Open AccessHuman urinary kallidinogenase in acute ischemic stroke: A single‐arm, multicenter, phase IV study (RESK study)
Author(s) -
Ni Jun,
Yao Ming,
Wang LiHua,
Yu Ming,
Li RunHui,
Zhao LiHong,
Wang JiaChun,
Wang YinZhou,
Wang Xin,
Song HaiQing,
Luo BenYan,
Wang JiaWei,
Huang YiNing,
Cui LiYing
Publication year - 2021
Publication title -
cns neuroscience and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 69
eISSN - 1755-5949
pISSN - 1755-5930
DOI - 10.1111/cns.13724
Subject(s) - medicine , tolerability , stroke (engine) , adverse effect , clinical endpoint , population , clinical trial , incidence (geometry) , blood pressure , mechanical engineering , physics , environmental health , optics , engineering
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.