COX-2 Selective Non-Steroidal Anti-Inflammatory Drugs and Risk of Serious Coronary Heart Disease

Lancet. 2002 Oct 5;360(9339):1071-3. doi: 10.1016/S0140-6736(02)11131-7.

Abstract

Results of premarketing and postmarketing trials have raised doubts about the cardiovascular safety of the non-steroidal anti-inflammatory drug (NSAID) rofecoxib, especially at doses greater than 25 mg. Between Jan 1, 1999, and June 30, 2001, we did a retrospective cohort study of individuals on the expanded Tennessee Medicaid programme (TennCare), in which we assessed occurrence of serious coronary heart disease (CHD) in non-users (n=202916) and in users of rofecoxib and other NSAIDs (rofecoxib n=24 132, other n=151 728). Participants were aged 50-84 years, lived in the community, and had no life-threatening non-cardiovascular illness. Users of high-dose rofecoxib were 1.70 (95% CI 0.98-2.95, p=0.058) times more likely than non-users to have CHD; among new users this rate increased to 1.93 (1.09-3.42, p=0.024). By contrast, there was no evidence of raised risk of CHD among users of rofecoxib at doses of 25 mg or less or among users of other NSAIDs.

Publication types

  • Comparative Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Celecoxib
  • Coronary Disease / chemically induced*
  • Coronary Disease / mortality
  • Cyclooxygenase 2
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors / administration & dosage
  • Cyclooxygenase Inhibitors / adverse effects*
  • Female
  • Humans
  • Ibuprofen / adverse effects
  • Isoenzymes / antagonists & inhibitors*
  • Lactones / administration & dosage
  • Lactones / adverse effects*
  • Male
  • Medicaid
  • Membrane Proteins
  • Middle Aged
  • Naproxen / adverse effects
  • Product Surveillance, Postmarketing
  • Prostaglandin-Endoperoxide Synthases
  • Pyrazoles
  • Regression Analysis
  • Retrospective Studies
  • Risk Factors
  • Sulfonamides / adverse effects
  • Sulfones
  • Tennessee / epidemiology

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors
  • Isoenzymes
  • Lactones
  • Membrane Proteins
  • Pyrazoles
  • Sulfonamides
  • Sulfones
  • rofecoxib
  • Naproxen
  • Cyclooxygenase 2
  • PTGS2 protein, human
  • Prostaglandin-Endoperoxide Synthases
  • Celecoxib
  • Ibuprofen