Efficacy and Safety of Mildronate for Acute Ischemic Stroke: A Randomized, Double-Blind, Active-Controlled Phase II Multicenter Trial
- 192 Downloads
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.
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.
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.
Mildronate injection is as effective and safe as cinepazide injection in treating acute cerebral infarction.
KeywordsCarnitine Acute Ischemic Stroke Barthel Index Acute Cerebral Infarction Barthel Index Score
This study was funded by Ge-Lin Biopharmaceutical Co. Ltd., Shenyang, China. The authors have no potential conflicts of interest that are directly relevant to the content of this study. The Steering Committee for this study consisted of Prof. Su Xiuchu, Prof. Xu Dezhong, Prof. Wu Baoren, and Dr. Fan Fulin. The Safety Board consisted of Prof. Huang Yuangui, Prof. Li Huanzhang, and Prof. Li Kaizong.
- 1.Naylor AR. Letter by Naylor regarding article, “Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association”. Stroke. 2011;42(6):e385; author reply e386.Google Scholar
- 22.Isajevs S, Isajeva D, Beitnere U, et al. Mildronate as a regulator of protein expression in a rat model of Parkinson’s disease. Medicina (Kaunas). 2011;47(10):552–9.Google Scholar
- 32.Fujishima M. Agents to improve cerebrovascular circulation and cerebral metabolism–cinepazide [in Japanese]. Nihon Rinsho. 1985;43(2):379-82.Google Scholar