EXAMINE: alogliptin does not increase cardiovascular risk in diabetic patients with ACS
EXAMINE: EXamination of CArdiovascular OutcoMes with AlogliptIN versus Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
Presented at the ESC congress 2013 by: William B WHITE (Farmington, US)
BackgroundThe Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) was set up as a non-inferiority study to exclude that the diabetic drug alogliptin gives an increased cardiovascular risk. The EXAMINE study therefore evaluated the cardiovascular outcomes of the DPP-4 inhibitor alogliptin once daily, in comparison with placebo, in addition to standard care, in patients with type 2 diabetes mellitus and acute coronary syndrome.
- After a mean follow-up of 18 months, alogliptin gave comparable primary endpoint rates to placebo, which was a composite endpoint of cardiovascular death, myocardial infarct and stroke (11.3% vs. 11.8%, P<0.001 for non-inferiority).
- Non-inferiority was seen for all endpoints, including the secondary endpoint, all CV mortality and all-cause mortality.
- At the end of the study duration HbA1c levels were significantly lower after treatment with alogliptin, as compared to placebo (mean change from baseline: -0.36% with alogliptin vs. +0.03% with placebo)
- No differences were seen between treatment groups with regard to the incidence of hypoglycaemia, reported malignancies (including pancreas cancer) and renal function.
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ConclusionThis is the first study into the cardiovascular safety of an anti-diabetic agent in patients with acute coronary syndrome. It is reassuring that patients with an increased CV risk, like those who recently underwent ACS, can use alogliptin without it causing a higher risk of CV morbidity and mortality.
In the panel discussion at the ESC congress it was remarked that the observed lowered blood glucose levels might induce a lower risk in the long run.