Tolerability profile of the antiinflammatory compound imidazole salicylate: a metanalysis of safety data in 1408 patients.

In order to evaluate the incidence of side-effects (S.E.), the withdrawal rate and the type of S.E. of the new antiinflammatory agent imidazole salicylate, we performed an analysis of 33 clinical trials involving 1408 patients treated with 750 mg t.i.d. (tablets or solution) or 1000 mg b.i.d. (granulated powder), taking into account all the factors (treatment duration, pharmaceutical form, indications, etc.) that could influence the type and incidence of S.E. Slight and transient episodes of pyrosis or epigastric pain represented the great majority of S.E. The overall rate of withdrawal was 1.8%. According to the duration of therapy, the incidence of S.E. was: 2-3 days, 3.3%; 5-7 days, 5.6%; 10-14 days, 8.8%; 30 days, 10.2%. The pharmaceutical forms, the treated pathologies and the various experimental designs adopted (double-blind, open, etc.) did not influence the S.E. rate. With imidazole salicylate the overall incidence of S.E. was always lower than other NSAID's ranging from 10% to 64% of that observed with the reference drugs (other salicylates, ibuprofen, naproxen, flurbiprofen, piroxicam, diclofenac). In conclusion, this analysis showed a linear relationship between S.E. and exposure time up to 10-12 days, followed by a clear trend toward a plateau of 10% of S.E. with treatments up to 30 days. Therefore the risk-benefit ratio, particularly when compared with that of the reference drugs, seems to be very favourable.