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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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