Dolgosrochnaya bezopasnost' i effektivnost' insulina aspart u patsientov s sakharnym diabetom 1 tipa

This article presents the results of an open multicenter study aimed to the assessment of long-term safety and efficacy of insulin aspart (lAsp) in basal-bolus regimen with NPH insulin. The study involved 72 patients with type 1 diabetes mellitus. More than half of the patients have received lAsp for 1,9-3,8 years, and 19 % - more than 3,8 years. As a result, the rate of hypoglycemic episodes was lower in the extension study (15.9 minor and 0.1 major episodes/year of exposure) than in the original study (22,4 minor and 0,2 major episodes/ year of exposure). In total, 41 (57 %) patients reported 132 adverse events. Mean HbA1c level during the extension phase decreased from 8,11 to 7,87 %; average 24-hour blood glucose (BG) was unaltered (8,1 mmol/L); the average prandial BG increments and mean BG range during the day were lower at the end of the extension study. Thus, long-term treatment with lAsp as prandial insulin in basal-bolus regimen with NPH insulin is well tolerated and provides long-term safety and efficacy.

insulin aspart, type 1 diabetes mellitus, efficacy, safety