Top

Published in:

01-01-2010 | Adis Drug Profile

Hylan G-F 20 Single-Injection Formulation

Author: James E. Frampton

Published in: Drugs & Aging | Issue 1/2010

Abstract

Hylan G-F 20, a cross-linked hyaluronic acid derivative, is an elastoviscous, high-molecular-weight (average 6000 kDa) fluid with rheological properties similar to those of knee synovial fluid of healthy young individuals.

In a 26-week, randomized, double-blind, multi-centre study in patients with symptomatic primary osteoarthritis of the knee (n = 253), one intraarticular injection of hylan G-F 20 (single-injection formulation) into the target knee significantly relieved pain (as measured by the Western Ontario and McMaster Universities Osteoarthritis Index pain [WOMAC A] subscale), including pain while walking on a flat surface (as assessed by the WOMAC A1 subscore), compared with placebo.

Observer-reported disease status and patient-reported health status were also significantly improved in hylan G-F 20-treated patients compared with placebo-treated patients.

A single intra-articular injection of hylan G-F 20 was generally well tolerated, with an adverse event profile similar to that of placebo.

Repeat administration of hylan G-F 20 after 6 months had a similar tolerability profile to that of the initial injection. However, no patient who developed a target-knee adverse event after their first injection experienced such an event following their second injection.

Dillon CF, Rasch EK, Gu Q, et al. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991–94. J Rheumatol 2006 Nov; 33(11): 2271–9PubMed

Jordan JM, Helmick CG, Renner JB, et al. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol 2007 Jan; 34(1): 172–80PubMed

Felsen DT, Naimark A, Anderson J, et al. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum 1987 Aug; 30(8): 914–8CrossRef

Knee osteoarthritis statistics. American Academy of Orthopedic Surgeons [online]. Available from URL: http://orthoinfo.aaos.org/topic.cfm?topic=A00399 [Accessed 2009 Aug 10]

Arthritis types — overview: osteoarthritis. Centers for Disease Control and Prevention [online]. Available from URL: http://www.cdc.gov/arthritis/arthritis/osteoarthritis.htm [Accessed 2009 Aug 10]

Recommendations for the medical management of osteoarthritis of the hip and knee. 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 2000 Sep; 43(9): 1905–15

Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartilage 2008; 16: 137–62CrossRef

Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology 2007; 44: 59–74PubMed

Adams ME, Lussier AJ, Peyron JG. A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee. Drug Saf 2000 Aug; 23(2): 115–30PubMedCrossRef

10.

Bellamy N, Campbell J, Robinson V, et al. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2006 Apr 19;(2): CD005321

11.

Divine JG, Zazulak BT, Hewett TE. Viscosupplementation for knee osteoarthritis: a systematic review. Clin Orthop Relat Res 2007 Feb; 455: 113–22PubMedCrossRef

12.

Waddell DD. Viscosupplementation with hyaluronans for osteoarthritis of the knee: clinical efficacy and economic implications. Drugs Aging 2007; 24(8): 629–42PubMedCrossRef

13.

Brzusek D, Petron D. Treating knee osteoarthritis with intra-articular hyaluronans. Curr Med Res Opin 2008 Dec; 24(12): 3307–22PubMedCrossRef

14.

Wang C-T, Lin J, Chee-Jen C, et al. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. J Bone Joint Surg 2004 Mar; 86A(3): 538–45

15.

Conrozier T, Chevalier X. Long-term experience with hylan GF-20 in the treatment of knee osteoarthritis. Expert Opin Pharmacother 2008 Jul; 9(10): 1797–804PubMedCrossRef

16.

Adams ME, Atkinson MH, Lussier AJ, et al. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multi-center trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthr Cartilage 1995 Dec; 3(4): 213–25CrossRef

17.

Wobig M, Dickhut A, Maier R, et al. Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther 1998 May; 20(3): 410–23PubMedCrossRef

18.

Raynauld JP, Torrance GW, Band PA, et al. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (part 1 of 2): clinical results. Osteoarthr Cartilage 2002 Jul; 10(7): 506–17CrossRef

19.

Waddell DD, Bricker DC. Clinical experience with the effectiveness and tolerability of hylan G-F 20 in 1047 patients with osteoarthritis of the knee. J Knee Surg 2006 Jan; 19(1): 19–27PubMed

20.

Kemper F, Gebhardt U, Meng T, et al. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin 2005 Aug; 21(8): 1261–9PubMedCrossRef

21.

Caborn D, Rush J, Lanzer W. A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol 2004; 31: 333–43PubMed

22.

Raman R, Dutta A, Day N, et al. Efficacy of hylan G-F 20 and sodium hyaluronate in the treatment of osteoarthritis of the knee: a prospective randomized clinical trial. Knee 2008 Aug; 15(4): 318–24PubMedCrossRef

23.

Reichenbach S, Blank S, Rutjes AW, et al. Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis. Arthritis Rheum 2007 Dec 15; 57(8): 1410–8PubMedCrossRef

24.

Cubukcu D, Ardic F, Karabulut N, et al. Hylan G-F 20 efficacy on articular cartilage quality in patients with knee osteoarthritis: clinical and MRI assessment. Clin Rheumatol 2005 Aug; 24(4): 336–41PubMedCrossRef

25.

Karatay S, Kiziltunc A, Yildirim K, et al. Effects of different hyaluronic acid products on synovial fluid NO levels in knee osteoarthritis. Clin Rheumatol 2005 Sep; 24(5): 497–501PubMedCrossRef

26.

Bagga H, Burkhardt D, Sambrook P, et al. Longterm effects of intraarticular hyaluronan on synovial fluid in osteoarthritis of the knee. J Rheumatol 2006 May; 33(5): 946–50PubMed

27.

Synvisc one™ (hylan G-F 20): information for prescribers. Ridgefield (NJ): Genzyme Biosurgery, a division of Genzyme Corporation, 2009 Mar 19

28.

Greenberg DD, Stoker A, Kane S, et al. Biochemical effects of two different hyaluronic acid products in a co-culture model of osteoarthritis. Osteoarthr Cartilage 2006 Aug; 14(8): 814–22CrossRef

29.

Shah RV, Ericksen JJ, Lacerte M. Interventions in chronic pain management: 2. New frontiers: invasive non-surgical interventions. Arch Phys Med Rehabil 2003 Mar; 84 (3 Suppl. 1): S39–44PubMedCrossRef

30.

Gomis A, Miralles A, Schmidt RF, et al. Nociceptive nerve activity in an experimental model of knee joint osteoarthritis of the guinea pig: effect of intra-articular hyaluronan application. Pain 2007 Jul; 130: 126–36PubMedCrossRef

31.

Moreland LW. Intra-articular hyaluronan (hyaluronic acid) and hyland for the treatment of osteoarthritis: mechanisms of action. Arthritis Res Ther 2003; 5: 54–67PubMedCrossRef

32.

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 Aug; 32(1): 10–37PubMedCrossRef

33.

Jackson DW, Simon TM. Intra-articular distribution and residence time of hylan A and B: as study in the goat knee. Osteoarthr Cartilage 2006; 14: 1248–57CrossRef

34.

Larsen NE, Dursema H, Skrabut EM. Clearance kinetics of a single injection crosslinked hylan-based viscosupplement in a rabbit model [abstract no. 99]. Osteoarthr Cartilage 2007; 15(Suppl. C): e64CrossRef

35.

Synvisc, solution for injection: data sheet. Auckland: Healthcare Logistics [online]. Available from URL: http://www.medsafe.govt.nz/Profs/Datasheet/s/Synviscinj.htm [Accessed 2009 Aug 28]

36.

Sakamoto T, Mizuno S, Miyazaki K, et al. Biological fate of sodium hyaluronate. Studies on distribution, metabolism and excretion of 14C-SPH in rabbits after intra-articular administration. Pharmacometrics 1984; 28(2): 375–87

37.

Chevalier X, Jerosch J, Goupille P, et al. Single, intraarticular treatment with 6mL of hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multi-centre, double-blind, placebo-controlled trial. Ann Rheum Dis. Epub 2009 Mar 19

38.

US Food and Drug Administration. Summary of safety and effectiveness data: hyaluronic acid, intraarticular (Synvisc one) [online]. Available from URL: http://www.accessda-ta.fda.gov/cdrh_docs/pdf/P940015S012b.pdf [Accessed 2009 Aug 19]

39.

Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986 Aug; 29(8): 1039–49PubMedCrossRef

40.

Kellgren JH, Lawrence JS. Radiographic assessment of osteoarthritis. Ann Rheum Dis 1957; 16: 494–502PubMedCrossRef

41.

Pham T, van der Heijde D, Altman RD, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr Cartilage 2004; 12(5): 389–99CrossRef

Title: Hylan G-F 20 Single-Injection Formulation
Author: James E. Frampton
Publication date: 01-01-2010
Publisher: Springer International Publishing
Published in: Drugs & Aging / Issue 1/2010
Print ISSN: 1170-229X
Electronic ISSN: 1179-1969
DOI: https://doi.org/10.2165/11203900-000000000-00000

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Hylan G-F 20 Single-Injection Formulation

Abstract

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2010

Drug-Induced, Dementia-Associated and Non-Dementia, Non-Drug Delirium Hospitalizations in the United States, 1998–2005

Differential Impact of NSAIDs on Rate of Adverse Events that Require Hospitalization in High-Risk and General Veteran Populations

Zonisamide in Parkinson’s Disease

Anaesthesia for Cataract Surgery

Autoimmune Bullous Dermatoses in the Elderly

Reasons for Undertreatment with Oral Anticoagulants in Frail Geriatric Outpatients with Atrial Fibrillation

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page