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Ultra-small phospholipid nanoparticles in the treatment of combined hyperlipidemia: a randomized placebo-controlled clinical trialстатья Исследовательская статья
- Авторы: Archakov A.I., Kukharchuk V.V., Lisitsa A.V., Ponomarenko E.A., Romashova Yu A., Pleshakova T.O., Yarovaya E.B., Kutsenko V.A., Guseva M.K., Beregovykh V.V., Ipatova O.M., Zubareva M.K., Tikhonova E.G., Ivanov S.V., Bedretdinov F., Markin S.S.
- Журнал: Research in Pharmaceutical Sciences
- Том: 19
- Номер: 6
- Год издания: 2024
- Издательство: Isfahan University of Medical Sciences
- Местоположение издательства: Iran, Islamic Republic of
- Первая страница: 656
- Последняя страница: 668
- DOI: 10.4103/rps.rps_274_23
- Аннотация: Background and purpose: Combined hyperlipidemia is associated with an increased risk of cardiovascular events. This clinical trial investigated phospholipovit (essential phospholipids, Institute of Biomedical Chemistry, Moscow, Russia), an ultra-small phospholipid nanoparticle (micelles), targeted to phospholipids of HDL in lowering non-HDL-cholesterol (non-HDL-C) and triglycerides (TG) levels in patients with combined hyperlipidemia and moderate cardiovascular risk.Experimental approach: A randomized, double-blinded, placebo-controlled phase II trial was conducted on 100 patients. Phospholipovit or placebo was randomly administered orally (500 mg) 2 times a day for 12 weeks. The primary endpoint was the percent change of non-HDL-C from baseline to 12 weeks of exposure.Findings/Results: Treatment with phospholipovit resulted in a mean non-HDL-C reduction of 13.2% versus 4.3% compared with placebo. The absolute decrease in non-HDL-C was -23.2 (-48.7 - 7.0) mg/dL versus -7.3 (-17.0 - 12.0) mg/dL, significantly. The therapeutic target of non-HDL-C less than 130 mg/dL (3.4 mmol) was achieved in 15 of 39 patients (38.5%) in the phospholipovit group versus 2 of 41 patients (4.9%) in the placebo group OR 11.8 (2.4 - 116). Significant reduction in TG, apolipoprotein B, total cholesterol, and very low-density lipoprotein cholesterol levels was also observed. There were no changes in the liver and kidney functions, vital signs, or electrocardiography. There were no serious adverse events.Conclusion and implications: Phospholipovit significantly reduced non-HDL-C, TG, and atherogenic lipoproteins in patients with combined hyperlipidemia and moderate cardiovascular risk. It can be used as an add-on therapy to statins.
- Добавил в систему: Иванов Сергей Витальевич