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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 riska (95% CI)

NNTpb or NNHc (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

  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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