for superiority 0.0001 0.3
Hazard ratio vs. PRADAXA 110 mg (95% CI) 0.72 (0.58, 0.90)
P-value for superiority 0.004
Table 5 Strokes and Systemic Embolism in the RE-LY Study PRADAXA
150 mg twice daily Warfarin Hazard ratio vs. warfarin
(95% CI)
Patients randomized 6076 6022
Stroke 122 186 0.64 (0.51, 0.81)
Ischemic stroke 103 134 0.75 (0.58, 0.97)
Hemorrhagic stroke 12 45 0.26 (0.14, 0.49)
Systemic embolism 13 21 0.61 (0.30, 1.21)
Table 6 Center INR Control in the RE-LY Study Centers with INR control
below the median of 67% Centers with INR control
above the median of 67%
Stroke/systemic embolism 0.57 (0.42, 0.76) 0.76 (0.55, 1.05)
All-cause mortality 0.78 (0.66, 0.93) 1.01 (0.84, 1.23)
Major bleed 0.82 (0.68, 0.99) 1.08 (0.89, 1.31)
PRADAXA 75 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with "R75". The color of the imprinting is black. The capsules are supplied in the packages listed:
PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with "R150". The color of the imprinting is black. The capsules are supplied in the packages listed:
Bottles
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Once opened, the product must be used within 30 days. Keep the bottle tightly closed. Store in the original package to protect from moisture.
Blisters
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Store in the original package to protect from moisture.
Keep out of the reach of children.
See Medication Guide
Inform patients that they may bleed more easily, may bleed longer, and should call their health care provider for any signs or symptoms of bleeding.
Instruct patients to seek emergency care right away if they have any of the following, which may be a sign or symptom of serious bleeding:
Instruct patients to call their health care provider or to get prompt medical attention if they experience any signs or symptoms of bleeding:
Instruct patients to call their health care provider if they experience any signs or symptoms of dyspepsia or gastritis:
Instruct patients to inform their health care provider that they are taking PRADAXA before any invasive procedure (including dental procedures) is scheduled.
Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so their health care provider knows about other treatments that may affect bleeding risk (e.g., aspirin or NSAIDs) or dabigatran exposure.
Distributed by:Boehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, CT 06877 USA
©Copyright 2010 Boehringer Ingelheim Pharmaceuticals, Inc. ALL RIGHTS RESERVED
75461-01IT5060AJ202010
75457-01IT5400A
MEDICATION GUIDEPRADAXA (pra dax´ a)(dabigatran etexilate mesylate) capsules
Read this Medication Guide before you start taking PRADAXA and each time you get a refill. There may be new information. This Medication Guide
