Table 6 |
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|
Cardio-renal adverse events reported in studies of patients treated for arthritis |
||||||||
|
Number of |
Incidence of events (%) |
|||||||
|
|
||||||||
|
Outcome/ comparisons |
Celecoxib daily dose |
Comparator and daily dose |
Trials |
Patients |
Celecoxib |
Comparator |
Relative riska (95% CI) |
NNTpb or NNHc (95% CI) |
|
|
||||||||
|
Myocardial infarction |
||||||||
|
Celecoxib v placebo |
Any |
Placebo |
16 |
9,315 |
0.12 |
0.07 |
10 events |
|
|
Celecoxib v paracetamol |
Any |
Paracetamol 4,000 mg |
2 |
1,056 |
0.00 |
0.00 |
0 events |
|
|
Celecoxib v rofecoxib |
Any |
Rofecoxib 25 mg |
5 |
2,667 |
0.00 |
0.08 |
1 event |
|
|
Celecoxib (200/400) v NSAID |
200–400 mg |
NSAID to maximum daily |
16 |
21,818 |
0.15 |
0.04 |
1.9 (0.87–4.1) |
23 events |
|
Celecoxib (any dose) v NSAID |
Any |
NSAID to maximum daily |
17 |
30,220 |
0.22 |
0.14 |
1.6 (0.93–2.6) |
56 events |
|
Celecoxib (any dose) v any active |
Any |
Any active comparator |
23 |
34,174 |
0.19 |
0.13 |
1.4 (0.87–2.3) |
57 events |
|
Celecoxib (any dose) v any comparator |
Any |
Any comparator |
30 |
38,499 |
0.18 |
0.12 |
1.4 (0.88–2.2) |
59 events |
|
Celecoxib (any dose) v noncoxib comparator |
Any |
Any noncoxib comparator |
28 |
36,316 |
0.19 |
0.12 |
1.4 (0.88–2.2) |
57 events |
|
|
||||||||
|
Cardiac failure |
||||||||
|
|
||||||||
|
Celecoxib v placebo |
Any |
Placebo |
16 |
9,834 |
0.06 |
0.03 |
5 events |
|
|
Celecoxib v paracetamol |
Any |
Paracetamol 4,000 mg |
2 |
1,056 |
0.00 |
0.00 |
0 events |
|
|
Celecoxib v rofecoxib |
Any |
Rofecoxib 25 mg |
5 |
2,671 |
0.15 |
0.60 |
10 events |
|
|
Celecoxib (200/400) v NSAID |
200–400 mg |
NSAID to maximum daily |
15 |
21,859 |
0.06 |
0.15 |
0.54 (0.29–1.02) |
21 events |
|
Celecoxib (any dose) v NSAID |
Any |
NSAID to maximum daily |
17 |
30,917 |
0.11 |
0.20 |
0.70 (0.43–1.1) |
45 events |
|
Celecoxib (any dose) v any active |
Any |
Any active comparator |
23 |
34,512 |
0.11 |
0.23 |
0.64 (0.41–1.0) |
55 events |
|
|
||||||||
|
Raised creatinine (above 1.3 × upper limit of normal) |
||||||||
|
|
||||||||
|
Celecoxib v placebo |
Any |
Placebo |
5 |
2,776 |
1.3 |
0.7 |
1.65 (0.69–4.0) |
|
|
Celecoxib v paracetamol |
Any |
Paracetamol 4,000 mg |
||||||
|
Celecoxib v rofecoxib |
Any |
Rofecoxib 25 mg |
||||||
|
Celecoxib (200/400) v NSAID |
200–400 mg |
NSAID to maximum daily |
9 |
15,319 |
0.3 |
0.5 |
0.78 (0.46–1.3) |
|
|
Celecoxib (any dose) v NSAID |
Any |
NSAID to maximum daily |
||||||
|
Celecoxib (any dose) v any active |
Any |
Any active comparator |
10 |
15,657 |
0.3 |
0.5 |
0.79 (0.47–1.3) |
|
|
|
||||||||
|
Hypertension and aggravated hypertension |
||||||||
|
|
||||||||
|
Celecoxib v placebo |
Any |
Placebo |
16 |
9,321 |
1.0 |
0.6 |
1.4 (0.85–2.4) |
|
|
Celecoxib v paracetamol |
Any |
Paracetamol 4,000 mg |
2 |
1,056 |
0.2 |
0.6 |
4 events |
|
|
Celecoxib v rofecoxib |
Any |
Rofecoxib 25 mg |
5 |
2,671 |
3.5 |
4.6 |
0.75 (0.52–1.1) |
|
|
Celecoxib (200/400) v NSAID |
200–400 mg |
NSAID to maximum daily |
16 |
22,518 |
1.3 |
1.4 |
0.92 (0.73–1.2) |
|
|
Celecoxib (any dose) v NSAID |
Any |
NSAID to maximum daily |
17 |
30,921 |
1.6 |
1.6 |
1.1 (0.90–1.3) |
|
|
Celecoxib (any dose) v any active |
Any |
Any active comparator |
23 |
34,512 |
1.7 |
1.8 |
1.0 (0.86–1.2) |
|
|
|
||||||||
|
Oedema at any site |
||||||||
|
|
||||||||
|
Celecoxib v placebo |
Any |
Placebo |
16 |
9,321 |
2.6 |
1.4 |
1.9 (1.4–2.7) |
79 (54–145)c |
|
Celecoxib v paracetamol |
Any |
Paracetamol 4,000 mg |
2 |
1,056 |
2.3 |
1.8 |
1.3 (0.56–3.0) |
|
|
Celecoxib v rofecoxib |
Any |
Rofecoxib 25 mg |
5 |
2,671 |
18.0 |
25.0 |
0.72 (0.62–0.83) |
14 (10–25)b |
|
Celecoxib (200/400) v NSAID |
200–400 mg |
NSAID to maximum daily |
16 |
21,825 |
2.4 |
2.5 |
0.98 (0.82–1.2) |
|
|
Celecoxib (any dose) v NSAID |
Any |
NSAID to maximum daily |
17 |
30,921 |
2.9 |
3.5 |
0.92 (0.81–1.05) |
|
|
Celecoxib (any dose) v any active |
Any |
Any active comparator |
23 |
34,512 |
3.8 |
5.4 |
0.84 (0.76–0.92) |
62 (48–87)b |
|
|
||||||||
|
aRelative risk: bold indicates statistically significant difference. bNNTp (number-needed-to-treat to prevent one event) is indicated by bold. cNNH (number-needed-to-treat to harm one patient; CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug. |
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|
Moore et al. Arthritis Research & Therapy 2005 7:R644 doi:10.1186/ar1704 |
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