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High dose Ibuprofen linked to CV events

The Annals of the Rheumatic Diseases has published an analysis of the TARGET study that suggests an increased risk of cardiovascular outcomes in high-risk patients treated with ibuprofen compared to two other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

The TARGET study compared treatment with lumiracoxib (400mg daily) to either ibuprofen (800mg three times daily) or naproxen (500mg twice daily). All patients were aged 50 or older and had osteoarthritis. Patients who had experienced a significant cardiac event in the last 6 months or who had severe heart failure (NYHA 3-4) were excluded but those taking aspirin were allowed to enrol.

In this post-hoc analysis, patients were assessed based upon baseline cardiovascular risk, treatment assignment and low-dose aspirin use. The primary outcome measure was cardiovascular mortality, nonfatal myocardial infarction, and stroke at 1 year with a secondary outcome measuring development of congestive heart failure (CHF).

In high risk patients taking aspirin the study found that, more patients taking ibuprofen experienced the primary outcome compared to lumiracoxib. Primary outcome event rates were similar when comparing lumiracoxib and naproxen.

In patients at high risk who were not taking aspirin, event rates in the primary outcome were similar for patients taking lumiracoxib and ibuprofen, but were reduced in those taking naproxen.

In all patients at high risk, irrespective of aspirin use, the secondary outcome of development of CHF was observed more in patients taking ibuprofen while rates were similar in those taking naproxen or lumiracoxib.

Important points to note from this analysis are:

  • This analysis is a post-hoc analysis and therefore should be used to generate further work rather than solid conclusions
  • The analysis only examined high-risk patients and the results should not be extrapolated to those at low risk
  • The TARGET study only used high doses of the study drugs and the results should not be extrapolated to low doses of the same drugs

Action: This analysis serves to reinforce the current advice from the Medicines and Healthcare products Regulatory Agency (MHRA) that NSAIDs should be used as second line to paracetamol. Where paracetamol is insufficient a risk assessment including consideration of gastro-intestinal, cardio-vascular and renal risk should be conducted and where NSAID therapy is considered necessary the drug of lowest risk should be used at the lowest possible dose and for the shortest possible duration.

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