Discussion


4. Discussion

The medicinal therapy of osteoarthritis is usually directed to suppress the secondary inflammatory component of the disease, mainly with NSAID’s or with corticosteroids. These drugs are able to suppress inflammation and pain, but do not act on the causes and on the natural evolution of the disease, that may even worsen under these therapies. An alternative and perhaps more rational therapeutic approach is using selective drugs for osteoarthritis that suppress the pathogenic mechanisms of the disease rather than the symptoms only.

Dorofen™ is one of the selective drugs for osteoarthritis. In fact the Glucosamine Sulfate component of Dorofen™ is a preferred and essential substrate for the synthesis of proteoglycans by the chondrocytes and is able to normalize and stimulate this biosynthesis. In addition Dorofen™ inhibits the generation of superoxide radicals and of lysosomal enzymes and inhibits the activity of cartilage destroying enzymes such as collagenase and phospholipase. By these mechanisms Dorofen™ selectively blocks the pathogenic processes of osteoarthritis, stops the evolution of the disease and relieves symptoms as shown by a large clinical experience.

In the investigations performed in comparison with NSAID’s, e.g. with ibuprofen, phenylbutazone, or piroxicam, Dorofen™ at a daily dose of (1500mg GS/150mg GBE/day) was equally effective on the symptoms of osteoarthritis as the reference NSAID’s, but was significantly better tolerated. This feature of Dorofen™ is due to the fact that Dorofen™ selectively curbs the pathogenic mechanisms of osteoarthritis and, unlike the NSAID’s, does not have general non-specific effects, such as inhibition of the cyclo-oxygenases, that also trigger several systemic effects including severe gastrointestinal or neurological adverse reactions.

For these properties Dorofen™ is presently considered one of the most important representative of the selective symptom modifying drugs for osteoarthritis. The efficacy of Dorofen™ on symptoms need some time to appear (1-2 weeks) because Dorofen™ has no direct analgesic effects but improves the biochemical and functional conditions of the joints. However, once the therapeutic effect is achieved it persists for a notable time also after discontinuation of treatment, contrary to the NSAID’s which need continuous administration. This is the so-called remnant effect which allows cyclic therapeutic courses lightening the drug burden on the patients. In addition, Dorofen™ contains a physiological substance used by the human body for biosynthesis of the proteoglycans. This explains the safety of Dorofen™ because the body is already accustomed to it and does not adversely react for its disposal. In our clinical study, we have fully confirmed the efficacy of Dorofen™ in the 88 patients with osteoarthritis of the knee who were treated for 4 weeks with a daily dose of (1500mg GS/150mg GBE/day) Dorofen™. We have also confirmed that Dorofen™ was significantly better tolerated than the reference ibuprofen, both with regard to the incidence of drug-related adverse reactions and drop-outs. Finally we confirmed the remnant benefits of Dorofen™ after therapy administration. We therefore conclude that Dorofen™ is a drug which selectively curbs the pathogenic mechanisms of osteoarthritis and combines efficacy with good tolerability. Dorofen™ therefore appears particularly useful in the long-term therapeutic treatment needed in this chronic disease.

Results

Summary



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