-- Mild injection site reactions remain the most common side effect
-- Injection site reactions did not worsen with longer-term dosing and
were not more prevalent in patients who self-administered mipomersen.
-- The incidence and severity of ALT elevations was less in the OLE study
than in the initial studies.
-- The maximal ALT seen in this study was 172 U/L.
-- No patient experienced an elevation of transaminase (ALT) associated
with increased bilirubin (Hy's Law). There were no bilirubins greater
than the upper limit of normal (ULN) observed in any subject.
-- Several patients who experienced increased ALTs either in the OLE
study or in the initial studies continued to receive mipomersen and
experienced decline in ALTs. No patient who experienced increased
ALTs greater than three times the ULN in their initial trial had
increased ALT values when they were retreated with mipomersen in the
"This open-label extension study suggests that mipomersen can be administered with a satisfactory safety profile and continued LDL reductions for prolonged periods of time in patients with familial hypercholesterolemia being treated with maximal doses of statins and other lipid lowering agents," said Evan Stein, M.D., Ph.D., Director, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio.
Conference Call Information
At 8:30 a.m. Eastern Time Monday, April 14, Isis will conduct a live webcast conference call to discuss mipomersen safety results. Interested parties may access the webcast at http://www.isispharm.com or listen to the call by dialing 877-856-1960. A webcast replay will be available for a limited time.
On January 7, 2008, Isis announced the licensing of mipomersen to
|SOURCE Isis Pharmaceuticals, Inc.|
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