Table 3.
Summary of non-significant safety findings for COX-2 inhibitors versus placebo in patients with osteoarthritis
| Outcomesa | No. of participants Follow-up |
Certainty of the evidence (GRADE) | Relative effect (95% CI) Risk Ratio | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with placebo | Risk difference with COX-2 inhibitors | ||||
| Total adverse events | 14,908 | ⊕⊕⊕◯ MODERATEb |
1.03 (0.97–1.10) | 471 per 1000 | 14 more per 1000 (14 fewer to 47 more) |
| Serious adverse events | 10,393 | ⊕⊕⊕⊕ HIGH |
0.76 (0.48–1.19) | 18 per 1000 | 4 fewer per 1000 (9 fewer to 3 more) |
| Constipation | 3066 | ⊕⊕⊕⊕ HIGH |
1.00 (0.58–1.75) | 16 per 1000 | 0 fewer per 1000 (7 fewer to 12 more) |
| Nausea or vomiting | 9956 | ⊕⊕⊕⊕ HIGH |
0.96 (0.75–1.22) | 31 per 1000 | 1 fewer per 1000 (8 fewer to 7 more) |
| Hypertension (celecoxib and etoricoxib only) | 5280 | ⊕⊕⊕⊕ HIGH |
1.21 (0.80–1.83) | 28 per 1000 | 6 more per 1000 (6 fewer to 23 more) |
| Central nervous system adverse events | 14,649 | ⊕⊕⊕⊕ HIGH |
0.94 (0.84–1.04) | 87 per 1000 | 5 fewer per 1000 (14 fewer to 3 more) |
| Rash or pruritus | 4248 | ⊕⊕⊕⊕ HIGH |
1.02 (0.76–1.37) | 36 per 1000 | 1 more per 1000 (9 fewer to 13 more) |
GRADE Working Group grades of evidence: High certainty we are very confident that the true effect lies close to that of the estimate of the effect; Moderate certainty we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different; Low certainty our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect; Very low certainty we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI confidence interval, COX-2 cyclooxygenase-2
aRenal and hepatic events and death were not reported as outcomes in sufficient studies to analyze
bI2 between 50 and 75% (p < 0.001)