An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee.
Osteoarthritis Cartilage
; 14(9): 859-66, 2006 Sep.
Article
in En
| MEDLINE
| ID: mdl-16626978
ABSTRACT
OBJECTIVE:
Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials.METHOD:
Trials were similar in design, patient population and outcome measures - all included the Lequèsne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized.RESULTS:
A total of 1155 patients with radiologically confirmed knee OA were enrolled 619 received three or five IA-HA injections; 536 received "placebo" saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequèsne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequèsne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses.CONCLUSIONS:
This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Osteoarthritis, Knee
/
Hyaluronic Acid
Type of study:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Osteoarthritis Cartilage
Journal subject:
ORTOPEDIA
/
REUMATOLOGIA
Year:
2006
Document type:
Article
Affiliation country:
United States