Probiotic, Red Yeast Rice Extract Combo May Cut Cholesterol

Patrice Wendling

May 05, 2017

PRAGUE, CZECH REPUBLIC — Supplementation with the probiotic Bifidobacterium longum BB536 added to red yeast rice extract improves lipid profiles in patients with moderate hypercholesterolemia, new research shows[1].

Among the 32 patients, LDL cholesterol dropped 26% from 183 to 136 mg/dL after 12 weeks of supplementation vs no change with placebo (P<0.0001; nonparametric t test).

Total cholesterol declined 17% vs 0% with placebo (P<0.0001).

The changes were already achieved after just 6 weeks, senior study author Dr Paolo Magni (University of Milan, Italy) reported here at the European Atherosclerosis Society (EAS) 2017 Annual Congress.

"A 26% reduction in LDL was what was we had in WOSCOPS on pravastatin 40 mg. So it's a very reasonable reduction," session moderator Dr Chris Packard (University of Glasgow, Scotland) told heartwire from Medscape.

To take this product forward, however, he said researchers will need to determine how much of the benefit was derived from each of the two key components in the supplement, which also contains niacin and coenzyme Q10.

Red yeast rice extract has been touted for decades for its cholesterol-lowering benefits, with an early American study reporting a 15% reduction in LDL-C levels over an 8-week period among patients taking a proprietary Chinese red yeast rice dietary supplement[2].

In the current double-blind, randomized study, baseline LDL-C levels ranged from 130 to 200 mg/dL among the 32 patients (50% male, aged 18–70 years) who had low cardiovascular risk and were randomly assigned to 1.8 g once-daily of the water-soluble supplement (Lactoflorene Colesterolo, Montefarmaco OTC) or placebo.

After 12 weeks, patients taking the supplement rather than placebo had lower apolipoprotein B (-20% vs -1%; P=0.0003) and non-HDL cholesterol (-24% vs 0%; no P value reported).

HDL cholesterol, apolipoprotein A, and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels were unchanged, and triglycerides similarly decreased (-12% vs -13%) in both arms.

Magni explained that B longum BB536 has high biliary salt hydrolase activity and may lower circulating cholesterol by reducing cholesterol absorption in the large intestine, whereas red yeast rice forms naturally occurring hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors and other monacolins that reduce cholesterol biosynthesis in hepatic cells.

"In my opinion, this is interesting because we can inhibit synthesis and reabsorption, and each of us is either a big producer or a big reabsorber. So in this way, we can interfere with both mechanisms," he told heartwire .

Analyses have also shown that the gut microbiota in patients' feces is unchanged after supplementation.

Magni recalled one "overresponder," a 70-year-old woman without cardiovascular disease whose total and LDL cholesterol suddenly shot up to 300 mg/dL and 220 mg/dL, respectively. After she took the supplement, her LDL-C was cut roughly in half to 104 mg/dL.

Overall, compliance was excellent at 97% and no adverse effects were reported, although myalgias have been previously reported with red yeast rice extract.

The supplement, which has been commercially available in Italy for the past year and may be launched elsewhere, may face stiff competition in the global market given the falling price of generic statins, Packard observed.

The study was supported by an unrestricted grant from Montefarmaco OTC. Packard reports consulting for MSD, Sanofi, Regeneron, and Pfizer and receiving speaker honoraria from MSD and Amgen and research grants from MSD and Roche. Disclosures were not available for Magni.

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