February 1, 2005
View Full PaperPatients Exposed to Rofecoxib and Celecoxib Have Different Odds of Nonfatal Myocardial Infarction
Key Result
Exposure to rofecoxib was associated with a significantly higher odds of nonfatal myocardial infarction compared with celecoxib (adjusted OR 2.72; 95% CI 1.24-5.95; P=0.01).
Study Design
Type
Case-Control (n=8,518)
Multicenter
Yes
Structured PICO
Does the use of COX-2 inhibitors (celecoxib or rofecoxib) affect the risk of nonfatal myocardial infarction compared to nonuse or nonselective NSAIDs?
P
Population
8,518 participants (1,718 cases with a first, nonfatal MI and 6,800 controls) from a 5-county area.
E
Exposure
Use of COX-2 selective inhibitors (celecoxib or rofecoxib) or nonselective NSAIDs (naproxen, ibuprofen, diclofenac) assessed via self-reported telephone interviews
C
Comparator
Nonuse of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) or alternative NSAIDs
O
Outcome
First, nonfatal myocardial infarction (MI)hard clinical
Rofecoxib and celecoxib are associated with different risks of nonfatal MI, with rofecoxib showing significantly higher odds compared to celecoxib.
Main Result
Odds Ratio: 2.72 (95% CI 1.24–5.95)
p-value: p=0.01
Limitations
- The possibility of recall bias and uncontrolled confounding in this observational study limit the ability to make definitive conclusions.
- The association of celecoxib with a lower odds of MI could have occurred by chance.
- Only about 50% of eligible participants completed telephone interviews.
Abstract
BACKGROUND: Studies have postulated that cyclooxygenase-2 (COX-2) selective inhibitors affect cardiovascular risk through various mechanisms. Some of these mechanisms could increase risk (for example, inhibition of prostacyclin production), and some could decrease risk (for example, inhibition of inflammation). OBJECTIVE: To determine the effect of COX-2 inhibitors on risk for nonfatal myocardial infarction (MI). DESIGN: Case-control study. SETTING: 36 hospitals in a 5-county area. PARTICIPANTS: 1718 case-patients with a first, nonfatal MI admitted to these hospitals and 6800 controls randomly selected from the same counties. MEASUREMENTS: Self-reported medication use assessed through telephone interviews. RESULTS: The adjusted odds ratio for MI among celecoxib users, relative to persons who did not use nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs), was 0.43 (95% CI, 0.23 to 0.79) compared with 1.16 (CI, 0.70 to 1.93) among rofecoxib users. The use of rofecoxib was associated with a statistically significant higher odds of MI compared with the use of celecoxib (adjusted odds ratio for rofecoxib vs. celecoxib, 2.72 CI, 1.24 to 5.95; P = 0.01). Nonselective NSAIDs were associated with a reduced odds of nonfatal MI relative to nonusers. Comparisons of COX-2 inhibitors with nonselective NSAIDs were the following: rofecoxib versus naproxen (odds ratio, 3.39 CI, 1.37 to 8.40) and celecoxib versus ibuprofen or diclofenac (odds ratio, 0.77 CI, 0.40 to 1.48). LIMITATIONS: The possibility of recall bias and uncontrolled confounding in this observational study limit the ability to make definitive conclusions. The association of celecoxib with a lower odds of MI could have occurred by chance. Only about 50% of eligible participants completed telephone interviews. CONCLUSION: Celecoxib and rofecoxib were associated with different odds of MI. Cardiovascular effects among the COX-2 inhibitors seem different, but further studies, preferably randomized trials, are needed to fully understand the spectrum of effects of COX-2 inhibitors and potential differences among them.
Cite This Study
Kimmel et al. (Tue,) conducted a case-control in first, nonfatal myocardial infarction (n=8,518). Rofecoxib vs. Celecoxib was evaluated on nonfatal myocardial infarction (MI) (OR 2.72, 95% CI 1.24-5.95, p=0.01). Exposure to rofecoxib was associated with a significantly higher odds of nonfatal myocardial infarction compared with celecoxib (adjusted OR 2.72; 95% CI 1.24-5.95; P=0.01).