Dyslipidemia is an abnormal amount of lipids in the blood. There are many types of dyslipidemia - for example, while some patients have high LDL (bad cholesterol), others may have high triglycerides, low HDL (good cholesterol), or other mixed dyslipidemias.
For more than half a century we have known that high doses of Vitamin B3 (Niacin) can effectively treat dyslipidemias that many other LDL(bad)-cholesterol-lowering medications cannot (Schandelmaier et al.). Niacin is, therefore, a unique tool that physicians can use to help correct complex lipid disorders beyond simply reducing high LDL-cholesterol.
VTS-63: ER-Niacin + VTS-Aspirin
ER (extended-release) niacin currently has six FDA approved indications and has been prescribed to millions of patients in the U.S. alone (Jackevicius et al.). However, a well-known side effect of treating with ER niacin is Niacin Flush (Mills et al.).
The Niacin Flush is a historical term for the medical syndrome of the “skin on fire” experience of these patients.
Niacin Flush can be felt and seen just hours after ingesting the ER niacin (Mills et al.) and can be incredibly painful. Patients who experience Niacin Flush skip doses of or discontinue ER niacin (Rhodes et al.), a potentially life-saving medication.
VTS-63 Pilot Study
In a Harvard University and Drexel University prospective, double-blind, placebo-controlled crossover trial (Banka et al.) of 26 healthy male and female subjects, those who had flush experienced statistically less moderate or severe flushes with VTS-63 when compared with niacin alone (p=0.03), and also when compared with niacin and standard aspirin taken concurrently.
VTS-63 uses a proprietary aspirin formulation to help reduce flush.
n = 26 p = 0.03
Adapted from Banka et al.
Existing FDA Indications
An adjunctive therapy for treatment of adult patients with very high serum TG levels who are at risk of pancreatitis
Treatment of primary hypercholesterolemia
An adjunct to diet for reduction of elevated total cholesterol (TC), low-density lipoprotein (LDL-C), apolipoprotein (Apo B), and triclyceride (TG) levels, and increased high-density lipoprotein (HDL-C) in patients with primary hypercholesterolemia
In patients with a history of MI (myocardial infarction) and hypercholesterolemia, indicated to reduce risk of recurrent nonfatal MI
Indicated to slow progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease
An adjunct to diet for reduced TC and LDL-C levels in adult patients with primary hypercholestermia
Adapted from ER Niacin FDA Approved Labeling: Jan 24, 2013