.2025.2497395","DOIUrl":"10.1080/14740338.2025.2497395","url":null,"abstract":"Background: Evidence is limited on the utilization of the Medication Regimen Complexity - Intensive Care Unit (MRC-ICU) scores for predicting clinical outcomes in critically ill patients. Therefore, this study aims to examine the impact of the MRC-ICU score on clinical outcomes for critically ill patients.Research design and methods: A single-center retrospective cohort study included adult ICU patients admitted for >72 hours between January and December 2021. Patients were categorized into two groups based on MRC-ICU scores assessed within 24 hours of ICU admission. The primary endpoint was the Multiorgan Dysfunction (MOD) score at 72 hours of ICU admission. Other clinical outcomes were considered secondary.Results: Of the 1406 patients included, 718 had an MRC-ICU score of nine or higher. Patients with MRC-ICU scores ≥9 had significantly higher MOD scores at 72 hours (median 5 vs 3, p < 0.001), longer hospital LOS, and higher mortality rates in crude analyses. Regression analysis showed a significant association between MRC-ICU score and MOD score at day 3 of ICU admission (coefficient: 0.49, 95% CI 0.07 to 0.92, p = 0.02). However, no significant differences were observed with ICU-LOS, vasopressor-free days, or mortality.Conclusions: Higher MRC-ICU scores might be linked to worse clinical outcomes, including greater organ dysfunction, and longer hospital stay.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1919-1925"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985375","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}

引用次数: 0

Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database. 便秘为主的肠易激综合征治疗方案利那洛肽、鲁比前列酮、普莱那肽和泰那诺：FDA不良事件报告系统（FAERS）数据库分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-06-13 DOI: 10.1080/14740338.2025.2519833

Michael B Andrews, Douglas G Adler

{"title":"Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database.","authors":"Michael B Andrews, Douglas G Adler","doi":"10.1080/14740338.2025.2519833","DOIUrl":"10.1080/14740338.2025.2519833","url":null,"abstract":"Background: FDA approved treatments for constipation-predominant irritable bowel syndrome (IBS-C) include secretagogues (Linaclotide, Lubiprostone, and Plecanatide) and a retainagogue (Tenapanor). The FDA Adverse Event Reporting System (FAERS) database collects suspected medication-related adverse events (AEs).Research design and methods: Reports in FAERS from the date of each medication's FDA approval until 30 June 2024 were analyzed. Reports containing other suspected medications or a reason for use outside of IBS and/or constipation were excluded.Results: Linaclotide was most associated with diarrhea (n = 2,082, 24.1%), abdominal pain (n = 815, 9.4%), abdominal bloating (n = 795, 9.2%), and nausea/vomiting (n = 266, 3.1%). Plecanatide was most associated with diarrhea (n = 137, 20.4%), abdominal pain (n = 76, 11.3%), abdominal bloating (n = 62, 9.2%), and nausea/vomiting (n = 34, 5.1%). Tenapanor was most associated with diarrhea (n = 51, 32.9%), abdominal pain (n = 13, 8.4%), and abdominal bloating and nausea/vomiting (n = 11 each, 7.1%). Lubiprostone was most associated with dyspnea (n = 221, 13.0%), nausea/vomiting (n = 161, 9.5%), chest pain (n = 157, 9.3%), abdominal pain (n = 85, 5.0%), and diarrhea (n = 79, 4.7%).Conclusions: This post-marketing analysis of the FAERS database revealed diarrhea, abdominal pain, bloating, and nausea/vomiting were the most frequently reported AEs across all medications. Novel findings include the potential for clinically significant dehydration from Linaclotide-induced diarrhea and Lubiprostone-associated dyspnea and chest pain.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1965-1972"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274552","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}

引用次数: 0

Tolerance of methotrexate co-administered with pegloticase in patients with uncontrolled gout: overview of the findings from the mirror RCT. 在不受控制的痛风患者中，甲氨蝶呤与pegloticase联合耐受：镜像随机对照试验结果概述。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-23 DOI: 10.1080/14740338.2026.2735075

Vinicius Domingues, Abdul Abdellatif, Alexis Woods, Quinnie Yang, Michael E Weinblatt, Junzhi Ji, Brad Marder, Brian LaMoreaux

{"title":"Tolerance of methotrexate co-administered with pegloticase in patients with uncontrolled gout: overview of the findings from the mirror RCT.","authors":"Vinicius Domingues, Abdul Abdellatif, Alexis Woods, Quinnie Yang, Michael E Weinblatt, Junzhi Ji, Brad Marder, Brian LaMoreaux","doi":"10.1080/14740338.2026.2735075","DOIUrl":"https://doi.org/10.1080/14740338.2026.2735075","url":null,"abstract":"Background: The efficacy of pegloticase in uncontrolled gout can be limited by antidrug antibody (ADA) formation. Methotrexate (MTX) reduces ADA development, but carries risks, including hepatotoxicity, myelosuppression, and gastrointestinal toxicity. This post hoc analysis of MIRROR evaluated MTX safety in patients with uncontrolled gout receiving pegloticase.Research design and methods: Patients with uncontrolled gout were randomized 2:1 to receive pegloticase (8-mg infusion every 2 weeks) with blinded MTX (oral 15 mg/week) or placebo (PBO) for 52 weeks. Safety data were collected from patients receiving ≥ 1 dose of blinded MTX or PBO during the run-in period and patients receiving ≥ 1 pegloticase infusion during treatment.Results: In the safety population (n = 96 for MTX and n = 49 for PBO), treatment-emergent adverse events were similar between groups. Liver enzymes and Fibrosis-4 Index scores, a predictor of hepatic fibrosis progression, were similar at Week 52. Stomatitis was rare (n = 1). Renal function remained stable in both groups. Liver function did not worsen among alcohol users and chronic kidney disease subgroups.Conclusions: MTX co-administration with pegloticase did not increase the incidence of liver dysfunction or infection in a post hoc analysis of MIRROR, suggesting that MTX was well tolerated in patients with uncontrolled gout.Clinical trial registration: https://clinicaltrials.gov/ identifier is NCT03994731.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024265","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}

引用次数: 0

A safety review of JAK inhibitors for managing alopecia areata. jak抑制剂治疗斑秃的安全性综述。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-20 DOI: 10.1080/14740338.2026.2734464

Kanchalit Thanomkitti, Sofia Spagnolini, Antonella Tosti

{"title":"A safety review of JAK inhibitors for managing alopecia areata.","authors":"Kanchalit Thanomkitti, Sofia Spagnolini, Antonella Tosti","doi":"10.1080/14740338.2026.2734464","DOIUrl":"10.1080/14740338.2026.2734464","url":null,"abstract":"Introduction: Alopecia areata (AA) is a chronic immune-mediated disorder associated with substantial psychosocial burden. Janus kinase (JAK) inhibitors have transformed the treatment of moderate-to-severe AA, but concerns regarding their long-term safety remain, particularly because class warnings are largely derived from higher-risk rheumatologic populations.Areas covered: This review evaluates the safety of JAK inhibitors used for AA in adults, with emphasis on baricitinib, ritlecitinib, and deuruxolitinib, alongside relevant evidence for other JAK inhibitors. PubMed/MEDLINE, Embase, and Scopus were searched from database inception through April 2026 for relevant clinical trials, long-term studies, meta-analyses, real-world studies, and pharmacovigilance reports. Adolescent data were considered only when reported within mixed adult-adolescent populations or pooled safety analyses. Infection, malignancy, cardiovascular and thromboembolic risk, laboratory abnormalities, special populations, and practical monitoring considerations are reviewed.Expert opinion: Current evidence suggests that serious adverse outcomes are uncommon in appropriately selected adults with AA and that risks observed in older, comorbidity-enriched rheumatologic populations should not be directly extrapolated to AA. Future management will increasingly depend on individualized risk stratification, long-term disease-specific safety data, and agent-specific rather than class-wide assessment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-17"},"PeriodicalIF":3.0,"publicationDate":"2026-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148963269","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}

引用次数: 0

Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network. 肝不良事件与间变性淋巴瘤激酶酪氨酸激酶抑制剂相关：基于FAERS数据库和药物-基因相互作用网络分析的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-18 DOI: 10.1080/14740338.2025.2467830

Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao

{"title":"Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.","authors":"Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao","doi":"10.1080/14740338.2025.2467830","DOIUrl":"10.1080/14740338.2025.2467830","url":null,"abstract":"Background: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This study examines hepatic adverse event (AE) signals related to ALK TKIs using the U.S. FDA Adverse Event Reporting System (FAERS) and explores potential mechanisms of liver injury.Research design and methods: AE reports from FAERS (Q3 2011 to Q1 2024) related to liver injury were analyzed using the reporting odds ratio (ROR) and multi-item gamma Poisson shrinker (MGPS) methods. Pathway enrichment and drug-gene network analyses were performed to investigate underlying mechanisms.Results: This study identified 2,132 AE reports from the FAERS database linking hepatic AEs to ALK TKIs therapy. Significant signals were detected by ROR and MGPS methods, with common AEs including aminotransferase abnormalities, hyperbilirubinemia, and increased blood alkaline phosphatase, mainly occurring within the first 30 days of treatment. Gene analysis revealed key nodes in the protein-protein interaction (PPI) network, such as PIK3CA, SRC, and PTK2. Enriched KEGG pathways included the MAPK, PI3K-Akt, and Ras signaling.Conclusion: This pharmacovigilance study identifies significant AE signals linking ALK TKIs to liver injury, highlighting potential mechanisms and providing insights for clinical management and patient outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1661-1671"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413753","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}

引用次数: 0

GLP-1 receptor agonists in older people with type 2 diabetes: safety evidence from the real world. GLP-1受体激动剂在老年2型糖尿病患者中的应用：来自现实世界的安全性证据

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-03-04 DOI: 10.1080/14740338.2026.2640982

Marella Marassi, Gian Paolo Fadini

{"title":"GLP-1 receptor agonists in older people with type 2 diabetes: safety evidence from the real world.","authors":"Marella Marassi, Gian Paolo Fadini","doi":"10.1080/14740338.2026.2640982","DOIUrl":"10.1080/14740338.2026.2640982","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1623-1627"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343926","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}

引用次数: 0

Are the current safety measures for the treatment of depression with esketamine sufficient? 目前艾氯胺酮治疗抑郁症的安全措施是否足够？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-02-19 DOI: 10.1080/14740338.2026.2627184

Kyle Valentino, Kayla M Teopiz, Christine E Dri, Jennifer Swainson, Yang Jing Zheng, Roger S McIntyre

引用次数: 0

Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database. CDK4/6抑制剂的肝脏不良事件：一项结合meta分析和FAERS数据库的系统综述。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-23 DOI: 10.1080/14740338.2025.2468357

Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao

{"title":"Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database.","authors":"Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao","doi":"10.1080/14740338.2025.2468357","DOIUrl":"10.1080/14740338.2025.2468357","url":null,"abstract":"Background: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities.Research design and methods: As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data.Results: Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40-2.22, I2 = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib.Conclusions: CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1641-1651"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440395","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}

引用次数: 0

Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis. 同时使用免疫检查点抑制剂和二甲双胍或他汀类药物的不良事件：一项观察性、回顾性歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-18 DOI: 10.1080/14740338.2025.2494684

Wenjie Li, Wei Wang

{"title":"Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis.","authors":"Wenjie Li, Wei Wang","doi":"10.1080/14740338.2025.2494684","DOIUrl":"10.1080/14740338.2025.2494684","url":null,"abstract":"Background: Preclinical investigations have indicated that the concurrent administration of ICIs with statins or metformin may enhance the anticancer properties. Nevertheless, the patterns of potential toxicity associated with this combination have yet to be elucidated.Research design and methods: We utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) to provide an overview of the adverse event landscape tied to the concomitant utilization of ICI and statins or metformin.Results: Our study reveals significant side effects associated with combining ICIs with metformin or statins, including gastrointestinal, respiratory, hepatobiliary, and renal disorders. Amalgamated treatment of ICIs plus metformin may heighten the likelihood of bone marrow aplasia, inflammatory bowel disease, intestinal perforation, hepatic impairments, insomnia, autoimmune nephritis, and eczematous manifestations. For ICIs plus statins, colitis, pneumonitis, interstitial lung disease, hypothyroidism, adrenal insufficiency, myocarditis, myositis, hypophysitis, myasthenia gravis, and hepatitis. Importantly, a significant number of adverse events occur within the first two months of starting ICIs alongside metformin or statins, with some appearing after a year of treatment, emphasizing the need for ongoing monitoring.Conclusion: The observations delineated offer pivotal insights into the refinement of the co-administration strategy for ICIs with metformin or statins, attenuating the incidence of adverse side effects.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1721-1730"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143992957","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}

引用次数: 0

Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study. 双重食欲素受体拮抗剂的安全性：一项真实世界的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-24 DOI: 10.1080/14740338.2025.2471520

Yu Sun, Tao Xu, Hongbin Xu

{"title":"Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study.","authors":"Yu Sun, Tao Xu, Hongbin Xu","doi":"10.1080/14740338.2025.2471520","DOIUrl":"10.1080/14740338.2025.2471520","url":null,"abstract":"Background: Dual orexin receptor antagonists (DORAs) are widely used for treating insomnia. However, real-world data on the adverse events (AEs) induced by DORAs are lacking.Methods: Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024. Two established signal quantification methods, the reporting odds ratios and proportional reporting ratios, were applied.Results: A total of 2665 reports on daridorexant (1738, 65.22%), suvorexant (667, 25.03%), and lemborexant (260, 9.75%) were obtained. 24 targeted systems for daridorexant, 24 for suvorexant, and 25 for lemborexant were involved. We analyzed the top 30 preferred terms (PTs) that met both algorithm criteria and identified 69 PTs. The highest signal of strength of PT was sleep paralysis for daridorexant and lemborexant, and abnormal sleep-related event for suvorexant. The most frequent PT was somnolence for lemborexant (30, 11.54%) and insomnia for daridorexant (252, 14.50%) and suvorexant (62, 9.30%) within the top 30 PTs.Conclusion: The analysis of disproportionality signals may prompt increased awareness of toxicities for DORAs. The results of serious reports and dosage of drugs provided supporting evidence for clinicians to manage AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1695-1701"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476156","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}

引用次数: 0