Intra-articular orgotein in osteoarthritis of the knee: a placebo-controlled efficacy, safety, and dosage comparison.

Abstract

PURPOSE:

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.

PATIENTS AND 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 Nonsteroidal anti-inflammatory agents were withdrawn to induce a flare of disease activity.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.

CONCLUSION:

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.

• Authors: H McIlwain, J C Silverfield, D E Cheatum, J Poiley, J Taborn, T Ignaczak, C V Multz
• Journal: The American journal of medicine (Am J Med) Vol. 87 Issue 3 Pg. 295-300 (Sep 1989) ISSN: 0002-9343 [Print] United States
• PMID: 2773967 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Metalloproteins
• Superoxide Dismutase
• orgotein

Topics

• Aged
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Injections, Intra-Articular
• Knee Joint
• Male
• Metalloproteins (administration & dosage)
• Osteoarthritis (drug therapy)
• Random Allocation
• Superoxide Dismutase (administration & dosage)