What is the clinical evidence from this study?

Study design: Cohort. Population: Prior myocardial infarction (n=97698). Intervention: NSAIDs vs. No NSAID use. Primary outcome: Cardiovascular death (HR 1.42, 95% CI 1.36-1.49).

January 30, 2013PLoS ONE70 citationsOpen Access

Cause-Specific Cardiovascular Risk Associated with Nonsteroidal Anti-Inflammatory Drugs among Myocardial Infarction Patients - A Nationwide Study

AOAnne‐Marie Schjerning OlsenDanish National Research Foundation EFEmil Loldrup FosbølStructural Heart Disease JLJesper LindhardsenPreventive Cardiology

Key Result

Overall use of NSAIDs in patients with prior myocardial infarction was associated with a 42% increased risk of cardiovascular death (HR 1.42) compared to no NSAID use.

Study Design

Type

Cohort (n=97,698)

Multicenter

Yes

Structured PICO

Does NSAID use increase the risk of cardiovascular death, recurrent MI, and stroke in patients with a prior myocardial infarction?

Population

97,698 patients aged >30 years admitted with first-time myocardial infarction during 1997-2009 in Denmark.

Intervention

Nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac, rofecoxib, ibuprofen, and naproxen.

Comparator

Non-use of NSAIDs (implied by hazard ratio analysis).

Outcome

Three cardiovascular specific endpoints: cardiovascular death, the composite of coronary death and nonfatal MI, and the composite of fatal and nonfatal stroke.hard clinical

The use of NSAIDs, particularly diclofenac and rofecoxib, is associated with a significantly increased risk of cardiovascular death in patients with a prior myocardial infarction, supporting caution with their use in this population.

Main Result

Effect estimate: HR 1.42 (95% CI 1.36-1.49)

Absolute Event Rate: 7.06% vs 4.96%

Limitations

Observational study design with potential for confounding by indication
Lack of information on precise indication for NSAID treatment
Calculations of dose and treatment duration represent approximations
Lack of data on cardiovascular risk factors such as lipid levels, smoking status, blood pressure, left ventricular ejection fraction, or obesity
Potential misclassification of death causes from death certificates
Lack of information on over-the-counter aspirin use and whether NSAID use led to premature aspirin discontinuation

Abstract

BACKGROUND: Non steroidal anti-inflammatory drugs (NSAIDs) increase mortality and morbidity after myocardial infarction (MI). We examined cause-specific mortality and morbidity associated with NSAIDs in a nationwide cohort of MI patients. METHODS AND RESULTS: By individual-level linkage of nationwide registries of hospitalization and drug dispensing from pharmacies in Denmark, patients aged >30 years admitted with first-time MI during 1997-2009 and their subsequent NSAID use were identified. The risk of three cardiovascular specific endpoints: cardiovascular death, the composite of coronary death and nonfatal MI, and the composite of fatal and nonfatal stroke, associated with NSAID use was analyzed by Cox proportional hazard analyses. Of 97,698 patients included 44.0% received NSAIDs during follow-up. Overall use of NSAIDs was associated with an increased risk of cardiovascular death (hazard ratio HR 1.42, 95% confidence interval CI 1.36-1.49). In particular use of the nonselective NSAID diclofenac and the selective cyclooxygenase-2 inhibitor rofecoxib was associated with increased risk of cardiovascular death (HR 1.96 1.79-2.15 and HR1.66 1.44-1.91, respectively) with a dose dependent increase in risk. Use of ibuprofen was associated with increased risk of cardiovascular death (HR 1.341.26-1.44), whereas naproxen was associated with the lowest risk of (e.g., HR 1.271.01-1.59. CONCLUSION: Use of individual NSAIDs is associated with different cause-specific cardiovascular risk and in particular rofecoxib and diclofenac were associated with increased cardiovascular morbidity and mortality. These results support caution with use of all NSAIDs in patients with prior MI.

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