A secondary analysis of the TECOS trial affirms sitagliptin does not raise heart collapse threat for patients along with kind 2 diabetes.
Previous trial outcomes have actually advised that dipeptidyl peptidase 4 inhibitor (DPP-4) usage could raise heart collapse (HF) threat in kind 2 diabetes mellitus (T2DM). The DPP-4 inhibitor sitagliptin has actually been revealed to be noninferior to placebo along with regard to primary and secondary composite atherosclerotic cardio (CV) outcomes in the Trial Analyzing cardio Outcomes along with Sitagliptin (TECOS).
The secondary analysis was provided to assess the organization of sitagliptin usage along with hospitalization for HF (hHF) and related outcomes.
TECOS was a randomized, double-blind, placebo-controlled study Analyzing the CV security of sitagliptin vs placebo, every included to usual antihyperglycemic procedure and CV treatment among patients along with T2DM and widespread atherosclerotic vascular disease. The median follow-up was 2.9 years. The specifying was 673 web sites in 38 countries. Participants included 14,671 patients along with T2DM and atherosclerotic vascular disease. The study dates were December 2008 with March 2015.
Patients were randomized to sitagliptin vs placebo included to standard care. Pre-stated secondary analyses compared the effect about hHF, hHF or CV death, and hHF or all-trigger death composite outcomes total and in prespecified subgroups. Supportive analyses included complete hHF occasions (initial plus recurrent) and post-hHF death. Meta-analyses evaluated DPP4i effects about hHF and about hHF or CV death.
Based about the outcomes from 14,671 patients, 7,332 were randomized to sitagliptin and 7,339 to placebo and mentioned that hospitalization for HF taken place in 3.1% (n = 228) and 3.1% (n = 229) of the sitagliptin and placebo groups, respectively. There was additionally no distinction in complete hHF occasions in between the sitagliptin (n = 345) and placebo (n = 347) teams (unadjusted hazard ratio, 1.00; 95% CI, 0.80-1.25). Post-hHF all-trigger death was comparable in the sitagliptin and placebo teams (29.8% vs 28.8%, respectively), as was CV death (22.4% vs 23.1%, respectively). No heterogeneity for the effect of sitagliptin about hHF was observed in subgroup analyses across 21 factors (P > .10 for all of interactions). Meta-analysis of the hHF outcomes from the 3 mentioned DPP4i CV outcomes trials revealed moderate heterogeneity (I2 = 44.9, P = .16).
The outcomes of the present analyses demonstrate that sitagliptin usage did not impact the threat for hHF or related edge medical outcomes, total or across decided on subgroups of interest. In the context of the primary findings from TECOS that shown noninferiority of the effects of sitagliptin vs placebo about significant atherosclerotic edge CV events, the present outcomes offer further Assist that sitagliptin might be safely maximized in a population of patients along with T2DM at higher CV risk.
Practice Pearls:
- This randomized, placebo-controlled medical trial included 14,671 grownups along with kind 2 diabetes mellitus and widespread atherosclerotic vascular disease.
- In secondary analyses, over a median follow-up of 2.9 years, there were no substantial distinctions in between sitagliptin vs placebo for the threat of hospitalization for heart collapse (3.1% vs 3.1%, respectively) or for the composite of hospitalization for heart collapse or cardio death (7.3% vs 7.2%, respectively).
- Sitagliptin usage has actually a neutral effect about hospitalization for heart collapse threat in patients along with kind 2 diabetes mellitus at higher cardio risk.
McGuire DK, et al. JAMA Cardiol. 2016;doi:10.1001/jamacardio.2016.0103; ENDO 2016: The Endocrine Society Annual Meeting
