Clinical Validity of a Program for Predicting Individual Cytoprotective Efficacy of Ethylmethylhydroxypyridine Malate
To assess the clinical validity of the clinical decision support system (CDSS) "Prognostika" for predicting individual cytoprotective efficacy of ethylmethylhydroxypyridine malate (EMHP-malate) in patients with ischemic heart disease (IHD), a retrospective analysis of a randomized clinical trial was performed (n = 60; stable exertional angina, functional class I–III). Patients were allocated into standard therapy (n = 30) and standard therapy plus EMHP-malate (n = 30); in the latter group a prognostic coefficient (PC) was retrospectively calculated, stratifying patients into subgroups with predicted presence [Group 2-PC(+), n = 18] or absence [Group 2-PC(−), n = 12] of cytoprotective activity. Validity was assessed by ROC analysis (AUC), decision curve analysis (DCA), and the Hosmer – Lemeshow test. AUC was 0.927 (95 % CI: 0.824–0.997); DCA demonstrated superiority of the CDSS over "treat-all" and "treat-none" strategies across all threshold probabilities (20–99 %); the Hosmer–Lemeshow test confirmed good calibration (χ² = 0.531; p = 0.912). The CDSS "Prognostika" demonstrates excellent discrimination, good calibration, and substantial clinical utility.
Romashchenko O.V., Alferov P.K., Rumbesht V.V., Ovchinnikov S.O., Yakunchenko T.I., Mevsha O.V., Smirnova M.A., Belova B.G. 2026. Clinical Validity of a Program for Predicting Individual Cytoprotective Efficacy of Ethylmethylhydroxypyridine Malate. Challenges in Modern Medicine, 49(2): 145–159 (in Russian). DOI: 10.52575/2687-0940-2026-49-2-145-159. EDN: UJZDAE
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Nattino G., Pennell M.L., Lemeshow S. 2020. Assessing the Goodness of Fit of Logistic Regression Models in Large Samples: A Modification of the Hosmer-Lemeshow Test. Biometrics. 76(2): 549–560. doi: 10.1111/biom.13249
Nazmun Nahar, Md. Shihab Uddin Sohag. 2025. Advancements in Mitochondrial-Targeted Antioxidants: Organelle-Specific Drug Delivery for Disease Management. Advances in Redox Research, Volume 17: 100142. doi:10.1016/j.arres.2025.100142
Rathore A.W.H., Naveed H., Nadeem A., Ishaque A., Iqbal S., Ilyas U., Arooj T., Rafaqat S. 2026. Relationship between the Oxidative Stress Biomarkers and Coronary Heart Disease: Pathogenesis to Therapeutic Aspects. World J Cardiol. 18(2): 113624. doi: 10.4330/wjc.v18.i2.113624
Romaschenko O.V., Pokrovsky M.V., Nadezhdin S.V., Rumbesht V.V., Zhernakova N.I., Alferov P.K., Grischenko N.D., Gorbach T.V., Sychenko A.V., Kharkiv K., Statsenko L.V., Kukes V.G. 2022. Personalized Approaches to the Use of the Antioxidant Ethoxidol in Patients with Coronary Heart Disease. Journal of Nanostructures. 12(2): 343–352. doi: 10.22052/JNS.2022.02.011
Uppal N., Uppal V., Uppal P. 2014. Progression of Coronary Artery Disease (CAD) from Stable Angina (SA) Towards Myocardial Infarction (MI): Role of Oxidative Stress. J Clin Diagn Res. 8(2): 40–3. doi: 10.7860/JCDR/2014/7966.4002
Vickers A.J., Holland F. 2021. Decision Curve Analysis to evaluate the Clinical Benefit of Prediction Models. Spine J. 21(10): 1643–1648. doi: 10.1016/j.spinee.2021.02.024
Vrints C., Andreotti F., Koskinas K.C., Rossello X., Adamo M., Ainslie J., Banning A.P., Budaj A., Buechel R.R., Chiariello G.A., Chieffo A., Christodorescu R.M., Deaton C., Doenst T., Jones H.W., Kunadian V., Mehilli J., Milojevic M., Piek J.J., Pugliese F., Rubboli A., Semb A.G., Senior R., Ten Berg J.M., Van Belle E., Van Craenenbroeck E.M., Vidal-Perez R., Winther S. 2024. ESC Scientific Document Group. 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. Eur Heart J. 45(36): 3415–3537. doi: 10.1093/eurheartj/ehae177
Vekic J., Stromsnes K., Mazzalai S., Zeljkovic A., Rizzo M., Gambini J. 2023. Oxidative Stress, Atherogenic Dyslipidemia, and Cardiovascular Risk. Biomedicines. 11(11): 2897. doi: 10.3390/biomedicines11112897
The study was supported by Medimax LLC (Kurgan, Russia).