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Frequency and clinical impact of serious adverse events on post-stroke recovery with NeuroAiD (MLC601) vs placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study

Cerebrovascular Diseases Mar 06, 2020

Venketasubramanian N, et al. - Researchers conducted an exploratory analysis of the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study safety database contrasting the frequency of serious adverse events (SAEs) and their clinical impacts among individuals having received MLC601 or placebo during the first 3 months post-stroke. In patients with acute ischaemic stroke of intermediate severity in the preceding 72 h, analyses were conducted by using the safety database of the multicentre, randomized, double-blind, placebo-controlled CHIMES study of 3 months of NeuroAiD vs placebo. Of the 1,099 individuals in the CHIMES study, 1,087 were involved in the safety analysis (MLC601 = 542) and (placebo = 545). Twelve who did not receive study treatment were eliminated. In total, 135 patients with SAEs (MLC601 = 60, placebo = 75) were included. This post hoc analysis of SAEs from the CHIMES study database indicates that patients receiving a 3-month course of MLC601 experienced fewer SAEs, with lower rates of harmful clinical impacts, particularly in terms of hospitalization duration. Such results could turn into an advantage in terms of both reducing the burden of health care and the additional medical costs.
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