One-year outcomes study of Lixiana shows efficacy in atrial fibrillation.- Daiichi Sankyo

Daiichi Sankyo announced one-year outcomes results from a study of 24,962 patients with non-valvular atrial fibrillation (NVAF) treated with Lixiana (edoxaban), including elderly NVAF patients and those with and without a history of intracranial haemorrhage (ICH). A new analysis, which reported the outcomes of 24,962 edoxaban-treated patients with NVAF at one year follow up supports the treatment's safety and efficacy profile in elderly and very elderly AF patients. The majority of these patients were aged 65 years or over.

Results showed that rates of major bleeding (MB), as defined by the International Society on Thrombosis and Haemostasis (ISTH), including ICH and ischaemic stroke were generally low amongst all patient groups. Per year, ISTH-defined MB occurred in 0.6% of patients aged less than 65, 0.9% patients aged from 65-75, 1.2% patients aged between 75 and 85 and 1.8% patients aged at least 85. ICH occurred in 0.2% patients aged below 65, 0.3% patients aged between 65 and 75, 0.3% patients aged 75 to 85 and 0.3% patients aged more than 85. Ishaemic stroke occurred in 0.6% of patients aged below 65, 0.7% patients aged from 65 to 75, 0.9% patients aged from 75 to 85 and 1.3% patients aged over 85. Whilst all-cause and CV mortality was shown to increase with age, as would be expected, CV mortality was a minor proportion of all-cause mortality in all age groups. There was also no increase in the rate of ICH with age. Per year, all-cause mortality/CV mortality occurred in 35 (1.1%)/18 (0.5%) of patients aged <65, 136 (1.8%) 62 (0.8%) of those aged between 65 and 75, 275 (3.3%) 116 (1.4%) of those aged from 75 to 85 and 196 (8.7%) 76 (3.4%) of those aged over 85.>

Additionally, a further 1-year follow-up analysis of the difference in outcomes between edoxaban-treated AF patients with history of ICH (i.e. those at higher risk of stroke, death and recurrent haemorrhage) and those without a history of ICH, showed that incidences of ISTH-defined MB (including ICH) and clinically relevant non-major bleeding (CRNMB) were generally low in both groups. ICH occurred in 3 (1.2%) patients with history of ICH and 56 (0.3%) patients without history of ICH, per year. The rate of ischaemic stroke was higher in patients with history of ICH (6 [2.4%]) than in those without (165 [0.8%]), per year. These new data suggest that edoxaban is an effective treatment option for patients with or without prior ICH, whilst also demonstrating the need for effective stroke prevention in NVAF patients with a history of ICH. One-year follow up data from the ETNA-AF (Edoxaban Treatment in routiNe clinical prActice) study were presented at ESC Congress 2019.