scholarly journals Efficacy and safety of dronedarone versus placebo in patients with atrial fibrillation stratified according to renal function: Post hoc analyses of the EURIDIS‐ADONIS trials

2022 ◽  
Author(s):  
Munveer Thind ◽  
Wojciech Zareba ◽  
Dan Atar ◽  
Harry J. G. M. Crijns ◽  
Jun Zhu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Efficacy And Safety ◽  
Post Hoc

scholarly journals Dronedarone vs placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a post hoc analysis of the ATHENA trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vamos ◽  
J Oldgren ◽  
G.-B Nam ◽  
G Lip ◽  
H Calkins ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Glomerular Filtration Rate ◽  
Renal Impairment ◽  
Glomerular Filtration ◽  
Filtration Rate ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract Background The use of antiarrhythmic drugs in patients with chronic kidney disease (CKD) is challenging due to issues with renal clearance, drug accumulation and increased proarrhythmic risks. Since CKD is a common comorbidity with atrial fibrillation (AF), it is important to establish the efficacy and safety for antiarrhythmic drug treatment in patients with CKD. Purpose To evaluate the efficacy and safety of dronedarone in patients with AF or atrial flutter (AFL) across different stages of renal impairment. Methods In this post-hoc analysis of ATHENA (NCT00174785), a randomised, double-blind trial of dronedarone 400 mg BID vs placebo in patients with AF or AFL plus additional risk factors for death and a calculated glomerular filtration rate ≥10 mL/min, the primary outcome was time to first cardiovascular (CV) hospitalisation or death. Renal function (estimated glomerular filtration rate [eGFR]) was assessed using CKD Epidemiology Collaboration equation and patients were grouped by eGFR (10–44, 45–59, ≥60 mL/min). Log-rank testing and Cox regression were used to compare time to events between treatment groups. Results In ATHENA, 43.6% of placebo and 42.2% of dronedarone patients had mild-to-moderate CKD (Table). Median time to CV hospitalisation/death was longer in all strata for dronedarone vs placebo, reaching significance in the 45–59 and ≥60 mL/min groups (Figure 1). There was a trend towards more treatment-emergent adverse events (TEAEs), deaths and discontinuations due to TEAEs in patients with eGFR 10–44 mL/min. No clear difference in safety was seen between treatment arms except for discontinuations, which were higher with dronedarone. Conclusions This analysis confirms the efficacy of dronedarone, demonstrated in ATHENA, across different stages of renal impairment. Further assessment of safety will require larger populations of patients with CKD. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi

scholarly journals Efficacy and safety of dronedarone vs placebo in patients with atrial fibrillation or atrial flutter across a spectrum of renal function: post hoc analyses of the EURIDIS-ADONIS trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Thind ◽  
W Zareba ◽  
D Atar ◽  
H Crijns ◽  
J Zhu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Adverse Events ◽  
Atrial Flutter ◽  
Cox Regression ◽  
Wide Spectrum ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Private Company ◽  
Post Hoc

Abstract Background/Introduction The use of antiarrhythmic drugs in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Since CKD commonly co-occurs with atrial fibrillation/atrial flutter (AF/AFL), it is important to establish efficacy and safety for such drugs when used in AF/AFL patients with CKD. Purpose To evaluate the efficacy and safety of dronedarone in patients with AF or AFL across different levels of renal function. Methods This post hoc analysis evaluated pooled data from two multicentre, double-blind, randomised (2:1) trials of rhythm control with dronedarone 400 mg twice daily vs placebo. Primary endpoint was time to first recurrence of AF or AFL. Renal function (estimated glomerular filtration rate [eGFR]) was assessed with the CKD-Epidemiology Collaboration equation. Patients were grouped by eGFR strata. Log-rank testing and Cox regression were used to compare time to events between treatment groups. Results Most (85%) patients had mild or mild-to-moderate decrease in eGFR (Table 1). Median time to first AF recurrence was significantly longer in the dronedarone vs placebo group for all eGFR subgroups except the 30–44 mL/min group (Figure 1), where the trend was consistent; however, the small population size may have precluded meaningful analyses in this subgroup. Serious adverse events, deaths, and treatment discontinuations did not differ notably between each group irrespective of eGFR strata. Conclusions This analysis confirms the efficacy and safety of dronedarone in patients with AF across a wide spectrum of renal function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi

Antithrombotic therapy in multimorbid patients with atrial fibrillation from standpoint of clinical recommendations of Ministry of Health of Russian Federation (2020). Effectiveness and safety of apixaban in patients with atrial fibrillation and concomitant diseases

2021 ◽  
Vol 1 (11) ◽  
pp. 12-19
Author(s):  
O. D. Ostroumova ◽  
V. N. Butorov ◽  
N. A. Arablinsky ◽  
R. R. Romanovsky ◽  
S. V. Batyukina
Keyword(s):  
Atrial Fibrillation ◽  
Russian Federation ◽  
Scientific Research ◽  
Chronic Obstructive ◽  
Efficacy And Safety ◽  
Ministry Of Health ◽  
Obstructive Pulmonary Disease ◽  
Risk Of Death ◽  
Post Hoc ◽  
Multimorbid Patients

Clinical practice and ongoing scientific research in recent years show the importance of the problem of multimorbidity in atrial fibrillation (AF). The prevalence of AF in the general population is 1–2%, while the frequency of its occurrence increases with age – from less than 0.5% at the age of 40–50 to 5–15% at the age of 80. Only 19.6% of patients with AF have no comorbidities, 69.3% of patients have 1 to 3 comorbidities, and 11.1% of patients with AF had 4 and more comorbidities. In patients with AF and with 4 and more comorbidities, the risk of death from all causes is almost seven times higher than in patients without comorbidities. As shown by the post hoc analysis of the ARISTOTLE study, apixaban was equally effective and safe in both patients without concomitant pathology and in muliborbid patients. The efficacy and safety of apixaban has been shown in AF and concomitant arterial hypertension, heart failure, coronary heart disease, including in patients with acute coronary syndrome, diabetes mellitus, chronic kidney disease and chronic obstructive pulmonary disease. The data of scientific research in recent years are reflected in the recommendations of the Ministry of Health of the Russian Federation on AF (2020), which presents a separate section on the management of patients with concomitant diseases. It is emphasized that apixaban has shown its superiority over warfarin and other direct oral anticoagulants in terms of efficacy and safety, both in isolated AF and in patients with concomitant diseases, which makes its choice preferable in the treatment of multimirbidity AF patients.

scholarly journals The impact of renal function on efficacy and safety of new oral anticoagulant in atrial fibrillation patients

Medicine ◽  
2019 ◽  
Vol 98 (48) ◽  
pp. e18205
Author(s):  
Yi-yue Gui ◽  
Song Zou ◽  
Wen-long Yang ◽  
Shen-zhen Gong ◽  
Zhi-fu Cen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Oral Anticoagulant ◽  
Efficacy And Safety ◽  
New Oral Anticoagulant ◽  
The Impact

Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial

2019 ◽  
Vol 6 (3) ◽  
pp. 167-175 ◽  
Author(s):  
André M Nicolau ◽  
Ramon Corbalan ◽  
Jose C Nicolau ◽  
Christian T Ruff ◽  
Wolfgang Zierhut ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Concomitant Disease ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Comorbidity Index ◽  
Post Hoc ◽  
The Impact ◽  
Burden Of Diseases

Abstract Aims Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs. Methods and results In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P < 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend < 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction > 0.10 for each). Conclusion  Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.

P4784Efficacy and safety of dronedarone by duration of atrial fibrillation history: a post-hoc analysis of the ATHENA trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Blomstrom-Lundqvist ◽  
N Marrouche ◽  
S Connolly ◽  
V Corp Dit Genti ◽  
M Wieloch ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
New York ◽  
Heart Disease ◽  
Sinus Rhythm ◽  
Structural Heart Disease ◽  
Efficacy And Safety ◽  
History Of ◽  
Summary Relative Risk ◽  
Post Hoc ◽  
Symptom Recurrence

Abstract Background Atrial fibrillation (AF) is known to progress over time and the effectiveness of antiarrhythmic therapy may vary based on the duration of a patient's AF history. Outcomes with dronedarone (DRO) based on duration of AF/atrial flutter (AFL) history have not been previously characterized. Purpose To evaluate the efficacy and safety of DRO by time since first known AF/AFL episode in patients studied in the ATHENA trial. Methods 2859 (61.8%) patients from ATHENA with documented first known AF/AFL episode (of 4628 total patients randomized) were included in the analysis. Among these patients, first AF/AFL episode was reported at <3 months (shorter history), 3 to <24 months (intermediate), and ≥24 months (longer) in 1296 (45.3%), 845 (29.6%) and 718 (25.1%) patients, respectively. AF/AFL recurrence was evaluated in patients in sinus rhythm at baseline by ECG during study visits or symptom recurrence. Results Demographics (age, sex) were similar across all groups. Patients with longer AF/AFL history tended to have higher prevalence of coronary heart disease and structural heart disease; and were more likely to have AF/AFL (by 12-lead ECG) at baseline (30%) compared to 26% and 16% for intermediate and shorter history groups. Patients with a longer AF history likely had a prior ablation for AF/AFL (7%) vs patients with an intermediate (2%) or shorter AF/AFL history (1%), and more likely required cardioversion during the study (24%) vs intermediate (17%) and shorter history groups (11%). Outcomes and efficacy are reported in Table 1. Rates of treatment-emergent adverse events (TEAEs), serious TEAEs, permanent drug discontinuations, and deaths were similar across all AF/AFL groups. Table 1. Outcomes and efficacy summary Relative Risk, dronedarone (DRO) vs placebo (PBO)1 (95% CI)1,2 AF/AFL <3 months AF/AFL 3 to <24 months AF/AFL ≥24 months PBO (n=626) DRO (n=670) PBO (n=429) DRO (n=416) PBO (n=363) DRO (n=355) First CV hospitalization3 or death (any cause) 0.79 (0.65, 0.96) 0.72 (0.56, 0.92) 0.84 (0.66, 1.07) First CV hospitalization 0.78 (0.64, 0.96) 0.70 (0.55, 0.91) 0.82 (0.63, 1.05) Death (any cause) 0.82 (0.54, 1.24) 0.85 (0.43, 1.68) 1.13 (0.61, 2.10) First AF/AFL recurrence4 0.80 (0.65, 0.97) 0.67 (0.53, 0.84) 0.81 (0.65, 1.02) 1Cox regression model. 2On study period, all randomized patients. 3Main reason was AF/other supraventricular rhythm disorders. 4On selected patients in sinus rhythm at baseline (AF/AFL <3 months: PBO n=514, DRO n=529; 3 to <24 months: PBO n=288, DRO n=312; ≥24 months: PBO n=252, DRO n=250). CV = Cardiovascular. Conclusions Nearly half the patients in ATHENA had a shorter history (<3 months) of AF/AFL prior to randomization. Patients with a longer history of AF/AFL had a greater burden of AF/AFL based on baseline rhythm status, ablation history, and cardioversions required post randomization. Despite these differences, clinical outcomes, efficacy, and safety of DRO appeared to be generally consistent irrespective of duration of AF/AFL history. Acknowledgement/Funding Sanofi, New York, New York, United States of America

scholarly journals Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation

Circulation ◽  
2014 ◽  
Vol 129 (9) ◽  
pp. 961-970 ◽  
Author(s):  
Ziad Hijazi ◽  
Stefan H. Hohnloser ◽  
Jonas Oldgren ◽  
Ulrika Andersson ◽  
Stuart J. Connolly ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Efficacy And Safety ◽  
Baseline Renal Function

Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial

2021 ◽  
pp. 1-7
Author(s):  
Wern Yew Ding ◽  
Gregory Y.H. Lip ◽  
Alena Shantsila
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Post Hoc Analysis ◽  
Time In Therapeutic Range ◽  
All Cause Mortality ◽  
Post Hoc ◽  
Moderate Renal Failure

<b><i>Background:</i></b> The benefit of anticoagulation therapy in atrial fibrillation (AF) and chronic kidney disease (CKD) remains controversial. We aimed to evaluate the impact of renal function on the quality of anticoagulation control, and the effects of both these factors on outcomes in AF. <b><i>Methods:</i></b> Post hoc analysis of the AMADEUS trial. Trial-related outcomes were adjudicated and we studied the composite of first stroke/major bleeding/all-cause mortality, ischaemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality. <b><i>Results:</i></b> We included 2,282 vitamin K antagonist (VKA)-treated patients {<i>n</i> = 787 (34.5%) females; median age 72 (interquartile ranges [IQR] 64–77) years}. Median follow-up was 365 (IQR 189–460) days. There were 1,922 (84.2%) non-CKD and 360 (15.8%) CKD patients. Renal function was inversely correlated with time-in-therapeutic range (<i>r</i> = −0.047, <i>p</i> = 0.025). There was no statistical difference in terms of crude study outcomes based on renal function. Multivariable regression analysis demonstrated that moderate renal failure with estimated glomerular filtration rate of less than 60 mL/min/1.73 m<sup>2</sup> (<i>p</i> = 0.032) and percentage of time-in-therapeutic range (<i>p</i> = 0.011) were independent predictors for the composite outcome of stroke, major bleeding, and all-cause mortality. <b><i>Conclusion:</i></b> Deteriorated renal function has a small negative impact on the quality of anticoagulation control with VKA which is linked to poor outcomes in AF. However, moderate renal failure itself was an independent risk factor for increased risk of stroke, major bleeding, and all-cause mortality amongst patients with AF.

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