A new analysis showed that patients with type 2 diabetes and cardiovascular disease with a history of heart failure could still take sitagliptin without an increased risk of cardiovascular complications. Findings from the study were presented at the European Society of Cardiology Congress 2015.
Earlier studies (SAVOR-TIMI 53 and EXAMINE) linked dipeptidyl peptidase-4 (DPP-4) inhibitors with an increased risk of heart failure. The TECOS (Trials Evaluating Cardiovascular Outcomes with Sitagliptin) study randomized 14,671 patients with type 2 diabetes and established cardiovascular disease to receive either sitagliptin or placebo in addition to their usual care and other antihyperglycemic agents when necessary. After a median follow-up of 2.9 years, sitagliptin achieved the primary endpoint of non-inferiority compared to placebo for the composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina. Also, there was no difference between the two groups in hospitalization for heart failure after adjusting for baseline heart failure status (HR: 1.00; 95% CI: 0.83–1.20).
Researchers from the University of Texas Southwestern Medical Center, in Dallas, TX, then presented unadjusted analyses based on the initial TECOS study findings. The new unadjusted results (HR 1.00, 95% CI: 0.84–1.20) and multivariable analyses (HR 1.02, 95% CI: 0.83–1.26) showed similar findings.
Study authors concluded that the incremental risk for heart failure is “no longer statistically significant when pooled in meta-analysis” with data from SAVOR TIMI 53 and EXAMINE in regards to heart failure. In analyzing heart failure in composite analyses with cardiovascular and all-cause death, and across subgroup analyses, researchers observed the “same reassuring signal of heart failure safety.”
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