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Methods: Pooled analysis of 51 RCTs >4 wks comparing celecoxib with NSAIDs or placebo. Patients with osteo-/rheumatoid arthritis, ankylosing spondylitis, chronic low back pain, Alzheimer’s Disease and polyps were included; most were treated >6 months. The adverse event (AE) profile in patients with clinically significant blood loss (decreases in hemoglobin ≥2 g/dl, and/or hematocrit ≥10% from baseline) was compared with patients without blood loss. For the primary analysis, an AE was considered to be associated with blood loss if it occurred at any time during the time window. Comparisons were based on percentage of patients with AEs and not annualized. Events occurring in <1% of patients in both groups were excluded from comparisons. >3-fold difference between groups was defined arbitrarily as being markedly higher.
Results: Overall 932/51,048 patients experienced clinically significant blood loss. Baseline demographics were similar in patients with/without blood loss. Incidence of AEs was markedly higher in patients with blood loss than those without. The majority of these differences were for GI AEs (gastric ulcer, GI hemorrhage, melena) or their likely sequelae (anemia, increase in blood creatinine, hemoglobin and/or hematocrit decrease) as might be expected following NSAID treatment. However, incidence of these non-GI AEs was also markedly higher in patients with blood loss compared with patients without: coronary artery disease (1.2% vs 0.3%), myocardial infarction (0.6% vs 0.2%), pneumonia (1.7% vs 0.4%). Withdrawals due to AEs were more common among patients with blood loss (16.7%) than without (10.4%).
Conclusions: Clinically significant blood loss may have clinically important adverse consequences beyond the sequelae previously known to be associated with NSAID-related GI effects.