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Statements

Subject Item
n2:RIV%2F00064203%3A_____%2F11%3A7092%21RIV12-MZ0-00064203
rdf:type
skos:Concept n5:Vysledek
rdfs:seeAlso
http://www.ncbi.nlm.nih.gov/pubmed/21722501
dcterms:description
Objectives To compare the efficacy and safety of a %22medium%22 molecular weight (MW) hyaluronan product (F60027, Structovial (R)) with a %22high%22 MW (Hylan G-F20, Synvisc (R)). Methods Prospective, randomised, multicentre, double-blind, active controlled, parallel-group study with a non-inferiority design. Patients with symptomatic KOA, global pain >= 40 mm (VAS, 0-100), Lequesne index (LFI, 0-24) score >7 and radiological Kellgren-Lawrence grade 213 were centrally randomised to receive F60027 or Hylan G-F20, administered via three weekly injections, with regular follow-up evaluations up to week 24 (W24). The primary outcome was LFI score change over 24 weeks. Secondary outcomes comprised pain VAS, quality of life, patient's and physician's global assessments, rescue medication consumption and OMERACT-OARSI responders rate. Results 276 patients were analysed in the fill analysis dataset (FAS), 236 in the Per Protocol dataset (PP). In the main efficacy analysis (PP), the difference of the LFI score change over 24 weeks between F60027 (-4.67 (0.27)) and Hylan G-F20 (-4.54 (0.28)) was 0.132 [95%CI: -0.598, 0.861] which met the predefined non-inferiority margin. Analyses of secondary efficacy criteria showed clinically relevant improvements of all outcomes at W24 for each treatment on both PP/FAS populations. Changes of LFI score between baseline and W24 were -5.73 in the F60027 and -5.57 in the Hylan G-F20 group (PP dataset). Few local reactions were reported: 3.6% of patients in each group. Conclusion F60027 and Hylan G-F20 were equally effective in reducing functional impairment and relieving pain in KOA patients, and well-tolerated. Objectives To compare the efficacy and safety of a %22medium%22 molecular weight (MW) hyaluronan product (F60027, Structovial (R)) with a %22high%22 MW (Hylan G-F20, Synvisc (R)). Methods Prospective, randomised, multicentre, double-blind, active controlled, parallel-group study with a non-inferiority design. Patients with symptomatic KOA, global pain >= 40 mm (VAS, 0-100), Lequesne index (LFI, 0-24) score >7 and radiological Kellgren-Lawrence grade 213 were centrally randomised to receive F60027 or Hylan G-F20, administered via three weekly injections, with regular follow-up evaluations up to week 24 (W24). The primary outcome was LFI score change over 24 weeks. Secondary outcomes comprised pain VAS, quality of life, patient's and physician's global assessments, rescue medication consumption and OMERACT-OARSI responders rate. Results 276 patients were analysed in the fill analysis dataset (FAS), 236 in the Per Protocol dataset (PP). In the main efficacy analysis (PP), the difference of the LFI score change over 24 weeks between F60027 (-4.67 (0.27)) and Hylan G-F20 (-4.54 (0.28)) was 0.132 [95%CI: -0.598, 0.861] which met the predefined non-inferiority margin. Analyses of secondary efficacy criteria showed clinically relevant improvements of all outcomes at W24 for each treatment on both PP/FAS populations. Changes of LFI score between baseline and W24 were -5.73 in the F60027 and -5.57 in the Hylan G-F20 group (PP dataset). Few local reactions were reported: 3.6% of patients in each group. Conclusion F60027 and Hylan G-F20 were equally effective in reducing functional impairment and relieving pain in KOA patients, and well-tolerated.
dcterms:title
Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non-inferiority, prospective, randomised, controlled trial Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non-inferiority, prospective, randomised, controlled trial
skos:prefLabel
Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non-inferiority, prospective, randomised, controlled trial Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non-inferiority, prospective, randomised, controlled trial
skos:notation
RIV/00064203:_____/11:7092!RIV12-MZ0-00064203
n5:predkladatel
n6:ico%3A00064203
n4:aktivita
n18:I
n4:aktivity
I
n4:cisloPeriodika
3
n4:dodaniDat
n11:2012
n4:domaciTvurceVysledku
n15:7671083
n4:druhVysledku
n17:J
n4:duvernostUdaju
n16:S
n4:entitaPredkladatele
n8:predkladatel
n4:idSjednocenehoVysledku
191014
n4:idVysledku
RIV/00064203:_____/11:7092
n4:jazykVysledku
n9:eng
n4:klicovaSlova
hyaluronans; non-inferiority comparative trial; intra-articular treatment; molecular weight; knee OA; double-blind; clinical-trials; recommendations; metaanalysis; acid; management; injections; hip; viscosupplementation; arthritis
n4:klicoveSlovo
n10:non-inferiority%20comparative%20trial n10:injections n10:metaanalysis n10:intra-articular%20treatment n10:knee%20OA n10:acid n10:hip n10:molecular%20weight n10:hyaluronans n10:recommendations n10:management n10:arthritis n10:viscosupplementation n10:clinical-trials n10:double-blind
n4:kodStatuVydavatele
IT - Italská republika
n4:kontrolniKodProRIV
[5AFB0364A978]
n4:nazevZdroje
Clinical and Experimental Rheumatology
n4:obor
n13:FP
n4:pocetDomacichTvurcuVysledku
1
n4:pocetTvurcuVysledku
7
n4:rokUplatneniVysledku
n11:2011
n4:svazekPeriodika
29
n4:tvurceVysledku
Berenbaum, F. Appelboom, T. Maheu, E. Jeka, S. Maasalu, K. Zaim, M. Trč, Tomáš
n4:wos
000293101500010
s:issn
0392-856X
s:numberOfPages
9