The NSAID and CVD Balancing Act

An Expert Interview With Daniel Solomon, MD

Linda Brookes; Daniel Solomon, MD


August 30, 2011

In This Article

Background to the Interview on Cardiovascular Risks and NSAID Use

The cardiovascular safety of NSAIDs, commonly used by patients for the pain of osteoarthritis and rheumatoid arthritis, remains a subject of controversy. Following the withdrawal of the cyclo-oxygenase (COX) 2 inhibitor rofecoxib from the US market in 2004[1] because of an increased risk for cardiovascular events and the subsequent boxed warning applied to the label of the only COX-2 inhibitor currently available, celecoxib,[2,3] attention turned to possible side effects of the traditional, nonselective NSAIDs.[4] In 2005, the US Food and Drug Administration (FDA) concluded that an increased risk for serious adverse cardiovascular events might be a class effect for NSAIDs (excluding aspirin) and requested that a boxed warning be added to the package insets for all NSAIDs highlighting the potential increased risk for cardiovascular events (as well as the risk for serious and potentially life-threatening gastrointestinal bleeding).[5] However, whereas the cardiovascular adverse effects associated with rofecoxib were demonstrated in a randomized trial[6] and subsequently confirmed in other trials and by a cumulative meta-analysis,[7] few data from large randomized trials are available about the cardiovascular safety of most of the nonselective NSAIDs. Further meta-analyses of randomized trials and observational studies of NSAIDs including nonselective drugs indicated that all NSAIDs are associated with an increase in cardiovascular risk, but that this varies with different agents. Several studies published earlier this year demonstrated cardiovascular effects in patients at high risk for or with established coronary artery disease,[8,9,10,11] and a population-based case-control study indicated that use of nonaspirin NSAIDs is associated with an increased risk for atrial fibrillation or flutter.[12]

Daniel Solomon, MD, MPH, spoke with Linda Brookes, MSc, for Medscape, about these studies and how the current understanding of the cardiovascular safety of NSAIDs should be taken into account when determining optimal analgesic strategies for their arthritis patients.


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