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Latest research on CS b-Bioactive®

The journal Annals of the Rheumatic Diseases (the highest impact journal in rheumatology worldwide with an impact factor of 9.270) has just published in its online edition the results from MOVES (Multicentre Osteoarthritis InterVEntion trial with Sysadoa), a large multicenter clinical trial led by Bioiberica, confirming the efficacy and safety of Droglican® for the treatment of osteoarthritis in patients with severe pain.

MOVES-studyThe Multicentric Osteoarthritis interVEntion Study with Sysadoa (MOVES) was designed as an international multicentric, phase IV, double-blind, non-inferiority, randomized trial to compare the efficacy and safety of a fixed dose combination of glucosamine hydrochloride + CS b-Biocative®  versus celecoxib in patients with symptomatic knee OA with moderate to severe pain.
606 participants were included from 42 medical centers in France, Germany, Poland and Spain, being one of the largest studies recently carried out in osteoarthritis. Eligible patients were aged 40 and above, had knee OA grade 2 or 3 radiographic severity and had a WOMAC pain scale of >301 units (0-500 scale). Patients with high gastrointestinal or cardiovascular risk were excluded, according to the contraindications associated to celecoxib. The primary outcome was the mean decrease in WOMAC Pain subscale after 6 months of treatment.

Both drugs reduced the WOMAC Pain subscale by 50% without significant difference between groups at the end of the study. Further, there was no difference in all secondary outcomes assessing patient’s pain, functional capacity, stiffness, inflammation, joint swelling, effusion, and overall quality of life.

Overall, there was similar rescue medication consumption in both arms, and no significant difference was found in the proportion of adverse events, that were mild and evenly distributed among treatment groups.

These results confirmed those from the NIH-sponsored trial published in the New England Journal of Medicine in 2006 (Clegg et al 2006), which suggested that the combination of glucosamine hydrochloride and chondroitin sulfate yielded significantly better results than placebo in severe pain patients. Moreover, the combination CS b-Bioactive® + Glucosamine has shown a comparable efficacy to Celecoxib, with a better safety profile, which is of critical importance in a chronic disease such as osteoarthritis, often concomitant to other comorbidities.

The MOVES study adds to the growing body of clinical evidence that makes CS b-Bioactive®  the most researched brand of chondroitin.
 
M. Hochberg, J. Martel-Pelletier, J. Monfort, I. Möller, J. R. Castillo, N. Arden, F. Berenbaum7, P. Conaghan, T. Pap, P. Richette, A. Sawitzke, P. du Souich, J. P. Pelletier, On behalf of MOVES Investigation Group. Multicentric osteoarthritis intervention study with SYSADOA (MOVES): Effects of combined glucosamine hydrochloride and chondroitin sulfate vs celecoxib for painful knee osteoarthritis. Ann Rheum Dis 2014;73(Suppl2)
A new randomized, double-blind clinical trial has shown that CS b-Bioactive®  treatment attenuates brain response to painful stimulus on the knee in patients with osteoarthritis. 
 
brain-MRIThis interesting study, developed in the Rheumatology Department and the MRI Research Unit of the Hospital del Mar in Barcelona is a phase IV, randomized, double-blind clinical trial in which 64 knee osteoarthritis patients received CS b-Bioactive® chondroitin sulfate 800 mg/day or placebo for a 4-month treatment course.
 
Patients were assessed at baseline and post-treatment by applying painful pressure on the patella surface and on the knee medial interline, during the acquisition of two fMRI sequences. The main outcome measurement was attenuation of the response evoked by knee painful stimulation in the pain-processing brain system. fMRI has proven its ability to comprehensively map brain activity associated with pain experience.
 
fMRI of patella pain, showed a larger activation reduction in the chondroitin sulfate group than in placebo in key regions of painprocessing network, as a posterior mesencephalon region including the periaqueductal gray (PAG), the primary somatosensory cortex (including the cortical representation of the leg) and extending to the primary motor cortex and posterior supplementary motor area.

These results confirmed the analgesic effect of CS b-Bioctive® on knee pain, assessed by an objective imaging technique as fMRI. The observed positive treatment effect of CS b-Bioactive® chondroitin sulfate is consistent with the known chondroitin action on cartilage protection due to chondrocyte regeneration. In addition, this study yielded further support to the utility of fMRI to objectify treatment effects on OA pain.

J. Monfort, J. Pujol, O. Contreras-Rodríguez, J. Llorente-Onaindia, M. Lopez-Solà, L. Blanco-Hinojo, J. Deus, H. Ortiz, F. J. Montañés, M. Campillo, P. Benito, L. Sánchez, M. Herrero, J. Vergés. Effects of chondroitin sulfate on brain response to painful stimulation in knee osteoarthritis patients. Ann Rheum Dis 2014;73(Suppl2)
According to the promising results of a new study, long-term use of CS b-Bioactive® chondroitin sulfate may reduce the need for total knee replacement.
 
knee-replacementKnee osteoarthritis is the most common indication for total knee arthroplasty, which drives a considerable part of the expenses related to the clinical management of these patients. Therefore, reducing total knee replacement could be considered an interesting outcome for any osteoarthritis therapy.
 
In order to determine the association between the use of CS b-Bioactive®  and the need for this type of surgery, an analysis was carried out on data sourced from SIDIAP. This is a public database that includes registers of more than 3400 general doctors, pharmacy invoice data and hospital admissions from Catalonia (North-East Spain), being representative of an 80% of the total population (>5 million of patients).
 
The use of 800 mg/day of CS b-Bioactive® chondroitin sulfate during 6 and 12 months was analyzed to study its association with the need for knee prosthesis. Propensity scores matching were used to minimize the bias due to confounding factors. This method has been shown to replicate randomized controlled trial results using electronic medical records data.
 
Preliminary results show a significant reduction of the risk of knee replacement in patients treated with CS b-Bioactive® namely 13% after 6 months of treatment and 23% after 12 months of treatment.
 
These results coming from a large and highly representative sample are consistent with previous findings that also suggested a reduction of total knee replacements in patients treated with CS b-Bioactive® chondroitin sulfate (Raynauld et al. 2013), and provide new evidence about the structure-modifying effect of the molecule.
 
Prieto-Alhambra D, Morros R, Arden N. Association between chondroitin sulphate use and the risk of total knee artrhoplasty in osteoarthitis patients: a propensity-score
matched cohort study. Basic Clin Pharmacol Toxicol 2013;113(Suppl.2)CP51:34
Results from a randomized double-blind placebo-controlled clinical trial confirm the disease-modifying effect of CS b-Bioactive® by means of nuclear magnetic resonance (MRI).
 
These results are very important because this is the first time that the disease-modifying effect has been demonstrated using a technique as objective as MRI, with visible results after six months of treatment. Previously, the technique used had always been X-rays, which are much less objective and precise than MRI.
 
The randomized, double-blind, placebo-controlled clinical trial was done on 70 patients with knee OA and synovitis who received 800 mg of CS b-Bioactive® chondroitin sulfate or a placebo for 12 months.
 
The results show that patients treated with CS b-Bioactive® experienced a reduction in the loss of cartilage volume in the lateral femorotibial compartment compared to placebo and a reduction in subchondral bone lesions compared to placebo.
 
In a subgroup of patients treated with CS b-Bioactive® and NSAIDS, there was a significant reduction in the thickness of the synovial membrane compared to the placebo + NSAIDS subgroup.  

cartilage-loss
 
Wildi et al, 2011 Chondroitin sulphate reduces both cartilage volume loss and bone marrow lesions in knee osteoarthritis patients starting as early as 6 months after initiation of therapy: a randomised, double-blind, placebo-controlled pilot study using MRI.  Ann Rheum Dis.  Jun;70(6):982-9

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