Expert Opinion on Drug Safety最新文献_第5页

Adverse drug reactions linked to fidaxomicin: insights from a retrospective analysis of the FAERS database. 与非达霉素相关的药物不良反应：来自FAERS数据库回顾性分析的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-31 DOI: 10.1080/14740338.2025.2487142

Parth Patel, Mohamad Ayman Ebrahim, Douglas G Adler

{"title":"Adverse drug reactions linked to fidaxomicin: insights from a retrospective analysis of the FAERS database.","authors":"Parth Patel, Mohamad Ayman Ebrahim, Douglas G Adler","doi":"10.1080/14740338.2025.2487142","DOIUrl":"10.1080/14740338.2025.2487142","url":null,"abstract":"Background: Clostridium difficile infection is a leading healthcare-associated infection, and fidaxomicin is recommended as a first-line treatment. Although generally well-tolerated, post-marketing surveillance of fidaxomicin's safety profile is necessary given its increased utilization.Research design and methods: This study utilized the FDA Adverse Event Reporting System to analyze adverse drug reactions potentially linked to fidaxomicin use from January 2011 to June 2024. Data were extracted on patient demographics, reported ADRs, and outcomes. Descriptive statistics were used to analyze the ADR reports.Results: A total of 1,187 reports of ADRs were analyzed, including 122 deaths (10.3%), 187 hospitalizations (15.8%), and 17 disabilities (1.4%). The most commonly reported ADRs were gastrointestinal (33%) in nature. Neurological ADRs accounted for 6% of reports, with dizziness and headache being the most prevalent. Psychiatric ADRs such as insomnia and anxiety were reported in 2.8% of cases, with more than half considered serious. Cardiovascular ADRs, though infrequent (2.2%), were largely severe, with heart failure and arrhythmias being the most common.Conclusion: While fidaxomicin is generally well-tolerated, our study identified rare but serious neuropsychiatric and cardiovascular ADRs. Further research is needed to investigate these effects and ensure informed, shared decision-making between prescribers and patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1771-1774"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751676","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

Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023. 左炔诺孕酮安全性概况的更新：2004 - 2023年基于FAERS的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-03 DOI: 10.1080/14740338.2025.2472908

Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng

{"title":"Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023.","authors":"Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng","doi":"10.1080/14740338.2025.2472908","DOIUrl":"10.1080/14740338.2025.2472908","url":null,"abstract":"Background: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented.Research design and methods: Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs.Results: A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions.Conclusions: Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1685-1693"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491445","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

Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events. 老年人抗高血压药物的安全处方和不良事件的风险管理。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-04-04 DOI: 10.1080/14740338.2026.2653753

Siddhant Passey, Maheen Erum, Nandan Patel, Shrey Chopra, Hritvik Jain, Jagriti Jha, Tyler Kingma, Obada Kholoki, Ashwin Pillai, Sai Vikram Alampoondi Venkataramanan, Wilbert Aronow

{"title":"Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events.","authors":"Siddhant Passey, Maheen Erum, Nandan Patel, Shrey Chopra, Hritvik Jain, Jagriti Jha, Tyler Kingma, Obada Kholoki, Ashwin Pillai, Sai Vikram Alampoondi Venkataramanan, Wilbert Aronow","doi":"10.1080/14740338.2026.2653753","DOIUrl":"10.1080/14740338.2026.2653753","url":null,"abstract":"Introduction: Older patients with hypertension have unique clinical challenges based on age-related physiological changes, multimorbidity, and vulnerability to drug side effects. The 2017 American College of Cardiology/American Heart Association guidelines propose initiating antihypertensive therapy at a systolic blood pressure threshold of 130 mm Hg for non-institutionalized ambulatory adults over the age of 65. They also recommended individualized treatment for adults with advanced frailty or high risk of adverse events.Areas covered: This article reviews evolving paradigms and strategies in blood pressure therapy in elderly individuals, based on shifting the approach from stringent treatment targets toward individualized management. Step-care management is one such strategy that involves prudent introduction of low doses of antihypertensives with regular follow-up to avoid side effects. Deprescribing is increasingly being promoted as a key intervention in reducing polypharmacy and maximizing safety in at-risk groups of patients.Expert opinion: There is an increased need to incorporate frailty and functional assessments into routine practice and clinical trials. Despite growing evidence, there are still implementation challenges such as insufficient robust long-term data for frail populations. Pragmatic trials, adoption of digital solutions, and implementation of individualized goals must be the targets of future research.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1629-1640"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147591118","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 celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system. 塞来昔布与中枢神经系统和癌症相关的不良事件：FDA不良事件报告系统的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-02 DOI: 10.1080/14740338.2025.2487140

Yikuan Du, Mengting Zhang, Mianhai Chen, Mianda Hu, Wenqi Zeng, Xiaolin Cai, Weichui Zhang, Jinfeng Zhu, Mingjun Zhong, Yi Liu, Chun Yang

{"title":"Adverse events of celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system.","authors":"Yikuan Du, Mengting Zhang, Mianhai Chen, Mianda Hu, Wenqi Zeng, Xiaolin Cai, Weichui Zhang, Jinfeng Zhu, Mingjun Zhong, Yi Liu, Chun Yang","doi":"10.1080/14740338.2025.2487140","DOIUrl":"10.1080/14740338.2025.2487140","url":null,"abstract":"Background: Celecoxib is now clinically recognized as a candidate for treating various neurological disorders and cancers. The recent emergence of some serious adverse reactions is concerning.Research design and methods: We carried out data mining on the FDA Adverse Event Reporting System (FAERS) for adverse events (AEs) with celecoxib as the main suspect drug and conducted a disproportionality analysis.Results: 111,155,092 AE reports were extracted from FAERS, and 32,841 AEs with celecoxib as the primary suspected drug were identified. Celecoxib AEs were predominantly reported in cardiac disorders (n = 9602) and nervous system disorders (n = 4045). Cerebrovascular accident (n = 3109, PRR = 3.24) ranked second in the number of reports and cerebrovascular disorder (n = 265, PRR = 5.06) ranked second in signal intensity, was described as rare in the instructions. Nine unexpected and serious AEs were discovered, such as Stevens-Johnson syndrome (n = 175, IC025 = 1.7), breast disease male (n = 4, IC025 = 1.54), and squamous cell carcinoma of the head and neck (n = 4, IC025 = 0.96). At 200 mg, celecoxib was more linked to musculoskeletal and connective AEs; At 400 mg, it was more linked to neurological and cardiovascular AEs.Conclusions: Unexpected AEs of celecoxib in neurological diseases and cancer have been identified, offering valuable insights for monitoring and risk assessment in future clinical applications.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1759-1770"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751691","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

Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system. 与环硅酸锆钠相关的上市后安全性：基于FDA报告系统的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-29 DOI: 10.1080/14740338.2025.2486310

Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin

{"title":"Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system.","authors":"Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin","doi":"10.1080/14740338.2025.2486310","DOIUrl":"10.1080/14740338.2025.2486310","url":null,"abstract":"Background: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS).Research design and methods: Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC.Results: Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients.Conclusions: This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1703-1710"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729531","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 treatments for children with functional constipation. 儿童功能性便秘治疗的安全性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-24 DOI: 10.1080/14740338.2026.2721396

Tirza M van Os, Megan A Read, Richard J Wood, Carlo Di Lorenzo, Marc A Benninga, Peter L Lu

{"title":"Safety of treatments for children with functional constipation.","authors":"Tirza M van Os, Megan A Read, Richard J Wood, Carlo Di Lorenzo, Marc A Benninga, Peter L Lu","doi":"10.1080/14740338.2026.2721396","DOIUrl":"https://doi.org/10.1080/14740338.2026.2721396","url":null,"abstract":"Introduction: Functional constipation (FC) in children is a common diagnosis that can be challenging to treat effectively. Internet and social media are shaping parental knowledge and beliefs has become of great importance.Areas covered: A literature review was conducted by searching electronic databases (inception-April 2026) for studies on safety of current management options for FC in children. Our main goal was to describe safety and patients' and parents' satisfaction regarding pharmacological, neuromodulation and surgical therapies. We also addressed myths commonly shared by the lay public. Current evidence supports osmotic and stimulant laxatives as safe first-line treatments for pediatric FC. More novel therapies such as secretagogues and noninvasive neuromodulation may shift management in the future, but long-term safety data regarding these treatments need to be collected. Surgical options are reserved for refractory cases due to complication risks.Expert opinion: Emphasizing safety and addressing misconceptions are essential in order to improve treatment adherence. The availability of more therapeutic options highlights the need for patient stratification to maximize benefit and minimize adverse effects. The growing influence of social media on caregivers underscores the importance of evidence-based communication and shared decision-making in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808508","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

Early recognition, prevention, and management of glucocorticoid toxicity in patients with rheumatic diseases. 风湿病患者糖皮质激素毒性的早期识别、预防和管理。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-19 DOI: 10.1080/14740338.2026.2718746

Louis Cohen, Vivekanand Tiwari, John Tesser, Martin Bergman

{"title":"Early recognition, prevention, and management of glucocorticoid toxicity in patients with rheumatic diseases.","authors":"Louis Cohen, Vivekanand Tiwari, John Tesser, Martin Bergman","doi":"10.1080/14740338.2026.2718746","DOIUrl":"https://doi.org/10.1080/14740338.2026.2718746","url":null,"abstract":"Introduction: Glucocorticoids (GCs) are the mainstay treatment for acute and chronic rheumatic diseases. However, several treatment guidelines recommend limited use of GCs due to their associated toxicity. Rheumatic diseases, including rheumatoid arthritis, vasculitis, and polymyalgia rheumatica, often entail prolonged GC treatment, which may lead to major GC-related adverse events (AEs), such as osteoporosis, fracture, hyperglycemia, infection, and weight gain, along with cardiovascular, ophthalmic, and psychiatric-related AEs.Areas covered: This review elaborates on common GC-associated toxicities, the requirement of baseline assessment of patients before GC initiation, and the use of steroid-sparing agents. It also indicates differences in GC-prescribing patterns between primary care physicians (PCPs) and specialists, highlighting referral delay challenges for suspected rheumatic disease cases.Expert opinion: Treatment guidelines recommend baseline assessment and continuous monitoring of patients prescribed long-term GC treatment. In patients with rheumatic diseases, different risk contributing factors are responsible for GC-related AEs and are found to be dependent on dose and duration. GC therapies are an integral part of managing rheumatic diseases; however, inclusion of steroid-sparing alternative therapies could help reduce the long-term GC toxicity burden. Early referral and good communication between PCPs and specialists play an important role in reducing the long-term GC treatment burden.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148790137","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

Lesser-known medication safety considerations in sickle cell disease. 镰状细胞病中鲜为人知的药物安全注意事项。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-19 DOI: 10.1080/14740338.2026.2719768

Najbah Galadanci, Julie Kanter

{"title":"Lesser-known medication safety considerations in sickle cell disease.","authors":"Najbah Galadanci, Julie Kanter","doi":"10.1080/14740338.2026.2719768","DOIUrl":"10.1080/14740338.2026.2719768","url":null,"abstract":"Introduction: Sickle cell disease (SCD) is a clinically heterogeneous condition in which individuals experience markedly different disease trajectories. As more people with SCD now survive to adulthood, their disease becomes more complicated due to comorbidities, both related and unrelated to SCD. Thus, a precision-oriented approach is essential when initiating new treatments to ensure the delivery of meaningful and sustained benefits for people with SCD.Areas covered: This expert review examines selected, underrecognized safety concerns related to disease-modifying therapies for SCD as well as for other medications often used in this population. We discuss examples of safety issues involving SCD-modifying therapies, cardiovascular and renal medications, antibiotics, and corticosteroids, highlighting how the unique pathophysiology of SCD may influence drug safety, tolerability, and organ injury. The review is based on a narrative assessment of published clinical trials, observational studies, post-marketing safety reports, registry data, and expert clinical experience.Expert opinion: Although SCD is recognized as a highly heterogeneous condition, this issue is not consistently considered in clinical trial design or when using non-SCD therapies in this population. The recent emergence of new drugs emphasizes the importance of longitudinal monitoring, real-world safety assessment, and multidisciplinary specialist care.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762999","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

Myositis in cancer patients receiving immune checkpoint inhibitors: the ARON-MOUSEION-017 systematic review and meta-analysis. 接受免疫检查点抑制剂的癌症患者的肌炎：ARON-MOUSEION-017系统评价和荟萃分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-14 DOI: 10.1080/14740338.2026.2719047

Elsa Vitale, Gerardo Cazzato, Lorenza Maistrello, Mario Della Mura, Mauro Francesco Pio Maiorano, Francesco Ciccimarra, Oronzo Brunetti, Concetta Calabrò, Brigida Anna Maiorano, Fernando Sabino Marques Monteiro, Enes Erul, Francesco Massari, Alessandro Rizzo, Matteo Santoni

{"title":"Myositis in cancer patients receiving immune checkpoint inhibitors: the ARON-MOUSEION-017 systematic review and meta-analysis.","authors":"Elsa Vitale, Gerardo Cazzato, Lorenza Maistrello, Mario Della Mura, Mauro Francesco Pio Maiorano, Francesco Ciccimarra, Oronzo Brunetti, Concetta Calabrò, Brigida Anna Maiorano, Fernando Sabino Marques Monteiro, Enes Erul, Francesco Massari, Alessandro Rizzo, Matteo Santoni","doi":"10.1080/14740338.2026.2719047","DOIUrl":"https://doi.org/10.1080/14740338.2026.2719047","url":null,"abstract":"Background: Myositis may present as a treatment-related adverse event (TRAE) during immune checkpoint inhibitor (ICI) therapy. In the ARON-MOUSEION-017 meta-analysis, we aimed to assess the frequency of myositis among cancer patients treated with ICIs.Research design and methods: The present systematic review and meta-analysis was registered in PROSPERO with ID no. CRD420261278193. Embase, PubMed, Scopus and Web of Science databases were consulted, using Boolean terms and keywords 'Immunotherapy,' 'Myositis' and 'Neoplasms.'Results: For myositis of any grade, 13 studies were included, suggesting that heterogeneity across studies was high and statistically significant (p < 0.001; τ2 = 3.78; I2 = 95.3%, 95% CI [93.1%; 96.7%]), and the pooled proportion of patients affected by any-grade myositis treatment-related adverse events (TRAEs) was 4.2% (95% CI = [1.1%; 14.6%]).Conclusions: ICI-myositis often appears in concomitance with other immune-mediated conditions, such as myocarditis and myasthenia gravis. These events are clinically relevant, since they are often associated with more severe disease courses and unfavorable outcomes, increasing morbidity and mortality.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148758081","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 profile of dual TIGIT and PD-L1 blockade with tiragolumab plus atezolizumab in solid tumors: a systematic review and meta-analysis of randomized controlled trials. tiragolumab + atezolizumab双重TIGIT和PD-L1阻断治疗实体瘤的安全性：随机对照试验的系统评价和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-12 DOI: 10.1080/14740338.2026.2704844

Zaher Mutaz Ashour, Mus'ab Theeb Mustafa, Osama Wadah Rammaha, Abdallah Moh'd Said Hamdan, Yihea Mohammad Al-Mashaqbah, Abdallah Yaser Alasmar, Lou'y Ahmed Al-Rabaeh, Mohammad AlElaimat, Ayham Omar Khalifah, Omar Jamal Ramadan, Aws Khalid Abushanab, Abdulqadir J Nashwan

{"title":"Safety profile of dual TIGIT and PD-L1 blockade with tiragolumab plus atezolizumab in solid tumors: a systematic review and meta-analysis of randomized controlled trials.","authors":"Zaher Mutaz Ashour, Mus'ab Theeb Mustafa, Osama Wadah Rammaha, Abdallah Moh'd Said Hamdan, Yihea Mohammad Al-Mashaqbah, Abdallah Yaser Alasmar, Lou'y Ahmed Al-Rabaeh, Mohammad AlElaimat, Ayham Omar Khalifah, Omar Jamal Ramadan, Aws Khalid Abushanab, Abdulqadir J Nashwan","doi":"10.1080/14740338.2026.2704844","DOIUrl":"10.1080/14740338.2026.2704844","url":null,"abstract":"Introduction: Dual immune-checkpoint blockade targeting T-cell immunoreceptor with Ig and ITIM domains (TIGIT) and programmed death-ligand 1 (PD-L1) shows synergistic antitumor activity. However, its safety profile remains incompletely defined. Our systematic review and meta-analysis aim to evaluate the safety of tiragolumab in combination with atezolizumab (TA) for the treatment of solid tumors.Methods: We conducted a comprehensive literature search up to March 2026. Eligible studies were Phase II or III randomized controlled trials (RCTs) comparing TA with atezolizumab-based regimens and reporting adverse events (AEs); pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated.Results: Five RCTs involving 1001 patients were included. TA was associated with significantly higher risks of rash (RR 1.66, 95% CI 1.16-2.37), pruritus (RR 2.28, 95% CI 1.65-3.16), and infusion-related reactions (RR 1.80, 95% CI 1.23-2.62). No significant differences were observed for gastrointestinal, hematologic, endocrine, laboratory, or high-grade AEs. Subgroup analyses of TA alone versus atezolizumab alone showed only a significantly higher rash risk (RR 3.85, 95% CI 1.40-10.53).Conclusions: TA increases rash, pruritus, and infusion-related reactions without a significant rise in severe toxicities. Limited trial numbers and clinical heterogeneity require cautious interpretation and further long-term safety evaluation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148435877","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