IQWiG assessment of Lixiana (edoxaban) shows considerable added benefit in prevention of stroke and systemic embolism- Daiichi Sankyo
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment of whether Lixiana (edoxaban), from Daiichi Sankyo, offers an added benefit for prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) with other risk factors for stroke; or for treatment and prevention of deep vein thrombosis and pulmonary embolism.
For prevention of stroke and systemic embolism in patients with NVAF with at least one other risk factor for stroke, it was found that major bleeding was less frequent in the total population of study participants who were taking edoxaban. Some advantages of edoxaban for different outcomes were only shown in women: they had fewer haemorrhagic strokes, fewer non-major bleeding events requiring treatment, and fewer severe side effects than the comparator group. Fewer disabling strokes occurred in patients with a high risk of stroke (CHADS2 score > 3). In conclusion, an indication of considerable added benefit in comparison with vitamin K antagonists was derived for the prevention of stroke and systemic embolism: Stroke, bleeding and severe side effects occurred less frequently under edoxaban.
For the treatment and prevention of (recurrent) deep vein thrombosis and pulmonary embolism, a distinction has to be made between two patient populations that require different treatment durations: either acute treatment and temporarily limited prevention of three to six months, or continuous prevention for longer than three to six months (long-term prevention). However, the manufacturer did not distinguish between these two patient populations in its dossier, so no hint of an added benefit can be derived.
Comment: Lixiana was shown in clinical trials to have comparable efficacy to warfarin but with a better safety profile and showed a reduced risk of bleeding (2.7% versus 3.4% with warfarin per year) in the stroke prevention group.
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