Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study).
CNS Neurosci Ther
; 27(12): 1493-1503, 2021 12.
Article
in English
| MEDLINE | ID: covidwho-1532765
ABSTRACT
AIMS:
Human urinary kallidinogenase (HUK) has shown favorable efficacies in acute ischemic stroke (AIS) treatment. We sought confirmation of the safety and efficacy of HUK for AIS in a large population.METHODS:
RESK study enrolled patients with AIS of anterior circulation to receive HUK infusion. The primary endpoint was the incidence of treatment-emergent adverse events (AEs). Secondary endpoints assessed neurological and functional improvements and stroke recurrent rate.RESULTS:
Of 1206 eligible patients, 1202 patients received at least one dose of HUK infusion and 983 (81.5%) completed the study. The incidence of treatment-emergent AEs and serious AEs were 55.99% and 2.41%, respectively. Pre-specified AEs of special interest occurred in 21.71% of patients, but the majority were mild and unrelated to therapy. Hypertension, age, treatment time, and drug combination were identified to be associated with drug-related blood pressure reduction. Neurological and functional evaluations revealed favorable outcomes from baseline to post-treatment assessment. The cumulative recurrence rate of stroke was 2.50% during the 90-day assessment.CONCLUSION:
HUK had an acceptable safety and tolerability profile in AIS patients. Besides, HUK demonstrated the neurological and functional improvements in AIS, further confirming its clinical efficacy in a real-world large population.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Kallikreins
/
Ischemic Stroke
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
CNS Neurosci Ther
Journal subject:
Neurology
/
Therapeutics
Year:
2021
Document Type:
Article
Affiliation country:
Cns.13724
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