Dataset Information

Myocardial Infarction and Its Association with the Use of Nonselective NSAIDs: A Nested Case-Control and Time-to-Event Analysis.

ABSTRACT: In April 2005, the US Food and Drug Administration issued a public health advisory warning to health care clinicians about the cardiovascular (CV) safety of nonsteroidal anti-inflammatory drugs (NSAIDs). Although the warning about cyclooxygenase-2 selective NSAIDs was anticipated, little data exists about the CV safety of nonselective NSAIDs. We analyzed data from a group of NSAID users to determine if specific nonselective agents were associated with an increased risk of myocardial infarctions (MIs) and sudden cardiac death (SCD).A nested case-control design was used to study NSAID users ages 18 to 84 years. Cases were defined by a hospital admission for MI or an out-of-hospital SCD. Study control subjects were matched for age, sex, current Kaiser Permanente membership, and geographic location (Northern or Southern California). Odds ratios (OR) were estimated using conditional logistic regression.Our base population included 1,394,764 NSAID users. From this population we identified 8143 cases and 31,496 matched study control subjects. The median time to event was <100 days for all NSAIDs. Two nonselective NSAIDs were associated with increased odds of adverse CV outcomes: indomethacin (OR, 1.27; 95% confidence interval, 1.04-1.56) and naproxen (OR, 1.14; 95% confidence interval, 1.00-1.30).Our results suggest that some nonselective NSAIDs are associated with an increased risk of MI and SCD. We found the increased risk to be small compared with the risk associated with rofecoxib. Cardiovascular events occurred early in therapy. Caution is warranted with some nonselective NSAIDs, especially those for which other studies have found evidence of risk.

SUBMITTER: Cheetham TC

PROVIDER: S-EPMC3042333 | biostudies-other | 2008

REPOSITORIES: biostudies-other

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Myocardial Infarction and Its Association with the Use of Nonselective NSAIDs: A Nested Case-Control and Time-to-Event Analysis.

Cheetham T Craig TC Graham David J DJ Campen David D Hui Rita R Spence Michele M Levy Gerald G Shoor Stanford S

The Permanente journal 20080101 1

<h4>Objective</h4>In April 2005, the US Food and Drug Administration issued a public health advisory warning to health care clinicians about the cardiovascular (CV) safety of nonsteroidal anti-inflammatory drugs (NSAIDs). Although the warning about cyclooxygenase-2 selective NSAIDs was anticipated, little data exists about the CV safety of nonselective NSAIDs. We analyzed data from a group of NSAID users to determine if specific nonselective agents were associated with an increased risk of myoca ...[more]

PMID: 21369507

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Project description:IntroductionUse of non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with an increased relative risk of acute myocardial infarction (AMI), but the label warnings refer particularly to patients with cardiovascular risk factors. The magnitude of relative AMI risk for patients with and without cardiovascular risk factors varies between studies depending on the drugs and doses studied.ObjectivesThe aim of our study was to estimate population-based relative AMI risks for individual and widely used NSAIDs, for a cumulative amount of NSAID use, and for patients with and without a prior history of cardiovascular risk factors.MethodsBased on data from the German Pharmacoepidemiological Research Database (GePaRD) of about 17 million insurance members from four statutory health insurance providers, for the years 2004-2009, a nested case-control study was conducted within a cohort of 3,476,931 new NSAID users classified into current, recent, or past users. Up to 100 controls were matched to each case by age, sex, and length of follow-up using risk set sampling. Multivariable conditional logistic regression was applied to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Duration of NSAID use was calculated by the cumulative amount of dispensed defined daily doses (DDDs), and stratified analyses were conducted for potential effect modifiers.ResultsOverall, 17,236 AMI cases were matched to 1,714,006 controls. Elevated relative AMI risks were seen for current users of fixed combinations of diclofenac with misoprostol (OR 1.76, 95% CI 1.26-2.45), indometacin (1.69, 1.22-2.35), ibuprofen (1.54, 1.43-1.65), etoricoxib (1.52, 1.24-1.87), and diclofenac (1.43, 1.34-1.52) compared with past use. A low cumulative NSAID amount was associated with a higher relative AMI risk for ibuprofen, diclofenac, and indometacin. The relative risk associated with current use of diclofenac, fixed combinations of diclofenac with misoprostol, etoricoxib, and ibuprofen was highest in the younger age group (<60 years) and similar for patients with or without major cardiovascular risk factors.ConclusionRelative AMI risk estimates differed among the 15 investigated individual NSAIDs. Diclofenac and ibuprofen, the most frequently used NSAIDs, were associated with a 40-50% increased relative risk of AMI, even for low cumulative NSAID amounts. The relative AMI risk in patients with and without cardiovascular risk factors was similarly elevated.

Dataset Information

Myocardial Infarction and Its Association with the Use of Nonselective NSAIDs: A Nested Case-Control and Time-to-Event Analysis.

Publications

Myocardial Infarction and Its Association with the Use of Nonselective NSAIDs: A Nested Case-Control and Time-to-Event Analysis.

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