Ultra-small phospholipid nanoparticles in the treatment of combined hyperlipidemia: a randomized placebo-controlled clinical trial.

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.