PMID- 27867433
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1874-3129 (Print)
IS  - 1874-3129 (Electronic)
IS  - 1874-3129 (Linking)
VI  - 10
DP  - 2016
TI  - Open-label Study of Initial and Repeat Treatment Cycles of Hylan G-F 20 in 
      Patients with Symptomatic Knee Osteoarthritis.
PG  - 88-100
AB  - OBJECTIVE: To evaluate the efficacy and safety of initial and repeat treatment 
      with hylan G-F 20 in patients with symptomatic osteoarthritis (OA) of the knee. 
      METHODS: A prospective, multicenter, open-label study in adult patients with 
      symptomatic knee OA (Kellgren-Lawrence grades I-III) undergoing repeat (SC group) 
      or initial (IC group) treatment courses (3 x 2 mL of hylan G-F 20 at weekly 
      intervals) was conducted with a maximum follow-up of 26 weeks. Reduction of pain 
      using the Verbal Pain Questionnaire (VPQ) and Patient Global Assessment (PTGA) 
      scores, concomitant pain medications use, and adverse events (AEs) were 
      evaluated. RESULTS: A total of 842 patients were included (SC group, n=314; IC 
      group, n=528), of whom 616 formed the intent-to-treat (ITT) population (SC group, 
      n=235; IC group, n=381). Of the 462 patients with follow-up at week 26, 311 
      (67.3%) were defined as responders. In the ITT population, VPQ scores decreased 
      significantly at 26 weeks (p<0.001) compared with baseline. VPQ and PTGA scores 
      decreased significantly (p<0.001) from baseline at all time points, without any 
      significant changes in concomitant medication use. Twenty-four treatment-related 
      AEs (TEAEs) were reported in 2.9% of patients, with most being mild or moderate 
      in intensity and resolving without sequelae. CONCLUSION: Initial and repeat 
      courses of hylan G-F 20 were effective with a favorable safety profile for knee 
      OA. The large patient population and the study's pragmatic design suggest that 
      these results could be replicated in routine clinical practice.
FAU - Heger, Robert
AU  - Heger R
AD  - Praxis fur Orthopadie, Eltinger Strasse 56 71229 Leonberg, Germany.
FAU - Paulsen, Gunther
AU  - Paulsen G
AD  - Chirurgische Gemeinschaftspraxis, Katharinenstr 34, 75031 Eppingen, Germany.
FAU - Fickert, Ulrich
AU  - Fickert U
AD  - Chirurgische Praxis, Am Kutzschenstein 2, 01591 Riesa, Germany.
FAU - Kresmann, Michael
AU  - Kresmann M
AD  - Gemeinschaftspraxis fur Orthopadie, Bahnhofsallee 20, 40721 Hilden, Germany.
LA  - eng
PT  - Case Reports
DEP - 20161031
PL  - United Arab Emirates
TA  - Open Rheumatol J
JT  - The open rheumatology journal
JID - 101480507
PMC - PMC5101633
OTO - NOTNLM
OT  - Hyaluronan
OT  - Hyaluronic acid
OT  - Hylan
OT  - Knee
OT  - Osteoarthritis
OT  - Pain
EDAT- 2016/11/22 06:00
MHDA- 2016/11/22 06:01
PMCR- 2016/01/01
CRDT- 2016/11/22 06:00
PHST- 2016/02/10 00:00 [received]
PHST- 2016/09/30 00:00 [revised]
PHST- 2016/10/13 00:00 [accepted]
PHST- 2016/11/22 06:00 [entrez]
PHST- 2016/11/22 06:00 [pubmed]
PHST- 2016/11/22 06:01 [medline]
PHST- 2016/01/01 00:00 [pmc-release]
AID - TORJ-10-88 [pii]
AID - 10.2174/1874312901610010088 [doi]
PST - epublish
SO  - Open Rheumatol J. 2016 Oct 31;10:88-100. doi: 10.2174/1874312901610010088. 
      eCollection 2016.