In this study, researchers from the United States and England stratified the risk of NSAID-related upper GI clinical events.
They determined risk factors for nonsteroidal anti-inflammatory drug (NSAID)-related clinical upper gastrointestinal (GI) events, absolute risk reductions, and numbers needed to treat for individual risk factors, for a nonselective NSAID and a selective cyclooxygenase 2 inhibitor.
Over 8000 rheumatoid arthritis patients aged 50 years or over (or 40 on corticosteroid therapy) were randomly assigned to rofecoxib 50 mg daily or naproxen 500 mg, twice daily for a median of 9 months.
The researchers assessed the development of clinical upper GI events (bleeding, perforation, obstruction, and symptomatic ulcer identified on clinically indicated work-up) in these patients.
Significant risk factors were identified, included prior upper GI events, age 65 years or over, and severe rheumatoid arthritis.
They also discovered that patients given naproxen, who had prior upper GI complications or who were aged 75 years or over, had 14 to 19 events per 100 patient-years. The risk of events remained constant over time.
The reduction in events with rofecoxib was similar in the high- and low-risk subgroups.
The number needed to treat with rofecoxib, instead of naproxen, to avert 1 GI event was 10-12 in highest risk patients, 17-33 in patients with other risk factors, and 42-106 in low-risk patients.
| Prior upper GI events and age influence risk of NSAID-related GI events.|
Dr Loren Laine's team concluded that, "NSAID-related GI events increase dramatically with risk factors such as prior events or older age".
"Furthermore, 10 to12 high-risk patients require treatment with a protective strategy such as the selective cyclooxygenase 2 inhibitor, rofecoxib, to avert a clinical GI event".