COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease.
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.
Ray
Wayne A
WA
Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232, USA. wayne.ray@mcmail.vanderbilt.edu
Stein
C Michael
CM
Daugherty
James R
JR
Hall
Kathi
K
Arbogast
Patrick G
PG
Griffin
Marie R
MR
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000068579:Celecoxib; D003327:Coronary Disease / Q000139:chemically induced* / Q000401:mortality; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008484:Medicaid; D008565:Membrane Proteins; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D011451:Prostaglandin-Endoperoxide Synthases; D011720:Pyrazoles; D012044:Regression Analysis; D012189:Retrospective Studies; D012307:Risk Factors; D013449:Sulfonamides / Q000009:adverse effects; D013450:Sulfones; D013714:Tennessee / Q000453:epidemiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D009288:Naproxen; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D000068579:Celecoxib; D007052:Ibuprofen