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

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Presentation transcript:

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

Disclaimer GLORIA-AF is sponsored by Boehringer Ingelheim Nils Schoof is an employee of Boehringer Ingelheim 2

Outline Background Objectives Study Population and Setting Design Methods Initial results from Phase I 3

Background 4 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 5 To characterize patients newly diagnosed with nonvalvular 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 6 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 7 Patients on dabigatran etexilate Baseline Visit Phase I Cross-sectional analysis All patients Phase II Cross-sectional, cohort, case-control analyses Phase III Cross-sectional and comparative analyses Baseline 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 8

Patient Disposition by Region (N=1063) 9 (N=291) (N=59) (N=713)

Demographics Site Types by Region 10 AsiaEurope Africa/Middle East Number of sites25 (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) 11 DemographicsAsia N=713 Europe N=291 Africa/Middle East N=59 Age (years) Median (IQR)69.0 ( ) 71.0 ( )65.0 ( ) Female N(%)305 (42.8) 147 (50.5)34 (57.6) BMI Median (IQR)23.9 ( ) 28.1 ( )27.3 ( )

Patient Demographics & Medical history (Asia) 12 Medical HistoryAsia N=713 (100%) Europe N=291 (100%) Africa/Middle East N=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 mellitus139 (19.5) 79 (27.1)22 (37.3) Chronic gastrointestinal diseases61 (8.6) 9 (3.1)3 (5.1)

Stroke and bleeding risk scores (Asia) 13 Asia N=713 (100%) Europe N=291 (100%) Africa/Middle East N=59 (100%) CHADS 2 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) CHA 2 DS 2 VAS C score class Low (score=0) Moderate (score=1) High (score ≥2) (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 individuals GLORIA-AF Phase I: Asian population AF population in China (Zhou et al. 2008) n=713n=224* Age (years) Mean (SD)67.4 (12.7)65.7 (11.0) Female (%) Comorbidities (%) Previous stroke Myocardial infarction Heart failure Hypertension Diabetes mellitus

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 15

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