Risk of cardiovascular events associated with selective COX-2 inhibitors

D Mukherjee ¹, S E Nissen , E J Topol

⁰Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, F 25, 9500 Euclid Ave, Cleveland, OH 44195, USA.

Jama +

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August 31, 2001

View abstract on PubMed

Summary

Selective cyclooxygenase 2 (COX-2) inhibitors may increase the risk of cardiovascular events. While some studies show no difference, others indicate higher rates of myocardial infarction with these arthritis drugs.

Area Of Science

Cardiovascular medicine
Rheumatology
Pharmacology

Background

Atherosclerosis involves inflammation; selective cyclooxygenase 2 (COX-2) inhibitors may offer antiatherogenic effects by reducing inflammation.
However, COX-2 inhibitors can decrease prostacyclin production, potentially increasing prothrombotic activity.

Purpose Of The Study

To assess the cardiovascular effects of COX-2 inhibitors in patients without coronary artery disease using arthritis and musculoskeletal pain medications.
To evaluate the safety of COX-2 inhibitors concerning thrombotic cardiovascular events.

Main Methods

Conducted a MEDLINE search for English-language articles on COX-2 inhibitors (1998-February 2001).
Reviewed pharmaceutical company submissions to the US Food and Drug Administration.
Analyzed data from two major randomized trials (VIGOR, CLASS) and two smaller trials.

Main Results

The VIGOR trial showed a 2.38-fold increased risk of thrombotic cardiovascular events with rofecoxib compared to naproxen.
The CLASS trial found no significant difference in cardiovascular events between celecoxib and nonsteroidal anti-inflammatory agents.
Annualized myocardial infarction rates were significantly higher with both rofecoxib (0.74%) and celecoxib (0.80%) compared to placebo (0.52%) in primary prevention trials.

Conclusions

Available data suggest a potential increased risk of cardiovascular events associated with COX-2 inhibitors.
Further prospective trials are needed to fully characterize and quantify this cardiovascular risk.

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