| 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. | |
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MedLine Citation:
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PMID: 16626978 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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V Strand; P G Conaghan; L S Lohmander; A D Koutsoukos; F L Hurley; H Bird; P Brooks; R Day; W Puhl; P A Band |
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Publication Detail:
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Type: Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't Date: 2006-04-19 |
Journal Detail:
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Title: Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society Volume: 14 ISSN: 1063-4584 ISO Abbreviation: Osteoarthr. Cartil. Publication Date: 2006 Sep |
Date Detail:
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Created Date: 2006-08-07 Completed Date: 2007-04-04 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9305697 Medline TA: Osteoarthritis Cartilage Country: England |
Other Details:
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Languages: eng Pagination: 859-66 Citation Subset: IM |
Affiliation:
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Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Double-Blind Method Drug and Narcotic Control Female Humans Hyaluronic Acid / administration & dosage*, adverse effects, therapeutic use Injections, Intra-Articular Male Middle Aged Osteoarthritis, Knee / drug therapy* Pain / chemically induced Randomized Controlled Trials as Topic Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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9004-61-9/Hyaluronic Acid |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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