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 kneel

Strand, V., Conaghan, P. G., Lohmander, L. S., Koutsoukos, A. D., Hurley, F. L., Bird, H., Brooks, P., Day, R., Puhl, W. and Band, P. A. (2006) 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 kneel. Osteoarthritis and Cartilage, 14 9: 859-866. doi:10.1016/j.joca.2006.02.012


Author Strand, V.
Conaghan, P. G.
Lohmander, L. S.
Koutsoukos, A. D.
Hurley, F. L.
Bird, H.
Brooks, P.
Day, R.
Puhl, W.
Band, P. A.
Title 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 kneel
Journal name Osteoarthritis and Cartilage   Check publisher's open access policy
ISSN 1063-4584
1522-9653
Publication date 2006
Sub-type Article (original research)
DOI 10.1016/j.joca.2006.02.012
Volume 14
Issue 9
Start page 859
End page 866
Total pages 8
Place of publication London, United Kingdom
Publisher W. B. Saunders
Collection year 2006
Language eng
Subject C1
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 Lequesne 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 Lequesne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequesne 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. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Keyword Osteoarthritis
Knee
Intra-articular
Hyaluronan
Hyaluronate
Hyaluronic
Viscosupplementation
Meta-analysis
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

 
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