title: The importance of high-quality evidence of the long-term impact of nonfatal events used in randomized controlled trials: a case study of prasugrel.
abstract: Randomized controlled trials (RCTs) are the centerpiece of evidence-based medicine. However, because of the limited follow-up, additional evidence on the long-term consequences of the outcomes used in trials is commonly required for clinical and policy decision making. This article provides insights into the importance and challenges of using such evidence through the case study of nonfatal myocardial infarction (MI) and nonfatal bleeding with prasugrel.
authors.affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA. christine_lu@harvardpilgrim.org
authors.forename: C Y
authors.initials: CY
authors.lastname: Lu
authors.forename: J
authors.initials: J
authors.lastname: Karnon
authors.forename: M J
authors.initials: MJ
authors.lastname: Sorich
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D019317:Evidence-Based Medicine; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D009203:Myocardial Infarction / Q000139:chemically induced; D010879:Piperazines / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D000068799:Prasugrel Hydrochloride; D016032:Randomized Controlled Trials as Topic / Q000401:mortality* / Q000706:statistics & numerical data*; D012107:Research Design; D009626:Terminology as Topic; D013876:Thiophenes / Q000009:adverse effects*
chemical_list: D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D000068799:Prasugrel Hydrochloride