Nursing Medical News about painful osteoarthritis; Euflexxa

Become a Member Today!
Register

Most Viewed Abstracts

1. Report Shows Shift in Starting Salaries for Physicians

2. Recommendations on the use of 18F-FDG PET in oncology

3. Use of Antiemetic Agents in Acute Gastroenteritis

4. Gene expression signatures, clinicopathological features, and individualized therapy in breast cancer

5. AHA Guidelines on Cardiac CT for Assessing Coronary Artery Disease

Your Article Summary

See Latest Articles

(Click the title below to leave the MDLinx Network and go to the Journal's Website)

A double-blind, randomized, saline-controlled study of the efficacy and safety of Euflexxa® for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial)
Seminars in Arthritis and Rheumatism, 06/29/09

Altman RD et al. – Study demonstrates that Euflexxa (1% sodium hyaluronate; IA-BioHA) therapy resulted in significant osteoarthritis (OA) knee pain relief at 26 weeks compared with intra-articular saline (IA-SA). Subjects treated with IA-BioHA also experienced significant improvements in joint function, treatment satisfaction, and HRQoL.

Methods

FLEXX trial: assessing the safety and efficacy of IA-BioHA therapy for knee OA at 26 wks
Subjects with chronic knee OA were randomized to 3 weekly IA injections IA-SA or IA-BioHA (20 mg/2 ml)
Primary efficacy outcome: subject recorded difference in least-squares means between IA-BioHA and IA-SA following a 50-foot walk test, measured via 100-mm VAS
Secondary outcome measures:
- Osteoarthritis Research Society International responder index
- Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales
- Patient global assessment
- Rescue medication, and
- Health-related quality of life (HRQoL) by the SF-36
Safety assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications

Results

588 subjects randomized to either IA-BioHA (n=293) or IA-SA (n=295), with an 88% 26 wk completion rate
No differences were noted between the treatment groups at baseline
In the IA-BioHA group, mean VAS scores decreased by 25.7 mm, vs 18.5 mm in the IA-SA group
This corresponded to a median reduction of 53% from baseline for IA-BioHA and a 38% reduction for IA-SA
The difference in least-squares means was -6.6 mm
Secondary outcome measures were consistent
Both IA-SA and IA-BioHA injections were well tolerated, with a low incidence of AEs
Injection-site reactions were reported by 1 (<1%) subject in the IA-SA group and 2 (1%) in the IA-BioHA group