PMID- 16083536
OWN - NLM
STAT- MEDLINE
DCOM- 20051228
LR  - 20220409
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 21
IP  - 8
DP  - 2005 Aug
TI  - Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with 
      osteoarthritis of the knee in clinical practice.
PG  - 1261-9
AB  - OBJECTIVE: To determine the tolerability and short-term effectiveness of hylan 
      G-F 20 (Synvisc) in patients with symptomatic osteoarthritis (OA) of the knee in 
      standard clinical practice. RESEARCH DESIGN AND METHODS: Over 800 orthopedic 
      surgeons in Germany recorded adverse events (AEs) for approximately five 
      consecutive patients each following 3 weekly intra-articular hylan G-F 20 
      injections. Patients assessed their pain on a 4-point scale before and 3 weeks 
      after the first injection. Potential risk factors for local AEs and possible 
      predictors of short-term effectiveness of hylan G-F 20 were explored with 
      logistic regression. RESULTS: 4253 patients were treated with 12699 injections by 
      840 physicians at 720 sites. Local, treatment related AEs (n = 302) were reported 
      in 180 patients (4.2% of patients; 2.4% of injections). The most frequently 
      reported AEs were joint effusion (2.4% of patients), joint swelling (1.3%), 
      arthralgia (1.2%), joint warmth (0.6%), and injection site erythema (0.3%). Most 
      AEs were mild (21.4%) to moderate (40.3%) in nature. One patient experienced a 
      serious AE of severe swelling and synovial fluid accumulation judged as possibly 
      treatment related. Patients < 70 years old, patients with a longer time since 
      diagnosis, and those previously treated with visco-supplementation were more 
      likely to experience a local AE. Pain significantly (p < 0.0001) decreased 3 
      weeks after the first injection compared with before treatment. Potential 
      predictors of hylan G-F 20 short-term effectiveness were being underweight, male 
      gender, shorter time since diagnosis, and severe baseline pain. CONCLUSIONS: In 
      this population of 4253 patients treated with hylan G-F 20 for OA knee pain, the 
      overall incidence of local, treatment-related AEs was low and consistent with 
      those reported in the current US product labeling and previously published 
      studies. Additionally, short-term effectiveness was confirmed.
FAU - Kemper, Ferry
AU  - Kemper F
AD  - Klinik Lohrey, Orthopadie und Rheumatologie, Bad Soden-Salmunster, Germany.
FAU - Gebhardt, Ullricht
AU  - Gebhardt U
FAU - Meng, Thomas
AU  - Meng T
FAU - Murray, Christopher
AU  - Murray C
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Adjuvants, Immunologic)
RN  - 125935-84-4 (hylan)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage/adverse effects/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Germany
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Injections, Intra-Articular
MH  - Knee/physiopathology
MH  - Knee Joint/drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Observation
MH  - Orthopedics
MH  - Osteoarthritis, Knee/*drug therapy/physiopathology
MH  - Pain/*drug therapy
MH  - Prospective Studies
MH  - Risk Factors
MH  - Time Factors
EDAT- 2005/08/09 09:00
MHDA- 2005/12/29 09:00
CRDT- 2005/08/09 09:00
PHST- 2005/08/09 09:00 [pubmed]
PHST- 2005/12/29 09:00 [medline]
PHST- 2005/08/09 09:00 [entrez]
AID - 10.1185/030079905X56501 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2005 Aug;21(8):1261-9. doi: 10.1185/030079905X56501.