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Two studies are reported with tolmetin sodium. The first compared tolmetin sodium, phenylbutazone and placebo in rheumatoid arthritis. The second compared tolmetin sodium and aloxiprin in osteoarthritis and soft tissue rheumatism. In the first study, a double-blind crossover trial involving 12 patients, tolmetin sodium (1600 mg daily) was shown to be superior to placebo and comparable to phenylbutazone (400 mg daily). The reductions in morning stiffness and pain were statistically significant when compared to placebo. Tolmetin sodium and aloxiprin were compared in the treatment of osteoarthritis in a single-blind study which investigated efficacy and safety over a 3-month period. Initial dosages were 1600 mg tolmetin sodium and 6 g aloxiprin (equivalent to 5 g aspirin) daily. Thirty-four patients were enrolled in the study. Both drugs produced an improvement over the 3-months treatment period. The reduction in pain was statistically significant. The dosage of tolmetin sodium remained at 1600 mg daily for the 3-month duration of the study but side-effects necessitated the reduction of the dosage of aloxiprin in many patients and after 3-months' treatment the mean dosage was 4 g daily. Five patients withdrew from the tolmetin sodium group and 11 from the aloxiprin group. Adverse reactions including limiting side-effects, were about twice as common with aloxiprin compared to tolmetin sodium.

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http://dx.doi.org/10.1185/03007998009112039DOI Listing

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