A comparative trial of timegadine and D-penicillamine in rheumatoid arthritis.

Forty-four patients with definite or classical rheumatoid arthritis were entered in a 48-week open study, comparing the long-term effects of Timegadine and D-penicillamine. Twenty-three and 21 patients were respectively allocated to the Timegadine and D-penicillamine groups. Two patients of the former group were lost for follow-up, soon after the first baseline. Thus data were available only for 42 patients, 21 in each group of whom eleven completed the 48-week period in each group. Seven patients in the Timegadine group stopped because of ineffectiveness, 2 because of skin eruption and 1 because of acute interstitial pneumonitis. In the D-penicillamine group, 9 patients dropped out: 3 because of proteinuria, 2 because of stomatitis, 1 because of dizziness and 1 because of headache. Pain (visual analogue scale), number of swollen and painful joints improved significantly in both groups (p less than 0.05). The acute phase reactants alpha1-acid-glycoprotein and ESR and the thrombocyte count significantly decreased in the penicillamine group (p less than 0.05). The other clinical, hematological and immunological tests did not change; neither did the liver and kidney function tests. The clinical results suggest that Timegadine is as effective as D-penicillamine in the treatment of rheumatoid arthritis. D-penicillamine takes advantage over Timegadine by decreasing significantly the acute phase reactants. However, Timegadine has a low profile of side-effects.

RCT Entities:   Population Interventions Outcomes