Patients with high cholesterol were treated for ten weeks with 400 mg/week of the drug ISIS 301012. In this study, increasing the dose of ISIS 301012 to 400 mg/week was well tolerated and further reduced atherogenic lipids, with median improvements in LDL-cholesterol of 70%.
Collectively, data from this study demonstrate that the anticipated doses 100-300 mg/week should have broad lipid-lowering activity and be well tolerated.
Notably, by ten weeks into the thirteen-week dosing period, all eight treated patients in the cohort had levels of apoB-100 that were at or below the lower limit of normal, and four of the eight had undetectable levels of apoB-100. All patients in this dose cohort achieved LDL-C levels below the recommended 100 mg/dL target for patients in the high risk category.
“The clinical evidence supporting the activity and tolerability of ISIS 301012 has accumulated to a point at which it seems clear that ISIS 301012 is likely to play an important role in the management of high cholesterol, according to Evan Stein, director, Metabolic and Atherosclerosis Research Center, Cincinnati.
“The drug’s pronounced activity, its predictability, its reduction of all atherogenic lipids and triglycerides, as well as the opportunity for assured patient compliance with infrequent subcutaneous dosing, are all attractive attributes.”