OBJECTIVE
Study of the therapeutic equivalence of forms for intramuscular and intravenous administration of the drug Cortexin in patients in the acute and early recovery periods of ischemic stroke (IS).
MATERIAL AND METHODS
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted. The study included 490 patients with acute IS, male (54.1%) and female (45.9%) aged from 30 to 80 years (average age 63.97+8.5 years), divided into 2 groups: 1 — main (Cortexin intravenous form, n=246), 2 — comparison (Cortexin intramuscular form, n=244). Patients in both groups received 2 courses of therapy lasting 10 days. In the first course: Group 1 — Cortexin 10 mg IV and placebo IM 2 times a day; Group 2 — Cortexin 10 mg IM and placebo IV 2 times a day. After 10 days, patients in both groups received a second course of therapy with Cortexin 10 mg, IM, 2 times a day, 10 days. The period of active treatment and observation for each patient was 90 days. The evaluation of the effectiveness of the studied Cortexin dosage forms was defined as the proportion of patients who reached 0—2 on the modified Rankin scale (mRS) on the 90th day of the study. Additionally, the dynamics of scores on the Stroke Scale of the National Institute of Health (NIHSS) and the Short Mental Status Assessment Scale (MMSE) were evaluated on the days of active treatment and follow-up. Safety was assessed by the frequency of adverse events (AE).
RESULTS
The proportion of patients who reached 0—2 on the mRS scale on day 90 was 93.64% and 86.50% in the groups receiving Cortexin intravenously and intramuscularly, respectively. By the end of the follow-up period, the total score on the NIHSS scale decreased by 3.93 and 3.72, respectively, in both groups. According to the MMSE scale, by the day of completion of the study, the overall dynamics of the average score in group 1 was 4.11, in the comparison group 3.88 (p=0.249). The study showed the comparable safety of the two dosage forms of Cortexin. In the main group 1, 74 AES were registered in 60 patients, in the comparison group — 51 AES in 41 people, the number of cases did not differ between the groups (p>0.05).
CONCLUSION
The intravenous form of Cortexin administration has been proven to be no less effective than the intramuscular form in restoring functional, neurological and cognitive deficits in patients with acute AI. Both dosage forms have shown a comparable safety profile, are therapeutically equivalent, and can be used in clinical practice at both the hospital and outpatient stages of managing patients with acute cerebral circulatory disorders.
