Table 2.

Trials assessing incident heart failure during study follow-up

Trial	Definition of new onset HF	Adjudicated results?	% new onset heart failure during trial follow-up	Specify inpatient vs. outpatient diagnosis of new HF?	Ejection fraction at HF diagnosis reported?	Natriuretic peptide at HF diagnosis reported?	Characterize HF treatment at time of new HF diagnosis?	Characterize clinical events subsequent to new HF diagnosis?
EMPA-REG OUTCOME (2015)(17,24)	Data provided on introduction of loop diuretics	Unclear if introduction of loop diuretics adjudicated	10.2%	No	No	No	No*	No
ELIXA (2015)(31)	Data provided on hospitalization for HF among patients without prior HF	HF hospitalization adjudicated	2.4%	Inpatient	No	No	No	No
EXAMINE (2013)(23,29)	Data provided on hospitalization for HF among patients without prior HF	HF hospitalization adjudicated	1.7%	Inpatient	No	No†	No‡	No
SAVOR-TIMI 53 (2013)(16,28)	Data provided on hospitalization for HF among patients without prior HF	HF hospitalization adjudicated	2.3% in saxagliptin arm; 1.7% in placebo arm§	Inpatient	No	No	No||	No
ORIGIN (2012)(32)	Data provided on hospitalization for HF in setting of baseline HF listed as trial exclusion criterion	HF hospitalization adjudicated	5.2%	Inpatient	No	No	No	No
BARI 2D (2009)(27)	Not provided	Yes	17.9%	No	No	No	No	No

Abbreviations: HF = heart failure

^*Analyses compared adjudicated and investigator-reported HF events with new initiation of loop diuretics.

^†Longitudinal NT-proBNP data provided for trial patients with and without baseline HF, but not provided at time of new onset HF event.

^‡Data regarding new initiation of loop diuretics by treatment arm in those with or without baseline HF were available.

^§Data represent 2-year study follow-up.

^||US Food and Drug Administration Advisory Committee records included information on symptoms and HF therapies at time of hospitalization for HF, but did not distinguish between event representing incident HF versus worsening of established HF.