Skip to main content
Erschienen in: Drugs & Aging 1/2010

01.01.2010 | Adis Drug Profile

Hylan G-F 20 Single-Injection Formulation

verfasst von: James E. Frampton

Erschienen in: Drugs & Aging | Ausgabe 1/2010

Einloggen, um Zugang zu erhalten

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.
Literatur
1.
Zurück zum Zitat 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 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
2.
Zurück zum Zitat 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 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
3.
Zurück zum Zitat 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 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
6.
Zurück zum Zitat 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 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
7.
Zurück zum Zitat 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 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
8.
Zurück zum Zitat Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology 2007; 44: 59–74PubMed Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology 2007; 44: 59–74PubMed
9.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Divine JG, Zazulak BT, Hewett TE. Viscosupplementation for knee osteoarthritis: a systematic review. Clin Orthop Relat Res 2007 Feb; 455: 113–22PubMedCrossRef Divine JG, Zazulak BT, Hewett TE. Viscosupplementation for knee osteoarthritis: a systematic review. Clin Orthop Relat Res 2007 Feb; 455: 113–22PubMedCrossRef
12.
Zurück zum Zitat Waddell DD. Viscosupplementation with hyaluronans for osteoarthritis of the knee: clinical efficacy and economic implications. Drugs Aging 2007; 24(8): 629–42PubMedCrossRef Waddell DD. Viscosupplementation with hyaluronans for osteoarthritis of the knee: clinical efficacy and economic implications. Drugs Aging 2007; 24(8): 629–42PubMedCrossRef
13.
Zurück zum Zitat Brzusek D, Petron D. Treating knee osteoarthritis with intra-articular hyaluronans. Curr Med Res Opin 2008 Dec; 24(12): 3307–22PubMedCrossRef Brzusek D, Petron D. Treating knee osteoarthritis with intra-articular hyaluronans. Curr Med Res Opin 2008 Dec; 24(12): 3307–22PubMedCrossRef
14.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Synvisc one™ (hylan G-F 20): information for prescribers. Ridgefield (NJ): Genzyme Biosurgery, a division of Genzyme Corporation, 2009 Mar 19 Synvisc one™ (hylan G-F 20): information for prescribers. Ridgefield (NJ): Genzyme Biosurgery, a division of Genzyme Corporation, 2009 Mar 19
28.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Moreland LW. Intra-articular hyaluronan (hyaluronic acid) and hyland for the treatment of osteoarthritis: mechanisms of action. Arthritis Res Ther 2003; 5: 54–67PubMedCrossRef 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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
36.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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
39.
Zurück zum Zitat 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 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.
Zurück zum Zitat Kellgren JH, Lawrence JS. Radiographic assessment of osteoarthritis. Ann Rheum Dis 1957; 16: 494–502PubMedCrossRef Kellgren JH, Lawrence JS. Radiographic assessment of osteoarthritis. Ann Rheum Dis 1957; 16: 494–502PubMedCrossRef
41.
Zurück zum Zitat 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 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
Metadaten
Titel
Hylan G-F 20 Single-Injection Formulation
verfasst von
James E. Frampton
Publikationsdatum
01.01.2010
Verlag
Springer International Publishing
Erschienen in
Drugs & Aging / Ausgabe 1/2010
Print ISSN: 1170-229X
Elektronische ISSN: 1179-1969
DOI
https://doi.org/10.2165/11203900-000000000-00000

Weitere Artikel der Ausgabe 1/2010

Drugs & Aging 1/2010 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.