According to American Heart Association, more than 100 million people in the U.S. have elevated cholesterol levels. The most common course of treatment is statin drug therapy, which not only hinders the body’s ability to manufacture artery-clogging cholesterol, but it’s also accepted that statins help the body reabsorb cholesterol that has accumulated in artery wall plaque to help prevent further blood vessel blockages. While there are many natural supplements that claim to help lower cholesterol, one company recently made news with bona fide proof that its natural supplement not only works, but also helps statin therapy to work better.

New York-based Diversified Natural Products, Inc, (DNP) is the maker of HEP-40, a cholesterol-lowering natural supplement that has been sold in Canada for the last five years. The company recently reported the results of a promising new study, which demonstrated that the addition of HEP-40 to statin therapy significantly lowered LDL cholesterol and improved lipid profiles in patients who had not reached target LDL levels. This information was presented at the 58th annual Scientific Sessions of the American College of Cardiology.

HEP-40 is a low molecular weight (approximately 40,000 Daltons) enzymatically hydrolyzed polysaccharide derived from food grade chitosan-a fiber that is obtained from the exoskeletons of shellfish, which has been highly deacetylated.

However, HEP-40 is not like other chitosans, explained Paul Jacobson, DNP’s CEO. “HEP-40 reduces LDL cholesterol levels without negatively impacting HDL cholesterol, and can delay the need for pharmaceutical drugs,” he said. “It is ideally suited for long-term continuous use.”

HEP-40 is not systemic, he added. “It works in the intestine and like a magnet, binding the fats in the intestine and forces their elimination before they can be absorbed into the blood stream,” he said. “This binding process prevents fats and lipids from being absorbed. As a result, more cholesterol passes through the digestive system and is eliminated naturally, without entering the bloodstream.”

Study Details

The randomized, double blind, placebo-controlled study included 68 patients who were on a low dose of Lipitor, Crestor and to a lesser extent, Zocor. Patients were treated for 12 weeks on the low dose statin plus HEP-40 or a low dose statin plus placebo. The HEP-40 plus statin group experienced a 25% additional reduction in LDL, relative to the placebo plus statin group. The HEP-40 plus statin group also experienced a 33% reduction in triglycerides, relative to the placebo plus statin group and there was a trend toward improved HDL in the HEP-40 group, relative to placebo (a 7% increase). HEP-40 was well tolerated and there were no significant side effects reported.

Of the 68 patients enrolled into the study, 52 were randomized to receive HEP-40 (N=25) or placebo (N=27) for 12 weeks. Of the 52 patients analyzed, 3 (5.8%) patients were lost to follow-up and an additional 3 (5.8%) discontinued due to a non-serious adverse event that was equal to the placebo. Mean (SD) age was 57 (11.2) and 73.5% of patients were male.

The study concluded that for patients not at target LDL cholesterol with statin monotherapy, the co-administration of HEP-40 is safe, well tolerated and significantly more effective in reducing LDL-C levels when compared to statin monotherapy.

Dr. John Sampalis, senior scientific director of JSS Medical, Quebec, Canada, and lead investigator of the HEP-40 clinical trial, summarized the presentation when he stated: “While the number of statin prescriptions continues to grow, physicians are increasingly wary of the tolerance issues associated with statins and are seeking to minimize the dose of statins where possible in order to limit side effects. The addition of HEP-40 to statin therapy appears to offer a natural, effective and safe addition to statin therapy that can improve efficacy.”

“In the present climate, natural products to treat cardiovascular disease and lipids have become increasingly important. There is widespread usage of omega 3 fish oil products and niacin to affect lipid and cardiac outcome,” commented Dr. Robert Weiss, MD, director of research, Maine Research Associates, and a member of the DNP Scientific Advisory Board. “Use of cholesterol-lowering spreads and additives has become popular. This early study of HEP-40 may add yet another safe and highly potent agent to the effective treatment of cardiovascular risk.”

Mr. Jacobson said DNP has the only commercial scale hydrolysis process in the world for producing short chain chitosans of a uniform size. “We’re now in discussion with the pharmaceutical industry to partner this with a drug company,” he said. “We’re looking at taking a natural product and turning it into a drug, both as a monotherapy and in combination with statins.”

HEP-40 currently retails for about $30 for a one month supply of capsules.

DNP develops natural products for treating chronic diseases, with “fewer side effects and long-term toxicity risks than prescribed drugs.” The company’s stable of five products have patent protection and clinical proof of efficacy and span cholesterol reduction, joint pain/arthritis and psoriasis. Other products in development focus on gastrointestinal and dermatological health.

“Our business model is to run clinical trials that are the equivalent of Phase II pharmaceutical grade double-blind, placebo-controlled studies,” concluded Mr. Jacobson. “If they don’t work, we don’t sell them.”