Efficacy

NVAF

In the RE-LY® Trial, Proven Efficacy in Nonvalvular Atrial Fibrillation (NVAF)

ONLY PRADAXA® delivers superior reduction of both ischemic AND hemorrhagic stroke vs. warfarin in NVAF^1-4

Pivotal RE‑LY® Trial: PRADAXA® vs warfarin Primary Efficacy Endpoint

PRADAXA® 150 mg BID (n=6,076)
warfarin (n=6,022)

RE_LY-PRADAXA-vs-warfarin-Primary-Efficacy-Endpoint

In NVAF, ischemic stroke is the most common type of stroke³
Hemorrhagic stroke can be a complication of anticoagulation therapy⁴

IN THE RE‑LY® TRIAL, REDUCTION IN MORTALITY IN NVAF VS. WARFARIN

Lower rate of all-cause mortality⁵

12% lower rate of all-cause mortality (3.6%/yr vs. 4.1%/yr, HR: 0.88, 95% CI [0.77, 1.00])

DVT/PE

PROVEN EFFICACY IN THE TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM (DVT AND PE)

As effective as warfarin for the treatment of DVT and PE⁶

RE-COVER® Trial⁶

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT⁶

(Primary efficacy endpoint: 34 vs. 32 events, HR: 1.05, 95% CI [0.65, 1.70]) The protocol specified non-inferiority margin (2.75) for the HR was derived based on the upper limit of the 95% CI of the historical warfarin effect. PRADAXA® retains at least 66.9% of the historical warfarin effect, based on the primary composite endpoint.

RE-COVER® Trial⁷

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT⁷

(Primary efficacy endpoint: 34 vs. 30 events, HR: 1.13, 95% CI [0.69, 1.85]) The protocol specified non-inferiority margin (2.75) for the HR was derived based on the upper limit of the 95% CI of the historical warfarin effect. PRADAXA® retains at least 63.9% of the historical warfarin effect, based on the primary composite endpoint.

PROVEN EFFICACY IN THE REDUCTION IN RISK OF RECURRENCE OF DVT AND PE

As effective as warfarin in the reduction in risk of recurrence of DVT and PE⁸

RE-MEDY™ Trial⁸

Composite of fatal PE, symptomatic non-fatal PE, and/or DVT
(Primary efficacy endpoint: 26 vs. 18 events, HR: 1.44, 95% CI [0.78, 2.64])⁸

Superior 92% reduction in risk of recurrence of DVT and PE vs. placebo⁸

RE-SONATE® Trial⁸

Composite of fatal PE, unexplained death, or symptomatic non-fatal PE and/or DVT

Footnotes:

* Total number of strokes in the RE‑LY® Trial: 123 for PRADAXA® vs. 187 for warfarin (HR: 0.64, 95% CI [0.51, 0.81] P<0.001).²
BID, twice daily; CAD, coronary artery disease; CrCl, Creatinine Clearance; DVT, deep vein thrombosis; INR, international normalized ratio; LMWH, low-molecular weight
heparin; LVEF, left ventricular ejection fraction; NVAF, non-valvular atrial fibrillation; NYHA, New York Heart Association; PE, pulmonary embolism; SE, systemic embolism;
TIA, transient ischemic attack; VTE, acute venous thromboembolism.

References:

Connolly SJ, Walletin L, Yusuf S. N Engl J Med. 2014;371(15):1464-1465.
Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Stroke. 2009;40(6):2068-2072.
Hart RG, Diener H-C, Yang S, et al. Stroke. 2012;43(6):1511-1517.
Connolly SJ, Ezekowitz MD, Yusuf S, et al. N Engl J Med. 2009;361(12):1139-1151.
Schulman S, Kearon C, Kakkar AK, et al. N Engl J Med. 2009;361(24)(suppl):23‍42-23‍52.
Schulman S, Kakkar AK, Goldhaber SZ, et al. Circulation. 2014;129(7)(suppl):764-772.
Schulman S, Kearon C, Kakkar AK, et al. N Engl J Med. 2013;368(8)(suppl):709-718.

PRADAXA®

Efficacy

NVAF