This paper presents a comprehensive assessment of safety monitoring of the use of botulinum toxin type A (BTA) drugs in the WHO databases (VigiBase) and automated information system (AIS) Roszdravnadzor-Pharmacovigilance, as well as a comparison of the dynamics of receipt of messages. The authors present a post-marketing study of domestic experience in the use of BTA drugs (Dysport, Botox, and Xeomin) based on a retrospective clinical and pharmacological analysis of 169 medical records of children with cerebral palsy in whom these drugs were used to treat spasticity syndrome. Analysis of the spectrum of adverse events, which were mentioned in 10 (5.9%) medical records, showed that their nature corresponded to the data set out in the instructions for medical use. Serious adverse reactions according to the criteria of severity death and threat to life, with a high degree of reliability of cause-and-effect relationship were not revealed during the study, which confirms a sufficiently high safety profile of these drugs. This paper focuses on improving the methodology for assessing the effectiveness and safety of BTA drugs for the treatment of spasticity syndrome in children and the need to identify and report all adverse drug reactions.

Aim. Patients with mild asthma may experience severe exacerbations. This analysis was conducted to investigate regional peculiarities of mild asthma population in Russia. Materials and methods. The SYGMA2 is a double-blind multinational study involving adult patients with mild asthma (n=4176). We conducted an open-label descriptive analysis of the baseline characteristics of the Russian group (n=579) of SYGMA2 trial comparing to SYGMA2 population from other countries. The subanalysis was descriptive only, and no hypothesis were tested. Results. The Russian population of patients with mild asthma was comparable to the rest of countries in terms of demographic characteristics, smoking status and duration of asthma. The spirometric parameters in the Russian group was slightly worse than in the other population. At the study entry 48% of Russian patients had symptom control on maintenance therapy, but 52% were uncontrolled on short-acting bronchodilators. While in other countries this ratio was inverse (55/45%). More patients with mild asthma in the Russian group had at least one severe exacerbation in the previous year (30.1% vs 20.7% in other countries). Conclusion. We revealed a delayed prescription of controller therapy and overuse of short-acting bronchodilators in the Russian group of mild asthma patients, that may increase risk of asthma non-control and severe exacerbation.