scholarly journals Evaluation of the Appropriateness of Direct Oral Anticoagulant Selection and Monitoring in the Outpatient Setting

2017 ◽  
Vol 33 (3) ◽  
pp. 108-113 ◽  
Author(s):  
Kristin N. Rieser ◽  
Eric I. Rosenberg ◽  
Katherine Vogel Anderson

Background: Direct oral anticoagulants (DOACs) share many indications with warfarin but require less frequent follow-up and monitoring. There is limited data available on the prescribing of DOACs and appropriate laboratory monitoring in a real-world clinical setting. Objective: To determine if patients receiving care at 2 University of Florida (UF) Health Internal Medicine clinics are prescribed DOACs according to Food and Drug Administration (FDA)–approved labeling. Secondary objectives were to determine the percentage of patients receiving appropriate baseline laboratory tests prior to DOAC initiation and the frequency of laboratory monitoring. Methods: This retrospective chart review evaluated patients enrolled at 2 UF Health Internal Medicine practices within the UF Health system who were prescribed a DOAC between April 2014 and April 2015. Adherence to FDA-approved dosing recommendations and baseline laboratory tests were compared to previously published data. This study was approved by the UF Institutional Review Board. Results: A total of 194 patients met inclusion criteria. Ninety-six patients (49.5%) were on a DOAC prior to data collection; 98 patients (50.5%) started a DOAC during data collection. Of the 194 patients, 155 (79.9%) were prescribed DOACs per FDA-approved labeling ( P = .0005); 79 (40.8%) obtained a complete blood count, serum creatinine, and liver function tests prior to DOAC initiation. Conclusions: Prescribing practices were significantly better than published data; however, 1 in 5 patients were not prescribed a DOAC according to FDA-approved labeling. Less than half of the patients started on a DOAC obtained the recommended labs prior to medication initiation.

Author(s):  
Margaret C. Fang ◽  
Alan S. Go ◽  
Priya A. Prasad ◽  
Jin-Wen Hsu ◽  
Dongjie Fan ◽  
...  

AbstractTreatment options for patients with venous thromboembolism (VTE) include warfarin and direct oral anticoagulants (DOACs). Although DOACs are easier to administer than warfarin and do not require routine laboratory monitoring, few studies have directly assessed whether patients are more satisfied with DOACs. We surveyed adults from two large integrated health systems taking DOACs or warfarin for incident VTE occurring between January 1, 2015 and June 30, 2018. Treatment satisfaction was assessed using the validated Anti-Clot Treatment Scale (ACTS), divided into the ACTS Burdens and ACTS Benefits scores; higher scores indicate greater satisfaction. Mean treatment satisfaction was compared using multivariable linear regression, adjusting for patient demographic and clinical characteristics. The effect size of the difference in means was calculated using a Cohen’s d (0.20 is considered a small effect and ≥ 0.80 is considered large). We surveyed 2217 patients, 969 taking DOACs and 1248 taking warfarin at the time of survey. Thirty-one point five percent of the cohort was aged ≥ 75 years and 43.1% were women. DOAC users were on average more satisfied with anticoagulant treatment, with higher adjusted mean ACTS Burdens (50.18 v. 48.01, p < 0.0001) and ACTS Benefits scores (10.21 v. 9.84, p = 0.046) for DOACs vs. warfarin, respectively. The magnitude of the difference was small (Cohen’s d of 0.29 for ACTS Burdens and 0.12 for ACTS Benefits). Patients taking DOACs for venous thromboembolism were on average more satisfied with anticoagulant treatment than were warfarin users, although the magnitude of the difference was small.


CHEST Journal ◽  
2019 ◽  
Vol 156 (4) ◽  
pp. A15
Author(s):  
Samir Patel ◽  
Sheldon Rao ◽  
Briana DiSilvio ◽  
Tariq Cheema ◽  
Lauren Finoli

2006 ◽  
Vol 52 (2) ◽  
pp. 325-328 ◽  
Author(s):  
Paul Froom ◽  
Zvi Shimoni

Abstract Background: The aim of this study was to explore whether electronically retrieved laboratory data can predict mortality in internal medicine departments in a regional hospital. Methods: All 10 308 patients hospitalized in internal medicine departments over a 1-year period were included in the cohort. Nearly all patients had a complete blood count and basic clinical chemistries on admission. We used logistic regression analysis to predict the 573 deaths (5.6%), including all variables that added significantly to the model. Results: Eight laboratory variables and age significantly and independently contributed to a logistic regression model (area under the ROC curve, 88.7%). The odds ratio for the final model per quartile of risk was 6.44 (95% confidence interval, 5.42–7.64), whereas for age alone, the odds ratio per quartile was 2.01 (95% confidence interval, 1.84–2.19). Conclusions: A logistic regression model including only age and electronically retrieved laboratory data highly predicted mortality in internal medicine departments in a regional hospital, suggesting that age and routine admission laboratory tests might be used to ensure a fair comparison when using mortality monitoring for hospital quality control.


Phlebologie ◽  
2014 ◽  
Vol 43 (05) ◽  
pp. 232-237
Author(s):  
M. Spannagl

ZusammenfassungDie zum niedermolekularen Heparin (NMH) ähnliche Pharmakokinetik der DOAKs (Direkte Orale Antikoagulanzien) ermöglicht im klinischen Alltag den Austausch dieser Substanzen unter Beibehaltung der Anwendungsfrequenz. Vor allem bei nicht sicherer oder nicht möglicher oraler Anwendung von DOAKs erfolgt die parenterale Gabe von NMH. Die benötigte Karenzzeit vor Interventionen oder Operationen ist für beide Anwendungen präzise darstellbar. Beide Substanzklassen werden, wo nötig, durch ähnliche Labortests überwacht.Ein generelles therapiebegleitendes Gerinnungsmonitoring, wie es seit vielen Jahrzehnten unter Verwendung von Vitamin-K Antagonisten üblich ist, ist unter Einnahme der neuen Xa- und Thrombin-Inhibitoren nicht erforderlich. Treten bei Patienten, die mit den DOAK behandelt werden, spezielle klinische Situationen auf (z.B. notfallmäßige Operationen oder Interventionen, akute Blutungssituation, akutes Organversagen), so können für den behandelnden Arzt Informationen über die Wirkspiegel im Plasma des Patienten die Einschätzung des Blutungsrisikos erleichtern. Da die DOAKs an zentraler Stelle in das Gerinnungssystem eingreifen, zeigen sie eine Interferenz mit den globalen Gerinnungstesten wie z.B. Thromboplastinzeit (TPZ; Quick/INR), aktivierte partielle Thromboplastinzeit (aPTT) und Thrombinzeit (TZ)(nur Thrombininhibitoren!) und speziellen gerinnungsphysiologischen Untersuchungen. Die Veränderungen in der Gerinnungsdiagnostik sind sowohl abhängig vom Wirkmechanismus des DOAK und der entsprechenden Halbwertszeit als auch vom Zeitpunkt der Tabletteneinnahme, der Dosierung und vom dem im Gerinnungslabor verwendetem Testsystem/Reagenz. Zur Interpretation der hämostaseologischen Messergebnisse muss dem behandelnden Arzt und dem Labormediziner bekannt sein, welches DOAK zu welchem Zeitpunkt eingenommen wurde. Weiters muss die Empfindlichkeit (Dosis-Wirkungskurve) des jeweiligen verwendeten Testsystems berücksichtigt werden. Mit den Globaltesten der Gerinnung können unter Behandlung mit DOAK lediglich abschätzende (semi-quantitative) Aussagen getroffen werden:Liegt unter Einnahme von Rivaroxaban die Thromboplastinzeit (Quick / INR) im Normbereich (vorausgesetzt es wurde im Labor ein auf Rivaroxaban empfindliches Reagenz, z.B. Neoplastin Plus benutzt), so kann gefolgert werden, dass eine klinisch relevante Restwirkung von Rivaroxaban im Patientenplasma unwahrscheinlich ist. Unter Einnahme von Dabigatran weist eine aPTT >80 sec im Talspiegel auf ein erhöhtes Blutungsrisiko hin, eine im Normbereich liegende TZ lässt auf die Abwesenheit von Dabigatran im Plasma schließen.Für die Quantifizierung der Plasmakonzentration von anti-Xa Inhibitoren stehen speziell auf die jeweilige Substanz kalibrierte chromogene anti-Xa-Teste zur Verfügung. Für die Quantifizierung der Plasmakonzentration von Dabigatran kann die kalibrierte verdünnte Thrombinzeit (Hemoclot®) eingesetzt werden. Eine Messung der Medikamentenkonzentrationen ist im klinischen Alltag jedoch bislang routinemäßig nicht vorgesehen, da die gemessenen Plasmakonzentrationen klinisch derzeit nicht für den einzelnen Patienten interpretiert werden können. Insgesamt muss der Einsatz hämostaseologischer Labormethoden zum Nachweis von DOAKS den lokalen Gegebenheiten entsprechend geplant und immer wieder (z. B. bei Reagenzienwechsel) zwischen Labor und Klinik abgestimmt werden.


2016 ◽  
Vol 58 (4) ◽  
pp. 22-25
Author(s):  
G. L. Muntingh

In the past 10 years or so, many alternatives to warfarin have been developed the first being the novel oral anticoagulants (NOAC) or better referred to as direct oral anticoagulants (DOAC) or target-specific oral anticoagulants (TSOAC). These drugs have some definite advantages and disadvantages that should be clear to physicians before prescribing any of them for patients. Many clinical trials have provided definitive information about the efficacy and safety of DOACs, yet many physicians remain sceptical about prescribing these drugs due to lack of answers to real world questions. The concerns are directed towards appropriate patient selection (the choice should be made according to age, renal function, compliance, cost, clinical condition, intake of other drugs), the mechanism of switching between agents, how these drugs affect routine laboratory tests and when monitoring is needed. Knowledge of other drugs that interact with the DOAC and management of severe bleeding will be reviewed and recommendations will be given to all of these concerns.


Cancers ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 271 ◽  
Author(s):  
Hanny Al-Samkari ◽  
Jean Connors

Venous thromboembolism (VTE) complicates the clinical course of approximately 5–10% of all cancer patients. Anticoagulation of the cancer patient often presents unique challenges as these patients have both a higher risk of recurrent VTE and a higher risk of bleeding than patients without cancer. Although low molecular weight heparins (LMWH) are the standard of care for the management of cancer-associated VTE, their use requires once or twice daily subcutaneous injections, which can be a significant burden for many cancer patients who often require a long duration of anticoagulation. The direct oral anticoagulants (DOACs) are attractive options for patients with malignancy. DOACs offer immediate onset of action and short half-lives, properties similar to LMWH, but the oral route of administration is a significant advantage. Given the higher risks of recurrent VTE and bleeding, there has been concern about the efficacy and safety of DOACs in this patient population. Data are now emerging for the use of DOACs in the cancer patient population from dedicated clinical trials. While recently published data suggest that DOACs hold promise for the treatment of cancer associated VTE, additional studies are needed to establish DOACs as the standard-of-care treatment. Many such studies are currently underway. The available data for the use of DOACs in the treatment of cancer-associated VTE will be reviewed, focusing on efficacy, safety, and other considerations relevant to the cancer patient.


Hemato ◽  
2021 ◽  
Vol 2 (2) ◽  
pp. 255-263
Author(s):  
Wafik G. Sedhom ◽  
Brady Lee Stein

Myeloproliferative neoplasms are a common cause of splanchnic vein thrombosis, which causes significant morbidity and mortality. Indefinite anticoagulation is the mainstay of therapy, and vitamin K antagonists (VKAs) are routinely used since hematologists have the most experience with this drug class. The role of direct oral anticoagulants (DOACs) is promising, but still undergoing evaluation. Cytoreduction with hydroxyurea or pegylated interferon is often used when cytosis is present, but their roles are yet to be defined when the complete blood count is normal. Janus kinase (JAK) inhibition may have a complementary role in reducing splenomegaly and portal hypertension.


2020 ◽  
Vol 40 (02) ◽  
pp. 184-200 ◽  
Author(s):  
Thomas Moner-Banet ◽  
Lorenzo Alberio ◽  
Pierre-Alexandre Bart

Abstract Background There is an increasing amount of literature on direct oral anticoagulant (DOAC) laboratory monitoring. The aims of the present review were to evaluate published data on monitoring DOACs, to provide clinical guidance on how to interpret results, and to summarize why, when, and how to monitor DOACs. Methods The publications screened for this review were obtained through a PubMed search for articles published in English or French before April 2019 that had the following as their main themes: DOAC monitoring, DOAC exposure–effect relationship, DOAC drug interactions, and pharmacokinetics and pharmacodynamics of DOACs. Results DOACs show important inter- and intrapersonal concentration variability and a significant exposure–effect relationship. Concentrations out of the expected range have been shown to lead to an increased adverse event rate and a lower efficacy. No definitive therapeutic range exists for DOACs except for dabigatran for which trough levels of 40 to 200 ng/mL seem to be the consensus. Indications to monitor include suspected drug accumulation in special patient populations, suspected drug failure, and acute situations such as hemorrhagic or thrombotic events. Conclusion There is a likely benefit to monitor DOACs in order to improve their safety and efficacy but randomized controlled trials are required to determine the therapeutic range of these drugs and evaluate whether DOAC monitoring can improve outcomes in a clinical setting.


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