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  1. Article ; Online: What are the Characteristics of Patients Experiencing Adverse Drug Reactions to Oral Anticogulants and How Can Such Reactions be Prevented?

    Spada, G / Vighi, G V / Pagani, S / Vighi, G D / Venegoni, M / Ruocco, M

    Current drug safety

    2019  Volume 15, Issue 1, Page(s) 38–44

    Abstract: Introduction: Oral anticoagulants, including vitamin K inhibitors (VKAs) and direct anticoagulants (DOACs) are important for preventing and treating thromboembolic diseases. However, they are not recommended for use in all patients due to negative side ... ...

    Abstract Introduction: Oral anticoagulants, including vitamin K inhibitors (VKAs) and direct anticoagulants (DOACs) are important for preventing and treating thromboembolic diseases. However, they are not recommended for use in all patients due to negative side effects and adverse drug reactions (ADRs). Currently, there is a paucity of information about their use in real life. Therefore, the aim of this pilot study is to report on the rate of serious ADRs in oral anticoagulant users, determine patient characteristics associated with increased risk of ADRs, and identify possible management strategies for reducing risk of ADRs within a hospital setting.
    Methods: Patients admitted to the Internal Medicine Department of the Vimercate Hospital were recruited between November 1, 2015 and October 31, 2016. All patients reporting an ADR associated with anticoagulant use were selected. Demographic, clinical, and observational data were extracted from electronic hospital records, in particular, by the hospital discharge letters and other clinical records. The main outcome of the study was to evaluate the incidence of anticoagulants serious adverse drug reactions conditioning hospital admission, the percentage of preventable reactions, and the determinants of those.
    Results and discussion: Of the 2,064 admissions, 102 (4.9%) eligible patients were identified. Age ranged from 60-95 years (mean = 81.9, standard deviation = 6,59) and 47.1% (n=48) were female. Of the 102 cases, 68 used VKAs and 34 used DOACs. The most common admission diagnosis was heart failure following anemia or hemorrhage (56 cases), followed by acute hemorrhage (with or without anemia; 29 cases), and anemia not associated with evident hemorrhage (17cases). The majority of VKA users (n=65, 95.6%) had a high risk of major bleeding. ADRs were found to be preventable in 96% of VKA users and 68% of DOACs users.
    Conclusion: This study highlights the large percentage of ADRs from oral anticoagulants that can be avoided with more careful patient management. Periodic check-up of cardiac and renal function, as well as blood count, may be useful for reducing the risk of ADRs, especially in older DOACs users. Further research is needed to get new data to improve the patients monitoring system.
    MeSH term(s) Aged ; Aged, 80 and over ; Anemia/chemically induced ; Anticoagulants/administration & dosage ; Anticoagulants/adverse effects ; Drug Interactions ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Female ; Hemorrhage/chemically induced ; Hospital Records ; Hospitalization/statistics & numerical data ; Humans ; Male ; Middle Aged ; Monitoring, Physiologic ; Vitamin K/antagonists & inhibitors
    Chemical Substances Anticoagulants ; Vitamin K (12001-79-5)
    Language English
    Publishing date 2019-11-13
    Publishing country United Arab Emirates
    Document type Journal Article
    ZDB-ID 2250840-5
    ISSN 2212-3911 ; 1574-8863
    ISSN (online) 2212-3911
    ISSN 1574-8863
    DOI 10.2174/1574886314666191003162104
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Major adverse cardiovascular events associated with VEGF-targeted anticancer tyrosine kinase inhibitors: a real-life study and proposed algorithm for proactive management.

    Vallerio, P / Orenti, A / Tosi, F / Maistrello, M / Palazzini, M / Cingarlini, S / Colombo, P / Bertuzzi, M / Spina, F / Amatu, A / Lombardo, R / Prata, I / Scaglione, F / Vighi, G D / Severgnini, B / Siena, S / Giannattasio, C / Boracchi, P / Sartore-Bianchi, A

    ESMO open

    2021  Volume 7, Issue 1, Page(s) 100338

    Abstract: Background: Vascular endothelial growth factor receptor (VEGFR)-targeted tyrosine kinase inhibitors (TKIs) are widely used in cancer treatment and burdened by cardiovascular toxicity. The majority of data come from clinical trials, thus in selected ... ...

    Abstract Background: Vascular endothelial growth factor receptor (VEGFR)-targeted tyrosine kinase inhibitors (TKIs) are widely used in cancer treatment and burdened by cardiovascular toxicity. The majority of data come from clinical trials, thus in selected populations. The aim of our study is to evaluate the cardiotoxicity profile of VEGFR-targeted TKIs and the impact of cardiovascular risk factors in a real-life population.
    Patients and methods: In this cohort, population-based study, patients treated with VEGFR-targeted TKIs, bevacizumab and trastuzumab between 2009 and 2014 were analyzed. A multi-source strategy for data retrieval through hospital, pharmaceutical and administrative databases of the Lombardy region, Italy, has been adopted. The primary endpoint was to determine the incidence and type of major adverse cardiovascular events (MACEs) along with their temporal trend. The secondary endpoint was to define the impact of cardiovascular risk factors in the occurrence of MACEs.
    Results: A total of 829 patients were treated with VEGFR-targeted TKIs. Eighty-one MACEs occurred in the first year of follow-up [crude cumulative incidence (CCI): 9.79%] mainly consisting of arterial thrombotic events (ATEs, 31 events, CCI: 3.99%), followed by rhythm disorders (22 events, CCI: 2.66%), pulmonary embolisms and heart failures (13 events each, CCI: 1.57%). While the incidence of most MACEs showed a plateau after 6 months, ATEs kept increasing along the year of follow-up. Hypertension and dyslipidemia were associated with an increase in risk of ATEs [relative risk difference (RRD) +209.8% and +156.2%, respectively], while the presence of previous MACEs correlated with a higher risk of all MACEs in multivariate analysis (RRD 151.1%, 95% confidence interval 53.6% to 310.3%, P < 0.001).
    Conclusions: MACEs occur in a clinically significant proportion of patients treated with VEGFR-targeted TKIs, with ATEs being predominant, mainly associated with hypertension and dyslipidemia. A clinical algorithm for effective proactive management of these patients is warranted.
    MeSH term(s) Algorithms ; Cardiotoxicity/epidemiology ; Cardiotoxicity/etiology ; Humans ; Protein Kinase Inhibitors/adverse effects ; Receptors, Vascular Endothelial Growth Factor ; Vascular Endothelial Growth Factor A
    Chemical Substances Protein Kinase Inhibitors ; Vascular Endothelial Growth Factor A ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1)
    Language English
    Publishing date 2021-12-15
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2059-7029
    ISSN (online) 2059-7029
    DOI 10.1016/j.esmoop.2021.100338
    Database MEDical Literature Analysis and Retrieval System OnLINE

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