Daiichi Sankyo Korea published the first real-world data on Koreans for its new oral anti-coagulant NOAC Lixiana (edoxaban) in the Journal of the American College of Cardiology Tuesday.
"As the only NOAC treatment developed in Asia, Lixiana is expected to remain firmly established as an optimal anticoagulant for Asians, including Koreans,” Daiichi Sankyo Korea CEO Kim Dae-jung said.
Professors Lee So-ryong from Soon Chun Hyang University and Choi Eue-keun from Seoul National University evaluated the efficacy and safety of edoxaban compared to warfarin with atrial fibrillation (AF).
"This study is meaningful in that it is the world's first real-world study of the efficacy and safety of edoxaban, and the largest study conducted in Korea and Asia for atrial fibrillation patients prescribed edoxaban," Professor Choi said. "It is likely to be an important basis for the treatment of anticoagulants in Asians who have not been taken into account in large-scale clinical trials."
Researchers compared 4,061 patients who took Lixiana to prevent strokes due to AF to 12,183 patients who received warfarin in a 1 to 3 propensity score matching method to compare the safety and efficacy of the drug.
The research team confirmed six types of endpoints to compare the safety and efficacy of Lixiana to warfarin. The six included ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, all-cause death, ischemic stroke + ICH + all-cause death, and composite outcome.
Results showed that Lixiana had lower risk in all six endpoints than warfarin.
Compared with warfarin, patients taking Lixiana showed a 30 percent reduction in the risk of ischemic stroke. The incidence of ischemic stroke during the follow-up period was 3.22 for 100-person-years in the Lixiana group and 3.89 in the warfarin group.
Findings showed Lixiana also reduced the risk of intracranial hemorrhage by 60 percent compared to warfarin. The incidence of intracranial hemorrhage was 0.66 per 100 person-years in the Lixiana group and 1.59 per 100 person-years in the warfarin group.
Those taking Lixiana had a 40 percent reduction in hospitalization rates because of gastrointestinal bleeding compared to warfarin. The percentage of hospitalization for gastrointestinal bleeding was 1.65 per 100 person-years in the epileptic group and 2.02 per 100 person-years in the warfarin group.
The results also showed Lixiana decreased the risk of hospitalization because of major bleeding compared to warfarin by 47 percent. The risk of hospitalization due to major bleeding was 2.32 cases per 100 person-years and 3.56 cases per 100 person-years.
Finally, Lixiana showed a 28 percent lower risk of death from all causes compared to warfarin. The incidence of death from all causes was 5.59 cases per 100 person-years and 6.63 cases per 100 person-years.
The composite outcome for the Lixiana group was 8.9 cases per 100 person-years while it was 11.2 cases per 100 person-years for the warfarin group, showing Lixiana had better results than warfarin.
In this study, a subgroup analysis was conducted to confirm the consistency of benefits of Lixiana versus warfarin. The subgroups consisted of age, sex, CHA2DS2-VASC score, and kidney function.
Results showed no significant interactions between treatment and all subgroups concerning the six endpoints, except for ischemic stroke in subgroups stratified by CHA2DS2-VASC.
In results, the research confirmed that Lixiana had a consistent benefit over warfarin even in high-risk patients.
"The results of this study showed that, in all clinical indices, Lixiana showed consistently low risk versus warfarin,” Professor Lee said. “The study confirmed superior efficacy and safety of edoxaban injections for ischemic stroke and all-cause mortality versus warfarin injections in Korean atrial fibrillation patients.”
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