DSM NUTRITIONAL PRODUCTS PROVIDES SUPPORT

FOR NEW NATIONWIDE EYE HEALTH STUDY

BEING CONDUCTED BY THE NATIONAL

INSTITUTES OF HEALTH (NIH)

(October 12, 2006, Parsippany, New Jersey) The National Institutes of Health (NIH)

announced today the launch of a nationwide study to see if a modified combination of

vitamins, minerals, and fish oil can further slow the progression of vision loss from

AMD, the leading cause of vision loss in the United States for people over age 60. This

new study, called the Age-Related Eye Disease Study 2 (AREDS2), will build upon

results from the earlier Age-Related Eye Disease Study (AREDS). The original study

results were released five years ago today. The study found that high-dose antioxidant

vitamins and minerals (vitamins C and E, beta-carotene, zinc, and copper), taken orally,

reduced the risk of progression to advanced AMD by 25 percent, and the risk of moderate

vision loss by 19 percent.

 AREDS2 will refine the findings of the original study by adding 10mg of lutein and 2mg

of zeaxanthin (plant-derived yellow pigments that accumulate in the macula, the small

area responsible for central vision near the center of the retina) and the omega-3 fatty

acids DHA and EPA (derived from fish oil) to the study formulation. The 5:1 ratio of

lutein to zeaxanthin was chosen for the study because it was found to be associated with

the benefits seen in observational studies. The main study objective is to determine if

these nutrients will decrease a person’s risk of progression to advanced AMD, which

often leads to vision loss. Previous observational studies have suggested these nutrients

may protect vision.

 DSM Nutritional Products, Inc., is supporting this major study by providing the lutein,

zeaxanthin and omega-3 fatty acid dietary supplements to be used in this trial.

  “Vision loss from AMD is an important public health issue. This study may help us find

a better way to treat this devastating disease,” said Elias A. Zerhouni, M.D., Director of

the NIH.

 “This study is very exciting and we believe it may help provide further support on the

health benefits of lutein, zeaxanthin and omega-3 fatty acid supplementation and

demonstrate their potential to help save the sight of thousands of individuals every year,”

said Dr. James Elliott, Director of Nutritional Science for DSM Nutritional Products, Inc.

 Paul A. Sieving, M.D., Ph.D., Director of the National Eye Institute (NEI) at NIH, said,

“Nearly two million Americans have vision loss from advanced AMD, and another seven

million with AMD are at substantial risk for vision loss. In the AREDS study, we found a

combination of vitamins and minerals that effectively slowed the progression of AMD for

some people. Now, we will conduct this more precisely-targeted study to see if the new

combination of nutrients can reduce AMD progression even further. This study may help

people at high risk for advanced AMD maintain useful vision for a longer time.”

 Emily Y. Chew, M.D., Study Chair and Deputy Director of the Division of Epidemiology

and Clinical Research at the NEI said, “The AREDS2 study is seeking 4,000 people

between 50 and 85 years of age with AMD in both eyes, or advanced AMD in one eye.

They must be available for yearly eye examinations for at least five years. Until we get

the results from AREDS2, we encourage people with AMD to visit their eye care

professional to see if they need to take the AREDS vitamin and mineral formulation. This

alone could save more than 300,000 people from vision loss over the next five years.”

 For a list of study centers, eligibility requirements, and other information, go to:

http://www.nei.nih.gov/AREDS2, or call 1-877-AREDS-80 (1-877-273-3780).

The National Eye Institute (NEI) is part of the National Institutes of Health (NIH) and is the

Federal government's lead agency for vision research that leads to sight-saving treatments and

plays a key role in reducing visual impairment and blindness. For more information, visit the

NEI Website at http://www.nei.nih.gov/.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency —

includes 27 Institutes and Centers and is a component of the U. S. Department of Health and

Human Services. It is the primary federal agency for conducting and supporting basic, clinical,

and translational medical research, and it investigates the causes, treatments, and cures for

both common and rare diseases. For more information about NIH and its programs, visit

http://www.nih.gov/. 

LANDMARK US GOVERNMENT STUDY VALIDATES ZAND® GLUCOSAMINE

IS EFFECTIVE FOR ARTHRITIC PAIN

(Ferndale, WA) A landmark new study about to be published by the US National Institutes of Health (NIH) proves the value and safety of glucosamine supplements, including ZAND® Glucosamine, to significantly reduce the pain of arthritic joints.†

National news has highlighted the undesirable side effects from many well-known prescription pain relief medications, including Celebrex®, Vioxx® and Naprosyn®.  The NIH study (below) is shows that glucosamine works without producing potentially dangerous side effects.

ZAND Glucosamine Liquid Supplement helps relieve joint pain with a full spectrum formula of Glucosamine, Chondroitin, and MSM.  The pleasant tasting liquid is fast acting, easy to swallow and easier to absorb than capsules and tablets.  Each daily 2 tablespoon dose of the naturally flavored formula delivers 1500mg of glucosamine, 750mg of chondroitin, 400mg of MSM in a delicious, mixed berry formula that is also low in sodium.

Manufactured under an FDA license that meets pharmaceutical quality standards, ZAND Glucosamine uses ingredients that are naturally occurring substances found in healthy cartilage. They are carefully selected to provide the body with what it needs to help regenerate cartilage and help alleviate pain.†

SYMTEC® Joint Movement Glucosamine® are registered trademarks of Botanical Laboratories, Inc.  Celebrex® is a registered trademark of G.D. Searle & Co.  Vioxx® is a registered trademark of Merck & Co., Inc.   Naprosyn® is a registered trademark of Syntex Laboratories, Inc.

# # #

Glucosamine better than common painkiller for knee arthritis

9/30/05 - Two long-awaited clinical trials on glucosamine have found the shellfish-derived substance to significantly reduce the pain of arthritic joints, and it may be better than a commonly used painkiller in Europe.

The results, posted in abstract form on the website of an upcoming conference, confirm what many osteoarthritis sufferers already know: US consumers spent $800 million on the supplement during 2004, and in Japan retail sales reached $200 million, according to Euromonitor.

Yet the findings will also lend scientific weight to earlier sometimes conflicting evidence on the efficacy of this natural supplement, both alone and in combination with chondroitin sulphate.

NEW NATIONAL INSTITUTE OF HEALTH STUDY

The first set of results come from the multi-centered Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) conducted by the US government-funded National Institutes of Health.

Almost 1,500 osteoarthritis patients were given a daily dose of either 1,500 mg of glucosamine hydrochloride, 1,200 mg of chondroitin sulphate, a combination of both supplements, 200 mg of the common prescription painkiller celecoxib (Celebrex) or a placebo for 24 weeks.

The patients were evaluated at baseline and every four weeks thereafter.

Both celecoxib and the glucosamine-chondroitin combination significantly reduced knee pain compared to placebo.

“Combination glucosamine and chondroitin sulphate is effective in treating moderate to severe knee pain due to osteoarthritis,” says the authors’ abstract.

It adds that a lack of response in patients with mild pain may be due to a floor effect, limiting ability to detect response.

Daniel Clegg from the University of Utah will present the full study findings at the American College of Rheumatology (ACR) meeting in San Diego on 14 November.

A SECOND, NEW EUROPEAN STUDY YIELDS SIMILAR RESULTS

The following day Dr Herrero-Beaumont from the Fundacion Jimenez Diaz in Madrid will disclose the results of a multi-centre European study, which has found glucosamine sulphate to be more effective than the over-the-counter painkiller acetaminophen on joint pain.

The Glucosamine Unum in Die Efficacy (GUIDE) trial compared a daily dose of 1500mg of glucosamine sulphate and 3000 mg of the OTC drug to a placebo in 318 patients.

After 24 weeks, the superior efficacy of the glucosamine supplement on various pain and mobility indices of osteoarthritis was evident.

Dr Herrero-Beaumont declined to comment further on the results to NutraIngredients.com ahead of the conference. However the abstract concludes: “Glucosamine sulphate…might be the preferred symptomatic medication in knee osteoarthritis.”

In both trials there were no differences among groups in safety.

Andrew Shao, in charge of scientific affairs at the US-based trade association the Council for Responsible Nutrition, noted that each trial can be considered “well-designed, well-conducted, gold-standard".

The glucosamine and chondroitin sulphate used in GAIT were required to meet pharmaceutical standards as it was conducted under an Investigational New Drug application.

Such high standards will be important if glucosamine makers are to attract new consumers that have been alerted to the risks of traditional treatments for arthritis by the makers of Cox-2 inhibitor drugs.

Indeed, the new findings on glucosamine and chondroitin sulphate will prove timely as the withdrawal of Cox-2 inhibitor drugs last year continues to prompt interest in natural substances to relieve joint pain.

At the same time, incidence of osteoarthritis is rapidly rising around the world due both to aging populations and increasing levels of obesity.

Patricia Estepa, product manager at Bioiberica, the Spanish firm that supplied the chondroitin sulphate used in the GAIT trial, said: "All the results are not included in the abstracts but as preliminary findings these are great, especially for our product."

"I think the whole category will see growth following these studies, and particularly in the US. It is the first time that such a large trial has been done in this country - a big food supplement market - at this level," she added.

© Copyright 2005, Decision News Media SAS.

News story link from Decision News Media:

http://NutraIngredients-usa.com/news/ng.asp?id=62903

TEXT OF THE NIH STUDY

Title: The Efficacy of Glucosamine and Chondroitin Sulfate in Patients with Painful Knee Osteoarthritis (OA): The Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)   Category: 7. Osteoarthritis—clinical aspects   Author(s): Daniel O. Clegg1, Domenic J. Reda2, Crystal L. Harris3, Marguerite A. Klein4, for the GAIT Investigators. 1University of Utah, Salt Lake City, UT; 2VACSP, Hines, IL; 3VACSP, Albuquerque, NM; 4NCCAM/NIH, Bethesda, MD   Presentation Number: 622   PURPOSE: Glucosamine (G) and chondroitin sulfate (CS) are widely promoted to “reduce joint pain and provide support for healthy cartilage and joint function.” GAIT was designed to rigorously assess the efficacy and safety of these agents alone and in combination. G and CS were required to meet pharmaceutical standards as GAIT was conducted under an Investigational New Drug application. METHODS: Patients were ≥40 years of age with knee pain (WOMAC Pain 125-400 mm) of at least 6 months duration and x-ray evidence of knee OA [Kellgren-Lawrence (KL) Grades 2 or 3]. Patients were randomly assigned double-blind to placebo (P); G(Glucosamine HCl 500 mg) tid; Sodium CS 400 mg tid; G+CS at the above doses tid; or celecoxib (CE) 200 mg daily. All patients were allowed up to 4000 mg daily of acetaminophen (APAP) as rescue analgesia, except within 24 hours of study visits. Allocation was stratified by Center and by WOMAC Pain severity (125-300mm and 301-400mm). Patients were evaluated at baseline and weeks 4, 8, 16 and 24. The primary outcome measure was a 20% improvement from baseline in WOMAC Pain at week 24. Adverse events were documented at each visit. Analysis was based on intention-to-treat. RESULTS: 3238 patients were screened at 16 US academic rheumatology centers. 1583 were randomized and 1258 (80%) completed the study. Baseline characteristics were: mean age 58.6 years, BMI 31.7 kg/m2, OA symptoms 10 years, 64% female, summed mean WOMAC Pain 236±73mm (206mm for 125-300mm stratum, 341mm for 301-400mm stratum), 59% KL Grade 2, and 78% were in the 125-300mm WOMAC Pain stratum and were evenly distributed across all arms. The response rate for CE (70.1%) was higher than the response rate for P (60.1%) in the primary outcome analysis of all patients (p=0.008). In the 301-400 mm WOMAC pain stratum, the response rate for G+CS (79.2%) was higher than P (54.3%) (p=0.002). Secondary outcomes in the 301-400 mm stratum, including 50% WOMAC Pain response, WOMAC Stiffness, WOMAC Function, HAQ, patient assessments, and use of rescue APAP all demonstrated changes consistent with the primary outcome. Adverse events were generally mild and evenly distributed among the groups. Response Rates by Treatment Group and Pain Stratum   All patients WOMAC Pain 301-400mm WOMAC Pain 125-300mm   P 60.1% 54.3% 61.7%   CE 70.1%** 69.4%¶ 70.3%*   G 64.0% 65.7% 63.6%   CS 65.4% 61.4% 66.5%   G+CS 66.6%+ 79.2%# 62.9%     ** p= 0.008 CE vs. P + p= 0.09 G+CS vs. P ¶p = 0.06 CE vs. P # p = 0.002 G+CS vs. P * p= 0.04 CE vs. P   CONCLUSIONS: Combination G+CS is effective in treating moderate to severe knee pain due to OA. The lack of response in patients with mild pain may be due to a floor effect, limiting ability to detect response. All study agents were well tolerated.

STORY LINK FOR THE NIH STUDY ON THE INTERNET

http://www.abstractsonline.com/viewer/?mkey=%7BF5B9F43A%2D15A0%2D467D%2D8458%2D5DF32518B4E3%7D%20

INSTRUCTIONS: On this page in the search bar enter GAIT.  On the page that comes up click on Presentation #5.