ARTICLE | Clinical News

Mipomersen: Additional Phase III data

September 6, 2010 7:00 AM UTC

Additional data from the double-blind, North American Phase III RADICHOL II trial in 124 patients showed that once-weekly subcutaneous injections of 200 mg mipomersen significantly reduced APOB by 26% from baseline to week 26 vs. a 7% increase for placebo (p<0.001). Mipomersen also significantly reduced total cholesterol and non-HDL cholesterol by 19% and 25%, respectively, vs. a 4% increase in both measures for placebo (p<0.001 for both). Additionally, mipomersen significantly reduced lipoprotein(a) (LPA) by 21% vs. no change for placebo (p<0.001). Patients were already receiving a maximally-tolerated dose of statin and other lipid-lowering therapies.

Updated safety data from the trial showed that 6 of 83 patients treated with mipomersen had persistent elevations, defined as consecutive elevations at least 1 week apart, in liver alanine transaminase (ALT) levels that were 3 times the upper limit of normal. Furthermore, mipomersen-treated patients had a median increase in liver fat from baseline of 4.9% vs. a 0.4% increase for placebo as measured by MRI. No patients had changes in other laboratory tests that would indicate hepatic dysfunction, and no cases of Hy's law have been reported. Nine patients discontinued the study due to adverse events, including ALT elevations (n=3), injection-site reactions (n=2), non-cardiac chest pain (n=2), injection-site reactions and flu-like symptoms (n=1), and constipation (n=1). Data were presented at the European Society of Cardiology meeting in Stockholm. ...