Background and Objectives: The clinical consequences of lower gastrointestinal bleeding resulting from nonselective nonsteroidal anti-inflammatory drug (NSAID) use are less well documented than upper gastrointestinal bleeding. The aim of this study was to assess the effect of clinically significant gastrointestinal blood loss on health-related quality of life (HRQoL) using the SF-36 in a large arthritis population. Study Design: To compare treatment-associated changes in HRQoL, data from 14 multinational randomized controlled trials (2-52 weeks' duration) involving 14,173 subjects with osteoarthritis/rheumatoid arthritis, treated with celecoxib versus placebo or active comparator NSAIDs or both, were pooled. Clinically significant blood loss was defined as hemoglobin decreases ≥2 g/dL from baseline versus no change (from -1 to +1 g/dL). Results: Subjects with no change in hemoglobin reported statistically significant and clinically meaningful improvements in all SF-36 domains. In those with clinically significant blood loss, improvements were reported in bodily pain (both females and males), and role physical and vitality domains (females) only. Change scores in SF-36 between subjects with significant blood loss and those with no changes in hemoglobin demonstrated statistically significant and clinically meaningful differences in physical function (both females and males) and role physical (males) domains - more pronounced in women and men with baseline hemoglobin values ≤14 and ≤15 g/dL, respectively. Conclusions: Treatment-associated improvements in physical function reported by subjects with no blood loss were not evident in those with significant blood loss. Differences between groups were statistically and clinically meaningful, and more pronounced when baseline hemoglobin levels were ≤14 g/dL for females and ≤15 g/dL for males. Use of medications with lower incidence of significant blood loss should be warranted in patients with arthritis.
- Cyclo-oxygenase 2
- Gastrointestinal bleeding
- Health-related quality of life
- Nonsteroidal anti-inflammatory drugs
ASJC Scopus subject areas
- Health Policy