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Embargoed For Release at 5:30 pm PT, Sunday Nov. 13, 2005

Arthritis News

GUIDE RESULTS TAP GLUCOSAMINE SULFATE AS PREFERRED MED FOR THE PAIN OF KNEE OSTEO ARTHRITIS

SAN DIEGO, CALIFORNIA –European GUIDE ( Glucosamine Unum In Die [once a day] Efficacy) medical investigation results indicate that glucosamine sulfate may have more ability to control pain due to knee osteoarthritis than does acetaminophen, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Diego, California.

Glucosamine, which is dispensed as a prescription drug in Europe and available as a dietary supplement in the U.S. , has been suggested to improve cartilage biology and counteract factors contributing to joint degeneration, inflammation and symptoms of osteoarthritis.

On-going randomized, placebo-controlled, double-blind trials are being conducted worldwide to assess the effectiveness of oral glucosamine in combating the discomfort of knee osteoarthritis compared to standard symptomatic medications . U.S. researchers from the National Institutes of Health are utilizing GAIT (the Glucosamine/Chondroitin Arthritis Intervention Trial) to compare nutraceutical glucosamine hydrochloride with the anti-inflammatory celecoxib (Celebrex), dividing the glucosamine into three separate daily doses.

European researchers, employing GUIDE , have been comparing glucosamine sulfate with the typically-recommended acetaminophen which is usually taken in three or four 1000 mg doses. The original prescription formulation of glucosamine sulfate soluble powder used provided higher glucosamine levels in the blood to mirror recent favorable glucosamine trials. (Glucosamine sulfate is a slightly different substance than glucosamine hydrochloride. The formulation used in GUIDE is not comparable to most formulations available in the U.S.)

GUIDE investigators followed 318 patients (88 percent women) with symptomatic knee osteoarthritis. Based on randomized groupings, patients took either oral glucosamine sulfate soluble powder (1500 mg once a day), acetaminophen (1000 mg tablets three times a day), or a placebo over a six-month period. All groups were allowed ibuprofen as needed.

Results showed that both glucosamine sulfate and acetaminophen had greater efficacy than placebo use in reducing pain. However, patients taking glucosamine sulfate appeared to experience more relief than did those on acetaminophen.

“Once-daily 1500 mg oral doses of glucosamine sulfate might be the preferred treatment for symptoms of knee osteoarthritis,” summarizes Gabriel Herrero-Beaumont, MD, Director of the Rheumatology Department, Jiménez Díaz Foundation - CAPIO, Madrid, Spain. “Based on these results, physicians who typically recommended acetaminophen may well find their patients gain more comfort taking glucosamine sulfate.”

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see www.rheumatology.org/annual.

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Editor's Notes: Dr. Herrero-Beaumont will present this research during a scientific session at the ACR Annual Scientific Meeting from 4:30 pm – 6:00 pm PT on Tuesday November 15th, 2005 in Room 28 of the San Diego Convention Center. He will be available for media questions and briefing at 8:30am PT on Tuesday, November 15, in Room 23 A of the Convention Center.

Presentation Number: 1203

Effects of Glucosamine Sulfate on 6-Month Control of Knee Osteoarthritis Symptoms vs Placebo and Acetaminophen: Results from the Glucosamine Unum in Die Efficacy (GUIDE) Trial

G. Herrero-Beaumont 1, JA Román 2, MC Trabado 3, FJ Blanco 4 , P. Benito 5, E. Martin-Mola 6, J. Paulino 7, JL Marenco 8, A. Porto 9, A. Laffon 10, D. Araùjo 11, M. Figueroa 12, J. Branco 13. 1 Fund. J. Diaz, Madrid, Spain; 2 H Peset, Valencia, Spain; 3 H Clinic, Barcelona, Spain; 4 CH Juan Canalejo, A Coruña, Spain; 5 H del Mar, Barcelona, Spain; 6 H U La Paz, Madrid, Spain; 7 C H C R, Ciudad Real, Spain; 8 H N.S. de Valme, Sevilla, Spain; 9 H U, Coimbra, Portugal; 10 H Princesa, Madrid, Spain; 11 H C. Bertiandos, Ponte de Lima, Portugal; 12 H Donostia, San Sebastian, Spain; 13 H E. Moniz, Lisboa, Portugal

Purpose: Two multicenter, randomised, placebo-controlled, double-blind trials have been lately investigating the efficacy of oral glucosamine in knee osteoarthritis (OA), using a symptomatic medication as reference: GAIT performed by the NIH in the US with nutraceutical glucosamine hydrochloride 500 mg t.i.d. vs celecoxib, and GUIDE performed in Europe with the original prescription glucosamine sulfate 1500 mg once-a-day (u.i.d.) vs acetaminophen, i.e. the preferred symptomatic medication in OA practice guidelines. We report the results of GUIDE.
Methods: 318 patients (88% women) with knee OA (ACR criteria) were randomised to double-dummy oral glucosamine sulfate soluble powder 1500 mg u.i.d., or acetaminophen 1000 mg tablets t.i.d. (3 g/day, as recommended in Europe), or placebo, for 6 months. The rescue medication consisted of standardised use of ibuprofen 400 mg tablets (daily diary recording). The primary efficacy parameter was the 6-month change in the Lequesne index in the ITT population, using the LOCF approach for patients not completing the study according to the protocol (34 on placebo, 28 in each the acetaminophen and glucosamine sulfate groups, without differences in drop-out reasons). Secondary efficacy parameters included the changes in the WOMAC index and the OARSI-A responder criteria. Statistical analysis on the indexes was performed by GLM-ANOVA, with Dunnett's pairwise comparisons vs placebo. The proportions of responders and patients using the rescue medication were compared by the chi-square test.
Results: The groups were comparable for demographics and baseline disease characteristics. Glucosamine sulfate efficacy vs placebo was significant on all parameters (table). Acetaminophen had more responders than placebo, but it failed to reach a significant difference on the Lequesne (p=0.18) and WOMAC (p=0.077) indexes.

More patients on placebo used the rescue medication (p=0.027 and 0.045 vs glucosamine sulfate and acetaminophen, respectively). There were no differences among groups in safety.

Conclusions: Glucosamine sulfate at the oral once-daily dose of 1500 mg might be the preferred symptomatic medication in knee OA.

Disclosure: G. Herrero-Beaumont, Rottapharm 2; J. Román, Rottapharm 2; M. Trabado, Rottapharm 2; F. Blanco, Rottapharm 2; P. Benito, Rottapharm 2; E. Martin-Mola, Rottapharm 2; J. Paulino, Rottapharm 2; J. Marenco, Rottapharm 2; A. Porto, Rottapharm 2; A. Laffon, Rottapharm 2; D. Araùjo, Rottapharm 2; M. Figueroa, Rottapharm 2; J. Branco, Rottapharm 2.