| Summary: | 1. An overall appraisal of the medical benefits and risks for the patient group as a whole does not show dabigatran to be superior to warfarin in treating patients with atrial fibrillation and a higher risk of stroke. Assuming that warfarin therapy is well managed, which is the norm in Sweden, dabigatran and warfarin show no substantial differences in risk, either for stroke and other types of blood clots, or for serious haemorrhaging generally or death regardless of cause. The specific risk for cerebral haemorrhage appears, however, to be lower with dabigatran than with warfarin even when warfarin therapy is well managed, but this must be viewed against the potential risks of dabigatran. 2. Conclusions from clinical studies are based on comparisons at the group level. Despite the conclusion presented under the first point, there are presumably individuals for whom dabigatran yields a better balance between risks and benefits than warfarin does, e.g., patients who have tried warfarin and for whom the dose could not be successfully established. 3. For patients where warfarin therapy was deemed inappropriate (contraindicated) from the outset, no evidence is available to appraise the benefits and risks of dabigatran. 4. Given the current price of dabigatran, and based on a comparison of centres with high-quality management of warfarin, warfarin therapy is the most cost-effective option. Since the health economic analysis is sensitive to costs associated with visits for specimen taking, there may be individuals for whom dabigatran is, for various reasons, more cost-effective than warfarin therapy
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