Efficacy and safety of mildronate for acute ischemic stroke: a randomized, double-blind, active-controlled phase II multicenter trial.

Abstract

BACKGROUND AND OBJECTIVE:

Mildronate, an inhibitor of carnitine-dependent metabolism, is considered to be an anti-ischemic drug. This study is designed to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

METHODS:

We performed a randomized, double-blind, multicenter clinical study of mildronate injection for treating acute cerebral infarction. 113 patients in the experimental group received mildronate injection, and 114 patients in the active-control group received cinepazide injection. In addition, both groups were given aspirin as a basic treatment. Modified Rankin Scale (mRS) score was performed at 2 weeks and 3 months after treatment. National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score were performed at 2 weeks after treatment, and then vital signs and adverse events were evaluated.

RESULTS:

A total of 227 patients were randomized to treatment (n = 113, mildronate; n = 114, active-control). After 3 months, there was no significant difference for the primary endpoint between groups categorized in terms of mRS scores of 0-1 and 0-2 (p = 0.52 and p = 0.07, respectively). There were also no significant differences for the secondary endpoint between groups categorized in terms of NIHSS scores of >5 and >8 (p = 0.98 and p = 0.97, respectively) or BI scores of >75 and >95 (p = 0.49 and p = 0.47, respectively) at 15 days. The incidence of serious adverse events was similar between the two groups.

CONCLUSION:

Mildronate injection is as effective and safe as cinepazide injection in treating acute cerebral infarction.

• Authors: Yi Zhu, Guangyun Zhang, Jun Zhao, Deshuai Li, Xiaodong Yan, Juanfang Liu, Xuedong Liu, Haibo Zhao, Jielai Xia, Xiao Zhang, Zhengyi Li, Baorong Zhang, Zongcheng Guo, Lianyuan Feng, Zhaodong Zhang, Fang Qu, Gang Zhao
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 33 Issue 10 Pg. 755-60 (Oct 2013) ISSN: 1179-1918 [Electronic] New Zealand
• PMID: 23949899 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cardiovascular Agents
• Methylhydrazines
• 3-(2,2,2-trimethylhydrazine)propionate

Topics

• Aged
• Brain Ischemia (diagnosis, drug therapy, physiopathology)
• Cardiovascular Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Methylhydrazines (adverse effects, therapeutic use)
• Middle Aged
• Stroke (diagnosis, drug therapy, physiopathology)
• Treatment Outcome