Purpose: to assess efficacy of correction of anxiety states by anxiolytic drug fabomotizole in ambulatory patients with arterial hypertension (AH) and / or ischemic heart disease (IHD).
Materials and methods: In the framework of multicenter cross-sectional study with participation of patients aged ≥55 years with verified AH / IHD we conducted the therapeutic part of the COMETA program in which we included patients with comorbid anxiety state (≥11 points on the Hospital Anxiety and Depression Scale Anxiety [HADS-A] and clinically expressed anxiety state) without clinically expressed depressive symptoms (<11 points on the HADS-Depression). Participants were randomized into main and control groups. Patients in the main group in addition to therapy prescribed because of AH / IHD were given a recommendation to take fabomotizole (10 mg thrice a day), patients of control group received standard therapy. Efficacy of therapy was evaluated by HADS and visual analog scale after 6 and 12 weeks of observation.
Results: We included 182 and 104 in the main and control groups, respectively. Most patients in main and control groups had AH (97.3 and 95.2 %, respectively, about one third had IHD (36.8 and 30.8 %, respectively). Social-demographic, clinical characteristics, and recommended for AH / IHD treatment of participants of both groups were similar. Portion of patients with complete reduction of anxiety symptoms (<8 points on HADS-A) was significantly higher already after 6 weeks of fabomotizole therapy (37.9 and 19.2 %, respectively, p<0.001). Analogous picture was noted by the end of observation (66.9 and 32 %, respectively; p<0.001). Mean estimate of chronic psychoemotional stress in the main group decreased by 25 % after 6 weeks (from 6.45±2.20 to 5.05±1.96 points; р<0.001) and by 40 % after 12 weeks (from 6.45±2.20 to 3.98±1.99 points; р<0.001). In the control group it also decreased but degree of lowering was 2 times less than in the main group (11.1 % vs. 25 % after 6 weeks, р=0.016; and 20 % vs. 40 % after 12 weeks, р<0.001, respectively).
Conclusion: The use of fabomotizole by patients with AH / IHD provided improvement of psychological status (reduction of anxiety symptoms and lowering of the level of chronic psychoemotional stress).