NDA / Serial Number : 21 - 686 Drug Name : Exanta ( ximelagatran ) 36 mg bid oral formulation Indication ( s ) : reduction of risk of stroke or systemic embolic events in patients with atrial fibrillation
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Drug Name: Exanta (ximelagatran) 36 mg bid oral formulation Indication(s): reduction of risk of stroke or systemic embolic events in patients with atrial fibrillation
منابع مشابه
Ximelagatran for stroke prevention in atrial fibrillation.
Atrial fibrillation is the most common sustained cardiac arrhythmia and the most frequently encountered cause of embolic stroke. Vitamin K antagonists (such as warfarin) have represented the cornerstone of anticoagulation practice for the last 60 years. Although highly effective in preventing thromboembolic events among patients with atrial fibrillation, warfarin therapy is limited by a multitu...
متن کاملXimelagatran in prevention of cardiovascular events.
Ximelagatran (Exanta (R) is the first oral anticoagulant in a new class of drugs called direct thrombin inhibitors. Two studies suggest that ximelagatran is at least as effective as warfarin in preventing stroke in high risk patients with atrial fibrillation. Ximelagatran may also reduce the rate of major cardiovascular events after a myocardial infarction, compared to placebo. Ximelagatran doe...
متن کاملPreventing stroke in atrial fibrillation: the SPORTIF programme.
Atrial fibrillation (AF) is the most common cardiac risk factor for stroke. Oral anticoagulants such as the vitamin K antagonist warfarin have been proven effective in reducing the risk of stroke in AF. Warfarin, however, has many disadvantages including the need for coagulation monitoring, a narrow therapeutic index, inter-/intra-patient variability and food-drug interactions. As a result, war...
متن کاملXimelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial.
CONTEXT In patients with nonvalvular atrial fibrillation, warfarin prevents ischemic stroke, but dose adjustment, coagulation monitoring, and bleeding limit its use. OBJECTIVE To compare the efficacy of the oral direct thrombin inhibitor ximelagatran with warfarin for prevention of stroke and systemic embolism. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized, multicenter trial (2...
متن کاملSecondary stroke prevention with ximelagatran versus warfarin in patients with atrial fibrillation: pooled analysis of SPORTIF III and V clinical trials.
BACKGROUND AND PURPOSE Patients with nonvalvular atrial fibrillation and prior stroke or transient ischemic attack (TIA) are at high risk for recurrent stroke. We investigated whether ximelagatran was noninferior to warfarin in patients with prior stroke or TIA. METHODS We analyzed pooled data from the SPORTIF III and V trials in patients with prior stroke/TIA. The primary outcome was the com...
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تاریخ انتشار 2004