Meta-Analysis of Randomized Clinical Trials Investigating the Effect of TDT 064, a Gel-Based Formulation Containing Ultra-Deformable Phospholipid Vesicles, in Patients with Knee Osteoarthritis
- *Corresponding Author:
- Matthias Rother, MD
International Medical Research (IMR) Partner GmbH
Department of Clinical Research, Graefelfing, Germany
Tel: + 49 (0)89 85 83 609 25
Fax: +49 (0)89 85 83 609 26
E-mail: [email protected]
Received Date: May 20, 2013; Accepted Date: June 28, 2014; Published Date: June 30, 2014
Citation: Rother M, Vester J, Bolten WW, Kneer W, Conaghan PG (2014) Meta-Analysis of Randomized Clinical Trials Investigating the Effect of TDT 064, a Gel-Based Formulation Containing Ultra-Deformable Phospholipid Vesicles, in Patients with Knee Osteoarthritis. Rheumatology (Sunnyvale) 4:138. doi: 10.4172/2161-1149.1000138
Copyright: © 2014 Rother M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: Ketoprofen-containing ultra-deformable phospholipid vesicles (IDEA-033) have been compared with drug-free vehicle (TDT 064) in randomized, controlled trials in knee osteoarthritis (OA). A pronounced treatment effect was reported for TDT 064, with an effect size (ES) comparable with celecoxib in one trial. Our meta-analysis determined whether these TDT 064 effects are beyond any expected placebo effect.
Methods: Five randomized, placebo-controlled studies of IDEA-033 in knee OA using TDT 064 as a control were included. Change from baseline in Western Ontario and McMaster Universities (WOMAC) OA Index pain and function subscale scores from each study were standardized and the ES calculated at various times. We compared our results with previously reported data on placebo response using similar methodology in a meta-analysis of 198 randomized OA trials.
Results: ES for pain relief at Week 6 was markedly higher for TDT 064 studies (ES: 1.04 [95% confidence interval (CI): 0.98–1.09]) than that previously reported for placebos in knee OA (ES: 0.54 [95% CI: 0.49–0.60]), as was the ES for function improvement (ES: 0.93 [95% CI: 0.87–0.98] vs ES: 0.49 [95% CI: 0.44–0.54], respectively). Higher ES for pain relief for TDT 064 studies was also reported with prior oral nonsteroidal anti-inflammatory drugs (NSAIDs) exposure (ES: 1.00 [95% CI: 0.93–1.07]), and in patients with high (ES: 1.08 [95% CI: 1.00–1.17]) or low baseline pain (ES: 1.03 [95% CI: 0.95–1.11]).
Conclusions: The magnitude of the effect with TDT 064 indicates this is unlikely to be solely a result of a placebo response.