References
1. Data on file. Fidia Farmaceutici S.p.A., Italy. 2. Altman RD, Moskowitz R; HYALGAN® Study Group. Intraarticular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. J Rheumatol. 1998;25(11):2203-2212. 3. Scali JJ. Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15(1):57-62. 4. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21(3):307-311. 5. Bruyere O, Cooper C, Pelletier JP, et al. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: A report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014;44(3):253-263. 6. Miller LE, Block JE. An 8-week multimodal treatment program improves symptoms of knee osteoarthritis: a real-world multicenter experience. Pragmatic and Observational Research. 2013;4:39-44. 7. Miller LE, Block JE. An 8-week knee osteoarthritis treatment program of hyaluronic acid injection, deliberate physical rehabilitation, and patient education is cost effective at 2 years follow-up: The OsteoArthritis Centers of America™ Experience. Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders. 2014;7:49-55.
STUDY SUMMARY: ALTMAN, 1998
Intra-articular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: A randomized clinical trial2
Study design
26-week, double-blind, placebo-controlled, multicenter study (N=495) in patients 40 years of age or older with K-L grade 2 or 3 OA of the knee, comparing IA HYALGAN® 20 mg weekly x 5 with IA saline and 500 mg bid naproxen. All patients were allowed up to 4000 mg/d for rescue analgesia (acetaminophen) as needed for pain
Results
- In the HYALGAN® pivotal trial (N=495), the 5-injection regimen significantly improved pain measures through 26 weeks of follow-up
- Patients receiving HYALGAN® experienced significantly less pain than those in the placebo group (P<.05) at Weeks 4, 5, 12, 21, and 26
- 2/3 of patients receiving HYALGAN® reported pain relief each month for 6 months
STUDY SUMMARY: SCALI, 1995
Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study3
Study design
30-month, repeat-use, open-label study (N=75) of IA HYALGAN® 20mg weekly x5, repeated every 6 months for 5 treatment cycles. One cycle=5 injections. A total of 5 IA injections were administered
Results
- Progressive improvement in pain relief with repeat cycles over 30 months
- Improvements were observed after the first treatment cycle at 6 months and resulted in a 55% reduction in spontaneous pain at the end of the study (P<.001)
- No significant adverse events with repeat cycles
- Repeated treatment cycles improved symptoms, particularly in patients with early stage OA of the knee
- General assessment of overall treatment efficacy rated as “good” or “very good” with significant difference from baseline (P=.05) in 88% of patients
STUDY SUMMARY: NEUSTADT, 2003
Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee4
Study design
Prospective cohort study to evaluate the long-term efficacy and safety of 5 weekly intra-articular injection of HYALGAN® in 76 patients (92 knees) with moderate to severe OA of the knee, whose pain was not controlled by conventional measures. Clinical improvement was defined as >50% reduction in a visual analog scale (VAS) for pain at rest, night pain, and pain on walking
Results
- Ten of 15 (67%) knees improved after a repeat treatment course
- 72% of patients achieved a greater than 50% improvement in VAS pain scores for 1 year or longer