Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2
diabetes mellitus.
Author(s): White WB(1), Pratley R, Fleck P, Munsaka M, Hisada M, Wilson C, Menon V.
Affiliation(s): Author information:
(1)Calhoun Cardiology Center, University of Connecticut School of Medicine,
Farmington, CT 06030, USA. wwhite@nso1.uchc.edu
Publication date & source: 2013, Diabetes Obes Metab. , 15(7):668-73
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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