Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports

Table 8 Endoscopically detected ulcers in patients treated for arthritis, with and without aspirin

			Number of		Incidence of events (%)
Outcome/ comparisons	Celecoxib daily dose	Comparator and daily dose	Trials	Patients	Celecoxib	Comparator	Relative risk^a (95% CI)	NNTp^b or NNH^c (95% CI)
*Analysis irrespective of aspirin use*
Celecoxib v placebo	Any	Placebo	2	1,737	3.9	2.2	1.8 (0.89–3.6)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	6	4,135	4.6	16.3	0.30 (0.24–0.37) ^a	8.6 (7.4–10) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	6	4,565	4.5	16.3	0.29 (0.24–0.36) ^a	8.4 (7.3–10) ^b
*Analysis without aspirin use*
Celecoxib v placebo	Any	Placebo	2	1,537	3.3	1.9	1.8 (0.79–3.9)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	5	3,053	4.5	17.6	0.28 (0.22–0.36) ^a	7.6 (6.5–9.1) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	5	3,440	4.2	17.6	0.28 (0.22–0.36) ^a	7.5 (6.4–8.9) ^b
*Analysis with aspirin use*
Celecoxib v placebo	Any	Placebo	2	200	7.9	4.1	1.7 (0.45–6.3)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	5	344	10.0	23.8	0.47 (0.27–0.83) ^a	7.3 (4.6–17) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	5	387	9.9	23.8	0.48 (0.28–0.83) ^a	7.2 (4.7–16) ^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.

ISSN: 1478-6362