[Comparative characteristics of the efficacy and safety of the original alteplase and its complete biosimilar in the treatment of ischemic stroke in real clinical practice]. / Sravnitel'naya kharakteristika effektivnosti i bezopasnosti original'noi alteplazy i ee bioanaloga pri lechenii ishemicheskogo insul'ta v real'noi klinicheskoi praktike.
Zh Nevrol Psikhiatr Im S S Korsakova
; 124(3. Vyp. 2): 49-54, 2024.
Article
en Ru
| MEDLINE
| ID: mdl-38512095
ABSTRACT
OBJECTIVE:
To conduct a comparative analysis between the original alteplase and its biosimilar in terms of efficacy and safety in real clinical practice in the Republic of Belarus. MATERIAL ANDMETHODS:
The cohort study included 420 patients. All included patients underwent thrombolytic therapy with alteplase within 4.5 hours of the onset of stroke symptoms according to the approved tactics of the Republic of Belarus and international recommendations. The patients were divided into 2 groups 215 received the drug Revelisa, 205 - Actilyse.RESULTS:
The patients were comparable in gender, age, ASPECTS assessment, but had statistically significant difference in NIHSS was found, due to the large number of patients with NIHSS=16-25 in the Actilyse group. The assessment of premorbid disability also showed a statistically significant difference there were more patients in the Revelisa group who had functional limitations of varying degrees before the disease, 83 (38.6%) versus 62 (28.3%) patients in the comparison group. Clinical outcomes were comparable, the proportion of patients achieving mRS=0-1 at discharge was 41.5% in group A and 42.8% in group P. The Revelisa demonstrated a statistically significant lower number of deaths in 15 (7.0%) and 29 (14.1%) in the comparison group. The development of a greater number of clinically insignificant petechial hemorrhages was noted after the use of Actilyse.CONCLUSION:
The analysis demonstrated a high level of safety in the use of alteplase preparations in routine practice. The compared fibrinolytics had comparable effectiveness in achieving functional independence after ischemic stroke, despite the more premorbid disability of patients who received a biosimilar.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Accidente Cerebrovascular
/
Biosimilares Farmacéuticos
/
Accidente Cerebrovascular Isquémico
Límite:
Humans
Idioma:
Ru
Revista:
Zh Nevrol Psikhiatr Im S S Korsakova
Asunto de la revista:
NEUROLOGIA
/
PSIQUIATRIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Belarús
Pais de publicación:
Rusia