The cardiovascular (CV) safety of alogliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor indicated for the treatment of type 2 diabetes mellitus (T2DM) patients, has been assessed in the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study [1,2].
T2DM patients are at increased risk of heart failure (HF), and biomarkers such as B-type natriuretic peptide (BNP) and the N-terminal part of the precursor molecule proBNP (NT-proBNP) have prognostic value with regard to HF and major CV events [3,4]. In this analysis of the EXAMINE study, the prognostic implications of changes in natriuretic peptide concentration over time were assessed, in patients with T2DM and ischemic heart disease. Moreover, the changes in BNP and NT-proBNP with alogliptin were evaluated.
EXAMINE was a double-blind, placebo-controlled, non-inferiority trial that recruited 5,380 T2DM patients with a recent acute coronary syndrome (ACS), who were randomized to receive either alogliptin or placebo. Median follow-up in EXAMINE was 597 days (IQR: 361–792 days). The primary end point was the composite of CV death, non-fatal myocardial infarction, or non-fatal stroke. For this analysis, the main endpoints of interest were CV death or hospitalization for HF.
In T2DM patients with a recent ACS, NT-proBNP concentrations at baseline and at 6 months identified those at high risk for adverse CV outcomes, including HF. Absolute and categorical increases of NT-proBNP levels between baseline and 6 months were associated with adverse CV outcomes. These data point at the potential value of serial monitoring of natriuretic peptides in patients with T2DM to identify those at high risk for CV events, including HF, potentially to give them specific treatment to lower this risk.
1. White WB, Bakris GL, Bergenstal RM, et al. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J 2011;162:620–626.e1
2. White WB, Cannon CP, Heller SR, et al.; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013;369:1327–1335
3. Maisel AS, Krishnaswamy P, Nowak RM, et al.; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med 2002;347:161–167
4. Morrow DA, de Lemos JA, Blazing MA, et al.; Investigators. Prognostic value of serial B-type natriuretic peptide testing during follow-up of patients with unstable coronary artery disease. JAMA 2005;294:2866–2871.
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