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Direct thrombin inhibition and stroke prevention in elderly patients with atrial fibrillation: experience from the SPORTIF III and V Trials.
- Source :
-
Stroke [Stroke] 2007 Nov; Vol. 38 (11), pp. 2965-71. Date of Electronic Publication: 2007 Sep 20. - Publication Year :
- 2007
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Abstract
- Background and Purpose: Warfarin prevents stroke in atrial fibrillation (AF); however, concerns regarding international normalized ratio control and hemorrhage limit its use in the elderly. The oral direct thrombin inhibitors (DTIs) are potential alternatives to warfarin, offering fixed dosing without drug and dietary interactions and the need for international normalized ratio monitoring. Although ximelagatran, a DTI studied in the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation trials, has been withdrawn, development of other DTIs continues. We report our experience in elderly high-risk AF patients on ximelagatran compared with warfarin therapy.<br />Methods: Data from patients with AF and stroke risk factors randomized in Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation III and V trials to ximelagatran or warfarin were analyzed for stroke/systemic emboli, bleeding, and raised alanine aminotransferase levels in those >or=75 (n=2804) and <75 (n=4525) years.<br />Results: Ximelagatran was as effective as warfarin in reducing stroke/systemic emboli in the elderly (2.23%/y with ximelagatran vs 2.27%/y with warfarin) as in younger patients (1.25%/y vs 1.28%/y). Total bleeds were significantly lower with ximelagatran compared with warfarin in elderly (40% vs 45%, P=0.01) and younger (27% vs 35%, P<0.001) patients. Raised alanine aminotransferase values (>3-fold elevation) among ximelagatran patients were more common in older (7.5% old vs 5.3% young) patients, particularly women (9.5% elderly women vs 6.1% elderly men).<br />Conclusions: In high-risk elderly AF patients, ximelagatran is as effective as warfarin with less bleeding, but alanine aminotransferase elevations are common, particularly in elderly women. Oral DTIs for stroke prevention show promise in elderly patients.
- Subjects :
- Administration, Oral
Age Factors
Aged
Aged, 80 and over
Alanine Transaminase blood
Alanine Transaminase drug effects
Anticoagulants administration & dosage
Anticoagulants adverse effects
Azetidines adverse effects
Benzylamines adverse effects
Cerebral Hemorrhage chemically induced
Cerebral Hemorrhage epidemiology
Double-Blind Method
Embolism drug therapy
Embolism etiology
Embolism prevention & control
Female
Humans
Intracranial Thrombosis etiology
Intracranial Thrombosis prevention & control
Male
Middle Aged
Sex Characteristics
Sex Factors
Stroke etiology
Stroke prevention & control
Treatment Outcome
Up-Regulation drug effects
Up-Regulation physiology
Warfarin adverse effects
Atrial Fibrillation complications
Azetidines administration & dosage
Benzylamines administration & dosage
Intracranial Thrombosis drug therapy
Stroke drug therapy
Thrombin antagonists & inhibitors
Warfarin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4628
- Volume :
- 38
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Stroke
- Publication Type :
- Academic Journal
- Accession number :
- 17885258
- Full Text :
- https://doi.org/10.1161/STROKEAHA.107.488007