Effectiveness and safety of 110 or 150 mg dabigatran vs. vitamin K antagonists in nonvalvular atrial fibrillation.

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.

• Authors: Patrick Blin, Caroline Dureau-Pournin, Yves Cottin, Jacques Bénichou, Patrick Mismetti, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Nicholas Moore
• Journal: British journal of clinical pharmacology (Br J Clin Pharmacol) Vol. 85 Issue 2 Pg. 432-441 (02 2019) ISSN: 1365-2125 [Electronic] England
• PMID: 30423205 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 The British Pharmacological Society.

Chemical References

• Anticoagulants
• Vitamin K
• Dabigatran

Topics

• Aged
• Aged, 80 and over
• Anticoagulants (administration & dosage, adverse effects)
• Atrial Fibrillation (complications, drug therapy)
• Dabigatran (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Embolism (epidemiology, etiology, prevention & control)
• Female
• Follow-Up Studies
• France (epidemiology)
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Incidence
• Male
• Middle Aged
• Prospective Studies
• Stroke (epidemiology, etiology, prevention & control)
• Treatment Outcome
• Vitamin K (antagonists & inhibitors)