Expert Opinion on Drug Safety最新文献_第9页

Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature. 氯氮平治疗的患者和成人心肌梗死：在文献背景下解释的VigiBase药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-13 DOI: 10.1080/14740338.2025.2518234

Carlos De Las Cuevas, Emilio J Sanz, Jose de Leon

{"title":"Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature.","authors":"Carlos De Las Cuevas, Emilio J Sanz, Jose de Leon","doi":"10.1080/14740338.2025.2518234","DOIUrl":"10.1080/14740338.2025.2518234","url":null,"abstract":"Background: Clozapine is the best treatment for treatment-resistant schizophrenia (TRS) but is associated with metabolic adverse drug reactions (ADRs).Research dosing/methods: The international pharmacovigilance database (VigiBase) uses the information component (IC) as a disproportionality analysis. On 1 July 2024, we studied in VigiBase: 1) the myocardial infarction (MI) ICs for antipsychotics and 2) clozapine reports for MI since clozapine's introduction. After excluding 298 patients with incomplete data, 1490 adults were studied for fatal outcomes using logistic regression with adjusted odds ratios (aOR) and survival analysis.Results: Clozapine was associated with the highest IC (IC = 0.903; IC025 = 0.835). Olanzapine (IC = 0.524; IC025 = 0.398) showed a lower but significant association. The ICs for quetiapine, risperidone and haloperidol were non-significant or negative. Mortality in 1490 adult clozapine-treated patients with MI was 68%. Using a baseline age 18-44 years, age 45-64 years had a significant (p < 0.001) aOR = 1.87 with CI 1.43-2.44, while age ≥65 years had a significant (p < 0.001) aOR = 4.07 with CI 2.77-5.97. High clozapine doses (>600 mg/day) displayed an aOR = 2.18 for fatal outcomes.Conclusion: A MI IC around 0.9 is higher than that of other antipsychotics, but we cannot rule out that it is explained by TRS present in clozapine-treated patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247207","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 : 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":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","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

Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases. 使用FAERS、JADER和CVAR数据库分析组胺H1受体拮抗剂与广泛痴呆事件之间的关系。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-12 DOI: 10.1080/14740338.2025.2517232

Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang

{"title":"Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases.","authors":"Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang","doi":"10.1080/14740338.2025.2517232","DOIUrl":"10.1080/14740338.2025.2517232","url":null,"abstract":"Background: Recent studies suggest histamine H1 receptor antagonists (H1RAs) may elevate broad dementia events risk, though real-world data remain scarce.Methods: This pharmacovigilance study analyzed FDA Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report (JADER), and Canada Vigilance Adverse Reaction (CVAR) databases from January 2004 to June 2024. Using disproportionality analyses such as the reporting odds ratio (ROR) and proportion reporting ratio (PRR), time-to-onset analysis, propensity score matching, and multivariate regression, we compared broad dementia event signals among first-generation H1RAs (FG-H1RAs), second-generation H1RAs (SG-H1RAs), and benzodiazepines (BDs).Results: According to the FAERS database, FG-H1RAs (ROR = 3.33, 95%CI 3.22-3.44; PRR = 3.11, χ2 = 5426.01), SG-H1RAs (ROR = 2.03, 95%CI 1.98-2.07; PRR = 1.97, χ2 = 3706.58), and BDs (ROR = 2.74, 95%CI 2.68-2.80; PRR = 2.6, χ2 = 8338.34) were significantly associated with broad dementia events, with FG-H1RAs having a stronger association with broad dementia events compared to SG-H1RAs (aROR = 0.60, 95%CI 0.54-0.67, p < 0.001). Analysis of the JADER and CVAR databases yielded similar results. FG-H1RAs exhibited immediate broad dementia events reporting (median = 0 days), while SG-H1RAs showed delayed onset (median = 1 day), both with early risk decay.Conclusion: This study provides evidence for the association between H1RAs treatment and broad dementia events, highlighting signaling differences among H1RAs. However, large-scale, high-quality epidemiological studies are still needed for validation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274551","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

Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS database. 阿比特龙和奥拉帕尼联合治疗与单药治疗前列腺癌相关不良事件的比较歧化分析：使用FAERS数据库的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-05 DOI: 10.1080/14740338.2025.2496434

Si-Han Zhang, Jin-Zhou Xu, Na Zeng, Zhi-Yu Xia, Lin-Tao Miao, Ci Zhang, Shao-Gang Wang, Qi-Dong Xia

{"title":"Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS database.","authors":"Si-Han Zhang, Jin-Zhou Xu, Na Zeng, Zhi-Yu Xia, Lin-Tao Miao, Ci Zhang, Shao-Gang Wang, Qi-Dong Xia","doi":"10.1080/14740338.2025.2496434","DOIUrl":"10.1080/14740338.2025.2496434","url":null,"abstract":"Objectives: This study compares adverse events (AEs) of combined abiraterone acetate and olaparib treatment with their individual treatments for prostate cancer, focusing on safety profile differences and their clinical implications.Methods: Data on AEs for abiraterone acetate and olaparib were extracted from the FDA Adverse Event Reporting System (FAERS) database between April 2011 and April 2024. The reporting odds ratio (ROR) was mainly utilized to analyze AEs and their preferred terms (PTs).Results: A total of 32,745 AE reports for abiraterone acetate, 2493 for olaparib and 113 for combination therapy in males were identified. The combination therapy was associated with a higher risk of hematologic and lymphatic disorders and cardiovascular events compared to monotherapy. Notably, venous embolism and acute myocardial infarction showed significant ROR values in the combination therapy group.Conclusions: Combining abiraterone and olaparib increases risks of acute myocardial infarction, embolism, and pneumonitis over monotherapy. Though this combination improves survival, it demands vigilant patient monitoring and risk assessment. We recommend patients undergo serum lipid measurement, electrocardiograms, and cardiac and vascular ultrasounds to facilitate early detection and management of potential adverse effects. Additional research is needed to confirm these results and ensure the safe application of this drug combination.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215315","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

Hemorrhagic events associated with tacrolimus: a real-world pharmacovigilance study. 与他克莫司相关的出血事件：一项真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-15 DOI: 10.1080/14740338.2024.2380792

Haolin Teng, Honglan Zhou, Faping Li

{"title":"Hemorrhagic events associated with tacrolimus: a real-world pharmacovigilance study.","authors":"Haolin Teng, Honglan Zhou, Faping Li","doi":"10.1080/14740338.2024.2380792","DOIUrl":"10.1080/14740338.2024.2380792","url":null,"abstract":"Background: Tacrolimus is a potent macrolide immunosuppressant frequently used to prevent graft rejection in organ transplantation. Despite the known side effect of hemorrhage, there are no extensive descriptive series of patients who experience hemorrhage events associated with tacrolimus. We sought to review and describe tacrolimus-related hemorrhage events reported by healthcare professionals to the United States Food and Drug Association Adverse Event Reporting System (FAERS) database.Methods: The FAERS database (2004q1-2022q4) was retrospectively analyzed to characterize reporting of hemorrhage adverse events (AEs) with tacrolimus. Subgroup analysis was completed on the hemorrhage.Results: A total of 75,310 tacrolimus-associated AEs were identified, of which 1,511 cases met specific inclusion/exclusion criteria with most occurring in the gastrointestinal tract (422 cases, 27.93% of all included cases). Death was reported in 558 patients (36.93% of hemorrhage cases), the most of which occurred in cases of brain hemorrhage (219 cases, 39.25% of death cases). Among definitive organ transplants, renal transplant was the most common indication for tacrolimus (62 cases, 4.10%) followed by bone marrow transplant (44 cases, 2.91%) and liver transplant (30 cases, 1.99%).Conclusions: This study presents the largest collective description of tacrolimus-related hemorrhage events. We additionally described a number of previously unreported tacrolimus-related hemorrhage events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"711-718"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619779","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

Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS). 双奥曲肽受体拮抗剂（DORAs）与自杀之间的关系：向美国食品药品监督管理局不良事件报告系统（FAERS）提交的报告。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-06-03 DOI: 10.1080/14740338.2024.2361300

Roger S McIntyre, Sabrina Wong, Angela T H Kwan, Taeho Greg Rhee, Kayla M Teopiz, Roger Ho, Bing Cao, Rodrigo B Mansur, Joshua D Rosenblat, Gia Han Le

{"title":"Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).","authors":"Roger S McIntyre, Sabrina Wong, Angela T H Kwan, Taeho Greg Rhee, Kayla M Teopiz, Roger Ho, Bing Cao, Rodrigo B Mansur, Joshua D Rosenblat, Gia Han Le","doi":"10.1080/14740338.2024.2361300","DOIUrl":"10.1080/14740338.2024.2361300","url":null,"abstract":"Background: Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS).Methods: The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC025). IC was significantly increased when the IC025 ≥0.Results: Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC025.Conclusion: We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"753-757"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141156790","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

Real-world safety and effectiveness of intravenous fomepizole in patients with ethylene glycol and methanol poisoning in Japan: results of a 7-year post-marketing surveillance study. 日本乙二醇和甲醇中毒患者静脉注射福美匹唑的实际安全性和有效性：上市后 7 年监测研究的结果。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-22 DOI: 10.1080/14740338.2024.2372410

Toshiharu Yoshioka, Momoha Koyanagi, Naoki Yoshida

{"title":"Real-world safety and effectiveness of intravenous fomepizole in patients with ethylene glycol and methanol poisoning in Japan: results of a 7-year post-marketing surveillance study.","authors":"Toshiharu Yoshioka, Momoha Koyanagi, Naoki Yoshida","doi":"10.1080/14740338.2024.2372410","DOIUrl":"10.1080/14740338.2024.2372410","url":null,"abstract":"Background: Fomepizole is a competitive alcohol dehydrogenase inhibitor used for the treatment of ethylene glycol and methanol poisoning. We evaluated the safety and effectiveness of fomepizole in patients with ethylene glycol or methanol poisoning in Japan.Research design and methods: This retrospective post-marketing surveillance study conducted in Japan registered patients who received fomepizole intravenous infusion per the package insert (January 2015-June 2022). Endpoints included adverse drug reactions/infections (ADRs), arterial blood pH, and treatment outcomes.Results: Of 147 patients registered (91 institutions), 131 and 126 were included in the safety and effectiveness analysis sets, respectively. Mean age was 43.6 years, and 66.4% were male. Mean time from poison ingestion to treatment was 15.1 hours; 66.4% received concomitant hemodialysis. No serious ADRs were reported. ADRs were reported in seven patients; the most-reported ADR was vomiting (2.3%). Seven patients died, 105 survived without sequelae, and 19 survived with sequelae. Most common sequelae were renal failure or renal dysfunction. Mean arterial blood pH increased to 7.4 by 4 hours of treatment, remaining stable for 24 hours post-treatment.Conclusions: Fomepizole is well tolerated and helps improve clinical outcomes in patients with ethylene glycol or methanol poisoning in Japan.Trial registration: Japanese Pharmaceutical Information Center (JapicCTI-152817).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"685-693"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456123","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

Data mining study on adverse events of tirzepatide based on FAERS database. 基于 FAERS 数据库的特西帕肽不良事件数据挖掘研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-15 DOI: 10.1080/14740338.2024.2376686

Yan Huo, Minghua Ma, Xiaolan Liao

{"title":"Data mining study on adverse events of tirzepatide based on FAERS database.","authors":"Yan Huo, Minghua Ma, Xiaolan Liao","doi":"10.1080/14740338.2024.2376686","DOIUrl":"10.1080/14740338.2024.2376686","url":null,"abstract":"Background: Tirzepatide is a novel dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) for type 2 diabetes or obesity. To explore the safety profile of tirzepatide in real-world clinical applications.Research design and methods: A retrospective analysis of adverse events (AEs) reports associated with tirzepatide was conducted from the second quarter of 2022 through the fourth quarter of 2023, utilizing the FDA Adverse Event Reporting System (FAERS) database. Signal mining utilized the reporting odds ratio (ROR) method, and onset time was analyzed utilizing the Weibull Shape Parameter (WSP).Results: We identified 25,215 AE reports related to tirzepatide, predominantly in the 65 to 85 age group. Four positive signals were found at the system organ classes level. Additionally,109 AEs at the preferred terms level with positive signals were indicated. Included among these are novel signals, such as the presence of thyroid mass, medullary thyroid carcinoma, and conditions affecting the reproductive system and breast. Most AEs occurred within the first 30 days. The WSP was 0.66, indicating a propensity for early failure type.Conclusions: This study identified several novel AE signals for tirzepatide, highlighting the need for careful monitoring, especially in the early stages of treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"675-683"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616139","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

Drug-Induced Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity. 药物性血小板减少的严重程度和毒性（ditpst）：根据人血小板减少毒性对药物进行二元分类。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-02 DOI: 10.1080/14740338.2025.2460439

Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan

{"title":"Drug-Induced Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity.","authors":"Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan","doi":"10.1080/14740338.2025.2460439","DOIUrl":"10.1080/14740338.2025.2460439","url":null,"abstract":"Background: Drug-induced thrombocytopenia (DITP) often occurs in patients during clinical treatment. However, clinicians usually fail to distinguish which drugs can be plausible culprits accurately. We aimed to develop a large comprehensive drug benchmark database with DITP toxicity using the recommended method by FDA.Research design and methods: We collected information from six databases that involved drug labeling information, literature, safety signal mining and laboratory testing to generate the annotated drug list with DITP toxicity. Then, we descripted the DITP positive-negative distribution based on the Anatomical Therapeutic Chemical (ATC) coding system; hotspot analysis was conducted to identify therapeutic categories of drugs within each organ system that warrant attention regarding DITP.Results: The DITPst database comprised 1,765 drugs, of which 858 were DITP-positives, whereas 907 were negatives. The investigation of distribution across various therapeutic categories revealed the most frequent DITP-positive categories were immunostimulants (10/11), anti-inflammatory, and antirheumatic products (28/32), and antibacterials for systemic use (102/121). On the contrary, the least frequent DITP-positive therapeutic categories were diagnostic radiopharmaceuticals (12/12), pituitary and hypothalamic hormones and analogues (17/18), and drugs for constipation (16/17).Conclusions: We consider the DITPst benchmark database to be an invaluable resource for the community to improve DITP safety research and drug development.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"731-743"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058462","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

Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life? 评估慢性淋巴细胞白血病治疗方案的不良事件负担：什么对患者生活质量最好？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-03-14 DOI: 10.1080/14740338.2025.2471508

Anna Korycka-Wołowiec, Dariusz Wołowiec, Hanna Ławnicka, Tadeusz Robak

{"title":"Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life?","authors":"Anna Korycka-Wołowiec, Dariusz Wołowiec, Hanna Ławnicka, Tadeusz Robak","doi":"10.1080/14740338.2025.2471508","DOIUrl":"10.1080/14740338.2025.2471508","url":null,"abstract":"Introduction: In recent years, chronic lymphocytic leukemia (CLL) treatment has changed dramatically. Chemoimmunotherapy with fludarabine/cladribine, cyclophosphamide, and rituximab have been almost completely replaced by targeted therapies with small molecules, such as Bruton's tyrosine kinase inhibitors or B-cell lymphoma 2 (BCL-2) antagonists. However, few studies have assessed the impact of novel therapies on patient quality of life (QoL).Areas covered: This article reviews the safety profile of new therapeutic options and their impact on the QoL of CLL patients. The MEDLINE database was searched for English language publications from 2010 through June 2024, including the Proceedings of the American Society of Hematology from over the past 5 years.Expert opinion: CLL is a clinically heterogenous disease predominantly affecting elderly patients. The variable clinical course of disease requires personalization and individualized treatment to achieve the optimal survival outcome and acceptable safety profile, especially in the case of poor prognosis. Clinical trials performed in the past decade indicate that novel drugs, used as a single agent or as part of a conventional chemotherapy, offer promise in minimalizing relapse rates, and may allow more effective and safer treatment options by reducing the risk of adverse events, especially cytopenias and infections.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"643-655"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482572","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