Key result
Alogliptin did not significantly increase the risk of major adverse cardiovascular events compared to placebo or active comparators in type 2 diabetes (HR 0.635; 95% CI 0.0-1.41).
Why the study?
Does alogliptin increase the risk of composite major adverse cardiovascular events in patients with type 2 diabetes mellitus?
Meta-Analysis (n=6,028)
Blinded adjudication
Does alogliptin increase the risk of composite major adverse cardiovascular events in patients with type 2 diabetes mellitus?
A pooled analysis of the alogliptin clinical trial database demonstrated no signal of increased cardiovascular risk compared to placebo or active comparators in patients with type 2 diabetes mellitus.
Answers are grounded in this paper and cite their sources.
Supports alogliptin cardiovascular safety in type 2 diabetes; confirms pooled trial evidence without new MACE signals.
AIM: As there have been concerns that some classes or agents for the treatment of type 2 diabetes may increase CV risk, we evaluated the cardiovascular profile of the dipeptidyl peptidase-4 inhibitor alogliptin. METHODS: We evaluated the incidence of CV events in patients treated with alogliptin, placebo or comparator antihyperglycaemic drugs in the clinical trial database for alogliptin using the composite major adverse cardiovascular event (MACE) endpoints of CV death, non-fatal myocardial infarction and non-fatal stroke. RESULTS: The pooled analysis included 4168 patients exposed to alogliptin 12.5 and 25 mg daily for 2023 patient-years compared to 691 patients treated with placebo for 263 patient-years and 1169 patients treated with other antidiabetic agents (metformin, sulfonylureas and thiazolidinediones) for 703 patient-years. CV events were adjudicated by an expert endpoint committee blinded to treatment allocation. The incidence rates of the combined MACE were not significantly different between patients treated with alogliptin and comparator therapies (hazard ratio=0.635, 95% confidence interval, 0.0, 1.41). Additionally, other types of serious CV events were not significantly different between patients treated with alogliptin and comparator therapies. CONCLUSION: These analyses have not shown a signal of increased CV risk with alogliptin in patients with type 2 diabetes. Future results from the adequately powered EXAMINE trial will definitively assess the CV safety profile of aloglipin in patients with type 2 diabetes mellitus.
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White et al. (2013) conducted a meta-analysis in Type 2 diabetes mellitus (n=6,028). Alogliptin vs. Placebo or other antidiabetic agents (metformin, sulfonylureas, and thiazolidinediones) was evaluated on Composite major adverse cardiovascular event (MACE) of CV death, non-fatal myocardial infarction and non-fatal stroke (HR 0.635, 95% CI 0.0-1.41). Alogliptin did not significantly increase the risk of major adverse cardiovascular events compared to placebo or active comparators in type 2 diabetes (HR 0.635; 95% CI 0.0-1.41).
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