Abstract
BackgroundIn osteoarthritis (OA) treatment, although chondroitin sulfate (CS) was found in a number of studies using radiography to have a structure-modifying effect, to date CS use is still under debate. A clinical study using quantitative magnetic resonance imaging (qMRI) is therefore of the utmost importance. Here we report data from a 24-month, randomised, double-blind, double-dummy, controlled, comparative exploratory study of knee OA. The primary endpoint was to determine the effect of CS 1200 mg/day versus celecoxib 200 mg/day on cartilage volume loss (CVL) in the lateral compartment over time as measured by qMRI. Secondary endpoints included assessment of the OA structural changes and signs and symptoms of OA.MethodsqMRI was performed at baseline and at 12 and 24 months. CVL, bone marrow lesion size, and synovial thickness were evaluated using qMRI. The primary statistical analysis was carried out on the modified intention-to-treat (mITT) population (n = 138) using chi-squared, Fisher’s exact, Wilcoxon Mann–Whitney, and Student’s t tests and analysis of covariance. Analyses were also conducted on the according-to-protocol (ATP; n = 120) population.ResultsIn the adjusted mITT analysis, compared with celecoxib treatment, patients treated with CS had a significant reduced CVL at 24 months in the medial compartment (celecoxib –8.1 % ± 4.2, CS –6.3 % ± 3.2; p = 0.018) and medial condyle (–7.7 % ± 4.7, –5.5 % ± 3.9; p = 0.008); no significant effect was seen in the lateral compartment. In the ATP population, CS reduced CVL in the medial compartment at 12 months (celecoxib –5.6 % ± 3.0, CS –4.5 % ± 2.6; p = 0.049) and 24 months (celecoxib –8.4 % ± 4.2, CS –6.6 % ± 3.3; p = 0.021), and in the medial condyle at 24 months (celocoxib –8.1 % ± 4.7, CS –5.7 % ± 4.0; p = 0.010). A trend towards a statistically reduced synovial thickness (celecoxib +17.96 ± 33.73 mm, CS –0.66 ± 22.72 mm; p = 0.076) in the medial suprapatellar bursa was observed in CS patients. Both groups experienced a marked reduction in the incidence of patients with joint swelling/effusion and in symptoms over time. Data showed similar good safety profiles including cardiovascular adverse events for both drugs.ConclusionThis study demonstrated, for the first time in a 2-year randomised controlled trial using qMRI, the superiority of CS over celecoxib at reducing CVL in knee OA patients.Trial registrationClinicalTrials.gov NCT01354145. Registered 13 May 2011.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-016-1149-0) contains supplementary material, which is available to authorized users.
Highlights
In osteoarthritis (OA) treatment, chondroitin sulfate (CS) was found in a number of studies using radiography to have a structure-modifying effect, to date CS use is still under debate
The use of the latest line of treatment has not reached a general consensus among different guidelines [6, 7], due in part to the unavailability of prescription quality symptomatic slow-acting drugs for osteoarthritis (SYSADOA) indicated for use in OA that have been evaluated by the US Food and Drug Administration [6]
Attention has recently been focused on the investigation and development of new types of drugs and treatments that can improve the clinical symptoms of OA and show better safety profiles, such as symptomatic SYSADOAs
Summary
In osteoarthritis (OA) treatment, chondroitin sulfate (CS) was found in a number of studies using radiography to have a structure-modifying effect, to date CS use is still under debate. A recent systematic literature review suggests that paracetamol, especially at the upper end of standard analgesic doses, can induce gastrointestinal events (i.e. gastroduodenal ulcers and complications such as upper gastrointestinal haemorrhages) and renal events (decrease in glomerular filtration rate) [8] For this reason, attention has recently been focused on the investigation and development of new types of drugs and treatments that can improve the clinical symptoms of OA and show better safety profiles, such as symptomatic SYSADOAs. SYSADOAs such as CS are characterised by a slow onset of action and a global efficacy at reducing OA symptoms similar to that of NSAIDs, and possess a carry-over effect. 6-month randomised controlled trials (RCTs) using similar grade preparations have shown that CS 1200 mg/day plus glucosamine 1500 mg/day can provide significant pain relief over placebo [9] and comparable pain relief with celecoxib [10] in a subgroup of patients with moderate-to-severe knee pain
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