| VIGOR (2000)2
|
8076 |
Rheumatoid arthritis |
Double blinded RCT (rofecoxib compared with naproxen) |
RR of MI in naproxen group was 0.2; overall mortality and death from cardiovascular causes similar |
| Graham et al (2005)17
|
All patients aged 18–84 treated with an NSAID over a three year period from a 6 million population database (2302029 person years) |
Various—no strict criteria |
Nested case‐control study of cardiac events |
Compared with celecoxib RR for rofecoxib was 1.59. For naproxen compared with remote NSAID use the adjusted OR was 1.14 |
| Juni et al (2004)18
|
21432 |
All bibliographic databases and files of the FDA that compared rofecoxib with other NSAIDs or placebo, and trials of cardiovascular risk and naproxen |
Meta‐analysis of 18 RCTs and 11 observational studies |
RR of MI for rofecoxib compared with placebo, naproxen, or other NSAIDs was 2.24 |
| Hippisley‐Cox and Coupland (2005)19
|
9218 cases and 86349 matched controls |
Primary care patients taking coxibs and NSAIDs over a five year period |
Nested case‐control study using QRESEARCH database (of 367 UK GP surgeries) |
Adjusted OR compared to no use of NSAID in past three years for rofecoxib was 1.32, for diclofenac was 1.55, and for ibuprofen was 1.24. Increased risks were also found for other coxibs and NSAIDs albeit less dramatic. |
| Bresalier et al (2005)
(APPROVe)21
|
1287 cases and1299 controls |
History of colorectal adenomas |
Double blinded RCT (rofecoxib compared with placebo) |
RR of confirmed thrombotic event (for example, MI, CVA) for rofecoxib was 1.92 compared with placebo |
| Hudson et al
(2005)23
|
2256 |
Patients aged ⩾66 prescribed celecoxib, rofecoxib, or a NSAID after index admission for CCF over a two year period |
Population based retrospective cohort study of hospital discharge summary and prescription drug databases |
Hazard ratio for death and recurrent CCF combined was 1.26 for patients prescribed NSAIDs or rofecoxib compared with celecoxib |
| Silverstein et al (2000) (CLASS)24
|
8059 |
Patients aged ⩾18 with osteoarthritis or rheumatoid arthritis |
Double blinded RCT (celecoxib compared with ibuprofen or diclofenac) |
No difference in cardiovascular events between celecoxib and NSAIDs |
| Farkouh et al (2004)
(TARGET)28
|
18325 |
Patients aged ⩾50 with osteoarthritis |
Double blinded RCT (lumiracoxib compared with naproxen or ibuprofen) |
Harzard ratio for MI for lumiracoxib compared with naproxen was 1.77 (non‐significant) and for lumiracoxib compared with ibuprofen was 0.75 (non‐significant) |
| Nussmeier et al (2005)31
|
1671 |
Patients with postoperative pain after CABG |
Double blinded RCT (parecoxib plus valdecoxib compared with placebo plus valdecoxib compared with placebo alone) |
RR for cardiovascular events (for example, MI, CVA, PE, cardiac arrest) for parecoxib plus valdecoxib compared with placebo was 3.7) |
| Soloman et al
(2005) (APC)36
|
2035 |
History of colorectal adenomas |
Double blinded RCT over three years (celecoxib low dose compared with celecoxib high dose compared with placebo) |
Hazard ratios for death from cardiovascular causes (for example, MI, CVA, CCF) compared with placebo for low dose (200 mg twice daily) celecoxib was 2.3 and for high dose (400 mg twice daily) celecoxib was 3.4 |
