THE LANCET PUBLISHES STUDY CONFIRMING DONA™ REDUCES PROGRESSION OF OSTEOARTHRITIS

London - January 27, 2001

THE LANCET PUBLISHES STUDY CONFIRMING DONA™ REDUCES PROGRESSION OF OSTEOARTHRITIS

UK-Today's issue of The Lancet reports the results of a clinical trial that showed administration of the nutritional supplement, glucosamine sulfate, slows disease progression in patients with knee osteoarthritis.

The three-year, double-blind, placebo-controlled study (Long -term effects of glucosamine sulfate on osteoarthritis progression: a randomized, placebo-controlled clinical trial .Reginster J-Y, et al ) was performed using 212 patients suffering from knee osteoarthritis who were randomly selected to receive 1500 mg once-a-day of oral original glucosamine sulfate or a placebo for the three-year period. Disease progression was evaluated by measuring the joint space width on x-rays of the knee. According to the study, patients who received a placebo experienced progressive joint space narrowing, representing further loss of cartilage, but patients who received original glucosamine sulfate showed no further joint space narrowing. Additionally, pain and function limitation worsened with the placebo, but improved with original glucosamine sulfate. The study also showed that original glucosamine sulfate is a safe compound.

"For the first time, we have shown that a treatment may be able to at least reduce the progression of osteoarthritis," said principal investigator, Professor Jean-Yves Reginster, MD PhD, University of Liege in Belgium.

"Further studies may be necessary to see if administration of glucosamine sulfate for even longer periods may reduce substantial disability after decades and/or the need for surgical joint replacement," added co-investigator Lucio Rovati, MD from Milan, Italy. The Lancet article warns against generalizing the results of this study to glucosamine products other than the one used in this study, DONA™, which is manufactured by Rotta Pharmaceuticals, Inc. DONA™ is sold as a prescription drug in Europe, and is also available in the United States as a dietary supplement.

Tim McAlindon, of the Arthritis Center at the Boston University and author of The Lancet Commentary about the glucosamine sulfate research, offers an interesting and accurate perspective on bringing effective nutritional supplements, such as the original glucosamine sulfate, closer to the forefront of the health care profession. Currently, health care professionals generally expect to be involved in medical decisions of public health importance, but the reality is that they are not regarded as a repository of objective advice about nutritional products and are generally kept out of the loop. Since glucosamine sulfate as a nutritional supplement is generally self-prescribed, there needs to be a shift in the medical profession to accommodate the possibility that many nutritional products, including the original glucosamine sulfate, may have valuable therapeutic effects and to regain the credibility of the public at large.

Osteoarthritis, the most common form of arthritis, is the deterioration of cartilage that cushions bones in the joints, leading to pain and function limitation. In the United States nearly 12% of the population suffers from osteoarthritis, accounting for 46 million physician visits, 3.7 million hospital admissions, 185 million bed days, and 68 million workdays lost per year. Many osteoarthritis sufferers eventually undergo surgical joint replacement or become disabled.

The most common treatments for osteoarthritis are analgesics and non-steroidal anti-inflammatory drugs which can relieve symptoms for short periods of time, but leave the progression of the disease unaltered, or may even make it worse. Availability of nutritional supplements such as the original glucosamine sulfate that give similar relief of symptoms and, in addition, could delay the progression of osteoarthritis offer hope for the future.