Effect of blood loss on physical function in arthritis patients: A pooled analysis

Vibeke Strand, Byron Cryer, Xuemei Luo, Andrew G. Bushmakin, Joseph C. Cappelleri, Brian Cuffel, George Sands, Annlouise R. Assaf

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalHealth Outcomes Research in Medicine
Volume2
Issue number1
DOIs
StatePublished - Feb 2011

Fingerprint

Arthritis
Hemoglobins
Celecoxib
Quality of Life
Hemorrhage
Non-Steroidal Anti-Inflammatory Agents
Osteoarthritis
Rheumatoid Arthritis
Anti-Inflammatory Agents
Randomized Controlled Trials
Placebos
Pain
Incidence
Therapeutics
Pharmaceutical Preparations
Population

Keywords

  • Cyclo-oxygenase 2
  • Gastrointestinal bleeding
  • Health-related quality of life
  • Nonsteroidal anti-inflammatory drugs

ASJC Scopus subject areas

  • Health Policy

Cite this

Effect of blood loss on physical function in arthritis patients : A pooled analysis. / Strand, Vibeke; Cryer, Byron; Luo, Xuemei; Bushmakin, Andrew G.; Cappelleri, Joseph C.; Cuffel, Brian; Sands, George; Assaf, Annlouise R.

In: Health Outcomes Research in Medicine, Vol. 2, No. 1, 02.2011.

Research output: Contribution to journalArticle

Strand, Vibeke ; Cryer, Byron ; Luo, Xuemei ; Bushmakin, Andrew G. ; Cappelleri, Joseph C. ; Cuffel, Brian ; Sands, George ; Assaf, Annlouise R. / Effect of blood loss on physical function in arthritis patients : A pooled analysis. In: Health Outcomes Research in Medicine. 2011 ; Vol. 2, No. 1.
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abstract = "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.",
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