LONDON, June 13, 2016 /PRNewswire/ --
- A new clinical study, conducted in full compliance with the most recent EMeA (European Medicines Agency) guidelines, shows that prescription chondroitin sulphate reduces pain and improves functional disability significantly better than placebo in patients with knee osteoarthritis (OA)
- Chondroitin sulphate proves to be equally effective as the anti-inflammatory drug (NSAID) celecoxib
- Patients treated daily, for 6 months, well tolerated chondroitin sulphate 800 mg oral dosage form. No serious treatment-related side effects were reported during the entire period of the study
IBSA, in occasion of the European Congress of Rheumatology (EULAR 2016), has presented the results of a new multicentre, randomised, double-blind and double-dummy phase III clinical trial named CONCEPT (ChONdroitin vs CElecoxib vs Placebo T rial).
The study, designed in full compliance with the most recent EMeA guidelines, was conducted in 16 centers located in Belgium, Czech Republic, Italy, Poland and Switzerland and involved 603 patients with knee OA with the aim to confirm the efficacy and the safety of prescription highly purified chondroitin sulphate versus placebo and celecoxib, as gold reference standard, for a 6-month treatment period.
The results, presented by Prof. Reginster, MD, PhD, Professor of Epidemiology, Public Health and Health Economics (University of Liège, Belgium), during IBSA satellite symposium "What treatment should we adopt as the preferred long-term therapy in knee OA" (http://www.ibsa-international.com/eular2016/) show that the two primary endpoints, the decrease of the Lequesne algo-functional index and the decrease of pain on a VAS scale, resulted both to be statistically significant (p<0.05) vs placebo, confirming the SYSADOA (Sympomatic Slow Acting Drug in OsteoArthritis) effect of chondroitin sulphate. In addition, chondroitin sulphate proves to be equally effective to the active comparator celecoxib and to possess a favourable benefit/risk profile.
"We are very pleased with the outcome of this trial" commented Giuseppe Mautone, Head of IBSA R&D, "since these evidences represent a step forward in the definition of which drugs physicians should adopt for the long term therapy of OA".
About Osteoarthritis (OA)
OA currently affects over 40 million Europeans; it accounts for a substantial number of healthcare consultations and is a leading indication for use of prescription drugs. With the increasing aging population, OA is expected to become the fourth leading cause of disability by 2020,.
The relief of pain, the improvement of the functionality and quality of life are the main goals for the treatment of OA. The main used treatments belong to analgesics and NSAIDs, which are effective but they often cause serious adverse reactions at GI and CV levels.
Several compounds have been investigated and tested so far for their effects on the relief of clinical symptoms and improvement of joint structural changes, but there is still a great debate on which treatment/drug should be adopted as the preferred long-term therapy in knee OA.
About chondroitin sulphate
IBSA chondroitin sulphate* is a prescription drug with a positive and well consolidated benefit/risk profile. Its efficacy and safety in the treatment of OA has been proved in several clinical trials involving more than 3,900 patients.
The product is currently available in 13 countries in EU and from the date of the first commercialization (1983, Switzerland) more than 55 million of patients have been treated.
*Most common brand names: Condrosulf®, Chondrosulf®.
IBSA is a medium-size pharmaceutical company headquartered in Lugano, Switzerland.
Currently the IBSA group employs over 1800 people and is present in over 80 countries through partnerships and local subsidiaries in Italy, France, Hungary, Slovak Republic, Poland, Turkey, China and Scandinavia. The activities cover 8 main treatment areas (pain/inflammation, rheumatology, reproduction and fertility, endocrinology, urology, dermatology and dermocosmetics, respiratory, cardiovascular), with over 60 exclusive patents.
- Conaghan P.G. et al. Ann Rheum Dis. 2014; 73 (8): 1442-5.
- Bruyère O. et al. Semin Arthritis Rheum. 2015; 45: S3-S11.