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Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case–control study in Italy.

ABSTRACT: PURPOSE: There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case–control approach to address these major methodological limitations. METHODS: A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006–2007 was enrolled and followed-up throughout 2009. Exposure was defined as adherence to each drug in terms of the proportion of days covered (cutoff???75%). Composite treatment groups, that is, groups with no EB therapy or therapy with one, two, three, or four EB drugs), were analyzed. Outcomes were overall mortality and reinfarction. Nested case–control studies were performed for both outcomes, matching four controls to every case (841 deaths, 778 reinfarctions) by gender, age, and individual follow-up. The association between exposure to EB drug therapy and outcomes was analyzed using conditional logistic regression, adjusting for revascularization procedures, comorbidities, duration of index admission, and use of the study drugs prior to admission. RESULTS: Mortality and reinfarction risk decreased with the use of an increasing number of EB drugs. Combinations of two or more EB drugs were associated with a significant protective effect (p?

SUBMITTER: Kirchmayer U

PROVIDER: S-EPMC3746119 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case–control study in Italy.

Kirchmayer Ursula U Di Martino Mirko M Agabiti Nera N Bauleo Lisa L Fusco Danilo D Belleudi Valeria V Arcà Massimo M Pinnarelli Luigi L Perucci Carlo Alberto CA Davoli Marina M

Pharmacoepidemiology and drug safety 20130601 6

<h4>Purpose</h4>There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case–control approach to address these major methodological limitations.<h4>Methods</h4>A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006–2007 was enrolled and followed-up throughout 2009. Exposure was defi ...[more]

PMID: 23529919

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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

Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case–control study in Italy.

Publications

Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case–control study in Italy.

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