Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial(®)) vs hylan G-F20 (Synvisc(®)) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
21875678
DOI
10.1016/j.joca.2011.07.016
PII: S1063-4584(11)00230-5
Knihovny.cz E-zdroje
- MeSH
- artróza kolenních kloubů farmakoterapie MeSH
- biokompatibilní materiály aplikace a dávkování terapeutické užití MeSH
- bolest farmakoterapie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- injekce intraartikulární MeSH
- kyselina hyaluronová aplikace a dávkování analogy a deriváty terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- měření bolesti MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- viskosuplementy aplikace a dávkování terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- biokompatibilní materiály MeSH
- hylan MeSH Prohlížeč
- kyselina hyaluronová MeSH
- viskosuplementy MeSH
OBJECTIVE: Knee osteoarthritis is a major cause of disability and pain. This phase III, double-blind (patient and observer blinded,) multicenter, randomized, non-inferiority study was conducted to demonstrate the non-inferiority of the highly purified intra-articular injection of hyaluronic acid (Sinovial(®)) in comparison to Hylan G-F20 (Synvisc(®)) in the treatment of knee osteoarthritis. METHODS: A total of 381 patients were randomly assigned to receive either the test drug, 16 mg/2 ml (0.8%) highly purified ia hyaluronic acid of biofermentative origin (Sinovial(®)), or the comparative drug, 16 mg/2 ml of 0.8% hylan G-F20 (Synvisc(®)). The duration of the treatment was 2 weeks (three injections at 1-week interval), followed by an observation period of 6 months. The primary efficacy variable was the improvement in mean Western Ontario and McMaster Universities (WOMAC) pain subscore from baseline to the final visit (week 26), compared between the two treatment groups. The acceptable margin for non-inferiority was chosen to be 8 mm. RESULTS: At week 26, WOMAC pain subscores decreased by a mean of 32.5 for both Sinovial(®) and Synvisc(®). These results met prespecified criteria for non-inferiority for both the Intent-to-Treat and Per-Protocol populations. There were no statistically significant differences between groups at 26 weeks, although Sinovial(®)-treated patients tended to have a slightly better outcome for select variables, as they did at earlier time-points, some of which reached statistical significance. Both hyaluronic acid preparations were well-tolerated, with no statistically significant differences in tolerability profile between groups. CONCLUSION: Sinovial(®) and Synvisc(®) treatments were found to be equivalent, both in terms of efficacy and safety. CLINICAL TRIAL NUMBER: NCT00556608 (ClinicalTrials.gov Identifier).
Citace poskytuje Crossref.org
Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice
ClinicalTrials.gov
NCT00556608
