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Findings about eprodisate (KIACTA(TM)) reported in the article include:
- At the end of the 24-month period, the disease had worsened in 24 of
89 patients assigned to eprodisate (KIACTA(TM)) (27%), and 38 of
94 patients given placebo (40%, p=0.06)(1).
- Eprodisate (KIACTA(TM)) decreased the risk of the primary endpoint, a
composite of worsening of renal function or death, by 42%
(HR 0.58, p=0.02)(2).
- Eprodisate (KIACTA(TM)) significantly reduced the risk of the doubling
of serum creatinine, the risk of 50% reduction in creatinine clearance
and the slope of decline in creatinine clearance.
- Eprodisate (KIACTA(TM)) treatment was associated with a reduction in
the risk of developing end-stage renal disease, one of the clinical
measures of the composite primary endpoint that was not statistically
significant at the two-year time point.
- There was no significant difference between the two groups in the risk
of death.
- Eprodisate (KIACTA(TM)) did not affect proteinuria, amyloid content in
abdominal fat and, as expected, did not change the blood level of serum
amyloid A protein.
- The frequency and types of adverse events and death were similar in the
treated and placebo groups. The most frequent adverse events (as
categorized by common terms) were diarrhea, headaches and nausea.
About Eprodisate (KIACTA(TM))
Eprodisate (KIACTA(TM)) was investigated in a landmark
international, randomized, double-blind, placebo-controlled, and
parallel-designed clinical trial in which 183 AA amyloidosis
patients were enrolled at 27 sites around the world. Patients who
completed the clinical trial were eligible for enrollment in an
ongoing open-label extension study, some of whom have now been
re
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