Abstract
BackgroundDiabetes is closely linked with coronary artery disease, either by means of direct effects of hyperglycemia, or indirectly by its frequent association with dyslipidemia. Any treatment for diabetes that has beyond the capacity of reduce glycated hemoglobin, the propensity to improve lipid profile and reduce weight will bring many benefits to patients.MethodWe compare the effects of vildagliptin with the gliclazide on lipid profile before and after a standardized meal test, on glycemic control and oxidative stress in diabetic patients using metformin without adequate glycemic control. This is a prospective study of 16 weeks with diabetic patients using metformin without adequate glycemic control. Patients were randomized to receive gliclazide 30–120 mg/day or vildagliptin 100 mg/day.Results36 patients were randomized, with no loss of follow up. Regarding the lipid profile the difference observed at the end of the study was a higher HDL level in the vildagliptin group compared with gliclazide fasting (62.3 vs. 51.3 mg/dL, p = 0.021) and postprandial (62.9 vs. 51.1 mg/dL, p = 0.015). We also observed a variation of negative weight (decrease the end compared to the beginning) of the vildagliptin and a positive (increase) in the gliclazide (−0.3 vs. +1.4 Kg, p = 0.048). The decrease in A1c was lower in the vildagliptin group compared to gliclazide (−1.7 vs.−2.3 %, P = 0.031), however there was no difference in the number of patients reaching target glycated hemoglobin <7 % (50 vs. 61.1 %, p = 0.738). Only the group of vildagliptin presented at the end of the study compared to the beginning, decreased insulin values (599.6 vs.705, 59 pg/ml, p = 0.021), glucagon (46.6 vs.65, 2 pg/ml, p = 0.004) and the marker of oxidative stress TBARS (8.0 vs. 9.0 nmol MDA/ml, p = 0.035).ConclusionVildagliptin showed some advantages in addition to metformin in relation to addition of gliclazide. Patients treated with vildagliptin had a higher HDL at the end of the study, less variance in weight, reduced insulin and glucagon as well as reduction of oxidative stress.
Highlights
Diabetes is a devastating disease that currently affects more than a billion people worldwide [1, 2]
Regarding the lipid profile the difference observed at the end of the study was a higher HDL level in the vildagliptin group compared with gliclazide fasting (62.3 vs. 51.3 mg/dL, p = 0.021) and postprandial (62.9 vs. 51.1 mg/dL, p = 0.015)
We observed a variation of negative weight of the vildagliptin and a positive in the gliclazide (−0.3 vs. +1.4 Kg, p = 0.048)
Summary
The study enrolled 36 patients, 18 randomized to Gliclazide group (mean daily dose 86.8 ± 28.1 mg) and 18 for the Vildagliptin. We observed an increase statistically significant in HDL cholesterol levels in fasting and postprandial (p = 0.021 and p = 0.015, respectively) in the Vildagliptin group (Table 2). No differences were observed between the two groups in fasting and postprandial glucose levels in pretreatment (p = 0.475 and p = 0.896, respectively) as well as post-treatment (p = 0.825 and p = 0.847). A1c showed no differences between groups in pre and post-treatment (p = 0.109 and p = 0.800 respectively) and in the number of patients reaching target glycated hemoglobin
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