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Boehringer Ingelheim to Launch RE-ALIGN™ Trial to Evaluate Dabigatran Etexilate in Patients with Mechanical Heart Valves
Date:8/26/2011

low-up period of one year.(11)

The RE-LY trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(11) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(11)  A PROBE design may reflect the differences in the management of warfarin and dabigatran in clinical practice.(11)

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(11) Safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.(11)

In the RE-LY trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(11)

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

- Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients wi
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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