Efficacy and Safety of Viscosupplementation With Hylan G-F 20 for the Treatment of Knee Osteoarthritis

Espallargues, Mireia; Pons, J

doi:10.1017/s0266462303000059

Cited by 40 publications

(26 citation statements)

References 5 publications

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“…Data obtained from our and other groups in previous studies support the hypothesis that VS may represent a valid therapeutic tool for the management of hip OA (21). These data seem to confirm that the benefits are similar to those achieved from injecting knee OA (12)(13)(14)(15)(16)(17)(18)(19)(20). This is the first 6-month post-marketing study to assess the safety and effectiveness of Sinovial" Forte 1.6% in a large cohort of patients with symptomatic hip OA.…”

Section: Discussionsupporting

confidence: 81%

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Intra-Articular Ultrasound-Guided Injection of Sinovial® Forte 1.6% in Patients Affected by Symptomatic Hip Osteoarthritis: Effectiveness and Safety in a Large Cohort of Patients

et al. 2012

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The aim of this prospective observational study is to assess the efficacy and safety profile of intraarticular Sinovial® Forte 1.6% administered under ultrasound-guidance in a large cohort of patients affected by symptomatic hip osteoarthritis (OA). Patients with symptomatic hip OA referred to our clinic in 2008–2010 received one 4 ml (2 vials) intra-articular injection of Sinovial® Forte 1.6% under ultrasound guidance. Patients were followed-up every 3 months for a total of 6 months and were offered an optional, additional injection at the 3-month follow-up visit if clinically justified. At each visit, pain scores [0–10 Visual Analogue Scale (pain VAS)], Lequesne index scores and NSAID intake were recorded. Adverse events (AEs) were recorded throughout the study. An effect size of 30% and 50% reduction in Lequesne index and Pain VAS scores was evaluated for each patient to ascertain the number of patients achieving partial remission of symptoms and functional impairment by the use of intra-articular hyaluronic acid in hip osteoarthritis. One hundred and fourteen patients completed the 6-month follow-up and received a total of 142 injections. A statistically significant reduction in Lequesne index scores, VAS pain scores and NSAID consumption was observed at all time-points ( p < 0.05). No systemic, severe or even moderate side effects were observed. Only 7 patients reported mild local reaction at the injection site, consisting of mild pain and localized warmth, which resolved spontaneously without any additional medication. This study provides evidence of the efficacy and tolerability of Sinovial® Forte 1.6% in the treatment of patients affected by symptomatic hip OA. Sinovial® Forte may also offer economical benefits, owing to the reduction in NSAID consumption associated with this treatment. The percentage of patients achieving the effect size of 30% and 50% reduction in Lequesne index and pain VAS scores encourages the use of intra-articular hyaluronic acid in patients with hip osteoarthritis.

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Section: Discussionsupporting

confidence: 81%

“…Several meta-analyses and systematic reviews have also been performed on the entire therapy class, which broadly agree that viscosupplementation is effective and safe (17)(18)(19)(20)(21).…”

mentioning

confidence: 98%

Intra-Articular Ultrasound-Guided Injection of Sinovial® Forte 1.6% in Patients Affected by Symptomatic Hip Osteoarthritis: Effectiveness and Safety in a Large Cohort of Patients

et al. 2012

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“…It is approved for topical applications [45,46], for internal visco-supplementation (e.g., as an injected treatment for osteoarthritis in knee joints [44,47]), for preventing tissue damage during and following eye surgery [48,49] and as a post-surgical adhesion preventative [50]. More recently, CD19+ CD4+ CD8+ CD19+ CD4+ CD8+ CD19+ CD4+ CD8+ CD19+ 0.5 20 18 50 10 10 80 8 8 30 10 10 10 2 25 20 70 12 13 95 10 12 100 20 20 50 14 35 30 90 8 8 50 8 8 90 25 15 60 26 5 5 75 10 10 60 8 8 80 25 20 35 74 5 5 40 10 10 40 8 8 80 20 a number of studies report that HA/drug mixtures increase targeted-delivery of drugs to tumors and enhance the drug's therapeutic efficacy [21,51], and HA by itself may have beneficial biomodifying effects [47,52,53].…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics and Pharmacodynamics of Hyaluronan Infused into Healthy Human Volunteers

Hamilton¹,

Veiseh²,

Tölg³

et al. 2009

Open Drug Metab J

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Abstract:The pharmacodynamics and elimination kinetics of escalating doses (1.5-12 mg/kg) of hyaluronan (HA) infusions were studied in healthy human volunteers. Metabolic breakdown of serum HA and associated adverse events were monitored throughout the study. The HA-binding capacities of circulating CD4+ and CD8+ T lymphocytes, CD19+ Blymphocytes and CD14+ peripheral blood monocytes (PBMC) were also quantified. Breakdown of infused HA into small fragments (<37 kDa) were not detected and adverse events related to HA infusions were infrequent and non-serious in nature. Binding of FITC-HA was greatest to CD14+ monocytes and the binding capacity of these cells for FITC-HA was significantly increased by the final HA infusion. At that time, binding to CD14+ monocytes was related to serum HA levels suggesting a close relationship between PK and PD of serum HA. Drug level analysis demonstrated a disproportional increase in the area under the serum concentration vs. time curve with increasing HA dose. The observed non-linear HA kinetics appears to result from a saturable elimination process as revealed by pharmacokinetic modeling. These results have implications for the use of injected HA for drug delivery or in imaging applications.

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“…Le linee guida per la gestione dell'artrosi del ginocchio e dell'anca, emanate dall'American College of Rheumatology (ACR), contemplano la terapia intraarticolare (a base di corticosteroidi e ialuronato sodico) come preziosa risorsa nell'armamentario terapeutico per la gestione dell'artrosi del ginocchio (9,10). In particolare, l'uso di acido di acido ialuronico cross-linked (Hylan GF-20) si è dimostrato particolarmente efficace, in virtù delle sue proprietà di elevata viscoelasticità (11). Un ciclo di 3 iniezioni di Hylan GF-20 risulta efficace per alleviare i sintomi per oltre 12 mesi in pazienti con gonartrosi (12); in letteratura si rinvengono numerose pubblicazioni inerenti il dosaggio, la tollerabilità e l'efficacia a lungo termine dei prodotti dell'acido ialuronico nel trattamento dell'artrosi di ginocchio (9)(10)(11)(12)(13)(14)(15)(17)(18)(19)(20).…”

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18 month observational study on efficacy of intraarticular hyaluronic acid (Hylan G-F 20) injections under ultrasound guidance in hip osteoarthritis

Migliore¹,

Tormenta²,

Massafra³

et al. 2011

Reumatismo

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rioramento della cartilagine e del sottostante osso subcondrale; tali fenomeni si riflettono, clinicamente, nel graduale sviluppo di dolore e nella riduzione della funzione articolare (1). La localizzazione coxofemorale dell'artrosi risulta particolarmente frequente, con un'incidenza media variabile a seconda delle casistiche da 88 a 47,3 casi per 100.000 abitanti (2, 3). Il sollievo dal dolore è, tuttora, un obiettivo primario nel trattamento dei pazienti affetti da coxartrosi. Analgesici, FANS, COX-2 inibitori sono diffusamente utilizzati e considerati, pertanto, un trattamento standard nella gestione dell'OA a carico del ginocchio e dell'anca. Sfortunatamente, molti pazienti sviluppano seri effetti collaterali, anche fatali, indotti dai FANS (4-6), prevalente- INTRODUZIONE L'artrosi (OA) è una malattia caratterizzata da una serie di modificazioni biochimiche, molecolari, biomeccaniche e morfologiche, a carico della matrice extracellulare e della componente cellulare, che inducono essenzialmente un dete- Reumatismo, 2006; 58(1):39-49 SUMMARY Objective: To evaluate the efficacy and the tolerability of viscosupplementation (VS) with hyaluronic acid (Hylan G-F 20) in a cohort of 36 patients affected by hip osteoarthritis through a 18 months follow-up. Methods: Viscosupplementation was performed with an anteriorsagittal approach, under ultrasound guidance. 36 patients were administered hyaluronic acid intraarticularly in the hip, with a unique injection of Hylan G-F20, which could be repeated after at least 3 months. Treatment efficacy was assessed by functional index WOMAC

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Efficacy and Safety of Viscosupplementation With Hylan G-F 20 for the Treatment of Knee Osteoarthritis

Cited by 40 publications

References 5 publications

Intra-Articular Ultrasound-Guided Injection of Sinovial® Forte 1.6% in Patients Affected by Symptomatic Hip Osteoarthritis: Effectiveness and Safety in a Large Cohort of Patients

Intra-Articular Ultrasound-Guided Injection of Sinovial® Forte 1.6% in Patients Affected by Symptomatic Hip Osteoarthritis: Effectiveness and Safety in a Large Cohort of Patients

Pharmacokinetics and Pharmacodynamics of Hyaluronan Infused into Healthy Human Volunteers

18 month observational study on efficacy of intraarticular hyaluronic acid (Hylan G-F 20) injections under ultrasound guidance in hip osteoarthritis

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