-
1دورية أكاديمية
المؤلفون: Masahiro Yasaka, Hiroyuki Yokota, Michiyasu Suzuki, Hidesaku Asakura, Teiichi Yamane, Yukako Ogi, Takaaki Kimoto, Daisuke Nakayama
المصدر: Cardiology and Therapy, Vol 12, Iss 4, Pp 723-740 (2023)
مصطلحات موضوعية: Anticoagulation, Dabigatran, Emergency reversal, Idarucizumab, Japanese postmarketing surveillance, Diseases of the circulatory (Cardiovascular) system, RC666-701
الوصف: Abstract Introduction Idarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect data on idarucizumab in Japanese patients. Interim results were published previously, and the final results are reported herein. Methods This multicenter, open-label, uncontrolled, non-interventional PMS study was conducted in Japanese patients who received idarucizumab at the approved dose (2 × 2.5 g/50 ml) and had uncontrolled bleeding (group A) or required an emergency procedure (group B). The primary endpoint was the frequency of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effects of dabigatran, within 4 h of idarucizumab administration, based on activated partial thromboplastin time (aPTT). Results The final analysis included 804 patients. ADRs during the idarucizumab treatment and post-treatment periods were reported in 17 of 542 patients (3.1%) in group A and 12 of 240 patients (5.0%) in group B. Thrombotic events were reported in 22 patients (4.1%) in group A and 15 patients (6.3%) in group B, and hypersensitivity occurred in four (0.7%) and five patients (2.1%), respectively. Among 793 patients evaluated for effectiveness, 78 in group A and 26 in group B had aPTT data at baseline (immediately before idarucizumab administration) and within 4 h of idarucizumab administration; in these patients, median maximum percentage reversal within 4 h of idarucizumab administration was 100%. Conclusions The final analysis from the PMS study confirms previous findings suggesting that idarucizumab can safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients in clinical practice. The results support the continued use of idarucizumab in Japan. Trial Registration This study is registered with ClinicalTrials.gov (NCT02946931). Graphical Abstract
وصف الملف: electronic resource
-
2دورية أكاديمية
المؤلفون: Aakjær, Mia, De Bruin, Marie Louise, Andersen, Morten
المساهمون: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation
مصطلحات موضوعية: adverse drug reactions, pharmacoepidemiology, pharmacovigilance, postmarketing surveillance, Toxicology, Pharmacology
الوصف: Background: Methods for safety signal detection in electronic healthcare data analysing data sequentially are being developed to meet the limitations of spontaneous reporting systems. Objectives: This study aims to provide an overview of the literature on sequential analysis of electronic healthcare data and describe the development and testing of a novel epidemiological surveillance system. Methods: We searched Medline, Embase, PubMed, Scopus, Web of Science, and the Cochrane Library applying similar in- and exclusion criteria as those of a previous systematic review. The proposed system consisted of repeated cohort studies and was tested in an emulated prospective setting. Two signal evaluations were performed with several sensitivity analyses and a target trial emulation. Findings: In the literature, 11 studies analysed the data sequentially of which two applied traditional epidemiological methods. Epidemiological surveillance of several exposures and outcomes can be successfully conducted with the newly proposed sequential analysis of electronic healthcare data. Signal evaluation studies confirmed the results of the system. Conclusions: Very few studies in the literature analysed data at multiple time points, although this seems to be a prerequisite for testing the methods in a realistic setting. We demonstrated the feasibility of a sequential surveillance system using electronic healthcare data.
وصف الملف: application/pdf
-
3دورية أكاديمية
المؤلفون: Brandon Michael Henry, Giuseppe Lippi, Ameen Nasser, Patryk Ostrowski
المصدر: Current Oncology, Vol 30, Iss 6, Pp 5932-5945 (2023)
مصطلحات موضوعية: postmarketing surveillance, pharmacovigilance, registry data, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
الوصف: The present study analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics, including outcome measures, interventions, sample sizes, and study design, different cancer types, and geographic regions. The analysis included 368 phase IV oncology studies. An amount of 50% of these studies examined both safety and efficacy, while 43.5% only reported efficacy outcome measures, and 6.5% only described safety outcome measures. Only 16.9% of studies were powered to detect adverse events with a frequency of 1 in 100. Targeted therapies accounted for the majority of included studies (53.5%), with breast (32.91%) and hematological cancers (25.82%) being the most frequently investigated malignancies. Most phase IV oncology studies lacked sufficient power to detect rare adverse events due to their small sample sizes and instead focused on effectiveness. To ensure that there is no gap in drug safety data collection and detection of rare adverse events due to limited phase IV clinical trials, there is a significant need for additional education and participation by both health care providers and patients in spontaneous reporting processes.
وصف الملف: electronic resource
العلاقة: https://www.mdpi.com/1718-7729/30/6/443Test; https://doaj.org/toc/1198-0052Test; https://doaj.org/toc/1718-7729Test
-
4دورية أكاديمية
المؤلفون: Shigeomi Iimura, Yasuyo Nose, Keiko Tabata, Kenji Oda, Yoshiyuki Yamashita, Naohiro Takahashi, Yoshiaki Kawano
المصدر: Toxins, Vol 15, Iss 9, p 553 (2023)
مصطلحات موضوعية: onabotulinumtoxinA, laryngeal dystonia, postmarketing surveillance study, Medicine
الوصف: This postmarketing surveillance study was conducted to evaluate the safety and effectiveness of onabotulinumtoxinA in Japanese patients with laryngeal dystonia (LD). Patients receiving onabotulinumtoxinA for the first time were enrolled and observed for up to 12 months following the first injection. Safety assessment included adverse drug reactions (ADRs), and effectiveness assessments included the Voice Handicap Index-10 (VHI-10) and physician’s global assessment (PGA). ADRs were observed in 48 (5.8%) of 834 patients in the safety analysis set, including dysphonia in 43 (5.2%) patients and dysphagia in 7 (0.8%) patients. The change in total VHI-10 score (mean) in 790 patients included in the effectiveness analysis set showed that improvement in adductor LD peaked at 2 months after the first injection, while patients with abductor or mixed LD showed a gradual attenuation of effect 2–4 weeks post-injection. The change in total VHI-10 score in subsequent injections was generally similar to that following the first injection. The overall effectiveness rate according to the PGA was 93.4% (738/790 patients). The results demonstrate that onabotulinumtoxinA is a well-tolerated and effective treatment for LD in real-world clinical practice.
وصف الملف: electronic resource
-
5دورية أكاديمية
المصدر: Saúde e Sociedade; v. 32 n. supl.1 (2023); e220937pt ; Saúde e Sociedade; Vol. 32 No. supl.1 (2023); e220937pt ; Saúde e Sociedade; Vol. 32 Núm. supl.1 (2023); e220937pt ; 1984-0470 ; 0104-1290
مصطلحات موضوعية: Fiscalização Sanitária, Medicamentos, Vigilância de Produtos Comercializados, Tomada de Decisão, Health Inspection, Drug Regulation, Postmarketing Surveillance, Decision Making
الوصف: A sociedade contemporânea convive com incertezas e vulnerabilidades que exigem a atuação dos sistemas regulatórios na fiscalização do comércio eletrônico de medicamentos não registrados e/ou falsificados. Investiga-se o trabalho dos profissionais da vigilância sanitária federal na fiscalização de medicamentos na internet e os elementos que orientam sua decisão técnica. A metodologia utilizada foi a pesquisa qualitativa, do tipo estudo de caso único, ancorada na abordagem ergológica, entre dezembro de 2020 e setembro de 2021, por meio de entrevistas e observação participante. Os mapas ergodialógicos, elaborados no Atlas.ti, subsidiaram a análise das práticas discursivas classificadas conforme esquema tripolar saber-agir-valor, resultando em três categorias. O profissional é sempre convocado a fazer escolhas e gerir situações imprevisíveis, havendo inquietações sobre a capacidade institucional para compreender e agir sobre o problema. O trabalho adquire, assim, o sentido de “enxugar gelo”, em função do volume de demandas e dos poucos efeitos da fiscalização no mercado eletrônico de medicamentos. As normas, o conhecimento técnico, a experiência e a responsabilidade social, dentre outros elementos, estão presentes na tomada de decisão dos profissionais, conscientes de que, ao agir, protegem a saúde da população. Constata-se que diferentes saberes, científicos ou empíricos, podem qualificar melhor o sistema decisório na fiscalização, tornando-o mais efetivo, assertivo e transparente. ; Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. ...
وصف الملف: application/pdf
-
6دورية أكاديمية
المؤلفون: Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini
المصدر: Pharmaceuticals; Volume 16; Issue 6; Pages: 867
مصطلحات موضوعية: angiogenesis, adverse drug reaction, VEGF, disproportionality analysis, postmarketing surveillance, spontaneous reporting systems
الوصف: Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs) in cancer patients and highlight if the found disproportionality signals of adverse events (AEs) were validated and thus mentioned in the respective Summary of product Characteristics (SmPC). This scoping review was conducted according to PRISMA guidelines for scoping reviews. A knowledge gap on the safety of AADs was found: firstly, several cardiovascular AEs were not mentioned in the SmPCs and no pharmacovigilance studies were conducted despite the well-known safety concerns about these drugs on the cardiovascular system. Second, a disproportionality signal (not validated through causality assessment) of pericardial disease was found in the literature for axitinib with no mention in SmPC of the drug. Despite the exclusion of pharmacoepidemiological studies, we believe that this scoping review, which focuses on an entire class of drugs, could be considered as a novel approach to highlight possible safety concerns of drugs and as a guide for the conduction of a target postmarketing surveillance on AADs.
وصف الملف: application/pdf
-
7دورية أكاديمية
المؤلفون: Hattersley, Anne M., Kiernan, Michael, Goldberg, David, Dierickx, Christine, Sliney, David H., Haedersdal, Merete, Nash, J. Frank
المصدر: Hattersley , A M , Kiernan , M , Goldberg , D , Dierickx , C , Sliney , D H , Haedersdal , M & Nash , J F 2023 , ' Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance ' , Lasers in Surgery and Medicine , vol. 55 , no. 4 , pp. 414-422 . https://doi.org/10.1002/lsm.23650Test
مصطلحات موضوعية: adverse events, home-use device, intense pulsed light (IPL), postmarketing surveillance
الوصف: Background and objectives: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. Materials and methods: For this analysis of voluntary reports, we queried a distributor′s postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. Results: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), “thermal burn” 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. Conclusion: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.
وصف الملف: application/pdf
الإتاحة: https://doi.org/10.1002/lsm.23650Test
https://curis.ku.dk/portal/da/publications/assessment-of-adverse-events-for-a-homeuse-intense-pulsed-light-hair-removal-device-usingTest-postmarketing-surveillance(017cc271-1f54-439c-b91a-b4833c15fab0).html
https://curis.ku.dk/ws/files/366265782/Lasers_Surg_Med_2023_Hattersley.pdfTest -
8دورية أكاديمية
المؤلفون: Jinyi Yuan, Xiaoping Zhang, Jing Chen, Yueyuan Zhang, Fengjia Zhu, Haihui Huang
المصدر: Frontiers in Pharmacology, Vol 13 (2022)
مصطلحات موضوعية: nemonoxacin, non-fluorinated quinolone, safety, postmarketing surveillance, systematic review, Therapeutics. Pharmacology, RM1-950
الوصف: Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in clinical studies and via postmarketing safety surveillance.Methods: We electronically and manually searched and screened safety data (including premarketing and postmarketing data) of oral nemonoxacin from clinical registries. We standardized and summarized the reported adverse events according to the Medical Dictionary for Regulatory Activities System Organ Class and Preferred Terms. We summarized and reported the number and frequency (%) of the AEs and serious AEs in patients with community-acquired pneumonia and in specific patients.Results: Three Phase II/III comparator studies (n = 670, nemonoxacin), one Phase IV study (n = 461), two special population pharmacokinetic studies (n = 40), four observational studies (n = 1,852), and one 5-year postmarketing surveillance project (n = 257,420) were included in this study. The Phase II/III studies showed that the commonly reported drug-related AEs were similar for oral 500 mg nemonoxacin and levofloxacin treatments, which mainly included increased alanine aminotransferase levels (4.4% vs. 2.5%), neutropenia (2.5% vs. 4.4%), nausea (2.5% vs. 1.6%), and leukopenia (2.3% vs. 3.2%). No drug-related deaths were reported. Postmarketing safety surveillance revealed that known adverse drug reaction characteristics were generally unchanged. Pharmacokinetic data suggested that dose adjustment was not necessary in elderly patients, which was confirmed by a Phase IV study in an elderly population, in patients with renal impairment with CLcr ≥50 ml/min, and in those with mild-to-moderate hepatic impairment.Conclusion: Clinical trial data of approximately 1,450 patients and postmarketing data of >257,420 patients suggest that nemonoxacin is generally well tolerated and can be a suitable alternative to fluoroquinolones for patients with CAP.
وصف الملف: electronic resource
العلاقة: https://www.frontiersin.org/articles/10.3389/fphar.2022.1067686/fullTest; https://doaj.org/toc/1663-9812Test
-
9دورية أكاديمية
المؤلفون: Min Fan, Adrienne Y. L. Chan, Vincent K. C. Yan, Xinning Tong, Lauren K. W. Lau, Eric Y. F. Wan, Eliza Y. T. Tam, Patrick Ip, Terry Y. Lum, Ian C. K. Wong, X. Li
المصدر: Orphanet Journal of Rare Diseases, Vol 17, Iss 1, Pp 1-8 (2022)
مصطلحات موضوعية: Orphan drug designation, Adverse events, Postmarketing surveillance, Medication safety, Risk–benefit trade-off, Medicine
الوصف: Abstract Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan drugs and to identify postmarketing safety-associated approval factors. Methods This retrospective cohort study includes all drugs with orphan drug designation approved by the Center for Drug Evaluation and Research of the US Food and Drug Administration between 1999 and 2018. Main outcomes are safety-related labelling changes up to 31 December 2019. We defined any safety-related labelling changes as postmarketing safety events (PMSE). Safety-related withdrawals, suspensions, and boxed warnings were further categorised as severe postmarketing safety events (SPSE). Outcome measurements include frequencies of PMSE, SPSE, and association between approval factors and the occurrence of safety events. Results Amongst the 214 drugs identified with orphan drug designation (25.7% biologics), 83.6% were approved through at least one expedited programme, and 29.4% were approved with boxed warnings. During a median follow-up of 6.74 years since approval, 69.2% and 14.5% of the analysed orphan drugs had PMSE and SPSE, respectively. Safety-related withdrawal (0%, 0/214), suspended marketing (0.46%, 1/214) and new boxed warnings are uncommon (3.7%, 8/214). The safety-related labelling changes were more frequent in the drugs approved with boxed warnings [Incidence rate ratio (IRR): 1.95 (1.02–3.73)] and approved for long-term use [IRR: 2.76 (1.52–5.00)]. Conclusions and Relevance In this long-term postmarketing analysis, approximately 70% of FDA-approved orphan drugs had safety-related labelling changes although severe safety events were rare. While maintaining early access to orphan drugs, the drug regulatory body has taken timely regulatory action with postmarketing surveillance to ensure patient safety.
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/1750-1172Test
-
10دورية أكاديمية
المصدر: Intestinal Research, Vol 19, Iss 4, Pp 419-429 (2021)
مصطلحات موضوعية: adalimumab, japanese, postmarketing surveillance, real-world study, ulcerative colitis, Medicine, Diseases of the digestive system. Gastroenterology, RC799-869
الوصف: Background/Aims Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC. Methods In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline. Results Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52. Conclusions This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.
وصف الملف: electronic resource
العلاقة: http://www.irjournal.org/upload/pdf/ir-2020-00033.pdfTest; https://doaj.org/toc/1598-9100Test; https://doaj.org/toc/2288-1956Test
النص الكامل