Mortality in diabetic patients with ACS is 2-3 times higher than in non-diabetics. Hyperglycemia adds to an already-poor prognosis. Vildagliptin, an oral anti-diabetic drug of the DPP4 inhibitor class, prevents breakdown of endogenous GLP1 and has been shown to reduce hyperglycemia in T2DM. We studied Vildagliptin for improved glucose levels control and clinical outcome of ACS in diabetics.
58 T2DM adult patients naïve to DPP4 Inhibitors were enrolled when admitted to ICCU with ACS diagnosis. Metformin was discontinued during hospitalization and patients divided into two groups in a randomized controlled manner. Control group received SC Insulin injections to control blood glucose values below 140 mg/dl or 180 mg/dl postprandial. Study group received SC Insulin and Vildagliptin with the same target. GFR > 50 ml/min patients received Vildagliptin 50mg x 2/day; GFR < 50 ml/min received 1/day. Blood glucose values, measured every 4 hours, were corrected with SC Insulin.
Data was documented for each measuring, mean glucose values per hospitalization day, insulin values given for correction (I.U.s) and any hypoglycemic events.
Power analysis showed power 70% and effect size 0.35 for current sample size. Preliminary tendencies depict lower mean±SD glucose levels during hospitalization in study group than controls, 159.40±30.87 mg/dl vs. 172.2±40.8 mg/dl respectively. Two severe hypoglycemia (Glucose< 40mg/dl ) documented in the Insulin arm translates to 7.41% vs. 0% probability of hypoglycemic event in control vs. study group.
In T2DM patients hospitalized for ACS, addition of Vildagliptin showed lower mean blood glucose values than in patients receiving only insulin. Lower dosage of insulin (I.U.s) was needed for correction of blood glucose values among study group patients, as compared to controls. These lower glucose values were achieved with no hypoglycemia using Vildagliptin and may address the unmet need in T2DM ACS patients
Patient recruitment is ongoing; data will be presented.
