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Table 6 Cardio-renal adverse events reported in studies of patients treated for 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/ comparisons

Celecoxib daily dose

Comparator and daily dose

Trials

Patients

Celecoxib

Comparator

Relative riska (95% CI)

NNTpb or NNHc (95% CI)

Myocardial infarction

        

Celecoxib v placebo

Any

Placebo

16

9,315

0.12

0.07

 

10 events

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.00

0.00

 

0 events

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,667

0.00

0.08

 

1 event

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

16

21,818

0.15

0.04

1.9 (0.87–4.1)

23 events

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

17

30,220

0.22

0.14

1.6 (0.93–2.6)

56 events

Celecoxib (any dose) v any active

Any

Any active comparator

23

34,174

0.19

0.13

1.4 (0.87–2.3)

57 events

Celecoxib (any dose) v any comparator

Any

Any comparator

30

38,499

0.18

0.12

1.4 (0.88–2.2)

59 events

Celecoxib (any dose) v noncoxib comparator

Any

Any noncoxib comparator

28

36,316

0.19

0.12

1.4 (0.88–2.2)

57 events

Cardiac failure

      

Celecoxib v placebo

Any

Placebo

16

9,834

0.06

0.03

 

5 events

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.00

0.00

 

0 events

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

0.15

0.60

 

10 events

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

15

21,859

0.06

0.15

0.54 (0.29–1.02)

21 events

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

17

30,917

0.11

0.20

0.70 (0.43–1.1)

45 events

Celecoxib (any dose) v any active

Any

Any active comparator

23

34,512

0.11

0.23

0.64 (0.41–1.0)

55 events

Raised creatinine (above 1.3 × upper limit of normal)

      

Celecoxib v placebo

Any

Placebo

5

2,776

1.3

0.7

1.65 (0.69–4.0)

 

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

      

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

      

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

9

15,319

0.3

0.5

0.78 (0.46–1.3)

 

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

      

Celecoxib (any dose) v any active

Any

Any active comparator

10

15,657

0.3

0.5

0.79 (0.47–1.3)

 

Hypertension and aggravated hypertension

      

Celecoxib v placebo

Any

Placebo

16

9,321

1.0

0.6

1.4 (0.85–2.4)

 

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

0.2

0.6

 

4 events

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

3.5

4.6

0.75 (0.52–1.1)

 

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

16

22,518

1.3

1.4

0.92 (0.73–1.2)

 

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

17

30,921

1.6

1.6

1.1 (0.90–1.3)

 

Celecoxib (any dose) v any active

Any

Any active comparator

23

34,512

1.7

1.8

1.0 (0.86–1.2)

 

Oedema at any site

      

Celecoxib v placebo

Any

Placebo

16

9,321

2.6

1.4

1.9 (1.4–2.7)

79 (54–145) c

Celecoxib v paracetamol

Any

Paracetamol 4,000 mg

2

1,056

2.3

1.8

1.3 (0.56–3.0)

 

Celecoxib v rofecoxib

Any

Rofecoxib 25 mg

5

2,671

18.0

25.0

0.72 (0.62–0.83)

14 (10–25) b

Celecoxib (200/400) v NSAID

200–400 mg

NSAID to maximum daily

16

21,825

2.4

2.5

0.98 (0.82–1.2)

 

Celecoxib (any dose) v NSAID

Any

NSAID to maximum daily

17

30,921

2.9

3.5

0.92 (0.81–1.05)

 

Celecoxib (any dose) v any active

Any

Any active comparator

23

34,512

3.8

5.4

0.84 (0.76–0.92)

62 (48–87) 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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