THE MODERATE INTESTINAL SIDE-EFFECTS OF AURANOFIN DO NOT REQUIRE PROPHYLACTIC THERAPY WITH A BULKFORMING AGENT

Incidences of diarrhoea and loose stools are reported up to 50% in pat ients starting treatment with auranofin. Moreover, +/-4% of patients d iscontinue treatment because of severe diarrhoea. We investigated whet her a water binding agent would diminish the incidence of loose stools and diarrhoea. Endpoints were the patient's general impression of the quality of stools and a daily assessment of stool's frequency/consist ency and adverse events. Secondly, some disease activity parameters we re used to evaluate whether the buIkforming agent influences the effic acy of auranofin. In this study 269 patients suffering from Rheumatoid Arthritis (RA) were treated with auranofin 6 mgr daily for a period o f six months. Simultaneously the patients were randomly treated with e ither a bulkforming agent (Volcolon(R): psyllium fibres) or placebo. R esults show a 15% incidence of loose stools and diarrhoea during treat ment with auranofin. During the treatment period the patients' general impression of defecation consistency showed a shift to softer types. The changes in defecation consistency was not significantly different between groups (Intention-to-treat analysis: C-2=4.01; p=0.13). Also, the percentage of patients experiencing episodes of diarrhoea (reporte d as an adverse experience) was not different (14% of the patients tre ated with bulkformer versus 15%,vith placebo). During the first month 7% (n=5) of placebo treated patients reported short episodes of watery stools versus none in the bulkformer treated group. The percentage of days with loose or watery stools, reported on the diary cards, was co nsistently lower in bulkformer treated patients. Both groups improved equally with respect to disease activity parameters. Sixty-eight perce nt of patients continued auranofin treatment after the study period. I n conclusion, these data do not support adjuvant therapy with a bulkfo rming agent on initiation of auranofin therapy. The overall low incide nce of loose stools and diarrhoea suggests that a dose increase to 9 m gr daily is an option to enhance the efficacy of auranofin treatment.