scholarly journals Primary Non-adherence to Treatment with New Oral Anticoagulants: The Results of a Prospective Observational Study «ANTEY»

2021 ◽  
Vol 15 (1) ◽  
pp. 56-61
Author(s):  
Sergey Martsevich ◽  
Yulia Lukina ◽  
Natalia Kutishenko

Aim: To assess the main characteristics of patients with non-valvular Atrial Fibrillation (AF) who are initially non-adherent to New Oral Anticoagulants (NOAC), and to identify factors associated with this version of non-adherence. Materials and Methods: The ANTEY study included 201 patients with non-valvular AF, who had indications and without contraindications for NOAC treatment. The patients had previously been advised to take oral anticoagulants but they did not comply with all medical recommendations. The observation period was 1 year, during which 2 in-person visits were performed: an inclusion visit (V0) and a visit (V1), as well as 1 telephone contact/follow up (FU); the interval between contacts was 6 months. All patients were recommended to take the NOAC by decision of the physician. During the V0, V1 and FU visits, the “National Society for Evidence-Based Pharmacotherapy (NSEPh) Adherence Scale” questionnaire was used to assess overall adherence and associated factors. 15 (7.5%) patients had not started NOAC therapy by the end of the study (primary non-adherent patients). Their characteristics are analysed in this work. Results: The main reasons for primary non-adherence to NOAC were high cost (33.3%), fears of adverse effects (AE) (33.3%), doubts about the need for treatment (13.3%) and the complex therapy regimen (13.3%). In the group of primary non-adherent patients in comparison with the rest of the patients there were significantly more patients with 1 point according to CHADS2VASc (20% and 2.2%, respectively, p = 0.029) and patients with 3 points according to HAS-BLED (33.3% and 9.1%, respectively, p = 0.006); they took antiplatelet drugs more often 73.3% versus 21.5%, respectively (p = 0.001). Full employment at work (OR = 5.2; CI95% [1.5; 18.1], p = 0.009), history of quitting smoking (OR = 5.1; CI95% [1.5; 17.0], p = 0,008), the presence of any pharmacotherapy AE (OR = 4.0; CI95% [1.01; 16.0], p = 0.048) increased the chance of primary non-adherence to NOAC by 4-5 times. Conclusion: The most vulnerable in relation to initiation of NOAC therapy for the prevention of thromboembolic complications in AF are those patients who continue to work or have any pharmacotherapy AE. The leading factors preventing the initiation of NOAC administration are their high cost, fear of the development of AE from the therapy, and patients’ doubts about the need for treatment with these drugs. The clinical trial registration number is NCT 03790917.

2020 ◽  
Vol 15 (6) ◽  
pp. 864-872 ◽  
Author(s):  
S. Yu. Martsevich ◽  
Yu. V. Lukina ◽  
N. P. Kutishenko ◽  
S. N. Tolpygina ◽  
V. P. Voronina ◽  
...  

Aim. To study adherence to treatment with new oral anticoagulants (NOAC) and factors associated with it in patients with non-valvular atrial fibrillation (AF) within the outpatient PROFILE registry.Material and methods. ANTEY study included 201 patients with AF from the PROFILE registry (89.3%): 118 males (58.7%) and 83 females (41.3%), aged 71.1Ѓ}8.7 years. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire – National society of evidence-based pharmacotherapy (NSEPh) adherence scale, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors’ questioning.Results. During V0 111 (55.2%) patients were recommended the use of rivaroxaban; 47 (23.4%) – the use of dabigatran and 43 (21.4%) – the use of apixaban. During V1 based on the results of the NSEPh adherence scale 155 (77.5%) patients were completely adherent (strictly followed doctors’ recommendations), 5 patients were partially adherent (violated doctors’ recommendations), 7 patients were partially non-adherent (stopped taking NOACs), and 33 patients were completely non-adherent (did not start taking NOACs). Out of 197 patients who completed MMAS-8 questionnaire 157 (79.7%) patients were partially adherent to treatment and 40 (20.3%) patients were non-adherent. None of the patients were completely adherent to treatment. According to doctors’ questioning, by the time of the PC 15 patients had not started taking the recommended NOAC – were completely non-adherent (CNA). According to the NSEPh adherence scale, by the time of the PC out of 197 patients (4 patients died) 158 patients were completely adherent to treatment, 6 – partially adherent, 18 – partially non-adherent and 15 – CNA. According to MMAS-8, by the time of the PC 153 (77.7%) patients were partially adherent to treatment, and 44 (22.3%) patients – non-adherent (none of the patients were completely adherent). Out of 15 CNA patients MMAS-8 revealed only 4 (27,6%) during B1, and 6 (40%) during the PC. NSEPh adherence scale revealed all CNA patients. The main reason for refusing to start NOAC therapy was their high price. Recently started use of NOACs was stopped mostly due to adverse effects of therapy (bleeding). The most common factors increasing patients’ adherence to NOACs were previous experience of taking this group of drugs and no history of any adverse effects during therapy.Conclusion. The ANTEY study showed relatively high adherence to NOACs prescribed by doctors of the specialized cardiology department of the scientific center. The most common factors associated with early non-adherence to the new drug were high price and adverse effects of therapy, the latter influenced prolonged adherence as well. Previous experience of taking this group of drugs and no history of any adverse effects during therapy increased adherence to NOACs.


2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.


2015 ◽  
Vol 10 (3) ◽  
pp. 208-216 ◽  
Author(s):  
Ian Pinto ◽  
Anshu Giri ◽  
Umbreen Arshad ◽  
Ajeet Gajra

2019 ◽  
Vol 477 (6) ◽  
pp. 1335-1343 ◽  
Author(s):  
Piotr Kasina ◽  
Alexander Wall ◽  
Lasse J. Lapidus ◽  
Ola Rolfson ◽  
Johan Kärrholm ◽  
...  

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Lisa M. Baumann Kreuziger ◽  
Joseph C. Keenan ◽  
Colleen T. Morton ◽  
David J. Dries

Ease of dosing and simplicity of monitoring make new oral anticoagulants an attractive therapy in a growing range of clinical conditions. However, newer oral anticoagulants interact with the coagulation cascade in different ways than traditional warfarin therapy. Replacement of clotting factors will not reverse the effects of dabigatran, rivaroxaban, or apixaban. Currently, antidotes for these drugs are not widely available. Fortunately, withholding the anticoagulant and dialysis are freqnently effective treatments, particularly with rivaroxaban and dabigatran. Emergent bleeding, however, requires utilization of Prothrombin Complex Concentrates (PCCs). PCCs, in addition to recombinant factor VIIa, are used to activate the clotting system to reverse the effects of the new oral anticoagulants. In cases of refractory or emergent bleeding, the recommended factor concentrate in our protocols differs between the new oral anticoagulants. In patients taking dabigatran, we administer an activated PCC (aPCC) [FELBA] due to reported benefit in human in vitro studies. Based on human clinical trial evidence, the 4-factor PCC (Kcentra) is suggested for patients with refractory rivaroxaban- or apixaban-associated hemorrhage. If bleeding continues, recombinant factor VIIa may be employed. With all of these new procoagulant agents, the risk of thrombosis associated with administration of factor concentrates must be weighed against the relative risk of hemorrhage.


The Lancet ◽  
2014 ◽  
Vol 384 (9937) ◽  
pp. 24
Author(s):  
Wim Opstelten ◽  
Maureen van den Donk ◽  
Ton Kuijpers ◽  
Jako S Burgers

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