The trials differ in size and, to some degree, in their target population spanning from higher to lower CV risk, with some studying only people with established CV disease (i.e. the highest CV risk population) and others a mixed population consisting of those with CV risk factors and/or previous macrovascular complications.
This trial commenced in December 2009 and completed recruitment in March 2011 of 4339 patients (mean age 62.4 years, HbA1c 8.2%, BMI 32.1 kg/m, women/men 34%/66%) with T2DM and established CV disease (62.7%) or CV risk factors.
The authors concluded that maybe gliptins have a protective effect only in earlier stages of the natural history of T2DM (i.e., in younger subjects with a short duration of disease and without an established CV disease) whereas this benefit is lost in older patients with already established CV disease [ 85].
The key inclusion criteria for the trial were that patients had established CV disease or increased risk for the development of CV disease.
In the current prospective analysis of plasma total adiponectin levels and CV mortality risk, where follow-up began at the time of blood collection, participants with established CV disease (defined as the occurrence of MI or coronary artery bypass grafting or stroke) before the diagnosis of diabetes were excluded from the present analyses [ 38, 39].
Similarly, established CV diseases were defined in the following standardized fashion.
There was a 9%% (54/591) prevalence of established CV disease which was accounted for largely by atrial fibrillation (AF) and coronary atherosclerosis (CAD).
A total of 5148 patients (73.8%) had prevalent kidney disease (defined as eGFR < 60 mL/min/1.73 m2 or macroalbuminuria [albumin-to-creatinine ratio > 300 mg/g]) and 3990 patients (57.2%) had established CV disease with increased albuminuria; these characteristics were not mutually exclusive.
Hill et al. [4] found a significant negative correlation between EPC number and the Framingham risk factor score, i.e. a crude estimate of the risk of coronary artery disease, in asymptomatic men with established CV risk factors.
Elevations were associated with established CV disease or high-risk phenotypes including T2DM.
