Studies of COX-2 inhibitors with findings relevant to CV risk

1
Studies of COX-2 inhibitors with findings
relevant to CV risk
Studies End point Duration Patients Comparator
Rofecoxib        
VIGOR GI toxicity 9 mo 8076 Naproxen
APPROVE Polyp prevention 3 y 2600 Placebo
Celecoxib        
CLASS GI toxicity 1 y 8059 Ibuprofen, diclofenac
APC Polyp prevention 3 y 2000 Placebo
PreSAP Polyp prevention 3 y 1600 Placebo
ADAPT Alzheimer's prevention 3 y 2400 Naproxen, placebo
Public Citizen. January 24, 2005. Available at
http//www.citizen.org.
Public Citizen petitions FDA to pull celecoxib
and valdecoxib Rheumawire gt News Jan 2X, 2005
2
Studies of COX-2 inhibitors with findings
relevant to CV risk
Studies End point Duration Patients Comparator
Valdecoxib/parecoxib        
Post-CABG trial 1 Post-op pain 14 d 462 Placebo
Post-CABG trial 2 Post-op pain 10 d 1636 Placebo
Post-general surgery Post-op pain 10 d 1050 Placebo
Lumiracoxib        
TARGET GI toxicity 1 y 18 325 Naproxen
Public Citizen. January 24, 2005. Available at
http//www.citizen.org.
Public Citizen petitions FDA to pull celecoxib
and valdecoxib Rheumawire gt News Jan 2X, 2005
3
Studies of COX-2 inhibitors with findings
relevant to CV risk
Studies End point Duration Patients Comparator
Etoricoxib        
EDGE GI toxicity 1 y 7111 Diclofenac
Osteoarthritis Efficacy 14 wk 617 Placebo, diclofenac
Rheumatoid arthritis (multinational study) Efficacy 12 wk 687 Placebo, naproxen
Rheumatoid arthritis (US) Efficacy 12 wk 816 Placebo, naproxen
Public Citizen. January 24, 2005. Available at
http//www.citizen.org.
Public Citizen petitions FDA to pull celecoxib
and valdecoxib Rheumawire gt News Jan 2X, 2005