Table

Effects of paracetamol (P) and ibuprofen (I) alone or in combination (P + I) in long term therapy of OA of the knee

Effects1P 3 × 1g/dI 3x 0.4g/dP (3 × 0.5g) + I (3 × 0.2g/d)P (3 × 1g) + I (3 × 0.4g/d)Comments
Pain reduction (mm reduction from baseline, day 10)210.113.312.815.0 **3 vs PP is inferior to I or P + I
Patients' global assessment (% rating good or excellent)38.154.6 *vs P53.961.4 **vs Pcombinations are not superior to I
AEs, any drug related4 527.521.0 p<?28.830.8P alone or in combination causes more AEs than I
Dyspepsia (day 10)45.06.311.76.3P alone or in combination causes as many dyspepsia or diarrhea as I
Diarrhoea (day 10)44.51.81.86.7
ALAT3 4 53.10.01.03.4P alone or in combination causes impairment of liver function
γ GT (> 2x normal limit)46.70.53.53.4
Hb ↓ (> 1 g from baseline, day 10)4 57.311.310.817.5 p<0.01**P and I cause blood loss; P + I (high dose) enhance blood loss
> 1 g at study endpoint4 520.319.624.138.4 p<0.01**Blood loss due to P + I reaches clinically relevant proportions with time
> 2 g at study endpoint4 50.90.91.86.9 p<?The effect of P + I appears more than additive (p<?)
  • 1 If not stated otherwise: at day 10

  • 2 As measured with a 10 cm VAS

  • 3 * p<0.05; ** p<0.01

  • 4 results as % of cohort

  • 5 Alanine transferase (alanine transaminase; % of patients showing > 2× normal limit)