Table 2: Trial and baseline patient comorbidities and medications for RCTs with primary cardiovascular outcomes*
Trial nameSAVOR-TIMI 53EXAMINETECOS
Trial characteristics
DPP-4 InhibitorSaxagliptinAlogliptinSitagliptin
Number of patients16 492538014 724
Enrolment periodOctober 2009-March 2013May 2010-December 2011December 2008-July 2012
Median follow-up (yr)2.11.53.0
Main inclusion criteria
A1C6.5%-12.0%6.5%-11.0%
(7%-11% if on insulin)		6.5%-8.0%
ClinicalEstablished CV disease or age > 55/60 (male/female)
and one other CV risk factor		ACS in previous 15-90 dEstablished CV disease and ≥ 50 years old
Patient comorbidities
Hypertension, %818386
Dyslipidemia, %71n/r77
Current smoker, %131411
Prior MI, %3888†43
Prior PCI, %2763†39
Prior CABG, %2413†25
Heart failure, %132818
Atrial fibrillation, %7n/r8 (incl. AFlutter)
Stroke, %13717 (+4% TIA)
Peripheral arterial disease, %121017
eGFR (mL/min/1.73 m2)73
(excluded dialysis)		71
(excluded dialysis)		75 (excluded < 30)
Medications
ASA, %759179
Any anti-platelet, %81n/r (80% thienopyridine)n/r (22% clopidogrel/ticlopidine, 7% vit K antagonist)
Statin, %789080
ACE Inhibitor/ARB, %79 (total)82 (total)79
Beta-blocker, %618264
Other antihypertensive agents, %4122 CCB
37 diuretic		34 CCB
41 diuretic

Note: ACE = angiotensin converting enzyme, ACS = acute coronary syndrome, ARB = angiotensin receptor blocker, Aflutter = atrial flutter, ASA = acetylsalicylic acid, CABG = coronary artery bypass grafting, CAD = coronary artery disease, CCB = calcium channel blocker, CV = cardiovascular; eGFR = estimated glomerular filtration rate, MI = myocardial infarction, n = number of patients, n/r = not reported, PCI = percutaneous coronary intervention, RCT = randomized controlled trial, TIA = transient ischemic attack, vit = vitamin.

*The 3 trials used virtually identical heart failure definitions: patients were required to be admitted to hospital or have an emergency department visit of more than 12 hours with clinical manifestations of heart failure, defined as at least 1 of new or worsening dyspnea, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema, bibasilar rales on pulmonary examination, jugular venous distention, new third heart sound, or radiographic evidence of heart failure; and receive at least 1 of intravenous treatment with a diuretic, inotrope, or vasodilator therapy, ultrafiltration or dialysis, or mechanical or surgical intervention (including heart transplant) specifically directed as treatment for their heart failure. The other smaller RCTs did not provide definitions, or specify whether the patients with heart failure required hospital admission or whether this outcome was subject to blinded adjudication.

†Includes index event before enrolment.