Table 5a

Gastrointestinal adverse events reported in studies of arthritis patients (part 1)

Number of

Incidence of events (%)


Outcome and comparisons

Celecoxib daily dose

Comparator and daily dose

Trials

Patients

Celecoxib

Comparator

Relative riska (95% CI)

NNTpb or NNHc (95% CI)


Gastrointestinal tolerability


Celecoxib v placebo

Any

Placebo

19

9,919

5.3

4.6

1.0 (0.82–1.2)

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

2.0

2.0

1.0 (0.43–2.4)

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

3.2

4.4

0.72 (0.49–1.06)

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

19

22,615

5.4

8.9

0.62 (0.56–0.68)

28 (24–36)b

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

19

23,743

5.5

8.9

0.61 (0.55–0.67)

29 (24–36)b

Celecoxib (any dose) v any active

Any

Any active comparator

25

27,334

5.2

8.0

0.63 (0.57–0.69)

35 (29–45)b


Nausea


Celecoxib v placebo

Any

Placebo

17

9,510

2.7

3.4

0.76 (0.60–0.97)

155 (71–840)b

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

2.9

1.8

1.6 (0.73–3.7)

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

4

1,579

1.8

2.8

0.62 (0.32–1.2)

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

17

22,072

2.7

3.3

0.87 (0.74–1.02)

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

18

31,168

3.8

5.6

0.80 (0.72–0.89)

56 (44–77)b

Celecoxib (any dose) v any active

Any

Any active comparator

23

33,667

3.7

5.3

0.81 (0.73–0.90)

63 (49–88)b


Vomiting


Celecoxib v placebo

Any

Placebo

15

9,030

1.1

0.7

1.4 (0.86–2.4)

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.7

1.0

0.73 (0.19–2.7)

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

3

769

1.0

0.8

1.3 (0.29-5.7)

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

16

21,825

0.8

1.4

0.64 (0.49–0.83)

173 (115–350)b

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

17

30,921

1.2

1.9

0.75 (0.62–0.90)

144 (100–250)b

Celecoxib (any dose) v any active

Any

Any active comparator

21

32,610

1.2

1.9

0.76 (0.64–0.91)

156 (110–280)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.

Moore et al. Arthritis Research & Therapy 2005 7:R644-R665   doi:10.1186/ar1704

Open Data