Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis
Authors' conclusion
At moderate doses, celecoxib was found to be noninferior to ibuprofen or naproxen with regard to cardiovascular safety.
Study context
- Population
- Patients requiring nonsteroidal antiinflammatory drugs (NSAIDs) for osteoarthritis or rheumatoid arthritis at increased CV risk
- Participants
- 24,081 patients
- Comparison
- Celecoxib vs naproxen or ibuprofen
- Primary endpoint
- CV death (including hemorrhagic death), nonfatal MI or nonfatal stroke
Methodological detailsnon-inferiority, 68.8% stopped study drug; 27.4% discontinued follow-up, Mean treatment duration 20.3±16.0 months; mean follow-up 34.1±13.4 months
- Non-inferiority
- 68.8% stopped study drug; 27.4% discontinued follow-up
- Mean treatment duration 20.3±16.0 months; mean follow-up 34.1±13.4 months
Primary result
As reported in the abstract
Hazard ratio (95% CI)P value
Celecoxib vs Naproxen
0.93(0.76–1.13)
P < 0.001 for noninferiorityCelecoxib vs Ibuprofen
0.85(0.70–1.04)
P < 0.001 for noninferiorityFurther findings
| Outcome | Celecoxib | Naproxen | Ibuprofen | HR (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Primary outcome, on-treatment analysisCelecoxib vs Naproxen · on-treatment | 1.7% | 1.8% | 1.9% | 0.90 (0.71–1.15) | P < 0.001 for noninferiority | |
| Primary outcome, on-treatment analysisCelecoxib vs Ibuprofen · on-treatment | 0.81 (0.65–1.02) | P < 0.001 for noninferiority | ||||
| 0.512Hazard ratio (log scale) |
Safety
Gastrointestinal events
- Significantly lower with celecoxib than naproxen
- P = 0.01
- Significantly lower with celecoxib than ibuprofen
- P = 0.002
Renal events
- Significantly lower with celecoxib than ibuprofen
- P = 0.004
- Not significantly lower with celecoxib than naproxen
- P = 0.19
Original publication
Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. Published 13 November 2016. doi:10.
Summarised from the published abstract; every number is checked against it