Key result
Dronedarone treatment in patients with atrial fibrillation significantly improved the AF-QoL psychological domain score by 16.0 points at 12 months in a real-world ambulatory care setting.
Why the study?
Does dronedarone improve quality of life in patients with atrial fibrillation in a real-world ambulatory setting?
Observational (n=549)
Open-label
Yes
Does dronedarone improve quality of life in patients with atrial fibrillation in a real-world ambulatory setting?
Mean Difference: 16
p-value: p=<0.0001
In a real-world ambulatory setting, dronedarone treatment for atrial fibrillation was associated with significant improvements in quality of life and a safety profile consistent with known data over 1 year.
May support QoL consideration in ambulatory AF; hypothesis-generating, requiring RCTs for confirmation.
BACKGROUND AND AIMS: The multichannel blocker dronedarone is currently indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF), with careful monitoring of cardiac, hepatic and renal function. We aimed to investigate patients' quality of life (QoL) and tolerability and effectiveness of dronedarone under real life conditions. METHODS: In the 1-year prospective, non-interventional IMPULS study, 161 office-based cardiologists, general practitioners and internists throughout Germany documented 549 patients with AF who were currently or newly prescribed dronedarone (safety set, SS). Of those, 342 patients (full analysis set, FAS) provided data on QoL at baseline, 6 months and 12 months). RESULTS: Mean age of patients was 67.6/66.3 years; 53.0 %/57.3 % were men (SS/FAS). AF type at inclusion in the SS/FAS was paroxysmal in 71.9 %/71.3 % and persistent in 26.0 %/26.6 % (missing in 2.0 %/2.0 %). The proportion of patients in sinus rhythm increased from 44.6 % at baseline to 70.2 % (SS). The mean value on the 100-point visual analogue scale (EuroQol EQ-5D) increased from 62.3 ± 17.1 at baseline by 11.4 ± 18.7 points (FAS, p<0.0001). The AF-QoL Psychological Domain improved from 44.6 ± 22.6 at baseline by 16.0 ± 23.5 points at 1 year (p<0.0001), the AF-QoL physical domain from 49.5 ± 22.1 by 10.9 ± 22.5 points (p<0.0001), and the AF-QoL sexual domain from 61.8 ± 27.1 by 6.6 ± 28.2 points (p<0.0001). In all, 136 patients (24.8 % of all patients in the safety set) had at least one adverse drug reaction (ADR) causally related to dronedarone. CONCLUSIONS: Various dimensions of quality of life of patients with AF were improved on dronedarone under clinical practice conditions. No previously unknown safety issues were noted.
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Goette et al. (2015) conducted an observational in Atrial fibrillation (n=549). Dronedarone vs. Baseline was evaluated on AF-QoL psychological domain score change from baseline to 12 months (MD 16.0, p=<0.0001). Dronedarone treatment in patients with atrial fibrillation significantly improved the AF-QoL psychological domain score by 16.0 points at 12 months in a real-world ambulatory care setting.
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