Diclofenac and acute myocardial infarction in patients with no major risk factors

Susan S Jick1, James A Kaye, Hershel Jick

  • 1Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, MA 02421, USA. sjick@bu.edu

Insights

Extensive diclofenac use significantly raises the risk of acute myocardial infarction (AMI). Ibuprofen and naproxen showed little to no increased AMI risk in long-term users.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacovigilance
  • Epidemiology

Background:

  • Recent findings suggest diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), may increase acute myocardial infarction (AMI) risk.
  • This risk appears similar to that associated with rofecoxib and celecoxib.

Purpose of the Study:

  • To investigate the association between long-term use of diclofenac and the risk of AMI.
  • To compare the AMI risk associated with diclofenac to that of ibuprofen and naproxen.

Main Methods:

  • Three nested case-control studies were conducted using the General Practice Research Database.
  • NSAID use (diclofenac, ibuprofen, naproxen) initiated after January 1, 1993, was analyzed for AMI cases between 1993 and 2000.
  • Relative risk (RR) for AMI was calculated based on the number of prescriptions, adjusted for potential confounding factors.

Main Results:

  • Diclofenac use, particularly with 10 or more prescriptions, showed a substantial increase in AMI risk (RR 1.9-2.0).
  • Ibuprofen and naproxen use, even with 20 or more prescriptions, did not demonstrate a significant elevation in AMI risk.

Conclusions:

  • Extensive use of diclofenac is associated with a significantly increased risk of acute myocardial infarction.
  • Ibuprofen and naproxen do not appear to carry a similar elevated risk of AMI with long-term use.
Abstract

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