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Cyclooxygenase-2 inhibitors and cardiovascular risk in a nation-wide cohort study after the withdrawal of rofecoxib
Magnus Bäck1, Li Yin, Erik Ingelsson
1Department of Cardiology, Karolinska University Hospital, L8:03, SE-171 76 Stockholm, Sweden. magnus.back@ki.se
European Heart Journal
|November 24, 2011
Summary
Selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) did not increase the risk of major cardiovascular events. However, coxib use was linked to a higher risk of developing atrial fibrillation, particularly etoricoxib.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Epidemiology
Background:
- Selective cyclooxygenase-2 (COX-2) inhibitors, known as coxibs, have raised concerns regarding cardiovascular safety.
- Post-marketing surveillance is crucial for evaluating drug safety in real-world populations.
Purpose of the Study:
- To assess the association between coxib use and the future risk of cardiovascular events.
- To investigate the cardiovascular safety of coxibs following official safety warnings.
Main Methods:
- A nationwide, population-based cohort study involving over 7 million individuals.
- Data linkage across multiple national registers (drug prescriptions, patient demographics, mortality, income, education, emigration).
- Follow-up period from July 2005 to December 2008, analyzing incident primary cardiovascular events.
Main Results:
- No significant association was found between coxib use and the risk of myocardial infarction, ischemic stroke, or heart failure.
- Coxib use was associated with an increased risk of incident atrial fibrillation (HR 1.16).
- Etoricoxib showed a significant association with atrial fibrillation (HR 1.35), while celecoxib did not (HR 0.94).
Conclusions:
- While safety measures may have mitigated serious cardiovascular risks associated with COX-2 inhibitors, the elevated risk of atrial fibrillation warrants attention.
- The potential for coxibs to induce atrial fibrillation may have been underestimated and requires careful consideration and patient monitoring.
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