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Table 5b Gastrointestinal adverse events reported in studies of arthritis patients (part 2)

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/ comparisons

Celecoxib daily dose

Comparator and daily dose

Trials

Patients

Celecoxib

Comparator

Relative riska (95% CI)

NNTpb or NNHc (95% CI)

Abdominal pain

      

Celecoxib v placebo

Any

Placebo

19

9,919

3.6

2.9

1.2 (0.92–1.5)

 

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.9

2.0

0.45 (0.15–1.3)

 

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

2.7

4.2

0.64 (0.42–0.97) a

67 (35–920) b

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

19

22,615

5.3

7.8

0.75 (0.68–0.83) a

41 (32–57) b

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

20

31,711

6.6

10.0

0.76 (0.70–0.82) a

29 (25–36) b

Celecoxib (any dose) v any active

Any

Any active comparator

26

35,302

6.2

9.2

0.75 (0.70–0.81) a

33 (28–41) b

Dyspepsia

      

Celecoxib v placebo

Any

Placebo

19

9,919

6.9

4.8

1.30 (1.08–1.6) a

46 (32–84)c

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

2.9

2.2

1.34 (0.63–2.9)

 

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

4.4

4.9

0.89 (0.63–1.3)

 

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

19

22,615

5.7

7.3

0.79 (0.71–0.88) a

61 (43–100) b

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

20

31,711

8.1

10.7

0.84 (0.78–0.90) a

39 (31–52) b

Celecoxib (any dose) v any active

Any

Any active comparator

26

35,302

7.8

9.9

0.85 (0.79–0.91) a

48 (37–68) b

Diarrhoea

      

Celecoxib v placebo

Any

Placebo

17

9,510

5.1

3.5

1.45 (1.16–1.82) a

53 (37–97)c

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

2.2

4.6

0.48 (0.24–0.95) a

41 (22–450) b

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

4.1

4.4

0.93 (0.65–1.3)

 

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

17

22,071

4.3

4.9

0.96 (0.85–1.1)

 

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

18

31,167

5.8

6.9

0.96 (0.88–1.1)

 

Celecoxib (any dose) v any active

Any

Any active comparator

24

34,758

5.6

6.6

0.95 (0.87–1.03)

 

Clinical ulcers and bleeds

      

Celecoxib v placebo

Any

Placebo

16

9,321

0.03

0.05

 

3 events

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.0

0.0

 

0 events

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

3

897

0.3

0.0

 

1 event

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

17

22,075

0.2

0.6

0.35 (0.22–0.56) a

250 (170–450) b

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

18

31,171

0.4

0.9

0.61 (0.46–0.81) a

200 (140–320) b

Celecoxib (any dose) v any active

Any

Any active comparator

22

32,508

0.4

0.8

0.61 (0.46–0.81) a

210 (150–350) b

  1. 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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Arthritis Research & Therapy

ISSN: 1478-6362

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