Clinical effectiveness and safety of prolonged release form of alimemazine in patients with generalized anxiety disorder

Abstract

The prolonged release tablets form of alimemazine is seen as a promising agent for the long-term treatment of generalized anxiety disorder (GAD).Objective: to investigate the efficacy and safety of therapy with alimemazine (Teraligen® retard, prolonged release film-coated tablets) in patients with GAD.Material and methods. The study design was a multicentre, open-label, non-comparative clinical trial (CT) with two doses of alimemazine 20 and 40 mg (Teraligen® retard, prolonged-release film-coated tablets). 129 patients diagnosed with GAD (criteria according to the ICD-10 classification), 86 women and 43 men were included, mean age 38.0±11.1 years. The level of anxiety, assessed by the Hamilton HARS scale, at Week 0 (Visit 1) was 24.8±7.3 points.Results. By Week 6, the level of anxiety statistically significantly decreased to a mean score of 10.8±6.6, while the dynamics of the mean score relative to baseline was -14.0±6.27 (p<0.0001). The proportion of patients with a decrease in the total score on the HARS scale by 50% or more compared with the initial value was: after 1 week of therapy – 10.3% (n=13); after 3 weeks of therapy – 60.5% (n=75; compared to baseline, p<0.0001); after 6 weeks of therapy – 69.4% (n=86; compared to baseline, p<0.0001). The therapy was well tolerated, among the adverse events (AEs) patients noted: morning sleepiness (7.8%; n=10); dry mouth (7.8%; n=10); general weakness (4.7%; n=6). Other AEs (dizziness, headache, impaired concentration, muscle weakness, memory impairment, tinnitus, tachycardia) were much less common. From the side of the liver, no AEs were detected, including changes in the activity of liver enzymes.Conclusion. Prolonged release alimemazine tablets 20 mg and 40 mg for six weeks resulted in a statistically significant reduction in anxiety levels, with at least two-thirds of patients experiencing more than half their anxiety. The effect increases with each week as you continue to take the drug. The prolonged release form of alimemazine is well tolerated, the treatment of GAD with the drug is effective and safe and may represent a rational alternative to antidepressant therapy.