scholarly journals Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland

2018 ◽  
Vol 85 (2) ◽  
pp. 422-431 ◽  
Author(s):  
Tanja Mueller ◽  
Samantha Alvarez‐Madrazo ◽  
Chris Robertson ◽  
Olivia Wu ◽  
Marion Bennie
2022 ◽  
Vol 17 (6) ◽  
pp. 831-836
Author(s):  
A. S. Gerasimenko ◽  
O. V. Shatalova ◽  
V. S. Gorbatenko ◽  
V. I. Petrov

Aim. To study the frequency of prescribing antithrombotic agents in patients with non-valvular atrial fibrillation (AF) in real clinical practice, to evaluate changes of prescriptions from 2012 till 2020.Material and methods. The medical records of inpatients (Form 003/y) with the diagnosis AF, hospitalized in the cardiological department were analyzed. According to the inclusion criteria, the patients were over 18 years of age, established diagnosis of non-valvular AF. There were two exclusion criteria: congenital and acquired valvular heart disease and prosthetic heart valves. In retrospective analysis we have included 263 case histories in 2012, 502 ones in 2016 and 524 in 2020. CHA2DS2-VASc score was used for individual stroke risk assessment in AF. The rational use of the antithrombotic therapy was evaluated according with current clinical practice guidelines at analyzing moment.Results. During period of observation the frequency of antiplatelet therapy significantly decreased from 25,5% to 5,5% (р<0.001), decreased the frequency of administration of warfarin from 71,9% to 18,3% (р<0.001). The frequency of use of direct oral anticoagulants increased in 2020 compared to 2016 (р<0.001). For patients with a high risk of stroke anticoagulant therapy was administered in 71.8% of cases in 2012, 88.5% in 2016 and 92.5% in 2020. Before discharge from hospital majority of patients (72%) achieved a desired minimum international normalized ratio (INR) from 2.0 to 3.0 in 2012. In 2016 and 2020 an only 33% and 40.6% of patients achieved INR (2.0-3.0).Conclusion. Doctors have become more committed to following clinical guidelines during the period of the investigation. In 2020 antithrombotic therapy for atrial fibrillation was suitable according to current clinical guidelines.


Kardiologiia ◽  
2021 ◽  
Vol 61 (6) ◽  
pp. 79-87
Author(s):  
S. G. Kanorskii

Senile patients with atrial fibrillation (AF) are at a higher risk of thromboembolism and hemorrhage than younger patients. Three direct oral anticoagulants (DOAC), apixaban, dabigatran, and rivaroxaban, are registered in the Russian Federation and are extensively used for prevention of stroke in patients with AF. The DOAC treatment of older patients requires considering peculiarities of these patients, clinical situation and properties of individual drugs to achieve the balance of efficiency and safety and a comprehensive protection. According to studies of real clinical practice DOAC may have advantages over warfarin (reduced risk of fractures, diabetes mellitus, and dementia). Compliance with and constancy of the DOAC treatment are important for its efficiency, particularly in senile age. Results of clinical trials and real clinical practice studies have confirmed that rivaroxaban may provide a comprehensive protection for a senile patient with AF due to favorable indexes of efficiency and safety, beneficial effect on the risk of coronary events and impairment оf renal function, whereas once a day dosing of rivaroxaban improves the compliance with this treatment and its constancy.


2021 ◽  
Vol 5 (4) ◽  
pp. 196-199
Author(s):  
M.V. Khruslov ◽  
◽  
A.S. Sorokina ◽  
Yu.A. Sapel'nikova ◽  
T.V. Vavilova ◽  
...  

Aim: to assess the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AFib) in real-world clinical practice. Patients and Methods: this non-interventional prospective study enrolled 356 patients aged 50-75 years with AFib and creatinine clearance ≥50 ml/min. All patients were divided into three age-matched groups based on DOACs prescribed. Group 1 patients (n=120) received rivaroxaban 20 mg daily. Group 2 patients (n=112) received dabigatran etexilate 150 mg twice daily. Group 3 patients (n=124) received apixaban 5 mg twice daily. The groups were comparable in comorbidities and the risks of thrombotic and hemorrhagic complications. Followup was 2 years after starting treatment. Thrombotic complications, massive bleedings, and death for any reason were considered end-points. Results: no significant differences in the rate of cardiogenic thrombotic complications between the groups were reported. In patients who received apixaban, fewer bleeding complications were diagnosed (insignificant differences). Conclusions: the efficacy and safety of DOACs in patients over 50 years are similar. KEYWORDS: atrial fibrillation, oral anticoagulants, thrombotic complications, infarction, stroke, bleedings. FOR CITATION: Khruslov M.V., Sorokina A.S., Sapel'nikova Yu.A., Vavilova T.V. Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice. Russian Medical Inquiry. 2021;5(4):196–199 (in Russ.). DOI: 10.32364/2587-6821-2021-5-4-196-199.


2021 ◽  
Vol 12 ◽  
Author(s):  
Nan-Nan Shen ◽  
Chi Zhang ◽  
Na Wang ◽  
Jia-Liang Wang ◽  
Zhi-Chun Gu ◽  
...  

Background: In routine clinical practice, non-standard doses of direct oral anticoagulants (DOACs) are commonly used in patients with atrial fibrillation (AF). However, data on the clinical outcomes of non-standard doses of DOACs are limited.Methods: The MEDLINE, Embase, and Cochrane Library databases were systematically searched from their inception until 30 June 2020 for studies that reported the effectiveness or safety outcomes of non-standard doses of DOACs compared with on-label doses of DOACs in patients with atrial fibrillation. Non-standard doses of DOACs were defined as under or over-dose of DOACs based on the recommended standard doses in drug labels. A random-effects meta-analysis was performed to calculate the pooled hazard ratio and associated 95% confidence interval (95% confidence interval). Subgroup analyses were conducted according to individual DOACs and different geographic regions.Results: Ten articles involving 148,909 patients with AF were included. There were no significant differences between under-dosing and on-label dosing with respect to stroke/systematic embolism (HR: 1.01, 95% CI: 0.93–1.09), major bleeding (HR: 0.98, 95% CI: 0.77–1.19), intracranial haemorrhage (HR: 1.07, 95% CI: 0.74–1.40), gastrointestinal bleeding (HR: 1.10, 95% CI: 0.82–1.39), and myocardial infarction (HR: 1.07, 95% CI: 0.89–1.25), except for an increased risk of death (HR: 1.37, 95% CI: 1.01–1.73). We observed a significant association between over-dosing of DOACs and increased risk of stroke/systematic embolism (HR: 1.18, 95% CI: 1.04–1.32), major bleeding (HR: 1.16, 95% CI: 1.03–1.29), and death (HR: 1.21, 95% CI: 1.03–1.38) compared with on-label dosing. Furthermore, over-dosing of DOACs increased the risk of stroke/systematic embolism (HR: 1.16; 95% CI: 1.00–1.33) and major bleeding events (HR: 1.18; 95% CI: 1.00–1.37) in Asian patients.Conclusion: A reduced dose of DOACs might be safely and effectively used in clinical practice, especially in Asian patients, whereas high-dose DOACs might not be well tolerated by Asian patients.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032646
Author(s):  
Anneka Mitchell ◽  
Tomas J Welsh ◽  
Margaret C Watson ◽  
Julia Snowball ◽  
Anita McGrogan

IntroductionWarfarin has frequently been underused in older people for stroke prevention in atrial fibrillation (AF). Direct oral anticoagulants (DOACs) entered the UK market from 2008 and have been recommended as an alternative to warfarin. This study aimed to describe any changes in the prescribing of oral anticoagulants (OACs) to people aged ≥75 years in UK general practice before and after the introduction of DOACs, to examine differences in patient characteristics which may influence prescribers’ decisions regarding anticoagulation, to evaluate the time people stay on OACs and switching between OACs.Methods and analysisA retrospective cohort study design will be used. Patients with a diagnosis of AF will be identified from the Clinical Practice Research Datalink (CPRD). The study period will run from 1 January 2003 to 27 December 2017. Patients enter the cohort at the latest date of the start of the study period, first AF diagnosis, 75th birthday or a year from when they started to contribute research standard data. Follow-up continues until they leave the practice, death, the date the practice stops contributing research standard data or the end of the study period (27 December 2017). Exposure to OACs will be defined as ≥1 prescription issued for an OAC of interest during the study period. Patients issued an OAC in the year preceding study entry will be defined as ‘prevalent users’. Patients starting on an OAC during the study period will be defined as ‘incident users’. Incidence and prevalence of OAC prescribing, patient demographics and characteristics will be described during three time periods: 2003–2007, 2008–2012 and 2013–2017. Persistence (defined as the time from initiation to discontinuation of medication) with and switching between different OACs will be described.Ethics and disseminationThe protocol for this study was approved by the CPRD Independent Scientific Advisory Committee. The results will be disseminated in a peer-reviewed journal and at conferences.Trial registration numberEUPAS29923.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Yamashita ◽  
C.C Wang ◽  
Y.-H Kim ◽  
R De Caterina ◽  
P Kirchhof ◽  
...  

Abstract Background The prevalence of atrial fibrillation (AF) and the need for appropriate anticoagulation increase with age. The benefit/risk profile of direct oral anticoagulants such as edoxaban in elderly population with AF in regular clinical practice is therefore of particular interest. Purpose Analyses of Global ETNA-AF data were performed to report patient characteristics, edoxaban treatment, and 1-year clinical events by age subgroups. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program conducted in Europe, Japan, Korea, Taiwan, and other Asian countries. Demographics, baseline characteristics, and 1-year clinical event data were analysed in four age subgroups. Results Of 26,823 patients included in this analysis, 50.4% were ≥75 years old and 11.6% were ≥85 years. Increase in age was generally associated with lower body weight, lower creatinine clearance, higher CHA2DS2-VASc and HAS-BLED scores, and a higher percentage of patients receiving the reduced dose of 30 mg daily edoxaban. At 1-year, rates of ISTH major bleeding and ischaemic stroke were generally low across all age subgroups. The proportion of intracranial haemorrhage within major bleeding events was similar across age groups. All-cause mortality increased with age more than cardiovascular mortality. Conclusion Data from Global ETNA-AF support the safety and effectiveness of edoxaban in elderly AF patients (including ≥85 years) in routine clinical care with only a small increase in intracranial haemorrhage. The higher all-cause mortality with increasing age is not driven by cardiovascular causes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo


2021 ◽  
Vol 10 (13) ◽  
pp. 2924
Author(s):  
Domenico Acanfora ◽  
Marco Matteo Ciccone ◽  
Valentina Carlomagno ◽  
Pietro Scicchitano ◽  
Chiara Acanfora ◽  
...  

Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI =Rate of EventsRate of Patients at Risk. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.


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