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More recent data with mipomersen, published at the end of 2011, come from patients who were considered high-risk and statin intolerant. This study looked at 33 patients who were randomized 2:1 to a weekly subcutaneous dose of mipomersen 200 mg versus placebo. The results were that LDL-C was reduced by 47%, with apoB and LP(a) also significantly reduced by 46% and 27%, respectively.
Four patients on active therapy and 2 placebo patients discontinued dosing prematurely due to adverse events. Persistent liver transaminase elevations >3 X ULN were observed in 7 subjects assigned to the active treatment arm. Liver fat content was assessed in selected subjects during and after treatment using magnetic resonance spectroscopy . Liver fat content increases in these patients ranged from 0.8% to up to 47%. Liver needle biopsy was performed in 2 of these subjects, confirming hepatic steatosis with minimal inflammation or fibrosis.