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Study of Memo in chronic
brain ischemia

Mexidol® and Mexidol® Forte 250 preparations showed a high degree of efficiency and safety in the international multicenter randomized double blind, a placebo-controlled study of evaluating the effectiveness and safety of consistent therapy of patients with chronic brain ischemia-memo [1].

A multicenter study - a study that is carried out in a large number of specialized clinical centers;
Randomized - a study in which patients are distributed into groups randomly;
Double blind placbo-controlled-a study in which neither a research doctor nor the patient knows what the patient receives:
the studied drug or placebo.

The purpose of the study was to study the effectiveness
and safety of consistent therapy with Mexidol®
Parentutral (intravenously) and Mexidol® Fort 250 orally
(using tablets) in patients with chronic
brain ischemia.

A multicenter study - a study that is carried out in a large number of specialized clinical centers;
Randomized - a study in which patients are distributed into groups randomly;
Double blind placbo-controlled-a study in which neither a research doctor nor the patient knows what the patient receives:
the studied drug or placebo.

Research design

The study of Memo was attended by 318 patients aged 40 to 90 years with chronic brain ischemia of 15 clinical centers of various regions of Russia and Uzbekistan. Patients were randomized in 2 groups.

visit 0 (no more than 7 days) - screening period;
visit 1 - the beginning of parenteral therapy;
visit 2 - completion of parenteral therapy;
visit 3 - a telephone survey of the patient;
visit 4-completion of the 1st month of tablet therapy;
Visit 5 - a final visit for 60 days of tablet therapy.

Patients of the 1st group (159 people) received a long sequential therapy with Mexidol® according to the scheme: Mexidol® in a dose of 500 mg per day intravenously 14 days with the subsequent transition to the tablet form of Mexidol® Forte 250, 1 tablet 250 mg three times per three times aid three times Day against the background of basic therapy for 60 days. The second group of patients (159 people), together with basic therapy, received a placebo according to a similar scheme.

Research design memo

15 clinical centers (Russian Federation + Republic of Uzbekistan)

Population - patients with chemicals (318 people were randomized)
Age of 40 - 90 years. Average age 60.4 +-9.45 years

The total duration of therapy is 75 days (2.5 months)

(Parenteral - 14 days, oral - 2 months)

Efficiency criteria

As the primary criterion of effectiveness, the average value of the change in the point on the Montreal scale of cognitive function assessment (MOCA) was estimated at the stage of completion by the patient compared to the initial level.

As secondary criteria for effectiveness, the dynamics assessment used:

On the Montreal scale of cognitive assessment (MOCA) in all visits,
according to the dialing test of digital characters (DSST),
on the subjective scale of asthenia assessment (MFI-20),
On the Bek anxiety scale,
on the scale of vegetative status (Wane questionnaire),
On the scale of balance and walking Tinetti,
according to the questionnaire for assessing the quality of life SF-36,
On the scale of the general clinical impression (CGI)

The safety of therapy was evaluated on the basis of the presence and severity of the undesirable phenomena recorded during the study.

Results

When analyzing the results of the primary criterion for the effectiveness in the Mexol® group, the improvement and normalization of cognitive functions to the end of therapy (75th day) was demonstrated: +4.2 points on the Mosa scale, which is significantly more than in the comparison group: +2, 2 points.

The dynamics of changes in the average score on the Mosa scale

The assessment of the results of secondary effectiveness criteria showed that the total average score on the Mosa scale in the main group reached the norm - 26.22 points, and in the placebo group remained at the level of cognitive violations - 24.17. The differences were reliable, starting from 2 visits (the completion of parenteral therapy), a positive dynamics increased against a long -term consistent therapy. Thus, the results obtained indicate the high effectiveness of the drug Mexidol® in the chronic ischem of the brain in relation to the main symptom - cognitive disorders.

Dynamics on the Mosa scale

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

Digital characters replacement test, dsst

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

The study showed a significant increase in the average score for the change in digital characters (+8 points in the group with the drug Mexidol® compared to +5 points in the placebo group).

Subjective scale for assessment of asthenia MFI-20

The average values of the absolute dynamics of points in the scale in the study groups and 95% trust intervals for medium, as well as the R-meaning of the criterion of the T-CRITENT T-CRITENT

When evaluating the severity of asthenic syndrome by the end of therapy, a reliable decrease in asthenia in patients of the main group (Mexidol®) was revealed: -8.3 points on the MFI -20 and -4.8 point in the comparison group (placebo).

Bek anxiety scale

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

The results of the examination on Bek’s anxiety showed a reliable decrease in anxiety level in patients of the 1st group (Mexidol®) by the end of therapy (75th day): -3 points, and in the 2nd group (placebo) -1 points.

Wane vegetative status scale

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

The study of the vegetative status in patients of both groups showed a statistically significant decrease in the manifestations of autonomic dysfunction in patients of the group with Mexidol® (-5 points) compared to the placebo group (-2 points) by the end of therapy (75th day).

Tinetti

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

When evaluating the equilibrium and walking of Tinetti, an improvement in the indicators was established in the group of the host Mexidol® +3 points, and in the placebo group +1 points, and statistically significant differences between groups were determined immediately after the end of injections of the drug Mexidol®.

Assessment of the quality of life of the patient SF-36

Medians of the absolute dynamics of points in the scale in the study groups, the 25th and 75th percentiles, and the R-meaning of the Mann-Uinty criterion are also given

A significant improvement in the quality of life in patients of the group 1 (Mexol®) was noted by the end of therapy (75th day), as patients (+5 points for the SF-36 VS +1 point in the placebo group), and treating doctors who noted “Strong or noticeable improvement” on the scale of the general clinical impression of CGI more than 53% of Mexidol® patients and 15% in the placebo group, and 48% of the placebo group on this scale “The condition has not changed/worsened”. Taking the drug Mexidol® in chronic brain ischemia significantly influenced the quality of life.

Thus, it can be said that prolonged sequential therapy with Mexidol® and Mexidol® Forte 250 contributed to a reliable reduction in the level of cognitive impairment, autonomic manifestations, equilibrium disorders, walking, a decrease in asthenia, a decrease in anxiety, and improving the quality of life and well -being. Positive dynamics was increasing in nature when evaluating all the above scales, tests and questionnaires, reaching the maximum of effectiveness to the end of a long consistent therapy (i.e. on the 75th day), which once again proves the importance of a full course of therapy.

Subanaliz in age groups of subanaliz in patients with arterial hypertension

Subanaliz
in age groups

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The study of Memo also confirms the effectiveness of prolonged sequential therapy with Mexidol® and Mexidol® Fort 250 in relation to cognitive, emotional and motor disorders in patients with chronic brainstream of various age -related subgroups. Subanaliz by age demonstrated the significant advantages of the drug Mexidol® over a placebo in patients in all age groups: 40-60, 61-75 and 76-90 years.

The primary criterion of effectiveness is the dynamics
of changing the average score on the Mosa scale
in different age groups

The results indicate the appropriateness of the use of long -term sequential therapy with
Mexidol® and Mexidol® Fort 250 in patients of different ages with chronic brain ischemia [2].

Subanalis in patients
with arterial hypertension

The study of Memo also confirms the effectiveness of prolonged sequential therapy with Mexidol® and Mexidol® Fort 250 in relation to cognitive, emotional and motor disorders in patients with chronic brain ischemia and arterial hypertension (hypertension). Subanalis in patients with hypertension demonstrated the significant advantages of Mexidol® over a placebo in patients with chemical and hypertension.

Primary endpoint: the dynamics of points on the
Mosa scale in patients with arterial hypertension (AG)

The results indicate the effectiveness of the use of long -term sequential therapy with
Mexidol® and Mexidol® Fort 250 in patients with chronic brain ischemia and arterial hypertension [3].

Conclusions

The results of the study convincingly indicate the high clinical efficiency of prolonged sequential therapy with Mexidol® and Mexidol® Forter Cerebus Cerebus, including in all age groups, which was expressed in the reliable regression of such important manifestations of chronic brain ischemic as cognitive, emotional, vegetative and motor Violations.

The simultaneous significant regression of all the main clinical manifestations of chronic brain ischemia is an important argument in favor of the fact that therapy with Mexidol® affects the pathogenetic links of chronic vascular brain damage, not limited to symptomatic improvement.

Safety

All unwanted phenomena registered in this study had an easy and moderate degree of severity, the differences between the groups were statistically insignificant. The results of laboratory analyzes and physics examination also testified to the lack of significant differences between the compared groups.

List of literature

Information is intended for medical and pharmaceutical workers. This information cannot serve as a replacement for a doctor’s consultation.

Source of photos and images Shutterstock.com

Study of Memo in chronic brain ischemia

Mexidol® and Mexidol® Forte 250 preparations showed a high degree of efficiency and safety in the international multicenter randomized double blind, a placebo-controlled study of evaluating the effectiveness and safety of consistent therapy of patients with chronic brain ischemia-memo [1].

Research design

Research design memo

Efficiency criteria

Results

Subanaliz in age groups

Subanalis in patients with arterial hypertension

Conclusions

Safety

List of literature

Study of Memo in chronic
brain ischemia

Subanaliz
in age groups

Subanalis in patients
with arterial hypertension