May 30th, 2013

Large Meta-Analysis Quantifies Risks Posed by Coxibs and Traditional NSAIDs

Findings from a very large meta-analysis of clinical trials of NSAIDs may now allow physicians to quantify the cardiovascular and gastrointestinal risks associated with these drugs. The results of the Coxib and traditional NSAID Trialists’ (CNT) Collaboration, employing data from more than 350,000 randomized patients, have been published in the Lancet.

Here are some of the key findings:
  • The risk for major vascular events — mostly major coronary events– was increased by one third in people taking coxibs or high-dose diclofenac. Ibuprofen significantly increased the risk for major coronary events but not major vascular events.
  • Compared with other traditional NSAIDs (not coxibs), high-dose naproxen was not associated with an increased risk for major vascular or coronary events.
  • All NSAIDs were associated with an increase in the risk for heart failure hospitalization and GI complications. The increase in the rate of GI complications was lowest for the coxibs.

The investigators said that NSAIDs and coxibs caused a similar proportional increase in events across the spectrum of baseline risk. They reported:

Among those at low risk of vascular disease (the majority of participants in these trials), the predicted absolute risks of major vascular events were small irrespective of the particular regimen chosen. For high-risk individuals (about 40% of whom were taking aspirin), for every 1000 patients allocated to a year of treatment with a coxib regimen or high-dose diclofenac regimen, about seven or eight more would have a major vascular event, of which two would be fatal. High-dose ibuprofen may be associated with a similar risk, but is also likely to yield a higher risk of upper gastrointestinal complications than either a coxib or diclofenac.

“Whilst NSAIDs increase vascular and gastrointestinal risks to a varying extent, our analyses indicate that the effects of different regimens in particular patients can be predicted, which may help physicians choosing between alternative NSAID regimens to weigh up which type of NSAID is safest in different patients,” said lead author Professor Colin Baigent, in a Lancet press release.

In an accompanying comment, Marie Griffin suggests that “long-term use of high-dose NSAIDs should be reserved for those who receive considerable symptomatic benefit from the treatment and understand the risks.”


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