270987 How well do the 56,183 atrial fibrillation patients enrolled in the Contemporary Novel Oral Anticoagulant (NOAC) trials reflect the real world?

Wednesday, October 31, 2012

Teresa Ann Simon, MPH , Global Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ
Han-Yao Huang, PhD , Pharmacoepidemiology, Bristol-Myers Squibb, Pennington
Hugh Kawabata, PhD , Center for Observational Research and Data Sources, Bristol Myers Squibb, Pennington, NJ
Laurent Azoulay, PhD, MD , Department of Oncology, Jewish General Hospital, Montreal, QC, Canada
Ed Ewen, MD , Christiana Care Outcomes Research, Newark, DE
Leif Friberg, MD, PhD , Karolinska Institute and Department of Cardiology, Danderyd Hospital, Stockholm, Sweden
Samy Suissa, PhD , Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, QC, Canada
Purpose: Compare baseline data of atrial fibrillation (AF) patients in Novel oral anti-coagulant (NOAC) trials compared to Real World (RW) AF. Methods: AF patients in 4 randomized trials (RCTs) (AVERROES ARISTOTLE, RE-LY and ROCKET AF) were compared to 5 RW sources by baseline characteristics. RW Data sources: UK General Practice Research Database, the Swedish Hospital Discharge Register, Christiana Care Health System and claims data from I3 InVision Data Mart and PharMetrics in the US. Results: Descriptive results representing over 56,000 AF patients in RCTs and 550,000 AF patients in the RW show that the RW populations have a higher proportion of > 75 (range 70 to 77 vs 69 to 73 RCTs) and slightly more females in RW ( 41 to 48% RW vs. 35 to 42% RCT). More RCT AF patients had a higher use of beta blockers ~ 60% in RCTs to 17 to 30% in RW. RCT patients had more prior strokes, hypertension and statin use. Conclusions: Females and > 75 years are under-represented in the RCTs. I3 and PharMetrics under-represent >65 so differences in the RW may be greater than represented here. Substantially more beta blockers in the RCTs. Drug use rates are lower in the RW cohorts despite fairly similar conditions, which may be an indicator of less adequate treatment in the RW. In the absence of evidence that baseline differences do not affect the effectiveness of NOACs, adjustments need to be made to assess the benefits and potential risks of NOACs in the RW.

Learning Areas:
Chronic disease management and prevention
Planning of health education strategies, interventions, and programs

Learning Objectives:
Compare baseline data of atrial fibrillation (AF) patients in Novel Oral Anticoagulant (NOAC) trials compared to Real World (RW) AF.

Keywords: Primary Prevention, Chronic Diseases

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: apixaban

Qualified on the content I am responsible for because: I worked with one the database reported here. I worked with observational databases for more than 10 years.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Bristol-Myers Squibb R&D Employment (includes retainer) and Stock Ownership

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.