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

Moore, R Andrew; Derry, Sheena; Makinson, Geoffrey T; McQuay, Henry J

doi:10.1186/ar1704

Table 4 Analysis of arthritis patients according to gastrointestinal adverse events

From: 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

			Number of		Incidence of events (%)
Outcome and comparisons	Celecoxib daily dose	Comparator and daily dose	Trials	Patients	Celecoxib	Comparator	Relative risk^a (95% CI)	NNTp^b or NNH^c (95% CI)
*Patient with any adverse event*
Celecoxib v placebo	Any	Placebo	19	9,919	55	48	1.08 (1.04–1.13) ^a	15 (11–21)^c
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	32	32	1.0 (0.84–1.2)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	3	769	48	49	0.97 (0.84–1.1)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,615	45	50	0.92 (0.89–0.95) ^a	18 (14–23) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,711	53	60	0.96 (0.94–0.98) ^a	15 (13–18) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	24	33,400	53	59	0.96 (0.94–0.98) ^a	17 (14–21) ^b
*Patient with any treatment-related adverse event*
Celecoxib v placebo	Any	Placebo	19	9,919	9.5	8.1	1.22 (1.06–1.40) ^a	71 (39–450)^c
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	3	1,056	9.0	8.8	1.04 (0.71–1.5)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	4	1,579	6.6	9.0	0.74 (0.53–1.04)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,615	13.0	17.3	0.77 (0.72–0.82) ^a	24 (19–31) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	19	23,743	12.7	17.3	0.77 (0.72–0.82) ^a	22 (18–27) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	24	26,242	12.3	16.2	0.78 (0.73–0.83) ^a	26 (21–33) ^b
*Patient with any serious adverse event*
Celecoxib v placebo	Any	Placebo	19	9,919	1.0	1.4	0.67 (0.46–0.98) ^a	280 (120–790) ^b
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	0.5	0.6	0.76 (0.14–4.1)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	2.3	2.1	1.1 (0.68–1.9)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,612	2.5	2.6	0.91 (0.77–1.08)
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,708	3.3	3.6	1.02 (0.91–1.15)
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,299	3.2	3.4	1.02 (0.91–1.15)
*Patient with any gastrointestinal adverse event*
Celecoxib v placebo	Any	Placebo	17	9,512	26.0	19.0	1.2 (1.1–1.4) ^a	14 (12–19)^c
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	12.0	11.0	1.1 (0.8–1.6)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	16.0	18.0	0.87 (0.74–1.03)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	18	30,043	26.0	34.0	0.84 (0.81–0.87) ^a	12 (10–13) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	18	31,171	26.0	34.0	0.84 (0.81–0.87) ^a	12 (10–13) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	24	34,762	26.0	32.0	0.85 (0.82–0.88) ^a	14 (12–16) ^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.

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