Vitaphospholip® (water-soluble phosphatidylcholine) in the treatment of combined hyperlipidemia: a randomized, placebo-controlled clinical trial

  
Kukharchuk V.V.1, Ponomarenko E.A.2, Lisitsa A.V.2, Romashova Yu.A.2, Pleshakova T.O.2, Yarovaya E.B.3, Kutsenko V.A.4, Guseva M.K.2, Ipatova O.M.2, Karpova E.A.2, Zubareva M.Yu.1, Pyatigorsky A.M.2, Ivanov S.V.2 , Beregovykh V.V.2, Kudlai D.A.5, Markin S.S.2, Archakov A.I.2

1. Academician E.I. Chazov National Medical Research Center of Cardiology, Moscow, Russia
2. Institute of Biomedical Chemistry, Moscow, Russia
3. Lomonosov Moscow State University, Moscow, Russia
4. National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia
5. State Scientific Center “Institute of Immunology”, Moscow, Russia
Section: Clinical and Diagnostic Research
DOI: 10.18097/PBMCR1619     
Year: 2025  Volume: 71  Issue: 5  Pages: 364-374
Vitaphospholip®, a water-soluble form of phosphatidylcholine, has been evaluated in a clinical trial aimed at reducing non-HDL-cholesterol (non-HDL-C) and triglyceride (TG) levels in patients with combined hyperlipidemia. The randomized, double-blind, placebo-controlled study included 100 patients. Vitaphospholip® or placebo was administered orally 500 mg twice a day for 12 weeks.Treatment with Vitaphospholip® resulted in a 13.2% decrease in non-HDL-C compared to 4.3% in the placebo group (p = 0.001). The absolute decrease of non-HDL-C was 0.6 mmol/l compared to -0.2 mmol/l in the placebo group (p = 0.001). The target non-HDL-C level of less than 3.4 mmol/L was achieved in 15 of 39 patients (38.5%) in the Vitaphospholip® group versus 2 of 41 patients (4.9%) in the placebo group (p = 0.000). The absolute decrease of TG in the group of patients treated with Vitaphospholip® was -0.7 mmol/l versus -0.1 mmol/L in the placebo group (p = 0.001). During therapy with Vitaphospholip®, a significant decrease in the levels of apolipoprotein B, total cholesterol, and very low-density lipoprotein cholesterol was observed. No changes in liver or kidney function, vital signs, or ECG were registered. No serious adverse events were identified. Thus, Vitaphospholip® significantly reduced the levels of non-HDL-C, TG, and atherogenic lipoprotein in patients with combined hyperlipidemia and moderate cardiovascular risk.
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Keywords: Vitaphospholip®, water-soluble phosphatidylcholine, combined hyperlipidemia, non-HDL-C, triglycerides
Citation:

Kukharchuk, V. V., Ponomarenko, E. A., Lisitsa, A. V., Romashova, Yu. A., Pleshakova, T. O., Yarovaya, E. B., Kutsenko, V. A., Guseva, M. K., Ipatova, O. M., Karpova, E. A., Zubareva, M. Yu., Pyatigorsky, A. M., Ivanov, S. V., Beregovykh, V. V., Kudlai, D. A., Markin, S. S., Archakov, A. I. (2025). Vitaphospholip® (water-soluble phosphatidylcholine) in the treatment of combined hyperlipidemia: a randomized, placebo-controlled clinical trial. Biomeditsinskaya Khimiya, 71(5), 364-374.
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