[Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results)]. / Neimmunogennaya stafilokinaza ­ novyi tromboliticheskii preparat v lechenii ishemicheskogo insul'ta (rezul'taty issledovaniya FRIDA).

AIM OF THE STUDY: To investigate the efficacy and safety of non-immunogenic staphylokinase (NS) compared with alteplase (A) in patients with acute ischemic stroke (AIS) within 4.5 h after symptom onset. MATERIAL AND METHODS: 336 patients with IS within 4.5 h after symptom onset were included in a randomized, open-label, multicenter, parallel-group, non-inferiority comparative trial of NS vs A (168 patients in each group). NS was administered as an intravenous bolus in a dose of 10 mg, regardless of body weight, over 10 s, A was administered as a bolus infusion in a dose of 0.9 mg/kg, maximum 90 mg over 1 hour. The primary efficacy endpoint was a favorable outcome, defined as a modified Rankin scale (mRS) score of 0-1 on day 90. Safety endpoints included all-cause mortality on day 90, symptomatic intracranial haemorrhage, and other serious adverse events (SAEs). RESULTS: At day 90, 84 (50%) patients reached the primary endpoint (mRS 0-1) in the NS group, 68 (41%) patients - in the A group (p=0.10, OR=1.47, 95% CI=0.93-2.32). The difference between groups NS and A was 9.5% (95% CI= -1.7-20.7) and the lower limit of the 95% CI did not cross the margin of non-inferiority (pnon-inferiority<0.0001). There were no significant differences in the frequency of deaths between the groups: on day 90, 17 (10%) patients in the NS group and 24 (14%) in the A group had died (p=0.32). There was a trend towards significant differences in the frequency of symptomatic intracranial haemorrhage: NS group - 5 (3%) patients, A group - 13 (8%) patients (p=0.087, OR=0.37, 95% CI=0.1-1.13). There were significant differences in the number of patients with SAEs: in the NS group - 22 (13%) patients, in the A group - 37 (22%) patients (p=0.044, OR=0.53, 95% CI=0.28-0.98). CONCLUSION: The presented results of the FRIDA trial are the first in the world to use a drug based on NS in patients with IS. It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.

[Clinical characteristics and quality assessment of the treatment of patients with chronic heart failure with diabetes mellitus].

AIM: A study of the clinical and instrumental characteristics and quality of treatment of patients with chronic heart failure (CHF) with diabetes mellitus. MATERIALS AND METHODS: The study was conducted by using the CHF register method, which is a computer program with remote access, which allows on-line data collection on patients who have been examined and treated in primary care and in hospitals. The study included 8272 patients with CHF IIIV FC (functional class) (New York Heart Association NYHA); among them 62% of patients were treated in hospital. RESULTS: The study showed that the frequency of diabetes was 21%. The main causes of CHF in diabetic patients are coronary artery disease, myocardial infarction (in anamnesis) and hypertension. These patients are more often diagnosed with III and IV CHF FC according to (NYHA) and retained LV (left ventricular) ejection fraction. The reduced ejection fraction was observed in 6.8% of cases, and the frequency of the intermediate LV was significantly higher than among patients with CHF and with diabetes and accounted for 18.9%. At patients with CHF with diabetes in comparison with patients with CHF without diabetes, atherosclerosis of the peripheral arteries, stroke (in anamnesis) and chronic kidney disease of stage III and IV were significantly more common. CONCLUSION: Under the treatment, patients with CHF with diabetes have higher levels of SBP (systolic blood pressure), lipids and glucose in the blood plasma, indicating a lack of quality of treatment and, accordingly, the doctors are not optimally performing the clinical guidelines on treating this category of patients.

[Clinical, Virusological and Immunological characteristics of hospitalised HIV-infected patients].

AIM: The primary objective of this study was to describe clinical, virusological and immunological characteristics of hospitalised HIV-infected patients, who had different stages of the disease. MATERIALS AND METHODS: This study was conducted at Moscow Infectious Diseases Hospital №2 in 2012-2015. We have clinically observed 5485 HIV-infected patientsand studied their clinical histories [age: 25-45 (87%), men - 3998 (72.9%), women - 1487 (27.1%)]. 593 (10.8%) have died. We have tested plasma and liquor HIV RNA viral load, immune status, number of viral DNA copies in blood, liquor, lavage, pleural fluid, large intestinal and esophagus biopsies and other materials. Statistica v. 10.0 and SPSS v. 20 were used for statistical analysis. RESULTS AND CONCLUSION: Clinical state of HIV-infected hospitalised patients has been described and the results of quantitive determination of HIV RNA in blood and liquor, absolute and relative CD4+ and CD8+ T-lymphocytes concentrations and immunoregulatory index in patients in various disease stages, including patients on antiretroviral therapy (ART) have been presented. Statistically significant correlation between blood and liquor HIV RNA load as well as between viral load and cellular immune markers in hospitalised HIV-infected patients has been found.

The prevalence of abdominal obesity and the association with socioeconomic status in Regions of the Russian Federation, the results of the epidemiological study - ESSE-RF.

AIM: The aim of the study is to determine the prevalence of AO in the population and to assess the association with socioeconomic factors according to the data of the ESSE-RF study (Epidemiology of Cardiovascular diseases in the Regions of the Russian Federation). MATERIALS AND METHODS: The object of the study is a random population sample of men and women aged 25-64 years from 13 regions of the Russian Federation (n=21 817). Abdominal obesity in men was defined as waist circumference (WC) >94 cm, and in women - WC >80 cm. Body mass index (BMI) >30.0 kg/m2 was adopted as the criterion of common obesity. RESULTS: The prevalence of AO in Russia was 55% (61.8% in women and 44% in men), while the percent of people with obesity, defined by BMI was significantly lower (33.4%). The number of examined patients with AO increased with age among both men and women (p<0.0001). A person with AO more often were people with low and very low income and low education levels (p<0.0001). Direct association between employment status and family status and AO in present study did not find, but WC was statistically significantly important criterion among male workers in comparison with those who never worked (p<0.0001), young men and women married, as well as married men of older age groups (p<0.0001).