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Subgroup analyses to determine cardiovascular risk associated with nonsteroidal antiinflammatory drugs and coxibs in

Daniel H Solomon1, Robert J Glynn, Kenneth J Rothman

  • 1Brigham and Women's Hospital, 1620 Tremont Street, Boston, MA 02120, USA. dhsolomon@partners.org

Abstract

Insights

Cyclooxygenase 2 inhibitors (coxibs) and NSAIDs generally do not increase cardiovascular disease risk. However, specific patient characteristics like age, hypertension, and prior heart conditions identify subgroups at higher risk with certain agents.

Area of Science:

  • Cardiovascular pharmacology
  • Drug safety and risk assessment
  • Rheumatology and arthritis management

Background:

  • Concerns exist regarding cardiovascular adverse effects of selective cyclooxygenase 2 inhibitors (coxibs) and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs).
  • These medications offer significant clinical benefits for patients with arthritis.
  • Understanding risk stratification is crucial for safe prescribing.

Purpose of the Study:

  • To investigate how patient clinical characteristics modify the association between coxibs/NSAIDs and cardiovascular disease (CVD) risk.
  • To identify specific patient subgroups with potentially elevated CVD risk when using these agents.
  • To inform clinical decision-making regarding NSAID and coxib prescriptions.

Main Methods:

  • Retrospective cohort study using Medicare beneficiary data (1999-2004).
  • Calculated relative risk (RR) for CVD events (MI, stroke, heart failure, cardiovascular death) comparing users to nonusers.
  • Assessed interactions between medication exposure and patient characteristics.

Main Results:

  • Rofecoxib use was associated with increased CVD risk (RR 1.22), while naproxen showed a decreased risk (RR 0.79).
  • Patient factors like age ≥80, hypertension, prior MI, prior CVD, rheumatoid arthritis, chronic renal disease, and COPD increased CVD risk with specific agents.
  • Rofecoxib and ibuprofen demonstrated increased risk in multiple patient subgroups.

Conclusions:

  • Many nonselective NSAIDs and coxibs are not linked to increased CVD risk.
  • Specific patient characteristics identify subgroups at elevated risk with particular coxibs or NSAIDs.
  • Risk assessment considering individual patient profiles is essential for safe use.

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