Home \ Areas of application of Mexidol®: prescriptions for diseases \ Efficacy of Mexidol® in ischemic stroke: from cellular damage to clinical recovery

Efficacy of Mexidol® in ischemic stroke: from cellular damage to clinical recovery

The fragile balance of the brain during a vascular accident

Statistics on stroke incidence and mortality alarm the global community year after year. The key to understanding the severity of this condition lies in its pathophysiology: the sudden cessation of cerebral blood flow causes an energy crisis in nerve cells and triggers a cascade of ischemic damage, leading to disruption of cellular structure and function.

Around the infarct zone, composed of brain cells killed by ischemia, a penumbra, or ischemic penumbra, forms, becoming the epicenter of the "battle" for brain survival. The penumbra is the region where cells, balancing on the brink of life and death, encounter a destructive wave of oxidative stress—the explosive formation of reactive oxygen species, which triggers cell death.

Penumbra cells can be saved by restoring their blood supply within the "therapeutic window," which for ischemic stroke, depending on the method, ranges from 4.5 to 6 hours. Therefore, time is of the essence, and the treatment strategy must be not simply symptomatic but pathogenetically based, aimed at preserving cell viability during the "therapeutic window" and expanding its boundaries.

All this explains the importance of using neurocytoprotectors with multimodal properties, possessing an extensive evidence base, high efficacy, and good tolerability, which help protect viable neurons from death [10] . Among neurocytoprotectors, Mexidol® (the original ethylmethylhydroxypyridine succinate), which acts on the main links of the ischemic cascade, occupies a special place [11] . But how does theory translate into practice? What evidence underlies its use? Let's turn to the results of clinical studies.

Acute Phase: Time vs. Neurological Deficit

The first hours of a stroke are crucial. A study evaluating the use of Mexidol in the prehospital setting reached an important conclusion: early administration of the drug during the "therapeutic window" contributed to a significant reduction in neurological deficits as measured by the NIHSS (National Institutes of Health Stroke Scale) [23] . Moreover, this effect was independent of the initial severity of the patient's condition. Furthermore, early administration of Mexidol increased the effectiveness of subsequent thrombolytic therapy [23] , preparing the brain for the restoration of blood flow.

The importance of early initiation of therapy was confirmed in a randomized, double-blind study in the acute phase of ischemic stroke. Administration of Mexidol within the first 6 hours of symptom onset yielded the most pronounced clinical effect [24] .

Scientists have proven that the drug not only protects cells but also has a significant impact on metabolism in the infarct zone . Magnetic resonance spectroscopy showed that Mexidol® significantly reduced lactate and inositol levels in both the infarct core and penumbra [25] . A reduction in lactate—a marker of anaerobic glycolysis—indicates that the drug restores energy metabolism and activates aerobic processes even under ischemic conditions, which promotes neuronal survival .

Recovery: The Long Road to Independence

Once the acute period is over, an equally important stage begins: rehabilitation. Here, doctors and patients are faced with the question: is it possible to accelerate and improve functional recovery with the help of pharmacotherapy? The answer was found in the EPICA (a multicenter, randomized, double-blind, placebo-controlled trial), in which patients with hemispheric stroke received long-term sequential therapy : first, intravenous infusions of Mexidol, then the tablet form [26] improvement compared to placebo was noted on the modified Rankin Scale (mRS) - the standard for assessing functional independence [18] . That is, patients receiving Mexidol® had a better chance of returning to independent living with minimal limitations . Neurological deficit, assessed by the NIHSS scale, also regressed faster.

Subgroup analysis revealed that Mexidol's efficacy remained high across all age groups, which is particularly important when treating elderly patients [27] . The study therapy was also well tolerated across all age groups, including elderly patients [27] . In patients aged 60–75 years with concomitant diabetes mellitus, a factor that worsens stroke outcomes, quality of life improved significantly compared to the placebo group. Among elderly patients (76–90 years), the Mexidol group statistically significantly outnumbered those who experienced no problems with mobility or self-care by the end of therapy [27] .

Go to the study of epic

International experience and summary analysis: evidence consolidation

In 2025, the results of the international multicenter MIR study , marking a significant step in the evaluation of Mexidol [28, 29] . This randomized, double-blind, placebo-controlled study meets the strictest standards of evidence-based medicine . The study confirmed and expanded on previous findings: long-term sequential therapy with Mexidol® (parenteral administration) and Mexidol® FORTE 250 (tablet form) is superior to placebo in terms of primary clinical outcomes.

A key difference in the MIR study results was the confirmation of efficacy in patients with moderate stroke (NIHSS score of 9-15) who did not receive reperfusion therapy (thrombolysis or thrombectomy) [20, 29]. It was in this very common group that Mexidol® demonstrated the ability to improve functional outcomes by day 70. Moreover, in the main group, complete regression of neurological symptoms (NIHSS score of 0) was significantly more common by the end of the observation period. The study noted good tolerability of the therapy and the absence of adverse drug interactions [29].

Learn more about RKI MIR

But science requires not only new data but also understanding of what has already been accumulated. This work was a systematic review and meta-analysis , which included 11 studies [30] , which allowed for compelling conclusions:

Dose-dependence effect: higher doses of Mexidol are associated with better clinical results.
Time effect: regression of neurological deficit increases with the duration of therapy and observation.
Effect of initial severity: the more severe the stroke, the more significant the positive effect of Mexidol on NIHSS scores.
Stability of the result: Mexidol therapy leads to a stable improvement in the functional outcome according to the mRS scale.

More about meta-analysis

From recovery to prevention and improved quality of life

The use of Mexidol® in stroke is not limited to the acute period. A five-year prospective study demonstrated its potential role in secondary prevention : therapy was associated with a reduction in the incidence of recurrent ischemic events, not only in the general population but also in patients with arterial hypertension, atrial fibrillation, and diabetes mellitus [31] . This suggests potential long-term benefits.

An important aspect is the impact on cognitive functions, which are often impaired after a stroke. Research shows that consistent Mexidol therapy promotes more complete recovery [32] , which directly impacts the patient's quality of life and social adaptation.

Data accumulated over years of research—from early studies examining metabolic effects to modern international RCTs and meta-analyses—prove the high efficacy and safety of Mexidol®, which is aimed at reducing the severity of neurological deficits, improving functional outcomes, and increasing independence in patients who have suffered a stroke .

In the arsenal of modern neurology, where every success in combating the consequences of stroke is a return to life, pathogenetically based neuroprotection remains an important and sought-after area.

Block of articles on this topic

The effect of therapy with the drug Mexol on the regression of neurological deficiency and a functional outcome in patients with ischemic stroke: a systematic review and meta analysis

Authors:
I.A. Voznyuk ^1.2 , S.V. Kolomensev ^2.3 , E.M. Morozova ¹

Treatment of patients with ischemic stroke in the vertebral-baslar system in the acute period: Experience in the use of the neuroprotective drug Mexidol

Authors:
Z.A. Goncharova, I.V. Chernikova, V.A. Nazarova, V.V. Tolmacheva, K.G. Ovsepyan
FSBEI in "Rostov State Medical University" of the Ministry of Health of Russia, Rostov-on-Don, Russia

Oxidative stress in the pathogenesis of cerebral stroke and its correction

Authors:
M.Yu. Martynov ^1.2 , M.V. Zhuravleva ^3.4 , N.S. Vasyukova ⁵ , E.V. Kuznetsova ⁶ , TR Kameneva ⁷

Study of the effectiveness and safety of the sequential use of Mexidol and Mexidol Forte 250 in the treatment of patients with acute ischemic stroke

Authors:
S.M. Karpov ¹ , M.Yu. Morozova ² , K.A. Muravyov ² , I.A. Prisilova ¹ , F.S. Kantemirova ³

Vascular inflammation based on the development of atherotrombotic stroke

Authors:
A.V. Romanenko, I.P. Amelina, E.Yu. Soloviev

FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia

The effectiveness and safety of the use of ethylmethylhydroxypyridine of succinate in patients with acute ischemic stroke

Authors:
M.V. Zhuravleva ^1.2 , I.A. Schukin ³ , M.S. Fidler ³ , A.B. Prokofiev ^1.2 , S.Yu. Serebrova ^1.2 , N.S. Vasyukova ⁴ , E.Yu. Demchenkova ¹ , V.V. Arkhipov ¹

Study of the effectiveness and safety of the drug Mexol Fort 250 as part of consecutive therapy in patients with a hemisphere ischemic stroke in acute and early recovery periods

Authors:
M.A. Loskutnikov, M.A. Domashenko, T.M. Vakin, I.A. Trushina, V.I. Konstantinov, O.S. Proskuryakova, E.P. Schukina

The effectiveness of the use of ethylmethylhydroxypyridine of succinate in the restoration treatment of patients who have undergone ischemic stroke

Authors:
M.V. Zhuravlev ^1.2 , A.B. Prokofiev ^1.2 , V.V. Arkhipov ¹ , S.Yu. Serebrova ^1.2 , G.I. Gorodetskaya ^1.2 , O.A. Demidova ¹

¹ FSBI “Scientific Center for Expertise of Medical Application” of the Ministry of Health of Russia, Moscow, Russia;
² FGAOU VO "First Moscow State Medical University named after THEM. Sechenov "Ministry of Health of Russia (Sechenov University), Moscow, Russia

Personal: Features of treatment and rehabilitation of patients who have undergone Covid-19 with ischemic stroke

Authors:
G.S. Rakhimbayeva, Sh.R. Gazieva, M.K. Atyaniyazov, F.Kh. Muratov, D.S. Tolipov, U.D. Shodiev

Tashkent Medical Academy, Tashkent, Republic of Uzbekistan