Pleurotus ostreatus, the oyster mushroom, naturally contains up to 2.8% lovastatin on a dry weight basis.
[15]
Compactin and lovastatin, natural products with a powerful inhibitory effect on
HMG-CoA reductase, were discovered in the 1970s, and taken into clinical development as potential drugs for lowering
LDL cholesterol.
[16][17]
In 1982, some small-scale clinical investigations of lovastatin, a polyketide-derived natural product isolated from
Aspergillus terreus, in very high-risk patients were undertaken, in which dramatic reductions in LDL cholesterol were observed, with very few adverse effects. After the additional animal safety studies with lovastatin revealed no toxicity of the type thought to be associated with compactin, clinical studies continued.
Large-scale trials confirmed the effectiveness of lovastatin. Observed tolerability continued to be excellent, and lovastatin was approved by the US
FDA in 1987.
[18] It was the first statin approved by the FDA.
[19]
Lovastatin is also naturally produced by certain higher
fungi, such as
Pleurotus ostreatus (oyster mushroom) and closely related
Pleurotus spp.
[20] Research into the effect of oyster mushroom and its extracts on the cholesterol levels of laboratory animals has been extensive,
[21][22][20][23][24][25][26][27][28][29][30][31] although the effect has been demonstrated in a very limited number of human subjects.
[32]
In 1998, the FDA placed a ban on the sale of dietary supplements derived from
red yeast rice, which naturally contains lovastatin, arguing that products containing prescription agents require drug approval.
[33] Judge
Dale A. Kimball of the
United States District Court for the District of Utah, granted a motion by Cholestin's manufacturer, Pharmanex, that the agency's ban was illegal under the
1994 Dietary Supplement Health and Education Act because the product was marketed as a dietary supplement, not a drug.
[34]
Connect With Us