The TECOS study [Green JB et al. New Eng J Med. 2015] was a large randomized placebo-controlled trial conducted in patients with type 2 diabetes mellitus (T2DM) and prevalent cardiovascular (CV) disease. Frans Van de Werf, MD, PhD, University of Leuven, Leuven, Belgium, presented the results of a prespecified secondary analysis from this trial.

The objective of the TECOS study was to evaluate CV risk with sitagliptin added to usual care. For the primary composite end point of CV death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina, sitagliptin was noninferior to placebo for CV risk (HR, 0.98; 95% CI, 0.88 to 1.09; P < .001).

Patients with T2DM and atherosclerosis are at an increased risk of hospitalization for heart failure (HF). Two large clinical trials have suggested that dipeptidyl peptidase-44 inhibitors could increase HF hospitalizations: saxagliptin in the SAVOR-TIMI 53 trial [Scirica BM et al. New Eng J Med. 2013] and alogliptin in the EXAMINE trial [White WB et al. New Eng J Med. 2013]. A prespecified secondary analysis of TECOS investigated the potential effects of sitagliptin on hospitalization for HF and associated outcomes in the study population and selected subgroups.

Of the 14 671 patients enrolled in TECOS, 457 (3.1%) had a hospitalization for HF during the study. Baseline characteristics for these 2 groups are presented in Table 1. There was no significant difference between sitagliptin and placebo in the time to first hospitalization for HF (HR, 1.00; 95% CI, 0.84 to 1.20; P = .95). In addition, no significant risk was noted in selected subgroups of age, sex, body mass index, diabetes duration, HbA_1c, insulin use, renal function, prior coronary artery disease, prior HF, and HF severity.

There were also no significant differences in other HF-related outcomes, such as hospitalization for HF or CV death (HR, 1.02; 95% CI, 0.90 to 1.14; P = .81), hospitalization for HF or all-cause death (HR, 1.00; 95% CI, 0.90 to 1.11; P = .93), and total hospitalization for HF events (first plus recurrent; HR, 1.00; 95% CI, 0.80 to 1.25; P = .996). In terms of HF-related outcomes in patients with prior HF at baseline (sitagliptin, n = 1303; placebo, n = 1340), there were no significant differences between treatment groups in hospitalization for HF (HR, 1.03; 95% CI, 0.77 to 1.36; P = .86), CV death (HR, 0.91; 95% CI, 0.71 to 1.17; P = .46), hospitalization for HF or CV death (HR, 0.96; 95% CI, 0.79 to 1.18; P = .71), or all-cause death (HR, 0.92; 95% CI, 0.75 to 1.14; P = .46).

Dr Van de Werf concluded that this prespecified analysis of the TECOS database does not suggest an increased risk of HF or related adverse events with sitagliptin in patients with T2DM and prevalent CV disease. These findings support the use of sitagliptin in these patients without concerns of worsening HF.