RESUMEN
Multiple sclerosis (MS) is a common neurological disease among young people of working age, which tends to increase the number of cases registered in the world and in the Russian Federation. However, with improved diagnostics and the emergence of new drugs that change the course of MS (disease-modifying therapy), people's life expectancy increases and the percentage of patients in the older age group increases as well. In this article, we consider the possibility of developing MS among people over 50 years of age, features of the course, diagnosis and treatment.
Asunto(s)
Esclerosis Múltiple , Humanos , Persona de Mediana Edad , Anciano , Adolescente , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/terapia , Esperanza de Vida , Federación de Rusia/epidemiologíaRESUMEN
AIM: To study the state of the cardiovascular system and peripheral microcirculation in young patients with relapsing-remitting multiple sclerosis (MS). MATERIAL AND METHODS: The study included 45 MS patients (17 men and 28 women, age 28 [24; 32] years, disease duration 5.5 [2; 7] years). The control group included healthy controls (age 30 [25; 33] years). Neurological and cardiologic examinations included 24-hour Holter ECG monitoring and 24-hour blood pressure monitoring with determination of the daily arterial vascular stiffness, echocardiography, laser doppler flowmetry followed by an occlusive test to assess the state of microvasculation, levels of serum vascular cellular adhesion molecule-1 (VCAM-1). RESULTS: In MS group, the results of 24-hour blood pressure monitoring showed that the variability of systolic blood pressure and diastolic blood pressure during daytime hours was reduced compared to the control group (p<0.026 and p<0.002, respectively). The indicators of daily arterial stiffness in MS group were significantly increased (p<0.001). According to the results of Holter ECG monitoring, no heart rhythm disorder was detected in both groups, except an increase in the number of supraventricular extrasystoles in MS patients compared to the control group (p<0.005). There were no between group differences in echocardiography indicators. The level of VCAM-1 was significantly increased in MS group compared to controls (p<0.001). CONCLUSION: Young MS patients are at risk of cardiovascular diseases associated with the variability of blood pressure and indexes of daily arterial vascular stiffness.
Asunto(s)
Enfermedades Cardiovasculares/complicaciones , Esclerosis Múltiple Recurrente-Remitente/complicaciones , Adulto , Presión Sanguínea , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Rigidez Vascular , Adulto JovenRESUMEN
The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD¼, Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) in patients with relapsing-remitting multiple sclerosis. METHODS: 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: BCD-063, copaxone-Teva and placebo, at a ratio of 2:2:1, respectively. RESULTS AND CONCLUSION: Efficacy analysis after 48 weeks of therapy demonstrated no differences between BCD-063 group and copaxone-Teva group in both MRI parameters and frequency of relapses. The mean (SD) of number of MRI-confirmed relapses per patient per year (the primary endpoint) in BCD-063 group was 0.098361 (0.351422), in copaxone-Teva group - 0.098361 (0, 351 422) and in placebo group - 0.178571 (0.390021). There were also no differences between the groups for all other efficacy parameters (EDSS and MSFC). Both investigational BCD-063 and copaxone-Teva demonstrated a favorable safety profile. The data obtained from the present study confirm the therapeutic equivalence of BCD-063 (CJSC BIOCAD, Russia) and copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.
Asunto(s)
Acetato de Glatiramer/uso terapéutico , Inmunosupresores/uso terapéutico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Método Doble Ciego , Humanos , Imagen por Resonancia Magnética , Péptidos , Recurrencia , Equivalencia TerapéuticaRESUMEN
OBJECTIVE: To study the efficacy and tolerability of generics (interferon beta-1a biosimilans) cinnovex for intramascular introduction and genfaxon-44 for subcutaneous injections in multiple sclerosis (MS). MATERIAL AND METHODS: One hundred patients were treated with cinnovex and 104 patients were treated with genfaxon-44 during one year. Patient's status was assessed using clinical approach, psychometric scales and MRI. RESULTS AND CONCLUSION: The high percentage of withdrawal of treatment due to the lack of clinical effect and intolerance to the drugs was identified during the treatment. Positive effect with respect to stabilization of MS course was found only in patients who earlier did not receive disease-modifying drugs. Double-blind studies are needed to resolve the question of the adequacy of brand-name drugs and generics.