Endocrine Abstracts

Objective: Objective to study the hypolipidemic efficacy, hepatoprotective activity, and tolerance of the fixed-dose combination of essential phospholipids with methionine (EPL+M) - Eslidine in the combination therapy with A in patients (pts) with cardiovascular diseases (CVD) and type 2 DM who suffer from hyperlipidemia (HL) in order to optimize their treatment in daily clinical practice.

Subjects and methods: The trial enrolled 60 pts (mean age 58.1±4.5 years) with type 2 DM. All the pts had essential hypertension, 84.8% were obese; 80% had increased echogenicity in the liver and its enlargement, as evidenced by ultrasound study. The patients received standard therapy appropriate for this disease, other than agents affecting blood cholesterol (Ch) levels. After adherence to a hypolipidemic diet for 2 weeks, the pts were randomized to two groups: i) 30 pts received A in a dose of 20 mg/day; 2) 30 pts had the drug in the same dose in combination with Eslidine (EPL+M). The therapy duration was 12 weeks. The impact of therapy on lipid, lipoproteins, hepatic enzymes.

Results: After 12 weeks, the group of pts receiving A showed a significant reduction in the levels of total Ch by 42.4%, LDL-Ch by 44.9%, and TG by 45.4%; in the A+ Eslidine group, these indicators decreased by 37.8, 47.9, and 26.4%, respectively. By the end of a course of therapy, the number of pts with LDL-Ch goals was 26.9 and 36.4% in Groups 1 and 2, respectively. In the pts with significant hypercholesterolemia (LDL-Ch ≥4.2 mmol/l), the LDL-Ch decline was 46.9 and 54.6% in those on A and A+Eslidine, respectively (P<0.05); in the pts with elevated TG levels (1.7 mmol/l or higher), the fall was 36.2 and 47.2%, respectively (P<0.05). A caused a 47% increase in ALT activity (P<0.05), without exceeding the upper normal range. In the pts on therapy A+ Eslidine, the activity of ALT was, on the contrary, unchanged, there was a significant decrease in total bilirubin concentrations, glutamyl transpeptidase activity, and bile acid levels.

Conclusion: A 20 mg/day and its combination with Eslidine showed a good hypolipidemic efficacy and tolerability in hyperlipidemic pts with CVD and type 2 DM. Addition of Eslidine to statin therapy resulted in a more reduction in LDL-Ch and TG levels and noticeably improved hepatic functional activity.