[Efficacy and safety of vildagliptin as a second-line therapy vs other oral antidiabetic agents in patients with type 2 diabetes: Czech results within the worldwide prospective cohort EDGE study]. / Úcinnost a bezpecnost vildagliptinu jako léku druhé volby ve srovnání s jinými perorálními antidiabetiky u pacientu s diabetes mellitus 2. typu: ceské výsledky v rámci celosvetové prospektivní kohortové studie EDGE.

INTRODUCTION: Metformin monotherapy is recommended as initial treatment of type 2 diabetes. The selection of optimal second-line therapy that is often necessary due to the progressive nature of the disease is still a subject of ongoing discussions. AIM OF THE STUDY: The aim of the international EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study was to prospectively compare the efficacy and safety of vildagliptin vs other oral antidiabetic agents in patients with type 2 diabetes not adequately controlled on monotherapy in a real-life clinical setting. In this paper, we present the data of patients participating in the EDGE study in the Czech Republic. MATERIAL AND METHODS: Patients with type 2 diabetes not adequately controlled on monotherapy were enrolled into the study, and randomised into either the vildagliptin arm or control arm with another OAD at the discretion of the treating physician. Patients with the addition of other incretin-based medications were not enrolled into the study. The efficiency was evaluated as a proportion of patients reaching the combined endpoint of decreasing HbA1c> 3 mmol/mol without hypoglycaemia, peripheral oedema or treatment termination due to gastrointestinal side effects during the 12 months of treatment. RESULTS: 654 patients were enrolled into the study in the Czech Republic. The mean age of the patients when enrolled into the study (vildagliptin group vs control group) was 59.5 ± 10.6 vs 63.7 ± 8.5 years, mean body mass index was 32.4 ± 5.7 vs 31.7 ± 6.5 kg/m2, mean HbA1c was 62 ± 12 vs 64 ± 11 mmol/mol. The probability of reaching the combined primary endpoint (calculated using a binary logistic regression model to calculate the odds ratios with 95% confidence intervals) was higher for vildagliptin regardless of baseline HbA1c or type of medication added in the control group. Primary endpoint was reached by 60.6 % of patients in the vildagliptin group vs 51.3 % of patients in the control group, odds ratio 1.46 (1.06, 1.99); p< 0.019. The proportion of patients reaching secondary endpoint (HbA1c< 54 mmol/mol without hypoglycemic event or weight gain 3 % with baseline glycated hemoglobin > 54 mmol/mol was higher for vildagliptin 45.7 % vs 31.4 % in the control arm, odds ratio 1.84 (1.26, 2.68), p< 0.001. The rate of adverse events was comparable in both groups. CONCLUSION: In a real-life clinical set-ting, the percentage of patients reaching the combined endpoint of decreasing HbA1c> 3 mmol/mol, without hypoglycaemia, peripheral oedema or treatment termination due to gastrointestinal side effects was higher after the addition of vildagliptin as compared to other antidiabetic agents with comparable rate of side effects.

[Clinical experience with changing type I diabetics from animal to human insulin administered by the NovoPen 3 applicator]. / Klinické zkusenosti z prevodu diabetiku I. typu ze zvírecích inzulinu na humánní inzuliny podávané aplikátory NovoPen 3.

The objective of the study was to assess the safety of changing ambulatory patients from animal insulin produced in the Czech Republic administered by classical insulin syringes to human insulins of the Danish firm Novo Nordisk, using a NovoPen 3 applicator. Furthermore antibody levels against hog, bovine and human insulin were assessed. Forty-seven patients with diabetes type I stabilized on an intensified insulin regime were after a four-day preparatory period divided at random into two groups. Patients in group A (n = 22) were after randomization changed to human insulin, patients in group B (n = 25) eight weeks later. From the onset of treatment with human insulins up to the end of the study the mean daily dose of insulin in both groups increased (in group A by 1.51 IU/day, in group 1.35 IU/day). This is not statistically or clinically significant. During the same period a statistically significant decline of the mean value of the daily 8-point glycaemic profile was recorded (in group A by 0.85 mmol/l, in group B by 0.51 mmol/l). Glycosylated haemoglobin declined also significantly in the course of the study (in group A by 1.64%, p = 0.00004, in group B by 1.02%, p = 0.0077). The greatest drop occurred during the preparatory period. Despite the increased daily insulin dose and improved compensation the number of hypoglycaemic events declined significantly in both groups (in group A by 0.78%, p = 0.0102, in group B by 0.74%, p = 0.0134). Hypoglycaemic coma was not recorded in either group. A significant drop of insulin antibodies was found in both group after the onset of treatment with human insulins. From the results of the study ensues that metabolically compensated type I diabetics with a mean daily insulin dose of 0.6 IU/kg body weight can be changed without any complications, in the ambulatory department, to human insulins with the same dosage. Concurrently a gradual decline of antibodies can be expected.