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  • Author: Corina Ioana Bocşan x
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Cristian-Ioan Crăciun, Anca-Elena Crăciun, Adriana Rusu, Corina Ioana Bocşan, Nicolae Hâncu and Anca Dana Buzoianu

Abstract

Chronic hyperglycemia is an important cause for the development of chronic complications of diabetes, but glycemic variability has emerged in recent years as an independent contributor to diabetes-related complications. Our objective was to evaluate glycemic variability in patients with T2DM treated with insulin compared with other antidiabetic drugs. In this retrospective study, we collected 24-hour continuous glucose monitoring (CGM) recording data from 95 patients with T2DM, of which 27 treated with insulin and 68 with non-insulin treatment. We calculated and compared 16 glucose variability parameters in the insulin-treated and non-insulin treated groups. Insulin treated patients had significantly higher values of parameters describing the amplitude of glucose value fluctuations (standard deviation of glucose values, percentage coefficient of variation [%CV], and mean amplitude of glycemic excursion [MAGE], p <0.05) and time-dependent glucose variability (percentage of time with glycemic values below 70 mg/dl and continuous overall net glycemic action [CONGA] at 2, 4 and 6 hours, p <0.05). In conclusion, insulin therapy in T2DM is correlated with significantly higher glycemic variability.

Open access

Ioana Todor, Dana Muntean, Maria Neag, Corina Bocsan, Anca Buzoianu, Laurian Vlase, Daniel Leucuta, Ana-Maria Gheldiu, Adina Popa and Corina Briciu

Abstract

Objective: To analyze a potential phenotypic variation within the studied group based on the pharmacokinetic profile of atomoxetine and its active metabolite, and to further investigate the impact of CYP2D6 phenotype on atomoxetine pharmacokinetics. Methods: The study was conducted as an open-label, non-randomized clinical trial which included 43 Caucasian healthy volunteers. Each subject received a single oral dose of atomoxetine 25 mg. Subsequently, atomoxetine and 4-hydroxyatomoxetine-O-glucuronide (glucuronidated active metabolite) plasma concentrations were determined and a noncompartmental method was used to calculate the pharmacokinetic parameters of both compounds. Further on, the CYP2D6 metabolic phenotype was assessed using the area under the curve (AUC) metabolic ratio (atomoxetine/ 4-hydroxyatomoxetine-O-glucuronide) and specific statistical tests (Lilliefors (Kolgomorov-Smirnov) and Anderson-Darling test). The phenotypic differences in atomoxetine disposition were identified based on the pharmacokinetic profile of the parent drug and its metabolite. Results: The statistical analysis revealed that the AUC metabolic ratio data set did not follow a normal distribution. As a result, two different phenotypes were identified, respectively the poor metabolizer (PM) group which included 3 individuals and the extensive metabolizer (EM) group which comprised the remaining 40 subjects. Also, it was demonstrated that the metabolic phenotype significantly influenced atomoxetine pharmacokinetics, as PMs presented a 4.5-fold higher exposure to the parent drug and a 3.2-fold lower exposure to its metabolite in comparison to EMs. Conclusions: The pharmacokinetic and statistical analysis emphasized the existence of 2 metabolic phenotypes: EMs and PMs. Furthermore, it was proved that the interphenotype variability had a marked influence on atomoxetine pharmacokinetic profile.