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CardioExchange\u2019s John Ryan<\/b> interviews Stuart J. Connolly<\/b> about his research group\u2019s analysis of data from the manufacturer-funded RE-LY trial. <\/i>The study, published in <\/i>JACC,<\/a> showed that the risk for ischemic events was inversely related to trough plasma concentrations of dabigatran and that the risk for major bleeding increased with dabigatran exposure.<\/i><\/p>\n Ryan:<\/i> Your study convincingly shows the relationship between dabigatran plasma-concentration levels and risk-benefit for patients with atrial fibrillation. Should we be dosing according to those levels? <\/b><\/p>\n Connolly:<\/i><\/b> The relationship between plasma concentration and outcomes is most convincing for bleeding. There is some reason to consider that measuring a trough plasma concentration after starting therapy would be useful in reducing bleeding risk, perhaps with a target concentration <250 ng\/mL. However, this has not been demonstrated in a prospective study. We currently have no clinically available way to measure the levels. A prospective trial would be best.<\/p>\n Ryan:<\/i> You find that many factors predicted levels. Do they reflect who was taking the medication regularly or differences in patient factors?<\/b>
\nConnolly: <\/i><\/b>Quite a lot of variation in plasma concentration is unexplained, although we know that renal function is very predictive of concentrations. A few other factors, such as concomitant medication, also have some effect on levels.<\/p>\n