Mitochondrial cytoprotectors in complex therapy of chronic heart failure in patients with metabolic syndrome or type 2 diabetes mellitus: subanalysis of the INDIKOR study

Objective. To study the effect of Mildronate on the quality of life (QOL) of patients with CHF, metabolic syndrome or type 2 DM. Material and methods. A multiple-center, controlled, non-interventional study INDIKOR (Insulin Resistance and Diabetes Mellitus as Cardiovascular Risk Factors: Metabolic Correctors in Combination Therapy for IHD and/or CHF with Metabolic Syndrome or Type 2 Diabetes Mellitus (T2DM)) included 2084 patients (median age 62 (55; 67) years) with a combination of two (or more) diagnoses (E66/E11+I20/I25/I50): E66 «Obesity»; E11 «Type 2 Diabetes Mellitus»; I20 «Angina Pectoris [Angina Pectoris]»; I25 «Chronic Ischemic Heart Disease»; I50 «Heart Failure». The present subanalysis for CHF included 1128 patients with a diagnosis of I50 «Heart Failure». Patients were divided into 2 groups depending on intake of Mildronate: group 1 — basic therapy for concomitant diseases (n=231; 20%), group 2 — basic therapy+Mildronate 1000 mg/day (n=897; 79%). The follow-up was 42±2 days. Results. Mildronate therapy for 42 days (1000 mg/day) as a part of therapy demonstrated better condition of patients with CHF against the background of metabolic disorders. There was significant improvement in functional class of CHF: reduced proportion of patients with class IV CHF (up to 0.1%), class III (up to 3.2%) and class II (up to 58.3%) compared to the control group (class III up to 10.8% and class II up to 62.3%, p<0.001 between groups in both cases); improvement of angina: complete disappearance of class IV, less incidence of class III (up to 2.8%) and II (up to 42.6%) compared to the control group (class III up to 10.4% and class II up to 45.9%) (p<0.001 between groups). In the main group, ECG monitoring revealed significant decrease in the incidence of blocks (13.6% versus 21.1%, p=0.011), arrhythmias (5.7% versus 14.3%, p<0.001) and proportion of ECG with deviations (41.1% versus 49.8%, p=0.028). Systolic BP decreased to 130 [122; 135] versus 130 [125; 140] mm Hg in the control group (p=0.002). QoL increased significantly according to the Seattle Questionnaire — median scores on seizure stability scale reached 100 [75; 100] versus 50 [50; 75] in the control (p<0.001); attack frequency scale — 80 [60;100] versus 60 [50;80] (p<0.001); physical activity limitation scale — 53.3 [42;62] versus 46.7 [33; 57] (p<0.001); treatment satisfaction scale — 76 [66;90] versus 65 [52; 76] (p<0.001); attitude towards disease scale — 66 [50; 75] versus 50 [41;66] (p<0.001). According to the Minnesota Quality of Life Questionnaire, total score significantly decreased (28.9±18.44) in the group of Mildronate compared to the control group (44.2±21.81, p<0.001). The Multidimensional Fatigue Inventory (MFI-20) showed significant decrease of asthenia under Mildronate therapy (total score decreased to 46.8±13.43) compared to the control group (61.4±15.29, p<0.001). Conclusion. Mildronate throughout 6-week therapy in patients with CHF against the background of metabolic disorders (obesity and/or type 2 diabetes) demonstrated significant clinical effects. Our results indicate better functional class of CHF and angina. Incidence and intensity of angina attacks significantly decreased, and ECG parameters with QOL improved. These data confirm the feasibility of Mildronate in complex treatment for these patients to achieve optimal clinical results.