PMID- 14594522
OWN - NLM
STAT- MEDLINE
DCOM- 20040129
LR  - 20061115
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 19
IP  - 6
DP  - 2003
TI  - An open-label study of a second course of hylan G-F 20 for the treatment of pain 
      associated with knee osteoarthritis.
PG  - 499-507
AB  - OBJECTIVE: To evaluate the efficacy and tolerability of a second course of hylan 
      G-F 20 for the treatment of osteoarthritic knee pain in patients who experienced 
      a clinical benefit with an initial course of therapy. RESEARCH DESIGN AND 
      METHODS: In this prospective, open-label study, men or women (>/=40 years of age) 
      with knee osteoarthritis (OA) received three weekly injections of hylan G-F 20. 
      Consecutive patients who requested a second course of hylan G-F 20 therapy due to 
      OA knee pain subsequent to pain relief with a first course of therapy were 
      enrolled between October 26, 2000 and January 18, 2001. MAIN OUTCOME MEASURES: 
      Pain while walking on a flat surface (Western Ontario and McMaster's Universities 
      Osteoarthritis Index, WOMAC, question A1), WOMAC domain C (physical functioning), 
      full WOMAC, and patient and investigator overall visual analog scales (VAS). 
      Efficacy variables were measured at baseline and at weeks 1, 2, 4, 8, 12 and 26. 
      An analgesic washout was required before all efficacy evaluations. RESULTS: 
      Patients receiving at least one injection of hylan G-F 20 (n = 71) were 
      predominantly Caucasian (84.5%) and female (64.8%), with a mean age of 65.5 years 
      and mean weight of 200.1 pounds. The mean time between the first and second 
      courses of hylan G-F 20 was 19.6 months (median 17.6 months). With hylan G-F 20, 
      pain while walking on a flat surface was significantly lower (p < 0.001) than 
      baseline at all time points up to week 26 (mean +/- SEM: -1.40 +/- 0.10 at week 
      26). Actual scores decreased from 2.4 +/- 0.10 at baseline to 0.97 +/- 0.11 at 
      week 26. Scores for the WOMAC domain C, full WOMAC and patient and investigator 
      overall VAS also significantly improved (p < 0.001) at all time points. A second 
      course of hylan G-F 20 was generally well-tolerated, based on the low incidence 
      of local adverse events (AEs) - only one patient (1.4%) experienced a severe 
      event, the types of AEs, and the fact that no patients discontinued the study due 
      to these AEs. The types of related AEs observed were not qualitatively different 
      from those listed in the current product information and published literature. 
      CONCLUSION: A second course of hylan G-F 20 therapy is an appropriate therapy for 
      the treatment of OA knee pain in patients who had a previous favorable clinical 
      response. For continued relief of osteoarthritis knee pain, this study supports 
      repeat use of hylan G-F 20 in these patients.
FAU - Waddell, David D
AU  - Waddell DD
AD  - Orthopedic Specialists of Louisiana, Inc., Shreveport, LA 71103, USA. 
      Oslresearch@aol.com
FAU - Cefalu, Charles A
AU  - Cefalu CA
FAU - Bricker, DeWayne C
AU  - Bricker DC
LA  - eng
PT  - Clinical Trial
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  - 125935-84-4 (hylan)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage/*analogs & derivatives
MH  - Injections, Intra-Articular
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*complications
MH  - Pain/*drug therapy/etiology
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Retreatment
EDAT- 2003/11/05 05:00
MHDA- 2004/01/30 05:00
CRDT- 2003/11/05 05:00
PHST- 2003/11/05 05:00 [pubmed]
PHST- 2004/01/30 05:00 [medline]
PHST- 2003/11/05 05:00 [entrez]
AID - 10.1185/030079903125002090 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2003;19(6):499-507. doi: 10.1185/030079903125002090.