experience in the GOUT 3 study was consistent and similar in nature and
pattern to that observed in the GOUT 1 and GOUT 2 studies and was
easily managed utilizing the methods specified in the study protocols.
As previously reported in GOUT 1, GOUT 2 and GOUT 3, there were a total
of seven patient deaths in the clinical program: 5 (5/169 or 3%) in
pegloticase treatment groups and two (2/44 or 4.5%) in the placebo
- Of these seven deaths, 3 were attributed to cardiac events. Two of
the events occurred in the pegloticase arms and one in the placebo
group as previously reported by the Company and not believed to be
Cardiovascular Serious Adverse Events (SAEs) in patients on pegloticase
GOUT 1 and GOUT 2 were as follows:
- There were two reported cardiac SAEs which were included among the
seven deaths indicated above.
- A third patient who was on pegloticase every 4 weeks, following a
placebo dose had an SAE relating to congestive heart failure which
was resolved after hospitalization. However, as previously
reported, this patient died of renal failure after voluntarily
withdrawing from renal dialysis.
- The remaining five patients with cardiac SAEs continued to receive
pegloticase in the trials. It is important to note that all five
patients continued treatment successfully despite their
None of these cardiovascular events, including the patient deaths were
thought to be causally related to pegloticase treatment by the
Investigators and Sponsor.
We believe the overall safety profile of pegloticase in the clinical
program indicates that long-term administration of 8 mg pegloticase in<
|SOURCE Savient Pharmaceuticals, Inc.|
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