New Study Demonstrates Improvements in LDL-Cholesterol on Top of Statin Therapy with HEP-40, a Novel Natural Product
NEW YORK--(BUSINESS WIRE)--Apr 3, 2009 - Diversified Natural Products, Inc. reported results of a new study presented this week at the 58th annual Scientific Sessions of the American College of Cardiology, demonstrating that the addition of HEP-40 (enzymatically hydrolyzed polysaccharide with a molecular weight of 40 kiloDaltons) to statin therapy significantly lowered low-density lipoprotein (LDL) cholesterol and improved lipid profiles in patients who had not reached target LDL levels.
Dr. John Sampalis, Senior Scientific Director of JSS Medical (Quebec, Canada) and lead investigator of the HEP-40 clinical trial 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.”
Clinical Trial Design and Results
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 (p=0.008). The HEP-40 plus statin group also experienced a 33% reduction in triglycerides, relative to the placebo plus statin group (p=0.008) and there was a trend to improved HDL in the HEP-40 group, relative to placebo (a 7% increase, p=0.08). HEP-40 was well tolerated and there were no significant side effects reported.
There were 68 patients enrolled into the study, 52 were randomized to receive HEP-40 (N=25) or placebo (N=27) for twelve 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. Mean (SD) age was 57.1 (11.2) and 73.5% of patients were male. The following table describes the lipid profile parameters from baseline to Week 12. Repeated measures analysis of variance showed a significant treatment effect over time for LDL-C (P=0.029). There were 3 (4.4%) patients who reported 5 non-serious adverse events related to treatment (HEP-40: 2; placebo: 3). There were no serious adverse events reported.
| Summary of HEP-40 Results
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| Lipids | Week 4 | Week 8 | Week 12 | |||||||||||
| (mg/dl) | HEP-40 | Placebo | HEP-40 | Placebo | HEP-40 | Placebo | ||||||||
| LDL-C | % Change | -16.61 | 0.23 | -16.63 | 14.19 | -14.85 | 10.70 | |||||||
| SD | 18.10 | 39.16 | 21.17 | 40.08 | 21.10 | 39.26 | ||||||||
| p-value | 0.056 | 0.002 | 0.008 | |||||||||||
| TC | % Change | -8.05 | 4.58 | -7.06 | 11.33 | -5.84 | 5.15 | |||||||
| SD | 18.47 | 26.40 | 20.45 | 27.25 | 22.82 | 27.40 | ||||||||
| p-value | 0.054 | 0.014 | 0.143 | |||||||||||
| HDL-C | % Change | 3.66 | 4.59 | 3.90 | 0.03 | 6.65 | 0.66 | |||||||
| SD | 10.45 | 18.88 | 12.25 | 10.64 | 16.49 | 8.45 | ||||||||
| p-value | 0.830 | 0.258 | 0.081 | |||||||||||
| TG | % Change | -16.12 | 2.63 | -13.39 | 4.45 | -21.62 | 3.15 | |||||||
| SD | 24.14 | 42.54 | 42.67 | 91.88 | 33.90 | 46.98 | ||||||||
| p-value | 0.023 | 0.180 | 0.008 | |||||||||||
For patients not at target LDL-C 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.
"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. Use of cholesterol-lowering spreads and additives have become popular. This early study of HEP-40 may add yet another safe and highly potent agent to the effective treatment of cardiovascular risk," said Dr. Robert Weiss, M.D., Director of Research, Maine Research Associates, and a member of the DNP Scientific Advisory Board.
Background on HEP-40
HEP-40 is the result of more than 10 years of research at the University of Sherbrooke, in Canada. HEP-40 works by binding to ingested fats and negatively charged bile acids and creating an insoluble complex that then transits through the gut and is excreted. This results in a significant reduction in LDL levels. Approximately, 300 patients have been treated in four clinical studies evaluating HEP-40. In all 4 studies, HEP-40 was shown to be safe, well tolerated and to significantly reduce LDL levels. Further information can be found at www.hep40.com.
About Diversified Natural Products
Diversified Natural Products, Inc, (DNP) is a closely-held company headquartered in New York, N.Y. DNP develops natural products for treating chronic diseases, with fewer side effects and long-term toxicity risks than prescribed drugs. DNP's products have patent protection and clinical proof of efficacy. DNP's current marketed products target cholesterol reduction, joint pain/arthritis and psoriasis. Other products in development focus on gastrointestinal and dermatological health.
Contact: Diversified Natural Products, Inc.
Paul Jacobson, 914-234-4548
Chief Executive Officer
