Multiple sclerosis (MS) is a chronic autoimmune demyelinating disorder of the central nervous system. Nowadays some disease-modifying drugs (DMD) in the Russian Federation (RF) are biosimilars. Their full spectrum of tolerability and efficacy is to be determined. Here we present results of two retrospective-prospective studies on efficacy and safety of a biosimilar interferon beta-1a (genfaxon) in treatment of MS in the RF.
determination of safety and efficacy profile of genfaxon in a routine neurological practice in the RF.
Trials were performed in 18 MS centers in the RF. A total of 649 patients aged from 18 to 68 years with the EDSS score no more than 6.0 were treated with genfaxon for 12 months. The first group was comprised of 'naÃ¯ve' patients without previous history of DMD administration. There were patients in the second group which have already received some of DMD. Statistical analysis was performed with the help of significance criteria (?-square), t-criteria of Student for analysis of independent samplings.
There were no serious adverse events during the period of the study. "NaÃ¯ve" patients had significantly lower number of adverse events, than patients with previous history of DMD usage. Efficacy results were comparable with results published for the Rebif.
Data, received from the studies show equal efficacy and tolerability of genfaxon compared with original DMD Rebif.
The authors describe the data of the screenings of the representative random samples from the open male population aged 20 to 54 years, carried out in accordance with the common program in 6 cities of this country. The prevalence of definite cases of cerebrovascular diseases (CVD) ranged from 7.7% in Moscow to 12% in Irkutsk. As to the structure of cerebrovascular injuries, the initial manifestations of brain blood supply insufficiency accounted for 68%. The prevalence of CVD turned out to be the greatest in Western Siberia, the least in the European region. The transcaucasian republics occupy an intermediate position.
Outcomes in 1102 patients with 3 main types of stroke have been analysed to determine the significance of basic stroke outcome predictors. They are: type of the stroke, location of the focus, gravity of the patient's condition when the first aid is performed, spectrum of hospital facilities, diseases of the patient before and besides the stroke. A decrease of the mortality rate and optimal level of ADL score after stroke can be provided in cases when intensive care units-general hospitals are the first step of treatment.
The clinical epidemiological and medical organizational characteristics of strokes in 621 patients resident of Puschkinsky district of the City of Saint-Petersburg is presented. In the district, the corresponding morbidity and mortality rate is higher as compared with similar indicators in the Russian Federation and the international community. The comprehensive program of target actions on the prevention and treatment of the patients with the stroke is proposed both during acute and rehabilitation period.
The prospective multicenter open noncomparative pharmaco-epidemiological observational project on the use of mydocalm in real clinical practice has been completed in 2013. The project has been performed in 2090 clinical/rehabilitation settings in 284 cities of 13 countries using the results of 35,383 patients. The project aimed to assess the safety of treatment (percentage of patients with adverse-effects) and pain relieving efficacy as well as patient's satisfaction with the treatment. In total, 6603 (19%) adverse-effects were recorded. Their severity was evaluated as mild in 84,48%, no serious adverse-effects were noted. The high efficacy of mydocalm in the treatment of pain syndromes with the muscle spasm has been demonstrated. The high level of tolerability and absence of the clinically significant increase of adverse effects in the combination with nonsteroidal anti-inflammatory drugs have been confirmed.