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KUDESan® (3% drops for oral use) in treatment of patieNts with heart failure: efficacy and safety In Combination with standard therapy (KUDESNIC). Design and results of a prospective, randomized, double-blind KUDESNIC study

Mareev V.Yu.1, Minina Yu.V.2, Begrambekova Yu.L.1
1 – Federal State Budgetary Educational Institution of Higher Professional Education, "M.V. Lomonosov Moscow State University", Leninskie Gory 1, GSP-1, Moscow 119991
2 – All-Russian Public Organization, "Society of Experts in Heart Failure", Moscow, info@ossn.ru

Keywords: Kudesan, coenzyme Q10, safety, efficacy, treatment, CHF

DOI: 10.18087/rhfj.2016.4.2257

Background. In addition to the standard therapy for CHF, a possible option for influencing symptoms and quality of life is acting on myocardial metabolism. One of cardioprotectors recommended for CHF treatment is coenzyme Q10, which reduces intensity of oxidative stress at the molecular level and possesses antioxidant properties. Aim. To evaluate clinical efficacy and safety of the drug Kudesan® in the dosage form of 3% oral drops as a part of multimodal therapy for CHF in the real practice setting. Materials and methods. The study included 148 patients aged 50 to 70 with FC II-III CHF. All patients received 3 ml of 3% Kudesan® solution (equivalent to Kudesan 90 mg per day) or placebo. Thorough clinical examination, including ECG, two-dimensional EchoCG (extended examination), 6-min walk test, CHF FC determination, clinical condition evaluation using the Clinical Condition Scale (CCS), evaluation of quality of life using different scales and questionnaires, measurement of blood BNP and coenzyme Q10, and recording the number of hospitalizations for decompensated CHF, were performed for all patients before and 6 months after the treatment. Safety was evaluated by records of adverse events (AEs) and changes in laboratory test results. Results. Study results demonstrated Kudesan® efficacy as evidenced by improved functional condition of patients, a significant increase in 6-min walk distance, improved CHF FC, a greater decrease in the CCS total score, a significant increase in LV EF, reduced dimensions of heart chambers, a tendency to decrease in BNP, and significant improvements in several parameters of quality of life. Analysis of all AEs ranged by their severity and relationship with the Kudesan® treatment showed good tolerability of Kudesan®. Conclusion. The study has demonstrated that Kudesan® is capable to considerably improve effects of the standard therapy for CHF.
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Mareev V.Yu., Minina Yu.V., Begrambekova Yu.L. KUDESan® (3% drops for oral use) in treatment of patieNts with heart failure: efficacy and safety In Combination with standard therapy (KUDESNIC). Design and results of a prospective, randomized, double-blind KUDESNIC study. Russian Heart Failure Journal. 2016;17 (4):236–249

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