IMIM - Institut Hospital del Mar d'Investigacions Mèdiques

Agenda

16/12/2015

"Risc d'infart de miocardi i l´ús de medicaments antiinflamatoris no esteroides (NSAID's): la contribució de 15 anys d'investigació en epidemiologia" a càrrec de la Dra. Cristina Varas

Sala Xipre (173.06-1a planta IMIM) a les 15:00 hores

En el marc de les sessions d'Epidemiologia i Salut Pública de l'IMIM, el proper dia 16 de desembre a les 15:00 h tindrà lloc a la Sala Xipre, la sessió "Risc d'infart de miocardi i l´ús de medicaments antiinflamatoris no esteroides (NSAID's): la contribució de 15 anys d'investigació en epidemiologia” a càrrec de la Dra. Cristina Varas, directora sènior en Epidemiologia a RTI Health Solutions.

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Abstract en anglès

In 2000, the VIGOR clinical trial found a five-fold increased risk of acute myocardial infarction (AMI) in patients randomized to rofecoxib versus those on naproxen, triggering patient safety concerns and regulatory reviews and actions.

Objective: To summarize the risk of AMI associated with NSAIDs evaluated in epidemiology studies conducted in different study populations and periods, using mostly information collected in automated health research databases from Europe and North America.

Methods: Will present six studies, including a meta-analysis of published observational studies. Adjusted relative risks (ARR, 95%CIs) of AMI were estimated for current use of NSAIDs compared with non-NSAID in each study. The Safety of NSAIDs (SOS) project (http://www.sos-nsaids-project.org), funded by the European Commission included a nested case-control study in a new NSAID user cohort from six European healthcare datasources. Meta-analytic odds ratio (OR) was used to summarize adjusted effect estimates in multisite studies and in meta-analysis of published studies.

Main Results: In 2000, we reported that current use of overall traditional NSAIDs was not associated with any beneficial effect on the risk of AMI, ARR [95%CI] =1.45 [1.18-1.79] in a cohort of women aged 50-74 years without history of cardiovascular disease in CPRD, UK. We also performed two cohort studies (one in CPRD before coxibs were available and the other in Saskatchewan, Canada, which included coxib users) including men and women. A modest increased risk of AMI with various traditional NSAIDs and COX-2 inhibitors, ARR 1.11 [0.84–1.47] for celecoxib and 1.32 [0.91–1.90] for rofecoxib were seen. In a multi-country (Medicare, US, Saskatchewan, and CPRD) cohort study of patients with recent hospitalization for acute coronary syndrome or coronary revascularizations, the risk of AMI relative to NSAID nonusers was higher for short term use of ibuprofen 1.67 [1.09- 2.57], diclofenac 1.86 [1.18-2.92], celecoxib 1.37 [0.96 -1.94]), and rofecoxib 1.46 [1.03-2.07], but not for naproxen 0.88 [0.50 to 1.55]. The systematic literature review up to May 4, 2011 with a meta-analysis of 18 independent study populations, supported the variability in the risk of AMI associated with current use of the most frequently used NSAIDs in comparison with nonuse. Low and high doses of diclofenac and rofecoxib were associated with high risk of AMI, with dose-response relationship for rofecoxib. In the SOS nested case-control analysis of 79,553 AMI cases from a cohort of 8.5 million new NSAID users estimated the risk of AMI relative to past use of NSAIDs for 28 individual NSAIDs, being highest for ketorolac 1.80 [1.49-2.18] followed by indometacin, etoricoxib, rofecoxib, diclofenac, piroxicam, ibuprofen, naproxen, celecoxib, meloxicam, nimesulide and ketoprofen.

Conclusion: The risk of AMI varies across individual NSAIDs in different study populations. The increased risk of AMI should not be considered an effect of selective COX-2 inhibitors only.

CV breu

Cristina Varas Lorenzo, MD, PhD (Universitat de Barcelona) va fer la seva formació mèdica a cardiologia a l'Hospital de Sant Pau (Barcelona, 1988). Va aconseguir el grau de MSc a l'Escola de Salut Pública, a la Universitat de Texas Health Science Center a Houston (1992). La Dra.

Varas té gairebé 30 anys d'experiència en recerca centrada en epidemiologia i prevenció de malalties cardiovasculars implementant enquestes de població, registres, i estudis de camp i de bases de dades automatitzades. Aquesta experiència inclou les seves contribucions al Estudi Manresa, Projecte Cor Corpus Christi, la vigilància del WHO-MONICA a Catalunya i l'enquesta EUROASPIRE. La seva experiència també inclou 10 anys en companyies multinacionals farmacèutiques, on dirigia i avaluava programes de recerca per a la seguretat, la gestió de riscos, desenvolupament i activitats reguladores aplicant mètodes de salut pública i epidemiològica, liderant la seguretat cardiovascular i l'estratègia de l'epidemiologia. Al 2007 es va unir a RTI Health Solutions, RTI International, a Barcelona on és actualmente directora sénior en epidemiologia.

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