M007: A SAFETY PROFILE OF INTRAVENOUS COLOMYCIN IN ADULT CF
CARE
S.P. Conway., M. Pond, A. Watson, H. Robey,* M. Goldman.*
(Regional Adult CF Unit, Seacroft Hospital, Leeds and *Pharmax
Ltd., U.K.)
71 patients entered the study, of whom 36 received Colomycin 2 MU tds alone and 35 Colomycin 2 MU plus a second antipseudomonal antibiotic. Study length was 12 days. Mono-and duotherapy groups were equivalent at day 0 for patient weight, age and % predicted FEV1. 5 patients were withdrawn from the mono and 4 from the duo therapy groups. Only 2 were related to treatment:: severe weakness and dizziness (definitely drug related), skin rash (possibly drug related). At entry, and on days 5 and 12, patients scored neurological symptoms if present as mild, moderate, or severe. Only 1 patient (mono-therapy gp) reported a severe neurological event. Mild and moderate symptoms were reported by both groups: numbness, tingling, unsteadiness, dizziness, muscle weakness. These were all transient and did not require interruption of therapy. Only 2 non-neurological events possibly related to treatment occurred; aching hands and a skin rash. Laboratory data were corrected for intention to treat analysis. There was no significant difference in mean values at days 0, 5, or 12 for hepatic transaminases, urea, creatinine or creatinine clearance in either group. Ward urine testing similarly showed no changes over the study period. Colomycin 2 MU tds is not toxic in adult patients with CF when given intravenously over 12 days.