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HYALGAN® References

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  1. Geba GP, Weaver AL, Polis AB, Dixon ME, Schnitzer TJ, for the VACT Group. Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized trial. JAMA. 2002;287:64-71.
  2. Ghosh P, Guidolin D. Potential mechanism of action of intra-articular hyaluronan therapy in osteoarthritis: are the effects molecular weight dependent? Semin Arthritis Rheum. 2002;32:10-37.
  3. Balazs E. The physical properties of synovial fluid and the specific role of hyaluronic acid. In: Helfet AJ, ed. Disorders of the Knee. 2nd ed. Philadelphia, Pa: JB Lippincott; 1982:61-74.
  4. Gotoh S, Miyazaki K, Onaya J, et al. Experimental knee pain model in rats and analgesic effect of sodium hyaluronate (SPH).[Japanese] Nippon Yakurigaku Zasshi. 1988;92:17-27.
  5. Pozo MA, Balazs EA, Belmonte C. Reduction of sensory responses to passive movements of inflamed knee joints by hylan, a hyaluronan derivative. Exp Brain Res. 1997;116:3-9.
  6. Smith MM, Ghosh P. The synthesis of hyaluronic acid by human synovial fibroblasts is influenced by the nature of the hyaluronate in the extracellular environment. Rheumatol Int. 1987;7:113-122.
  7. Díaz-Gallego L, Prieto JG, Coronel P, et al. Apoptosis and nitric oxide in an experimental model of osteoarthritis in rabbit after hyaluronic acid treatment. J Orthop Res. 2005;23:1370-1376.
  8. Altman RD, Moskowitz R, and the HYALGAN® Study Group. Intraarticular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. J Rheumatol. 1998;25:2203-2212.
  9. Data on File. Sanofi-aventis U.S. LLC.
  10. HYALGAN® (sodium hyaluronate) Prescribing Information.
  11. Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion. Eur J Rheumatol Inflamm. 1995;15:25-31.
  12. Bragantini A, Cassini M, De Bastiani G, Perbellini A. Controlled single-blind trial of intra-articularly injected hyaluronic acid (HYALGAN®) in osteo-arthritis of the knee. Clin Trials J. 1987;24:333-340.
  13. Grecomoro G, Martorana U, Di Marco C. Intra-articular treatment with sodium hyaluronate in gonarthrosis: a controlled clinical trial versus placebo. Pharmatherapeutica. 1987;5:137-141.
  14. Leardini G, Mattara L, Franceschini M, Perbellini A. Intra-articular treatment of knee osteoarthritis: a comparative study between hyaluronic acid and 6-methyl prednisolone acetate. Clin Exp Rheumatol. 1991;9:375-381.
  15. Corrado EM, Peluso GF, Gigliotti S, et al. The effects of intra-articular administration of hyaluronic acid on osteoarthritis of the knee: a clinical study with immunological and biochemical evaluations. Eur J Rheumatol Inflamm. 1995;15:47-56.
  16. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43:1905-1915.
  17. HYALGAN® Published Clinical Studies (1987-present), data on file, sanofi-aventis U.S. LLC.
  18. HYALGAN® safety data, data on file, Fidia Farmaceutici S.p.A.
  19. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on Health: Osteoarthritis. Available at: www.niams.nih.gov/hi/topics/arthritis/oahandout.htm Accessed 3/23/07.
  20. Arthritis Foundation. Disease Center: Causes. Available at: www.arthritis.org/conditions/diseasecenter/OA/oa_causes.asp Accessed 3/22/07.
  21. Kelly MA, Goldberg VM, Healy WL, Pagnano MW, Hamburger MI. Osteoarthritis and beyond: a consensus on the past, present, and future of hyaluronans in orthopedics. Orthopedics. 2003;26:1064-1079.
  22. Arthritis Foundation. Disease Center: Diagnosis. Available at: www.arthritis.org/conditions/diseasecenter/OA/oa_diagnosis.asp Accessed 3/22/07.
  23. Arthritis Foundation. Disease Center: Treatment. Available at: www.arthritis.org/conditions/diseasecenter/OA/oa_treatment1.asp Accessed 3/22/07.
  24. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21:307-311.
  25. Scali JJ. Intra-articular sodium hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15:57-62.
  26. Hammesfahr JFR, Knopf AB, Stitik T. Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. Am J Orthop. 2003;32:277-283.
  27. Goldberg VM, Coutts RD. Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment. Clin Orthop. 2004;419:130-137.
  28. Synvisc® (hylan G-F 20) Prescribing Information.
  29. Orthovisc® High Molecular Weight Hyaluronan Prescribing Information.
  30. Supartz® (sodium hyaluronate) Prescribing Information.
  31. Euflexxa® (1% sodium hyaluronate) Prescribing Information.
  32. HYALGAN® (sodium hyaluronate) and Synvisc (hylan g-f 20) Approval Letters. Food and Drug Administration Web site. Available at: http://www.fda.gov/cdrh/pdf/p950027.pdf, http://www.fda.gov/cdrh/pdf/p940015.pdf Accessed March 2005.
  33. Jones AC, Pattrick M, Doherty S, Doherty M. Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis. Osteoarthritis Cartilage. 1995;3:269-273.
  34. Brown DJ, Beinat L. Safety and efficacy of an hyaluronan of 500-730 KDa and Hylan G-F 20 in clinical practice. Osteoarthritis Cartilage. 2003;11:S118.
  35. Graf J, Neusel E, Schneider E, Niethard FU. Intra-articular treatment with hyaluronic acid in osteoarthritis of the knee joint: a controlled clinical trial versus mucopolysaccharide polysulfuric acid ester. Clin Exp Rheumatol. 1993;11:367-372.
  36. Pietrogrande V, Melanotte PL, D'Agnolo B, et al. Hyaluronic acid versus methylprednisolone intra-articularly injected for treatment of osteoarthritis of the knee. Curr Ther Res. 1991;50:691-701.

Important Safety Information for HYALGAN®

  • HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpha-rmacologic therapy, and to simple analgesics, eg, acetaminophen
  • HYALGAN® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site
  • The effectiveness of a single treatment cycle of less than 3 injections has not been established
  • In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain
  • Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN®-treated and placebo groups
  • In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle

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US.HYA.08.11.016 Last Update: December 2008