Comparative efficacy assessment for various insulin regimens in patients with type 2 diabetes mellitus, ischaemic heart disease and frequent hypoglycemic events

Abstract

Aims. To study influence of combined treatment with human insulin analogues (insulin aspart and insulin detemir) on glycemic control,insulin resistance and development of ischaemic heart disease (IHD) in patients with type 2 diabetes mellitus (T2DM) and frequenthypoglycemic events in comparison with that of human insulins (soluble and isophane). Materials and methods. 54 patients (mean age 61.2?0.7) with T2DM and IHD participated in this study. All included patients experiencedfrequent mild and moderate hypoglycemic events (3+ episodes per week). We analyzed frequency and severity of hypoglycemia,parameters of glycemic and lipid metabolism, number of ischaemic episodes per day, duration and depth of ST depression, circadianindex, incidence of different types of arrhythmia and conduction abnormalities as measured by Holter ECG monitoring.All patients were subdivided into two groups by random sampling: 21 patient (first group) carried on with human soluble insulin andisophane in an optimized basal-bolus regimen. In 33 patients, comprising second group, treatment was changed for combination ofinsulin aspart (NovoRapid?, Novo Nordisk, Denmark) and insulin detemir (Levemir?, Novo Nordisk, Denmark). Follow-up periodwas set to 6 months. Results. In patients with frequent hypoglycemic experience different types of arrhythmia and heart conduction abnormalities wereobserved in 75.9% of cases. Most patients had complex types of arrhythmic disorders (70.4%) with ventricular extrasystole being themost common one. Signs of myocardial ischaemia were registered in 48.1% of patients.After 6 months of follow-up patients from the second group demonstrated a statistically significant decrease in fasting and postprandiallevels of glycemia (p=0.000001). Both groups also had a significantly lower rate of hypoglycemic events. Moreover, in the second groupall episodes of hypoglycemia were mild and occurred only in 36.4% of cases. Additionally, after 6 months of treatment with humaninsulin analogues ventricular extrasystoles were registered only in 24.2% of patients, while rate and duration of ischaemic episodesdropped to 4.25?1.51 (p=0.012, comparing with first group). Conclusion. Treatment with human insulin analogues NovoRapid? and Levemir? is associated with 1.6% decrease in HbA1c levels.Mild hypoglycemia was 72.2% less frequent, as compared with rates in the group on human soluble and isophane insulin, while moderateand severe hypoglycemic events were not observed at all. In turn, decrease in frequency and severity of hypoglycemia was associatedwith substantial improvement in cardiovascular status due to lower number and duration of ischaemic episodes (including painlessvariant) and lower frequency of heart rhythm disorders.

Keywords

• diabetes mellitus type 2
• hypoglycemia
• ischaemic heart disease
• insulin analogues