Hj. Vanbeusekom et al., THE MODERATE INTESTINAL SIDE-EFFECTS OF AURANOFIN DO NOT REQUIRE PROPHYLACTIC THERAPY WITH A BULKFORMING AGENT, Clinical rheumatology, 16(5), 1997, pp. 471-476
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.