Long-term therapy with tolfenamic acid pINN. A clinical and toxicological study with special reference to clinical...

48 patients with rheumatic diseases underwent long-term treatment with a new antirheumatic compound, tolfenamic acid pINN. The dosage was 2 capsules of 100 mg 3 times daily. At the time of summing-up 9 patients had been treated for one year, 41 for 6 months and 7 had been eliminated after 1 month of treatment, because of side-effects in the form of diarrhoea, dyspepsia, vomiting and 1 ulcer patient got an attack of duodenal ulcer. Of the 41 patients who completed the 6 month trial 33 reported good therapeutic effect. A significant fall in the erythrocyte sedimentation reaction (p less than 0.01) was observed. 19 patients reported side-effects in the trial period, but at the end of the trial only 5 complained of side-effects. In the male patients occasional slight dysuria was the most common side-effect. Of the 9 patients who were treated for one year all reported a good effect from the preparation and none of them complained of side-effects after 1 year of treatment. Apart from eosinophilia in 2 patients, who were eliminated from the trial because of diarrhoea, none of the laboratory values showed any signs of the preparation having any toxic effects.