Intra-articular orgotein in osteoarthritis of the knee: a placebo-controlled efficacy, safety, and dosage comparison.
OBJECTIVE
Superoxide dismutase (orgotein for injection) has been used in managing osteoarthritis for more than seven years in Europe; however, well-controlled studies to establish an optimum dosage regimen have not been conducted. In this study, three orgotein dose/regimens were compared with placebo in terms of efficacy, safety, and duration of effect in patients with active osteoarthritis of the knee.


METHODS
A total of 139 patients with osteoarthritis of the knee were enrolled in the study. Nonsteroidal anti-inflammatory agents were withdrawn to induce a flare of disease activity. Patients were then randomly assigned to receive one intra-articular injection of either placebo or orgotein (8 mg to 32 mg) each week for three weeks. Both investigators and patients evaluated disease activity and adverse experiences at a series of follow-up visits for three months.


RESULTS
Orgotein was effective in reducing symptoms of osteoarthritis for up to three months after treatment; 16 mg given twice was the most effective and most best-tolerated regimen. Discomfort at the injection site was drug related, although this effect also occurred occasionally after injection of placebo.


CONCLUSIONS
The long-lasting effects of intra-articular superoxide dismutase contribute to a favorable risk-benefit ratio and support the importance of the free-radical anion, superoxide (O2-), in the biochemical pathology of osteoarthritis.
McIlwain
H
H
DDI Pharmaceuticals, Inc., Mountain View, California 94043.
Silverfield
J C
JC
Cheatum
D E
DE
Poiley
J
J
Taborn
J
J
Ignaczak
T
T
Multz
C V
CV
D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007270:Injections, Intra-Articular; D007719:Knee Joint; D008297:Male; D008667:Metalloproteins / Q000008:administration & dosage*; D010003:Osteoarthritis / Q000188:drug therapy*; D011897:Random Allocation; D013482:Superoxide Dismutase / Q000008:administration & dosage*
D008667:Metalloproteins; D013482:Superoxide Dismutase; C005180:orgotein