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Effectiveness and safety of 110 or 150 mg dabigatran vs. vitamin K antagonists in nonvalvular atrial fibrillation. : Br J Clin Pharmacol
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International audience. BACKGROUND: We compared the 1-year safety and effectiveness of dabigatran 110 mg (D110) or 150 mg (D150) to vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation (NVAF), METHODS: New user cohort study of patients dispensed D110 or D150 vs. VKA in 2013 for NVAF, followed 1 year in the French Systeme National des Donnees de Sante (SNDS, 66 million persons). D110 and D150 users were matched 1:1 with VKA users on sex, age, date of first drug dispensing, and high-dimensional propensity score (hdPS). Hazard ratios (HR [95% confidence intervals]) for stroke and systemic embolism (SSE), major bleeding (MB), and death were computed using Cox proportional hazards or Fine and Gray models during exposure. RESULTS: In 14,442 matched D110 and VKA patients, mean age 79, 49% male, 91% with CHA2 DS2 -VASc >/=2 and 8% with HAS-BLED >3, incidence rates of SSE were 1.9% and 2.6% person-years (HR 0.69 [0.56-0.84]), MB 1.8% and 2.9% (0.62 [0.51-0.76]), death 7.2% and 8.6% (0.84 [0.76-0.94]). In 8,389 matched D150 and VKA patients, mean age 67, 67% male, 65% with CHA2 DS2 -VASC >/= 2; < 5% HAS-BLED > 3, incidence rates were for SSE 1.4% and 1.9% (0.76 [0.56-1.04]), MB 0.6 % and 1.9% (0.30 [0.20-0.46]), death 1.6% and 3.6% (0.46 [0.35-0.59]). Numbers needed to treat to observe one fewer death were 78 for D110, 88 for D150 CONCLUSION: In real life D110 and D150 were at least as effective and safer than VKA.
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