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 2 Analysis of discontinuations by comparator, in studies of adverse events associated with celecoxib in arthritis

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)
*All-cause discontinuation*
Celecoxib v placebo	Any	Placebo	19	9,919	28	40	0.64 (0.61–0.68) ^a	8.4 (7–10) ^b
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	17	25	0.69 (0.54–0.88) ^a	13 (8–35) ^b
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	14	14	1.0 (0.8–1.2)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,616	23	23	0.96 (0.91–1.01)
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,711	31	34	0.96 (0.93–0.99) ^a	28 (22–40) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,302	29	32	0.95 (0.92–0.98) ^a	36 (27–57) ^b
*Lack-of-efficacy discontinuation*
Celecoxib v placebo	Any	Placebo	19	9,914	17	28	0.53 (0.49–0.57) ^a	9.0 (8–11) ^b
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	7.2	11	0.66 (0.45–0.97) ^a	27 (14–390) ^b
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	2.2	1.5	1.5 (0.84–2.6)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,613	8.0	6.3	1.1 (1.02–1.23) ^a	58 (42–97)^c
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,708	11.3	10.4	1.02 (0.96–1.1)
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,299	10.6	9.6	1.0 (0.95–1.1)
*Adverse-event discontinuation*
Celecoxib v placebo	Any	Placebo	19	9,914	6.6	5.5	1.2 (0.97–1.4)
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	4.3	5.4	0.81 (0.47–1.4)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,662	6.2	6.8	0.91 (0.68–1.2)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,613	8.5	9.9	0.84 (0.77–0.92) ^a	74 (47–180) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,708	11.4	14.6	0.86 (0.81–0.91) ^a	31 (25–41) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,299	10.9	13.5	0.87 (0.82–0.92) ^a	38 (30–51) ^b
*Gastrointestinal-adverse-event discontinuation*
Celecoxib v placebo	Any	Placebo	11	5,933	2.5	2.0	1.2 (0.8–1.7)
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	726	1.6	2.6	0.6 (0.2–1.6)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	2.2	2.9	0.7 (0.5–1.2)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	11	18,639	4.8	6.5	0.7 (0.6–0.8) ^a	58 (42–98) ^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	12	27,299	6.4	9.6	0.75 (0.7–0.8) ^a	31 (26–40) ^b
Celecoxib (any dose) v any active	Any	Any active comparator	18	30,560	6	8.7	0.75 (0.7–0.8) ^a	37 (30–48) ^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.

Back to article page

ISSN: 1478-6362

Contact us

Submission enquiries: denizelucille.paraiso@springernature.com
General enquiries: info@biomedcentral.com

Arthritis Research & Therapy

Contact us