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RE-LY : Results with Dabigatran Etexilate

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The Long Term Multi- Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. To reviewers and moderators: These are preliminary slides. The figures are going to be upgraded this week and I can send these to you if you email me at [email protected]

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slide1

The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study

To reviewers and moderators: These are preliminary slides. The figures are going to be upgraded this week and I can send these to you if you email me at [email protected]

re ly results with dabigatran etexilate
RE-LY: Results with DabigatranEtexilate
  • Dabigatran (DE) 150 mg BID and 110 mg BID versus warfarin
  • An 18,113 Patient Global Clinical Trial Mean follow up 2 years
  • DE 150 reduced stroke/SEE by 35% versus warfarin
  • DE 110 non-inferior to warfarin, with 20% reduction in major bleeding
  • Greater than 50% reduction in intracranial bleeding with both doses compared to warfarin
  • Regulatory approval in 79 countries as of November 2012

Reference

rely able design
RELY-ABLE Design
  • Descriptive study to assess long-term efficacy and safety of two doses of DE
  • 28 months of additional treatment with DE following RE-LY
  • Patients eligible if completed RE-LY
    • Alive and on study medication
  • DE blinded dose continued in RELY-ABLE
  • No event adjudication
  • Follow up stopped if study medication discontinued
data analysis
Data Analysis

Primary analysis

RELY-ABLE patients during RELY-ABLE period of follow up

Secondary Analyses

RELY-ABLE patients followed from beginning of RE-LY to end of RELY-ABLE

All dabigatran patients, from beginning of RE-LY to the end of RELY-ABLE

stroke or see
Stroke or SEE

RELY-ABLE Patients in RELY-ABLE Period

major bleeding
Major Bleeding

RELY-ABLE Patients in RELY-ABLE Period

major bleeding1
Major Bleeding:

RELY-ABLE Only

All Dabigatran

sub groups re ly rely able
Sub-groups: RE-LY + RELY-ABLE

Stoke or Systemic embolism

Major Bleeding

Total Mortality

150mg better

110mg better

150mg better

110mg better

150mg better

110mg better

# PTS

P(INTER)

P(INTER)

P(INTER)

OVERALL

12091

AGE <65

2028

AGE 65-74

5248

AGE 75+

4815

0.60

0.95

0.31

MALE

7705

FEMALE

4385

0.14

0.76

0.39

STROKE/

SEE/TIA

2666

NONE

9424

0.86

0.02

0.04

CHADS 0-1

3921

CHADS 2

4224

CHADS 3+

3945

0.36

0.44

0.03

CCLEAR <50

49

CCLEAR 50-79

2379

CCLEAR 80

5655

0.64

0.42

0.63

0.0

0.5

1.00

1.5

2.0

0.0

0.5

1.00

1.5

2.0

0.0

0.5

1.00

1.5

2.0

Hazard Ratio

Hazard Ratio

Hazard Ratio

conclusions
Conclusions
  • During 2.3 years of treatment on dabigatran, after RE-LY, rates of stroke and major bleeding remain low on dabigatran
  • Including all dabigatran follow up, there is a dose response effect
    • With dabigatran 150 mg compared to 110 mg
      • 22% reduction in ischemic stroke
      • 20% increase in major bleeding
      • Very similar mortality
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