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| __NOTOC__
| | #REDIRECT [[Dabigatran#Clinical Studies]] |
| {{Dabigatran}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Clinical Studies==
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| The clinical evidence for the efficacy of PRADAXA was derived from RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy), a multi-center, multi-national, randomized parallel group trial comparing two blinded doses of PRADAXA (110 mg twice daily and 150 mg twice daily) with open-label warfarin (dosed to target INR of 2 to 3) in patients with non-valvular, persistent, paroxysmal, or permanent atrial fibrillation and one or more of the following additional risk factors:
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| *Previous stroke, transient ischemic attack (TIA), or systemic embolism
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| *Left ventricular ejection fraction <40%
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| *Symptomatic heart failure, ≥ New York Heart Association Class 2
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| *Age ≥75 years
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| *Age ≥65 years and one of the following: diabetes mellitus, coronary artery disease (CAD), or hypertension
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| The primary objective of this study was to determine if PRADAXA was non-inferior to warfarin in reducing the occurrence of the composite endpoint, stroke (ischemic and hemorrhagic) and systemic embolism. The study was designed to ensure that PRADAXA preserved more than 50% of warfarin’s effect as established by previous randomized, placebo-controlled trials of warfarin in atrial fibrillation. Statistical superiority was also analyzed.
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| A total of 18,113 patients were randomized and followed for a median of 2 years. The patient’s mean age was 71.5 years and the mean CHADS2 score was 2.1. The patient population was 64% male, 70% Caucasian, 16% Asian, and 1% black. Twenty percent of patients had a history of a stroke or TIA and 50% were Vitamin K antagonist (VKA) naïve, defined as less than 2 months total lifetime exposure to a VKA. Thirty-two percent of the population had never been exposed to a VKA. Concomitant diseases of patients in this trial included hypertension 79%, diabetes 23%, and CAD 28%. At baseline, 40% of patients were on aspirin and 6% were on clopidogrel. For patients randomized to warfarin, the mean percentage of time in therapeutic range (INR 2 to 3) was 64%.
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| Relative to warfarin and to PRADAXA 110 mg twice daily, PRADAXA 150 mg twice daily significantly reduced the primary composite endpoint of stroke and systemic embolism (see Table 4 and Figure 2).
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| The contributions of the components of the composite endpoint, including stroke by subtype, are shown in Table 5. The treatment effect was primarily a reduction in stroke. PRADAXA 150 mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.
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| In the RE-LY trial, the rate of all-cause mortality was lower on dabigatran 150 mg than on warfarin (3.6% per year versus 4.1% per year). The rate of vascular death was lower on dabigatran 150 mg compared to warfarin (2.3% per year versus 2.7% per year). Non-vascular death rates were similar in the treatment arms.
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| The efficacy of PRADAXA 150 mg twice daily was generally consistent across major subgroups (see Figure 3).
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| In RE-LY, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = 31 January 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Direct thrombin (II) inhibitors]]
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| [[Category:Anticoagulants]]
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| [[Category:Cardiovascular Drugs]]
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