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Complexity and clinical significance of drug-drug interactions (DDIs) in oncology: challenging issues in the care of patients regarding cancer-associated thrombosis (CAT).

Cancer patients have an increased risk of developing venous thromboembolic events. Anticoagulation management includes prophylactic or therapeutic doses of low molecular weight heparins (LMWHs) or direct oral anticoagulants (DOACs). However, the management of thrombosis in patients with cancer is complex due to various individual and disease-related factors, including drug-drug interactions (DDIs). Furthermore, DDIs may impact both, cancer and venous thrombosis, treatment effectiveness and safety; their relevance is highlighted by the advances in cancer therapeutics. Given that these new oncol

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… (rivaroxaban, HR 1.24; 0.94–1.65, and dabigatran HR 0.84; 0.48–1.45). … Serrao A et al. [ 22 ] reported two cases of cancer patients who developed bleeding complications after receiving azacitidine and apixaban or dabigatran. …

Blood Coagulation and Beyond: Position Paper from the Fourth Maastricht Consensus Conference on Thrombosis.

The Fourth Maastricht Consensus Conference on Thrombosis included the following themes. Theme 1: The "coagulome" as a critical driver of cardiovascular disease. Blood coagulation proteins also play divergent roles in biology and pathophysiology, related to specific organs, including brain, heart, bone marrow, and kidney. Four investigators shared their views on these organ-specific topics. Theme 2: Novel mechanisms of thrombosis. Mechanisms linking factor XII to fibrin, including their structural and physical properties, contribute to thrombosis, which is also affected by variation in microbio

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… are both efficient in blocking their target proteases, rivaroxaban could preserve endothelial barrier function while dabigatran failed to protect endothelial integrity. … The agents are categorized in reversal of dabigatran (anti-IIa), anti-Xa anticoagulants or with universal action. …

Trends in Anticoagulant Utilization and Clinical Outcomes for Cancer-Associated Thrombosis: A Multicenter Cohort Study in Thailand's Upper-Middle-Income Country Setting.

PURPOSE: To evaluate anticoagulant trends and clinical outcomes in the management of cancer-associated thrombosis (CAT) within Thailand, an upper-middle-income country (UMIC). METHODS: This multicenter retrospective cohort study included adult patients with cancer diagnosed with venous thromboembolism (VTE) hospitalized in Thailand from 2017 to 2021. Anticoagulants were classified as low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and warfarin. Prescription trends were assessed, and patients were followed for 1 year, or until 2022 to evaluate outcomes. The primary eff

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… The DOACs used in this study were dabigatran, rivaroxaban, apixaban, and edoxaban. Decisions regarding drug dosage adjustments and temporary discontinuation of anticoagulation were at the discretion of the treating physicians. … Because of the limited number of patients who received apixaban, edoxaban, and dabigatran, it was not possible to conduct a meaningful comparison among the different DOACs. …

ESCP Spring Workshop 2023: Advancing clinical pharmacy and care in diabetes and cardiovascular comorbidities-Antwerp, 20-21 April 2023.

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… Results: A total of 38 patients receiving rivaroxaban (n = 19), dabigatran (n = 6) or edoxaban (n = 13) were involved. In this cohort, DOAC concentration level intervals in blood were 8–480 ng/mL for rivaroxaban, 24–237 ng/mL for dabigatran and 9–481 ng/mL for edoxaban. … Seventeen (rivaroxaban n = 10, dabigatran n = 2, and edoxaban n = 5) patients received amiodarone several days before and on the procedure day. …

Prevention of venous thromboembolism in ambulatory patients with cancer.

Patients with cancer are at high risk of venous thromboembolic events, and this risk can be further increased in patients with certain cancer types and by cancer treatments. Guidelines on the prevention of cancer-associated thrombosis (CAT) recommend thromboprophylaxis for hospitalised patients; however, this is not routinely recommended for ambulatory patients receiving chemotherapy and is limited to specified high-risk patients. Identification of the ambulatory patients at risk of CAT who would most benefit from anticoagulant therapy is therefore critical to reduce the incidence of this comp

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… Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342–52. 10.1056/NEJMoa0906598 67. The EINSTEIN Investigators Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499–510. 10.1056/NEJMoa1007903 68. … Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013;368:709–18. 10.1056/NEJMoa1113697 74. Levine MN, Gu C, Liebman HA, et al. A randomized phase II trial of apixaban for the prevention of thromboembolism in patients with metastatic cancer. …

Critical analysis of the prescription and evaluation of monoclonal antibodies approved in Germany for the outpatient setting from 2010-2021.

Monoclonal antibodies (mAbs) are increasingly being launched on the German market and account for a growing share of total drug costs every year. In 2021 alone, eleven monoclonal antibodies were among the 30 best-selling drugs, accounting for 9.91% of total drug costs. In contrast, a considerable additional benefit of the newly introduced monoclonal antibodies is not predominantly demonstrable. Therefore, our objective was to analyze the drug prescriptions and associated costs in comparison to the benefit assessment of the Federal Joint Committee (GBA). This paper analyzes 62 monoclonal antibo

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… soft tissue sarcoma, in combination with Doxorubicin 45 | Dinutuximab(Unituxin) (O) | 2016 | Not assigned by the WHO | Not assigned by the WHO | High-risk neuroblastoma in patients aged 1—17 years 46 | Idarucizumab (Praxbind) | 2016 | Not assigned by the WHO | Not assigned by the WHO | Antidote for Dabigatran … Idarucizumab is a Dabigatran antagonist and Gemtuzumab Ozogamicin is used as a CD33-targeted cytostatic inhibitor. Bezlotoxumab neutralizes toxin B of Clostridium Dificile and Ibalizumab binds to CD4-positive T cells and blocks the binding of the HIV-1 virus (European Medicines Agency n.d. ). …

Pharmacoeconomic evaluation of direct oral anticoagulants for cancer-associated thrombosis: a systematic review.

OBJECTIVE: To synthesize pharmacoeconomic evidence of prevention and treatment of venous thromboembolism (VTE) in cancer patients with direct oral anticoagulants (DOACs) and evaluate the quality of the studies. METHODS: PubMed, Embase, Scopus, the Cochrane Library, the Center for Reviews and Dissemination Database, the Health Technology Assessment Database, and the China National Knowledge Infrastructure Database were searched to collect economic evaluations. The search covered publications from their inception until June 13, 2024. Study selection was conducted independently by two researcher

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… The commonly used DOACs in clinical practice include apixaban, rivaroxaban, edoxaban, and dabigatran. … Because the mechanism of action of dabigatran differs from that of factor Xa inhibitors like apixaban, and evidence for treating CAT is insufficient, its efficacy requires further confirmation through research ( 12 ). …

Responsible, Safe, and Effective Use of Antithrombotics and Anticoagulants in Patients Undergoing Interventional Techniques: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Interventional pain management involves diagnosis and treatment of chronic pain. This specialty utilizes minimally invasive proc … res.4. There is good evidence that discontinuation of anticoagulant therapy with warfarin, heparin, dabigatran (Pradaxa®), argatroban (Acova®), bivalirudin (Angiomax®), lepirudin (Refludan®), desirudin (Iprivask®), hirudin, apixaban (Eliquis®), rivaroxaban (Xarelto®), edoxaban (Savaysa®, Lixiana®), Betrixaban(Bevyxxa®), fondaparinux (Arixtra®) prior to inter …

Interrupted versus uninterrupted anticoagulation for cardiac rhythm management device insertion.

BACKGROUND: Guideline-recommended strategies to interrupt chronic anticoagulation with warfarin or direct oral anticoagulants (DOAC) during … in anticoagulation, with or without heparin bridging; and (2) continued DOAC (apixaban, betrixaban, dabigatran, edoxaban, or rivaroxaban) vs. interrupted DOAC, with or without heparin bridging. DATA COLLECTION AND ANALYSIS: Primary outcomes were composite thromboembolic events (transient ischemic attack, ischemic stroke, deep vein thrombosis, pulmonary embo …

Bloodstream Infection and Endocarditis Caused by Staphylococcus aureus in Patients with Cancer: A Multicenter Cohort Study.

IntroductionIn a large cohort of patients with Staphylococcus aureus bloodstream infection (SABSI), we aimed to analyze the incidence and risk factors for infective endocarditis (IE) among patients with active cancer (PAC) in comparison with those without cancer (PWC).MethodsMulticenter cohort study of patients with SABSI admitted to two tertiary care hospitals, from 2011 to 2019. PAC were defined as those with an active solid organ cancer or hematological malignancies. SABSI and S. aureus IE were compared between PAC and PWC.ResultsAmong 978 episodes of SABSI, 217 (22.2%) occurred in PAC. PAC

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… Recently, the use of dabigatran was also associated with a lower risk of SABSI in a large cohort of patients and with a lower risk of IE in an animal model [ 30 , 31 ]. … Dabigatran and the risk of Staphylococcus aureus bacteremia: a nationwide cohort study. Clin Infect Dis. 2021;73:480–486. doi: 10.1093/cid/ciaa661. …

Артериальный тромбоэмболизм

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… Of 16 patients taking dabigatran, one patient (6.3%) each developed VTE, stroke and major bleeding. Peak dabigatran levels were measured in 12 patients (mean 57 ng/mL, 95% CI 22‐91 ng/mL); nine (75%) were below and none were above the therapeutic range. …

Treatment and Prevention of Cancer-Associated Thrombosis in Frail Patients: Tailored Management.

Advanced age is one of the major determinants of frailty in patients with cancer-associated thrombosis. However, multiple other factors contribute to frailty in these patients. The identification of frailty in patients with cancer-associated thrombosis is critical as it influences the complexity of the anticoagulant treatment in this population at high risk of venous thromboembolism and bleeding. Factors that contribute to frailty in patients with cancer-associated thrombosis include age, type of cancer, comorbidities such as chronic kidney disease, poly-pharmacotherapy, treatment compliance,

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… swallowing disorders Oral anticoagulants more practical than LMWH Type of cancer | Pancreas Multiple myeloma | LMWH for VTE prophylaxis and treatment LMWH if concomitant use of IMiDs Comorbidities | Renal impairment Hepatic impairment | LMWH or DOAC in patients with CrCl <15 mL/min (<30 mL/min for dabigatran … Both LMWH and DOACs may be used in patients with CrCl >15 mL/min, with the exception of the DOAC dabigatran which should not be used in patients with CrCl <30 mL/min. 5. …

Issues Related to the Frequency of Exploratory Analyses by Evidence Review Groups in the NICE Single Technology Appraisal Process.

BackgroundEvidence Review Groups (ERGs) critically appraise company submissions as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal (STA) process. As part of their critique of the evidence submitted by companies, the ERGs undertake exploratory analyses to explore uncertainties in the company's model. The aim of this study was to explore pre-defined factors that might influence or predict the extent of ERG exploratory analyses.ObjectiveThe aim of this study was to explore predefined factors that might influence or predict the extent of ERG explora

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… severe chronic obstructive pulmonary disease TA245 Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults TA248 Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes TA249 Dabigatran … severe chronic obstructive pulmonary disease TA245 | Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults TA248 | Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes TA249 | Dabigatran …

Polycythemia Vera: Barriers to and Strategies for Optimal Management.

Polycythemia vera (PV) is a subtype of myeloproliferative neoplasms characterized by impaired quality of life and severe complications. Despite the increasingly in-depth knowledge of this condition, it necessitates a multifaceted management approach to mitigate symptoms and prevent thrombotic and hemorrhagic events, ensuring prolonged survival. The therapeutic landscape has been revolutionized in recent years, where venesection and hydroxycarbamide associated with antiplatelet therapy have a central role and are now accompanied by other drugs, such as interferon and Janus kinase inhibitors. On

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… In MVA, high-risk of thrombosis in patients with dabigatran and edoxaban, younger age, and history of thrombosis MPN-DOACs study 34 442 MPN patients with DOAC indication for AF or VTE Recurrent thrombosis in 10 cases (2.1% patients’ year) and 22 cases (9.2%) AVAJAK, NCT05198960 Designed to compare the … In MVA, high-risk of thrombosis in patients with dabigatran and edoxaban, younger age, and history of thrombosis MPN-DOACs study 34 | 442 MPN patients with DOAC indication for AF or VTE | Recurrent thrombosis in 10 cases (2.1% patients’ year) and 22 cases (9.2%) AVAJAK, NCT05198960 | Designed to compare …

Doubly blind: a systematic review of gender in randomised controlled trials.

BackgroundAlthough observational data show social characteristics such as gender or socio-economic status to be strong predictors of health, their impact is seldom investigated in randomised controlled studies (RCTs).Objective & designUsing a random sample of recent RCTs from high-impact journals, we examined how the most often recorded social characteristic, sex/gender, is considered in design, analysis, and interpretation. Of 712 RCTs published from September 2008 to 31 December 2013 in the Annals of Internal Medicine, British Medical Journal, Lancet, Canadian Medical Association Journal, or

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… and warfarin in patients with mechanical heart valves | Excess thrombolysis and bleeding in dabigatran group such that study was terminated | N =252 Women=35% Age 18–75 | Reported a harmful outcome from the study drug and terminated the study early Estruch (primarily public) ( 34 ) | Can a Mediterranean … Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206–14. doi: 10.1056/NEJMoa1300615. 34. Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. …

EHA Guidelines on Management of Antithrombotic Treatments in Thrombocytopenic Patients With Cancer.

In cancer patients, thrombocytopenia can result from bone marrow infiltration or from anticancer medications and represents an important limitation for the use of antithrombotic treatments, including anticoagulant, antiplatelet, and fibrinolytic agents. These drugs are often required for prevention or treatment of cancer-associated thrombosis or for cardioembolic prevention in atrial fibrillation in an increasingly older cancer population. Data indicate that cancer remains an independent risk factor for thrombosis even in case of thrombocytopenia, since mild-to-moderate thrombocytopenia does n

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… Clinically relevant DDIs should be always considered, especially for clopidogrel, ticagrelor, warfarin, and dabigatran (see Suppl. Table S1 ). Level 1, grade D e. … In this respect, the 2020 ESC AF guidelines suggest reduced-dose rivaroxaban (15 mg od) or dabigatran (110 mg bid) for high-bleeding risk patients in case of combined antithrombotic therapy. 59 In patients with grade 3–4 TP, AF, and recent ACS, we recommend withdrawing DOAC and continuing with SAPT with …

Cancer-associated thrombosis: an overview.

Venous thromboembolism (VTE) is a common complication in patients with malignant disease. Emerging data have enhanced our understanding of cancer-associated thrombosis, a major cause of morbidity and mortality in patients with cancer. In addition to VTE, arterial occlusion with stroke and anginal symptoms is relatively common among cancer patients, and is possibly related to genetic predisposition. Several risk factors for developing venous thrombosis usually coexist in cancer patients including surgery, hospital admissions and immobilization, the presence of an indwelling central catheter, ch

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… . | -LMWH preferred to VKA - In patients not treated with LMWH, VKA therapy is preferred to dabigatran or rivaroxaban - Patients receiving extended therapy should continue with the same agent used for the first 3 months of treatment | - LMWH is recommended for long-term therapy for DVT and PE - VKAs … Novel Oral Anticoagulants Recently, the development of novel oral anticoagulants (NOACs) that directly inhibit factor Xa (eg, rivaroxaban, apixaban, or betrixaban) or thrombin (for example, dabigatran etexilate) is a milestone achievement in the prevention and treatment of VTE. 87 Unlike LMWHs and warfarin …

Hematology

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… Similar to fondaparinux, but specifically inhibits factor Xa by binding to its active site without interacting with AT DVT prophylaxis (phase II) Complications —bleeding Monitor —antifactor Xa activity Direct thrombin inhibitors: Dabigatran Desirudin Lepirudin Argatroban Ximelagatran Direct thrombin … Does not depend on AT for action and thus unaffected by AT deficiency HITT (lepirudin, argatroban) ACS (hirudin, argatroban) DVT prophylaxis (hirudin, dabigatran) For HITT, lepirudin 0.1–0.4 mg/kg IV bolus, then 0.1–0.15 mg/kg/h; argatroban 2 µg/kg/min infusion Complications —bleeding Monitor —aPTT …

Primary Thromboprophylaxis in Patients with Malignancies: Daily Practice Recommendations by the Hemostasis Working Party of the German Society of Hematology and Medical Oncology (DGHO), the Society of Thrombosis and Hemostasis Research (GTH), and the Austrian Society of Hematology and Oncology (ÖGHO).

Patients with cancer, both hematologic and solid malignancies, are at increased risk for thrombosis and thromboembolism. In addition to general risk factors such as immobility and major surgery, shared by non-cancer patients, cancer patients are exposed to specific thrombotic risk factors. These include, among other factors, cancer-induced hypercoagulation, and chemotherapy-mediated endothelial dysfunction as well as tumor-cell-derived microparticles. After an episode of thrombosis in a cancer patient, secondary thromboprophylaxis to prevent recurrent thromboembolism has long been established

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… Of note, no trials exist for edoxaban and dabigatran in this setting. … Solubility of rivaroxaban, edoxaban, and dabigatran is pH-dependent. Therefore, these DOACs require gastric acidity for their absorption. …

Incidence of stroke in the first year after diagnosis of cancer-A systematic review and meta-analysis.

BackgroundPatients newly diagnosed with cancer represent a population at highest risk for stroke. The objective of this systematic review and meta-analysis was to estimate the incidence of stroke in the first year following a new diagnosis of cancer.MethodsWe searched MEDLINE and EMBASE from January 1980 to June 2021 for observational studies that enrolled adults with a new diagnosis of all cancers excluding non-melanoma skin cancer, and that reported the incidence of stroke at 1 year. PRISMA guidelines for meta-analyses were followed. Two reviewers independently extracted data and appraised r

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… While patients with cancer were excluded from the large DOAC trials comparing rivaroxaban, apixaban, dabigatran, and edoxaban to warfarin ( 69 – 72 ), recent observational data suggests that DOAC is comparable to warfarin in terms of efficacy and safety profiles, and the Canadian Cardiovascular Society … Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. (2009) 361:1139–51. 10.1056/NEJMoa0905561 71. Granger CB, Alexander JH, McMurray JJV, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus warfarin in patients with atrial fibrillation. …