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

Abstract

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.

Keywords: combined hyperlipidemia; non-HDL-C; triglycerides; water-soluble phosphatidylcholine.