Increased Gastrointestinal GI Ulcer With Cox2 Inhibitor Rofecoxib Combined With LowDose Aspirin

1
Increased Gastrointestinal (GI) Ulcer With Cox-2
Inhibitor Rofecoxib Combined With Low-Dose Aspirin

• GI Ulcers gt 3 to 5 mm
• Ulcer rates for Rofecoxib Aspirin significantly
  higher compared with placebo (difference 10.3
  95 CI, 5.8 14.8 P lt 0.001) or Aspirin
  (difference 8.9 95 CI, 4.213.5 P lt
  0.001) alone.1
• Incidence rates with combo therapy comparable to
  nonselective NSAIDs like Ibuprofen (16.1
  vs17.1,
• P lt 0.001 vs. placebo and vs. aspirin).1
• Mean increases in the number of ulcers after 12
  wks Placebo, 0.17 Aspirin, 0.85 (P lt 0.002 vs.
  placebo) Rofecoxib Aspirin, 1.67 and
  Ibuprofen, 1.91 (both P lt 0.001 vs. Aspirin and
  Placebo).1
• Unlike Low-Dose Aspirin, GI ulcers with
  non-aspirin NSAIDs and COX-2 selective inhibitors
  are predictive of clinical bleeding.2, 3

Patient Population Osteoarthritis patients aged
gt50 without ulcers or erosive esophagitis at
baseline endoscopy Therapy Enteric-coated
Aspirin 81 mg/day Rofecoxib 25 mg Aspirin 81
mg/day or Ibuprofen 800 mg TID

• Laine L, Maller ES, Yu C, Quan H, Simon T.
  Gastroenterology 2004127395402.
• Laine L, Harper S, Simon T, et al.
  Gastroenterology 1999117776783.
• 3. Hawkey C, Laine L, Simon T, et al. Arthritis
  Rheum 200043370377.