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Hot Topics in Primary Care: The Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs: Putting the Evidence
1Professor of Clinical Family Medicine, David Geffen School of Medicine at UCLA, Vice Chair for Academic Affairs, UCLA Department of Family Medicine, Los Angeles, CA, USA.
Abstract:
The Vioxx Gastrointestinal Outcomes Research (VIGOR) trial, published in 2000, was the first to raise concerns that NSAIDs (specifically, the COX-2 selective inhibitor rofecoxib) might be associated with a higher risk for cardiovascular (CV) events. As discussed in this article, subsequent trials and meta-analyses have demonstrated a higher CV risk with use of not only COX-2 inhibitors (coxibs) but also certain tNSAIDs. These investigations have contributed to actions by the US Food and Drug Administration (FDA), most recently in July 2015, requiring strengthening of CV risk warnings on labels for all prescription and over-the-counter NSAIDs, despite evidence suggesting that differences in CV risk may exist among the NSAIDs.
Insights
Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and some traditional NSAIDs, are linked to increased cardiovascular risk. Regulatory agencies now require stronger warnings for all NSAIDs due to these concerns.
Area of Science:
- Cardiology
- Pharmacology
- Drug Safety
Background:
- The VIGOR trial (2000) first indicated a potential cardiovascular (CV) risk associated with NSAIDs, specifically the COX-2 inhibitor rofecoxib.
- Subsequent research, including trials and meta-analyses, has explored the CV risk profile of various NSAIDs.
Purpose of the Study:
- To review the evidence linking NSAIDs to cardiovascular events.
- To discuss the regulatory actions taken by the FDA regarding NSAID cardiovascular risk warnings.
Main Methods:
- Review of published clinical trials and meta-analyses concerning NSAID use and cardiovascular events.
- Analysis of FDA actions and labeling requirements for NSAIDs.
Main Results:
- Evidence suggests an increased CV risk with both COX-2 selective inhibitors (coxibs) and certain traditional NSAIDs (tNSAIDs).
- The FDA mandated strengthened CV risk warnings for all prescription and over-the-counter NSAIDs in July 2015.
Conclusions:
- NSAIDs, as a class, carry a cardiovascular risk that necessitates updated safety information.
- Despite class-wide warnings, potential differences in CV risk among individual NSAIDs warrant further investigation.
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