1 Objectives, design and initial results from Phase I Nils Schoof Corp. Dept. Global Epidemiology, Boehringer Ingelheim GmbH.

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Objectives, designand initial results from Phase I

Nils SchoofCorp. Dept. Global Epidemiology, Boehringer Ingelheim GmbH

Disclaimer

• GLORIA-AF is sponsored by Boehringer Ingelheim

• Nils Schoof is an employee of Boehringer Ingelheim

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Outline

• Background• Objectives• Study Population and Setting• Design• Methods• Initial results from Phase I

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Background

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• Atrial fibrillation (AF) is the most common cardiac arrhythmia

• AF is affecting 1-2% of the population and raises the risk of stroke 5-fold.

• Vitamin K antagonists (VKA) were the gold standard treatment for about 5 decades

• New oral anticoagulants (NOACs), like dabigatran, are changing treatment patterns of AF patients

• GLORIA-AF is a large, international, observational registry program of patients with newly diagnosed AF at risk of stroke

Objectives of GLORIA-AF

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• To characterize patients newly diagnosed with non-valvular AF at risk for stroke in various regions of the world

• To describe current patterns of antithrombotic treatment

• To assess data on the safety and effectiveness of antithrombotic treatments

Study Population and Setting of GLORIA-AF

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• Up to 56,000 patients in up to 50 countries• Five regions: Asia, Europe, North America, Latin America and

Africa/Middle East

Design of GLORIA-AF

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Patients on dabigatran etexilate

Baseline Visit

Phase ICross-sectional analysis

All patients

Phase IICross-sectional, cohort, case-control analyses

Phase IIICross-sectional and comparative analyses

Baseline VisitBaseline Visit

3M 6M 1YR 2YR 6M 1YR 2YR 3YR

• Status:Currently ongoing

• Status:Ended Jan 2013

• Status:Start upon comparability of treatment groups in Phase II

Initial results from Phase I

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Patient Disposition by Region (N=1063)

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67%

27%

6%Asia (China)

Europe (Nether-lands, Spain, Germany, Croa-tia)

Middle East (Egypt, Lebanon, Turkey, UAE)

(N=291)(N=59)

(N=713)

DemographicsSite Types by Region

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Asia Europe Africa/Middle East

Number of sites 25 (100.0) 31 (100.0) 3 (100.0)

Type of site [N (%)]

GP/primary care

Specialist office

Community hospital

University hospital

Out-patient health care center

Anticoagulation clinics

Other

2 (8.0)

0 (0.0)

1 (4.0)

22 (88.0)

0 (0.0)

0 (0.0)

0 (0.0)

2 (6.5)

12 (38.7)

1 (3.2)

13 (41.9)

0 (0.0)

0 (0.0)

3 (9.7)

0 (0.0)

2 (66.7)

0 (0.0)

1 (33.3)

0 (0.0)

0 (0.0)

0 (0.0)

Patient Demographics & Medical history (Asia)

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Demographics AsiaN=713

EuropeN=291

Africa/Middle EastN=59

Age (years) Median (IQR) 69.0 (59.0-77.0) 71.0 (64.0-79.0) 65.0 (57.0-74.0)

Female N(%) 305 (42.8) 147 (50.5) 34 (57.6)

BMI Median (IQR) 23.9 (21.5-26.10) 28.1 (25.4-31.2) 27.3 (24.2-33.3)

Patient Demographics & Medical history (Asia)

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Medical History AsiaN=713 (100%)

EuropeN=291 (100%)

Africa/Middle EastN=59 (100%)

Previous stroke 73 (10.2) 31 (10.7) 6 (10.2)

Myocardial infarction (MI) 59 (8.3) 32 (11.0) 8 (13.6)

Coronary artery disease (CAD)

181 (25.4) 59 (20.3) 16 (27.1)

Congestive heart failure 176 (24.7) 65 (22.3) 15 (25.4)

History of hypertension 500 (70.1) 248 (85.2) 47 (79.7)

Diabetes mellitus 139 (19.5) 79 (27.1) 22 (37.3)

Chronic gastrointestinal diseases

61 (8.6) 9 (3.1) 3 (5.1)

Stroke and bleeding risk scores (Asia)

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AsiaN=713 (100%)

EuropeN=291 (100%)

Africa/Middle EastN=59 (100%)

CHADS2 score class Low (score=0) Moderate (score=1) High (score ≥2)

84 (11.8)270 (37.9)359 (50.4)

16 (5.5)95 (32.6)180 (61.9)

2 (3.4)21 (35.6)36 (61.0)

CHA2DS2VASC score class Low (score=0) Moderate (score=1) High (score ≥2)

0 184 (25.8)529 (74.2)

0 (0.0)36 (12.4)255 (87.6)

0 (0.0)6 (10.2)53 (89.8)

HAS-BLED score class Low (score <3) High (score ≥3) Missing

596 (83.6)88 (12.3)29 (4.1)

224 (77.0)23 (7.9)

44 (15.1)

40 (67.8)10 (16.9)9 (15.3)

Comparison of AF patients characteristics (Asia)

DISCLAIMER: Studies differ in region, study period and in- & exclusion criteria * Assessed within a general population of 29079 individuals

GLORIA-AF Phase I:Asian population

AF population in China

(Zhou et al. 2008)

n=713 n=224*

Age (years) Mean (SD) 67.4 (12.7) 65.7 (11.0)

Female (%) 42.8 45.1

Comorbidities (%) Previous stroke Myocardial infarction Heart failure Hypertension Diabetes mellitus

10.28.3

24.770.119.5

13.0--

54.05.8

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Conclusions

• GLORIA-AF registry program addresses the need for data from routine clinical practice

• Enhancement of knowledge on the NOACs and in particular on dabigatran.

• Allows comparative analyses when comparability between treatment groups is reached to ensure efficient use of available information.

• Data collection from the time prior to NOACs entering the market (Phase I) was finished including 1063 patients with 67% of the patients from China

• High proportions of patients at high risk of stroke (CHA2DS2-VASc: 74.2%) and at low risk of bleeding (HAS-BLED: 83.6%) are present in China

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Acknowledgement

Scientific steering committee• MV Huisman, Leiden University Medical Center, Netherlands• GYH Lip, University of Birmingham, UK• HC Diener, Universitätsklinikum Essen, Germany• SJ Dubner, Clinica y Maternidad Suizo, Argentina• JL Halperin, Mount Sinai School of Medicine, USA• CS Ma, Beijing An Zhen Hospital, China• KJ Rothman, Harvard School of Public Health, USA

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Boehringer Ingelheim Study team• D Ackermann• DB Bartels• A Clemens• E Kleine• Nicole Malek• Liz Nacar• M Parquette• C Teutsch• K Zint