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Combined Chondroitin Sulfate and Glucosamine for Painful Knee Osteoarthritis

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Combined Chondroitin Sulfate and Glucosamine for Painful Knee Osteoarthritis ARD Online First, published on January 14, 2015 as 10.1136/annrheumdis-2014-206792 Clinical and epidemiological research Ann Rheum Dis: first published as 10.1136/annrheumdis-2014-206792 on 14 January 2015. Downloaded from EXTENDED REPORT Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib Marc C Hochberg,1 Johanne Martel-Pelletier,2 Jordi Monfort,3,4 Ingrid Möller,5 Juan Ramón Castillo,6 Nigel Arden,7,8,9 Francis Berenbaum,10 Francisco J Blanco,11 Philip G Conaghan,12 Gema Doménech,13 Yves Henrotin,14,15 Thomas Pap,16 Pascal Richette,17,18 Allen Sawitzke,19 Patrick du Souich,20 Jean-Pierre Pelletier,2 on behalf of the MOVES Investigation Group Handling editor Tore K Kvien ABSTRACT INTRODUCTION ▸ Additional material is Objectives To compare the efficacy and safety of Osteoarthritis is the most common form of arthritis published online only. To view chondroitin sulfate plus glucosamine hydrochloride in Western populations. It most frequently affects please visit the journal online (CS+GH) versus celecoxib in patients with knee the knee, causing joint pain, tenderness, limitations (http://dx.doi.org/10.1136/ osteoarthritis and severe pain. of movement and impairment of quality of life, annrheumdis-2014-206792). Methods Double-blind Multicentre Osteoarthritis resulting in a social and economic burden.1 It fi For numbered af liations see interVEntion trial with SYSADOA (MOVES) conducted accounts for a substantial number of healthcare end of article. in France, Germany, Poland and Spain evaluating visits and costs in populations with access to 2 Correspondence to treatmentwithCS+GHversuscelecoxibin606 medical care. With increasing life expectancy, Professor Marc C Hochberg, patients with Kellgren and Lawrence grades 2–3 osteoarthritis is anticipated to become the fourth University of Maryland School knee osteoarthritis and moderate-to-severe pain leading cause of disability by the year 2020.1 of Medicine, 10 S. Pine St., (Western Ontario and McMaster osteoarthritis index Standard treatment focuses on symptom relief MSTF 8-34, Baltimore, MD ≥ – fl 21201, USA; mhochber@ (WOMAC) score 301; 0 500 scale). Patients were with analgesics and non-steroidal anti-in ammatory medicine.umaryland.edu randomised to receive 400 mg CS plus 500 mg GH drugs (NSAIDs), though the latter can cause serious three times a day or 200 mg celecoxib every day for gastrointestinal and cardiovascular adverse effects, – Received 14 October 2014 6 months. The primary outcome was the mean leading to concerns over long-term use.3 5 Revised 19 December 2014 Accepted 20 December 2014 decrease in WOMAC pain from baseline to 6 months. Various clinical trials have been performed with Secondary outcomes included WOMAC function and symptomatic slow-acting drugs for osteoarthritis – stiffness, visual analogue scale for pain, presence of (SYSADOA).6 9 Specifically, the Glucosamine/chon- joint swelling/effusion, rescue medication droitin Arthritis Intervention Trial (GAIT) was a consumption, Outcome Measures in Rheumatology randomised, double-blind, placebo-controlled http://ard.bmj.com/ Clinical Trials and Osteoarthritis Research Society study comparing the efficacy and safety of glucosa- International (OMERACT-OARSI) criteria and mine hydrochloride and chondroitin sulfate, EuroQoL-5D. alone and in combination, and celecoxib for the Results The adjusted mean change (95% CI) in treatment of knee osteoarthritis.10 While no statis- WOMAC pain was −185.7 (−200.3 to −171.1) tically significant effects were observed for the (50.1% decrease) with CS+GH and −186.8 (−201.7 combination group in the overall study population, on October 2, 2021 by guest. Protected copyright. to −171.9) (50.2% decrease) with celecoxib, a significant difference was observed for the combin- meeting the non-inferiority margin of −40: −1.11 ation arm in patients with moderate-to-severe (−22.0 to 19.8; p=0.92). All sensitivity analyses pain for the primary outcome, defined as a 20% were consistent with that result. At 6 months, 79.7% decrease in Western Ontario and McMaster osteo- of patients in the combination group and 79.2% in arthritis index (WOMAC) pain score (p=0.002). the celecoxib group fulfilled OMERACT-OARSI criteria. Additionally, patients with moderate-to-severe pain Both groups elicited a reduction >50% in the showed significant differences in the combination presence of joint swelling; a similar reduction was versus placebo group for Outcome Measures in seen for effusion. No differences were observed for Rheumatology Clinical Trials and Osteoarthritis the other secondary outcomes. Adverse events were Research Society International (OMERACT-OARSI) low and similarly distributed between groups. response (p=0.001), 50% decrease in WOMAC Conclusions CS+GH has comparable efficacy to pain (p=0.02), WOMAC pain score (p=0.009), To cite: Hochberg MC, celecoxib in reducing pain, stiffness, functional WOMAC function score (p=0.008), normalised Martel-Pelletier J, Monfort J, limitation and joint swelling/effusion after 6 months WOMAC score (p=0.017) and Health Assessment et al. Ann Rheum Dis in patients with painful knee osteoarthritis, with a Questionnaire pain score (p=0.03). Published Online First: fi To confirm these effects, the Multicentre [please include Day Month good safety pro le. Year] doi:10.1136/ Trial registration number: NCT01425853. Osteoarthritis interVEntion trial with SYSADOA annrheumdis-2014-206792 (MOVES) was conducted to test whether Hochberg MC, et al. Ann Rheum Dis 2015;0:1–8. doi:10.1136/annrheumdis-2014-206792 1 Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd (& EULAR) under licence. Clinical and epidemiological research Ann Rheum Dis: first published as 10.1136/annrheumdis-2014-206792 on 14 January 2015. Downloaded from chondroitin sulfate plus glucosamine hydrochloride has compar- celecoxib in the assessment of change in the WOMAC pain sub- able efficacy to celecoxib after 6 months of treatment in patients scale. With 280 patients per group, the study would have 90% with painful knee osteoarthritis. power assuming the expected difference in means was 0, the common SD was 26 (0–100 scale), according to previous – METHODS studies,12 16 with a delta of eight units (0–100 scale),13 16 17 a Study design one-sided significance level of 2.5% and assuming a 20% The MOVES trial was a phase IV, multicentre, non-inferiority, dropout rate. A delta of eight units in a range from 0 to 100 randomised, parallel-group, double-blind study. Patients were (the same as a delta of 40 units in the original range from 0 to recruited consecutively by physicians in public or private prac- 500) was used in the study. tice at sites in France, Germany, Poland and Spain (see online The main analyses were performed using the per-protocol supplementary table S1 for a list of investigators by study site population, defined as all randomised patients meeting the and country). inclusion criteria, who received study medication, had a baseline and at least one postbaseline efficacy measurement (for the Patients primary efficacy variable) and did not have major protocol vio- Eligible patients were ≥40 years of age, with a diagnosis of lations. In non-inferiority trials, the per-protocol set is used in primary knee osteoarthritis according to the American College of the primary analysis as it is the most conservative approach. Rheumatology, with radiographic evidence (Kellgren and Additionally, the primary efficacy analysis was performed Lawrence grade 2 or 3) of osteoarthritis, and severe pain according to intention to treat to test the robustness of the (WOMAC pain score ≥301 on a 0–500 scale) at inclusion. results.18 19 The safety population was defined as all randomised Patients were excluded if they had concurrent medical or arthritic subjects who took at least one dose of the study medication. conditions that could confound the evaluation of the index joint Continuous efficacy variables were analysed by means of a or coexisting disease that could preclude successful completion mixed models for repeated measurements (MMRM) approach, of the trial such as history of cardiovascular or gastrointestinal including time, treatment-by-time interaction and baseline value events and were excluded due to use of celecoxib. The full list of as a covariate. The variance–covariance matrix was unstruc- selection criteria is detailed in online supplementary table S2. tured. For categorical variables, Fisher’s exact test was used for between-treatment comparisons, by time-point when applicable. Treatment regimens and randomisation Missing data in the main outcome were handled using a conser- Eligible subjects were randomised to 400 mg chondroitin sulfate vative approach by imputation using the dropout reason (IUDR) plus 500 mg glucosamine hydrochloride (Droglican, Bioiberica, (the worst value for dropouts due to safety issues) or the last S.A., Barcelona, Spain) three times a day or 200 mg celecoxib observation carried forward approach in case of lack of efficacy. (Celebrex, Pfizer) every day for 6 months. Subjects were Other reasons were not imputed and were handled by the assigned sequentially in a 1:1 ratio using a computer-generated MMRM approach, which relies on the missing at random randomisation list prepared by an independent biostatistician assumption. Sensitivity analyses were conducted using the base- (GD) using proc Plan SAS System (V.9.1.3) software. Subjects line observation carried forward
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