Clinical and laboratory evaluation of the effectiveness of the nootropic drug Actitropil (fonturacetam) in the treatment of asthenic syndrome

Abstract

Background. Asthenia is one of the most common symptoms in the clinical practice of a doctor of any specialty. This is due to the high incidence of this pathology: in patients with chronic somatic diseases from 45% to 90%, with an acute pathological process – about 55%. There are no uniform standards for the treatment of asthenic disorder; however, the basis for the medical correction of this pathology is nootropic drugs.
 Aim. To study the clinical efficacy and safety of the nootropic drug Actitropil (fonturacetam) in patients with various types of asthenic disorder.
 Materials and methods. The observational clinical program included 50 patients (average age 43.22±14.60) with asthenic symptoms. Patients received Actitropil (fonturacetam) at a dose of 200 mg per day, divided into two doses. The duration of therapy was 30 days, the total duration of follow-up was 60 days. The effectiveness of treatment was evaluated before and after the course of therapy, as well as in the delayed period according to the scales of asthenia MFI-20, well-being, activity, mood SAN, anxiety and depression HADS (part 1), sleep quality Spiegel, quality of life EQoL-5D-3L. Patients' satisfaction with the treatment and tolerability of therapy were also assessed on 5-point scales; adverse events were recorded and the number of patients with good, satisfactory and unsatisfactory treatment results was calculated based on the subjective assessment of the subjects. Blood parameters analysis was used as laboratory assessment methods: erythrocytes, leukocytes, reticulocytes, platelets, hemoglobin, hematocrit, blood sedimentation rate, total protein, glucose, alanine aminotransferase, aspartate aminotransferase, prothrombin and thrombin time, prothrombin, international normalised ratio, activated partial thromboplastin time, fibrinogen.
 Results and conclusion. The results of the study showed high efficacy (98%) and safety of the use of Actitropil (absence of adverse events, low adverse events level during the course of treatment, no negative effect on liver function, blood coagulation and carbohydrate metabolism) in the treatment of various types of asthenic syndrome, including those associated with comorbid diseases. There is a significant therapeutic effect of Actitropil on concomitant symptoms of asthenia: anxiety, sleep status and quality of life. The antiasthenic effect of the drug does not differ depending on age and increases in the delayed period.