title: Will personalized drugs for cardiovascular disease become an option? - Defining 'Evidence-based personalized medicine' for its implementation and future use.
abstract: It is generally accepted that the implementation of pharmacogenomics and, more broadly, personalized medicine will have to be 'evidence-based'. However, there is a lack of consensus on the level of evidence required to justify the use of pharmacogenomic testing in clinical practice. In the cardiovascular field, this lack of agreement has led to somewhat contradicting recommendations by different organizations regarding the clinical utility and use of pharmacogenomic tests or information. Here, we argue that randomized, controlled trials are paramount in order to enable and accelerate the widespread implementation of pharmacogenomics, not only to demonstrate the clinical efficacy and cost-effectiveness of such tests, but because such level of evidence is required to support the considerable changes associated with the implantation of pharmacogenomics in clinical practice.
authors.affiliation: a 1 Université de Montréal, Faculty of Pharmacy , Montreal, Canada.|b 2 Université de Montréal Beaulieu-Saucier Pharmacogenomics Center , Montreal, Canada.|c 3 Research Center, Montreal Heart Institute , Montreal, Canada.
authors.forename: Simon
authors.initials: S
authors.lastname: de Denus
authors.affiliation: b 2 Université de Montréal Beaulieu-Saucier Pharmacogenomics Center , Montreal, Canada.|c 3 Research Center, Montreal Heart Institute , Montreal, Canada.|d 4 Université de Montréal, Faculty of Medicine , Montreal, Canada , +1 514 376 3330 ; +1 514 593 2521 ; jean-claude.tardif@icm-mhi.org.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Dubé
authors.affiliation: b 2 Université de Montréal Beaulieu-Saucier Pharmacogenomics Center , Montreal, Canada.|c 3 Research Center, Montreal Heart Institute , Montreal, Canada.|d 4 Université de Montréal, Faculty of Medicine , Montreal, Canada , +1 514 376 3330 ; +1 514 593 2521 ; jean-claude.tardif@icm-mhi.org.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Tardif
mesh_terms: D002317:Cardiovascular Agents / Q000191:economics / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000191:economics; D003362:Cost-Benefit Analysis; D019317:Evidence-Based Medicine; D006801:Humans; D010597:Pharmacogenetics; D057285:Precision Medicine; D016032:Randomized Controlled Trials as Topic
chemical_list: D002317:Cardiovascular Agents
keywords: cardiovascular; clinical trial; dalcetrapib; pharmacogenomics