APPENDIX
Table 1 Baseline Medication by Treatment Received among ITDM Patients
PCI
CABG
325
277
Diabetes Medications
100% ( 325/ 325)
100% ( 277/ 277)
Sulfonylurea
16.6% ( 54/ 325)
22.4% ( 62/ 277)
0.08
Glyburide
6.2% ( 20/ 325)
8.3% ( 23/ 277)
0.34
Glipizide
2.8% ( 9/ 325)
4.3% ( 12/ 277)
0.37
Glimepiride
3.7% ( 12/ 325)
3.2% ( 9/ 277)
0.83
Sulfonylurea – other
4.0% ( 13/ 325)
6.5% ( 18/ 277)
0.20
40.9% ( 133/ 325)
39.4% ( 109/ 277)
0.74
Alpha-Glucosidase
inhibitor
0.3% ( 1/ 325)
0.7% ( 2/ 277)
0.60
Thiazolidinedione
8.0% ( 26/ 325)
6.5% ( 18/ 277)
0.53
Repaglinide
1.2% ( 4/ 325)
0.4% ( 1/ 277)
0.38
Nateglinide
0.0% ( 0/ 325)
0.0% ( 0/ 277)
NA.
Other DM
1.2% ( 4/ 325)
2.5% ( 7/ 277)
0.36
No. of Patients
Biguanides
FREEDOM insulin subgroup analysis
P-value
Page 1
Table 2. Baseline Medication by Treatment received among non-ITDM Patients
PCI
CABG
631
617
Diabetes Medications
89.7% ( 566/ 631)
88.2% ( 544/ 617)
0.42
Sulfonylurea
55.3% ( 349/ 631)
55.6% ( 343/ 617)
0.96
Glyburide
24.1% ( 152/ 631)
26.4% ( 163/ 617)
0.36
Glipizide
5.9% ( 37/ 631)
7.1% ( 44/ 617)
0.42
Glimepiride
9.8% ( 62/ 631)
7.5% ( 46/ 617)
0.16
Sulfonylurea – other
15.8% ( 100/ 631)
15.4% ( 95/ 617)
0.88
Biguanides
63.4% ( 400/ 631)
63.9% ( 394/ 617)
0.91
Alpha-Glucosidase
inhibitor
2.4% ( 15/ 631)
1.1% ( 7/ 617)
0.13
Thiazolidinedione
7.4% ( 47/ 631)
9.4% ( 58/ 617)
0.22
Repaglinide
1.3% ( 8/ 631)
2.3% ( 14/ 617)
0.20
Nateglinide
0.3% ( 2/ 631)
0.0% ( 0/ 617)
0.50
Other DM
3.6% ( 23/ 631)
2.4% ( 15/ 617)
0.25
No. of Patients
FREEDOM insulin subgroup analysis
P-value
Page 2
Appendix Figure 1. Kaplan-Meier estimated percentage of subjects with ITDM vs. nonITDM by intention to treat analysis
FREEDOM insulin subgroup analysis
Page 3
Appendix Figure 2. Kaplan-Meier estimated percentage of subjects achieving the
primary composite outcome by intention to treat analysis.
FREEDOM insulin subgroup analysis
Page 4
FREEDOM TRIAL Data and Safety Monitoring Board
Chairman:
Carl J. Pepine, M.D. University of Florida
Members:
Jeffrey Brinker, M.D. Johns Hopkins Hospital
Sarah Fowler, Ph.D. George Washington University
Evelyn C. Chan, M.D. University of Houston Medical School
Bruce Reitz, M.D. Stanford University School of Medicine
Charles Clark, Jr., M.D. Indiana University School of Medicine
Kevin Schulman, M.D. Duke Clinical Research Institute
FREEDOM insulin subgroup analysis
Page 5
FREEDOM TRIAL STEERING COMMITTEE
NAME
INSTITUTION
EXPERTISE
ADDRESS
Fuster, Valentin, MD, Ph.D.*
Mount Sinai School of
Medicine, NY, NY
Chair, Steering and Executive
Committees
Mount Sinai Medical
Center
Adams, David, MD*
Mount Sinai School of
Medicine, NY, NY
Cardiac Surgery
Mount Sinai Medical
Center
Bertrand, Michel, MD
Lumberyard, France
European Leader
Buller, Christopher, MD
Buse, John, MD
Vancouver Hospital & Health
Science Centre, Vancouver,
BC, Canada
University of North
Carolina School of Medicine,
Chapel Hill, NC
Dangas, George, MD, Ph.D.*
Beth Israel Deaconess Medical
Center, Boston, MA
Cardiovascular
Research Foundation,
Columbia University Medical
Center, New York, NY
Domanski, Michael,
MD*
NHLBI
Cohen, David, MD
Farkouh, Michael
E., MD*
Canadian Leader
Hospital Cardiologique
Providence Health
Care-St. Paul's
Hospital/Interventional
Cardiology Research
Diabetes Mellitus
University of North
Carolina
Interventional
Cardiology
St. Luke's Hospital/Mid
America Heart Institute
Interventional
Cardiology
Columbia University
Medical Center
NHLBI Program
Representative
NHLBI
2005-2010
Mount Sinai Medical
Center
Peter Munk Cardiac
Center, Toronto
Co-PI, Clinical
Coordinating Center
Flather, Marcus, MD
Mount Sinai School of
Medicine, NY, NY
Royal Brompton
Hospital
London, England, UK
Herrmann Howard, MD
University of Pennsylvania
Medical Center Philadelphia
Interventional
Cardiology
Royal Brompton
Hospital,
Hospital of the
University of
Pennsylvania
Holmes, Jr. David
R., MD
Mayo Clinic, Rochester, MN
Interventional
Cardiology
Mayo Clinic
King, III Spencer
B., MD
Cardiology of Georgia,
Atlanta, GA
Interventional
Cardiology
St. Joseph’s Hospital,
Atlanta
Cardiac Surgery
Medical City Dallas
Hospital
Interventional
Cardiology
Columbia University
Medical Center
European Leader
Moses, Jeffrey W., MD
Medical City Dallas
Hospital, Dallas, TX
Cardiovascular
Research Foundation Columbia
University Medical Center, NY,
NY
Nesto, Richard, MD
Lahey Clinic, Boston,
MA
Diabetes Mellitus
Lahey Clinic
Schaff Hartzel, MD
Mayo Clinic, Rochester,
MN
Cardiac Surgery
Mayo Clinic
Sherman, David,
MD
University of Texas, San
Antonio, TX
Neurology
University of Texas
Siami, F. Sandi, MPH*
New England Research
Institutes, Inc. Watertown, MA
PI, Data
Coordinating Center
New England Research
Institutes
Mack, Michael, MD
FREEDOM insulin subgroup analysis
Page 6
Sleeper, Lynn, ScD
New England Research
Institutes, Inc. Watertown, MA
Statistics
New England Research
Institutes
Stone, Gregg W., MD *
Columbia University
Medical Center, NY, NY
Institute Dante
Pazzanese of Cardiology, Sao
Paulo, Brazil
Cardiovascular
Research Foundation Columbia
University Medical Center, NY,
NY
Weinberger, Jesse, MD
Mount Sinai School of
Medicine, NY, NY
Neurology
Mount Sinai Medical
Center
Williams, David, MD
The Rhode Island
Hospital, Providence, RI
Interventional
Cardiology
Brigham and Women’s
Hospital, Boston
Smith, Craig, MD
Sousa, Eduardo, MD
FREEDOM insulin subgroup analysis
South American
Leader
Columbia University
Medical Center
Institute Dante
Pazzanese of
Cardiology
Interventional
Cardiology
Columbia University
Medical Center
Cardiac Surgery
Page 7