Patrick Blin1, Caroline Dureau-Pournin1, Yves Cottin2, Jacques Bénichou3,4, Patrick Mismetti5, Abdelilah Abouelfath1, Regis Lassalle1, Cécile Droz1, Nicholas Moore1,3. 1. Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, CHU de Bordeaux, 33076, Bordeaux, France. 2. CHU de Dijon, Service de Cardiologie, 21079, Dijon, France. 3. INSERM U1219, Université de Bordeaux, 33076, Bordeaux, France. 4. CHU de Rouen, Unité de Biostatistique, 76031, Rouen, France. 5. Hôpital Nord, Unité de Recherche Clinique Innovation et Pharmacologie, 42055, Saint-Etienne, France.
Abstract
AIMS: We compared the 1-year safety and effectiveness of dabigatran 110 mg (D110) or 150 mg (D150) twice daily to vitamin K antagonists (VKA) in patients with nonvalvular atrial fibrillation. METHODS: New user cohort study of patients dispensed D110 or D150 vs. VKA in 2013 for nonvalvular atrial fibrillation, followed 1 year in the French Système National des Données de Santé (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. 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 score >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 8389 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.
AIMS: We compared the 1-year safety and effectiveness of dabigatran 110 mg (D110) or 150 mg (D150) twice daily to vitamin K antagonists (VKA) in patients with nonvalvular atrial fibrillation. METHODS: New user cohort study of patients dispensed D110 or D150 vs. VKA in 2013 for nonvalvular atrial fibrillation, followed 1 year in the French Système National des Données de Santé (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. 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 score >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 8389 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.
Authors: Julien Bezin; Mai Duong; Régis Lassalle; Cécile Droz; Antoine Pariente; Patrick Blin; Nicholas Moore Journal: Pharmacoepidemiol Drug Saf Date: 2017-05-24 Impact factor: 2.890
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Authors: Patrick Blin; Caroline Dureau-Pournin; Yves Cottin; Jacques Bénichou; Patrick Mismetti; Abdelilah Abouelfath; Regis Lassalle; Cécile Droz; Nicholas Moore Journal: Br J Clin Pharmacol Date: 2018-12-16 Impact factor: 4.335
Authors: Patrick Blin; Caroline Dureau-Pournin; Yves Cottin; Jacques Bénichou; Patrick Mismetti; Abdelilah Abouelfath; Regis Lassalle; Cécile Droz; Nicholas Moore Journal: Br J Clin Pharmacol Date: 2018-12-16 Impact factor: 4.335
Authors: Hendrika A van den Ham; Patrick C Souverein; Olaf H Klungel; Robert W Platt; Pierre Ernst; Sophie Dell'Aniello; Sven Schmiedl; Birgit Grave; Marietta Rottenkolber; Consuelo Huerta; Elisa Martín Merino; Luz M León-Muñoz; Dolores Montero; Morten Andersen; Mia Aakjaer; Marie L De Bruin; Helga Gardarsdottir Journal: Pharmacoepidemiol Drug Saf Date: 2021-07-22 Impact factor: 2.890