The Tell-Tale Heart: Population-Based Surveillance Reveals an Association of Rofecoxib and Celecoxib with Myocardial Infarction
Open Access
- 5 September 2007
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 2 (9), e840
- https://doi.org/10.1371/journal.pone.0000840
Abstract
COX-2 selective inhibitors are associated with myocardial infarction (MI). We sought to determine whether population health monitoring would have revealed the effect of COX-2 inhibitors on population-level patterns of MI. We conducted a retrospective study of inpatients at two Boston hospitals, from January 1997 to March 2006. There was a population-level rise in the rate of MI that reached 52.0 MI-related hospitalizations per 100,000 (a two standard deviation exceedence) in January of 2000, eight months after the introduction of rofecoxib and one year after celecoxib. The exceedence vanished within one month of the withdrawal of rofecoxib. Trends in inpatient stay due to MI were tightly coupled to the rise and fall of prescriptions of COX-2 inhibitors, with an 18.5% increase in inpatient stays for MI when both rofecoxib and celecoxib were on the market (P<0.001). For every million prescriptions of rofecoxib and celecoxib, there was a 0.5% increase in MI (95%CI 0.1 to 0.9) explaining 50.3% of the deviance in yearly variation of MI-related hospitalizations. There was a negative association between mean age at MI and volume of prescriptions for celecoxib and rofecoxib (Spearman correlation, −0.67, P<0.05). The strong relationship between prescribing and outcome time series supports a population-level impact of COX-2 inhibitors on MI incidence. Further, mean age at MI appears to have been lowered by use of these medications. Use of a population monitoring approach as an adjunct to pharmacovigilence methods might have helped confirm the suspected association, providing earlier support for the market withdrawal of rofecoxib.Keywords
This publication has 49 references indexed in Scilit:
- Suicide Rates and Antidepressant Prescribing: A Casual or Causal Relationship?PLoS Medicine, 2006
- Modeling of the Temporal Patterns of Fluoxetine Prescriptions and Suicide Rates in the United StatesPLoS Medicine, 2006
- Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trialsBMJ, 2006
- Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention TrialThe New England Journal of Medicine, 2005
- Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma PreventionThe New England Journal of Medicine, 2005
- Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac SurgeryThe New England Journal of Medicine, 2005
- Accuracy of medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital recordsAmerican Heart Journal, 2004
- Quantitative Methods in PharmacovigilanceDrug Safety, 2003
- Dietary Fat Intake and the Risk of Coronary Heart Disease in WomenThe New England Journal of Medicine, 1997
- Decline in the Risk of Myocardial Infarction among Women Who Stop SmokingThe New England Journal of Medicine, 1990