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There were no serious adverse events in the study, and ISIS 301012 was well tolerated. A single patient had a transient increase in liver transaminase (ALT) that exceeded three times the upper limit of normal (3xULN), which the investigator attributed to alcohol as documented by patient admission.
ISIS 301012 in Homozygous Familial Hypercholesterolemia
The data presented are part of a single-arm, open-label, dose-escalation study. Because the study was designed principally to assess the safety of ISIS 301012 in HoFH and in combination with high-dose concurrent lipid- lowering therapies, the protocol initially called for five weeks of dosing. Based on a strong safety profile at five weeks with doses through 200 mg/week, the study was amended to include a cohort of patients dosed at 300 mg/week for three months, and it is that cohort for which preliminary data were subject of today's presentation. Full results from the study will be presented in the future, as will data from the ongoing double-blind, placebo-controlled heterozygous FH study.
Table 1: ISIS 301012 in HoFH, Summary of Results
Lipid values are presented in mg/dL and % change from baseline.
Patient 1 Patient 2 Patient 3
80 mg atorvastatin +
Concurrent 80 mg 10 mg ezetimibe + 40 mg rosuvastatin +
therapies atorvastatin 625 mg colesevelam + 10 mg ezetimibe
1 g niacin
Age (years) 23 48 32
Lipids: Baseline Day % Baseline Day % Baseline Day %
85 change 78 change 43 change
apoB-100 369 191
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