A Call for More Complete Reporting of Cardiovascular Death
Abstract
ardiovascular (CV) death is frequently used as part of composite end points in major clinical trials, such as 3-point major adverse CV events or CV death + heart failure hospitalization.However, it is important to recall that CV death is a composite end point in and of itself.Although the aggregate is frequently reported as a secondary end point, it is somewhat unusual for the individual elements of CV death to be similarly reported.This lack of clarity can make interpretation of data more difficult.A case in point is the reporting of CV death in the major CV outcomes trials for the sodium glucose transporter-2 inhibitors.The 5 major outcomes trials published to date for this class are the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) 1 investigating empagliflozin; the CANVAS trial program (Canagliflozin Cardiovascular Assessment Study), 2 with data from the CANVAS and CANVAS-R (A Study of the Effects of Canagliflozin [JNJ-28431754] on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) trials investigating canagliflozin presented in an integrated fashion; the DECLARE-TIMI 58 trial (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events) 3 investigating dapagliflozin; and, most recently, the CRE-DENCE trial (Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy) 4…
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