Introduction: GLP1 receptor agonist lixisenatide has demonstrated its efficacy in numerous clinical trials, nevertheless its real-life effectiveness data is limited. Aim: To describe effectiveness and safety of lixisenatide in routine clinical practice in the Czech Republic and the Slovak Republic, as recorded by the Registry-Based Observational Study. Methods: Multinational, multicenter, observational, non-interventional, 6-month prospective product registry of patients with type 2 diabetes mellitus aged > 18 years who were initiating therapy with lixisenatide. Patients were enrolled into this registry, provided written informed consent, between 1 May 2013 and 31 December 2015. Evaluations were performed at baseline and after 3 and 6 months of lixisenatide treatment. The primary objective of the study was the absolute change in glycated hemoglobin (HbA 1c ) from baseline to month 6 after lixisenatide initiation. The study was approved by responsible ethics committees and performed in accordance with the Helsinki Declaration. Informed consent was obtained from all patients before enrolment in the study. Results: Overall 772 eligible patients (51.4 % males), mean age 56.7 (± 9.3) years, with mean diabetes duration 7.7 (± 5.5) years, mean duration of treatment with oral antidiabetic drugs 6.8 (± 4.9) years, and body mass index 37.6 (± 5.9) kg/m 2 were enrolled in the study. Overall, 93.6 % were obese, 86.3 % subject were treated for hypertension, and 76.0 % for dyslipidemia. In total 96.1 % of patients completed the 6 months' therapy. Lixisenatide significantly reduced HbA 1c (decrease by 9.7 ± 14.4 mmol/mol [3.1 ± 0.2 % DCCT] after 6 months in per protocol population), and body weight (decrease by 3.5 ± 5.4 kg). The best responders to the treatment were younger patients with higher BMI, who had a shorter duration of diabetes. Overall safety profile of lixisenatide was satisfactory in the study. The most frequent adverse events were functional disorders affecting the gastrointestinal system. There was no episode of severe hypoglycemia reported throughout the study. Conclusion: In a real-life practice cohort of patients with type 2 diabetes mellitus 6 months treatment with once-daily GLP1 receptor agonist lixisenatide significantly improved glucose control and decreased body weight without increasing the risk of symptomatic and/or severe hypoglycemia risk. Funding: Sanofi Czech Republic.
Diabetes and its long- term unsatisfactory compensation can be one of the factors which affect left ventricular transient ischemic dilation.
OBJECTIVES: Vitamin D substitution is recommended in patients with infl ammatory bowel disease. Specifi c guidelines are lacking. The aim of this study was to assess the effect of vitamin D supplementation with respect to dosage and patient compliance. METHODS: A prospective cohort study of 167 Crohn disease/ulcerative colitis outpatients. Patients were screened for serum vitamin D (25OHD 2+3) at the end of summer and in late winter. Demographic data, history of vitamin D supplementation were recorded and matched with prescription records. RESULTS: A total of 57 subjects used vitamin D supplementation (mean dose 1104 IU/day). 25OHD 2+3 levels were lower (p < 0.001) in winter both in substituted and unsubstituted group, without any differences between groups within the same season. 25OHD 2+3 levels did not correlate with the substitution dose. 52.1 % of subjects were fully compliant with substitution. 25OHD 2+3 and prevalence of vitamin D defi cit in this group were comparable with unsubstituted subjects except a higher prevalence of vitamin D insuffi ciency (p < 0.02). CONCLUSION: Fixed dosage of 1100 IU/day of vitamin D was insuffi cient to correct the defi ciency. Patient compliance with vitamin D supplementation was low, however this fact did not signifi cantly contribute to the degree of vitamin D defi ciency in this dosage (Tab. 3, Fig. 1, Ref.
Type 2 diabetes mellitus (T2DM) is associated with compromised health-related quality of life 1 and premature death from vascular disease and several types of cancers. 2 Insulin resistance is the earliest feature in the development of T2DM. Insulin resistance is induced by obesity, inflammation, 3 and low physical activity. 4 Conversely, physical activity accompanied by weight loss leads to improvement in insulin sensitivity. 5
Recent studies have demonstrated that adipocyte fatty acid binding proteins (FABP) may play a role in the etiopathogenesis of insulin resistance. The aim of our study was to assess serum FABP levels in obese patients with type 2 diabetes mellitus (T2DM) before and after 3 months of treatment with PPAR-α agonist fenofibrate (F) and to explore the relationship of FABP to biochemical parameters and measures of insulin sensitivity assessed by hyperinsulinemic-isoglycemic clamp. We measured biochemical parameters by standard laboratory methods, insulin sensitivity by hyperinsulinemic-isoglycemic clamp and serum concentrations of FABP by commercial ELISA kit in 11 obese females with T2DM before and after three months of treatment with PPAR-α agonist fenofibrate and in 10 lean healthy control women (C). Serum FABP levels were 2.5-fold higher in T2DM group relative to C and were not affected by fenofibrate treatment (C: 20.6±2.1 μg/l, T2DM before F: 55.6±5.7 μg/l, T2DM after F: 54.2±5.4 μg/l, p<0.0001 for C vs. T2DM before F). Hyperinsulinemia during the clamp significantly suppressed FABP levels in both C and T2DM group. FABP levels positively correlated with BMI, triglyceride levels, blood glucose, glycated hemoglobin, atherogenic index and insulin levels. An inverse relationship was found between FABP and HDL levels, metabolic clearance rate of glucose, M/I and MCRglc/I sensitivity indexes. We conclude that FABP levels are closely related to BMI, parameters of insulin sensitivity, HDL levels and measures of diabetes compensation. This combination makes FABP a valuable marker of metabolic disturbances in patients with type 2 diabetes mellitus.
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