Hospitalisation Due to Heart Failure with Gliptins and Universal Label Change (FDA)-Still Justified? A Meta-Analysis of 5 Cardiovascular Outcomes Trials

Introduction: The addition of gliptins in the management of type 2 diabetes was a welcome addition due to its neutral impact on weight and lower risk of hypoglycemia in addition to moderate anti-hyperglycemic effects. They were also the first anti-hyperglycemic group exposed to the scrutiny of cardiovascular safety assessed through cardiovascular outcomes trial. The disparate signals emanating from the different CVOTs along with recent FDA label change (hospitalisation due to heart failure), prompted us in performing this meta-analysis.Materials and methods: After conducting an extensive database search, we selected 5 CVOTs for this metaanalysis based on a pre-specified set of inclusion criteria. Sufficient caution was exercised in analyzing data heterogeneity and detecting publication bias.Results: The meta-analysis of the 5 CVOTs with respect to hospitalization due to heart failure resulted in a risk ratio of 1.013 with a 95% CI of 0.857-1.197. The effect size analysed with the random effect model was statistically non-significant (P=0.879).Conclusion: This meta-analysis did not find a statistically significant increased risk for hHF in patients with high cardiovascular risk while on a gliptin.