Perceived Psychological Well-Being in Patients with Hemodynamically Insignificant Carotid Arteries Stenosis.

BACKGROUND: Analysis of the perception of the disease in borderline stenosis of the orifice of the internal carotid artery (ICA) (up to 69% in diameter) in asymptomatic patients. SUBJECTS AND METHODS: 48 patients (28 men and 20 women). Group 1: stenosis up to 49% - 23 people (13 men, 10 women), mean age 50.4±16.1 y.o. Group 2: stenosis 50-59% - 18 people (10 men, 8 women), mean age 57.3±16 y.o. Group 3: stenosis 60-69% - 7 people (5 men, 2 women), mean age 61±12.3 y.o. All patients underwent ultrasound Doppler of brachiocephalic arteries, examination with Brief Illness Perception Questionnaire E. Broadbent (Russian version). RESULTS: According to the results of examination of patients with ICA stenosis, patients with more pronounced lesions (60-69%) more often have a type of reaction "negative attitude to the consequences of the disease". CONCLUSIONS: The majority of patients (54.2%) have a "negative type of attitude towards the consequences of the disease". This type of attitude to the disease is most pronounced in women and patients with stenosis of the ICA 60-69%. It is necessary to perform the psychological work with patients with carotid stenosis in order to form in them more adaptive types of perception of the disease, understanding of the disease and a positive attitude towards treatment.

Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab.

Currently, eculizumab is the main effective treatment for paroxysmal nocturnal hemoglobinuria (PNH). The aim of this randomized multicenter noninferiority study was to evaluate the efficacy and safety of the Biosimilar (Elizaria) in comparison with the Originator (Soliris) in patients with PNH. Biosimilar and Originator were administered at a dose of 600 mg weekly for 4 weeks at the initial stage in naive patients, as well as for maintenance therapy at a dose of 900 mg every 2 weeks in all patients. The primary endpoint was a comparative assessment of hemolytic activity based on the area under the lactate dehydrogenase (LDH) concentration-time curve during the maintenance therapy. Thirty-two (32) patients were randomized for therapy with Biosimilar (n = 16) or Originator (n = 16). The mean values of LDH concentration-time curve were similar in both treatment groups without statistically significant differences (p > 0.05). Evaluation of secondary endpoints has shown no statistically significant differences between the groups. Safety values were comparable in both treatment groups. The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056.