The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

• Klíčová slova
• intra-articular hyaluronic acid, knee, therapeutics, viscosupplementation,
• Publikační typ
• časopisecké články MeSH

• MeSH
• artróza kolenních kloubů diagnóza   farmakoterapie   patofyziologie   MeSH
• biomechanika MeSH
• injekce intraartikulární MeSH
• kolenní kloub účinky léků   patofyziologie   MeSH
• kyselina hyaluronová aplikace a dávkování   škodlivé účinky   MeSH
• lidé MeSH
• obnova funkce MeSH
• rozsah kloubních pohybů MeSH
• směrnice pro lékařskou praxi jako téma MeSH
• viskoelastické doplňky kloubní tekutiny aplikace a dávkování   škodlivé účinky   MeSH
• viskosuplementace škodlivé účinky   metody   normy   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• kyselina hyaluronová MeSH
• viskoelastické doplňky kloubní tekutiny MeSH