Abstract
Objectives
To review the clinical experience in the United Kingdom with icodextrin (Ic).
Design
A retrospective multicenter study.
Patients
(1) the MICAS 1 patients who received Ic and elected to continue using it (called MICAS 2 patients), and (2) patients started on Ic on a named-patient basis (called compassionate use patients). Nearly all this latter group had ultrafiltration (UF) failure and were approaching hemodialysis (HC).
Interventions
The institution of one Ic bag, as the overnight exchange, usually in addition to three glucose bags.
Results
(1) MICAS 2: Of the 67 patients who received Ic and completed MICAS 1, 48 (72%) patients from eight units in the United Kingdom wished to continue Ic. Forty two percent of MICAS 2 patients were well on Ic after approximately 30 months of study (including the 6 months on MICAS 1). The main reasons for withdrawal were transplantation (21 %), death (17%), or transfer to HC for reasons other than UF failure (10%). There were no significant changes in laboratory data, including hematology, simple biochemistry, bone biochemistry, liver function tests, serum osmolality, and maltose levels. The adverse events reported were incidental to Ic. (2) Compassionate use: 30/63 (48%) patients remain well on Ic after 10 months of study. Eight patients (12%) went on to experience UF failure (again) after 13 months on Ic, requiring transfer to HC. The other main outcomes were death (11 %), transplantation (11 %), or transfer to HC for reasons unrelated to Ic (16%), usually intractable peritonitis. The serum sodium concentration decreased from 136.6±3.8 to 134.4±4.2 mmol/L (p < 0.05). There were no other significant changes in hematology or biochemistry measurements.
Conclusion
In MICAS 2 Ic probably maintained its effects, since there were no withdrawals due to UF failure. The compassionate use program has shown that a single Ic exchange is useful in UF failure, being able to prevent or delay transfer to hemodialysis. In both studies the safety and efficacy of Ic has been demonstrated in a large group of patients. A total of 192 patient-years of experience (including MICAS 1) has been accumulated to date. Properly controlled studies are needed to determine whether Ic, in its present form, should remain a “special needs” product (for UF failure) or whether it could replace glucose as the treatment of choice for CAPC patients.
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