Controversy has surrounded the question about whether high-dose rofecoxib increases or naproxen decreases the risk of serious coronary heart disease.
Dr Graham and colleagues from America sought to establish if risk was enhanced with rofecoxib at either high or standard doses compared with remote non-steroidal anti-inflammatory drug (NSAID) use or celecoxib use.
Celecoxib is the most common alternative to rofecoxib.
The researchers undertook a nested case-control study using data from Kaiser Permanente in California to assemble a cohort of all patients age 18–84 years treated with a NSAID between Jan 1, 1999, and Dec 31, 2001.
The investigators risk-set matched cases of serious coronary heart disease (acute myocardial infarction and sudden cardiac death) with 4 controls for age, sex, and health plan region.
|During 2,302,029 person-years of follow-up, 8143 cases of serious coronary heart disease occurred|
The researchers then compared current exposure to cyclo-oxygenase 2 selective and non-selective NSAIDs with remote exposure to any NSAID, and rofecoxib was compared with celecoxib.
The researchers found that during 2,302,029 person-years of follow-up, 8143 cases of serious coronary heart disease occurred, of which 27% were fatal.
The research team compiled multivariate adjusted odds ratios vs celecoxib and these were: for rofecoxib (all doses), 1·59 ; for rofecoxib 25 mg/day or less, 1·47 ; and for rofecoxib greater than 25 mg/day, 3·58.
The researchers found that for naproxen vs remote NSAID use, the adjusted odds ratio was 1·14.
Dr Graham concluded, "Rofecoxib use increases the risk of serious coronary heart disease compared with celecoxib use."
"Naproxen use does not protect against serious coronary heart disease."