Alirocumab, an investigational PCSK9 inhibitor, was reported to significantly reduce LDL-C levels in patients with primary hypercholesterolemia and moderate cardiovascular risk in the phase 3 ODYSSEY MONO trial, according to Sanofi and Regeneron Pharmaceuticals. The 24-week study, which involved 103 patients randomized to receive either ezetimibe 10 mg or alirocumab starting at 75 mg every two weeks and increasing to 150 mg at week 12 if the 8-week LDL-C levels were greater than 70 mg/dL, showed a 47.2% reduction in LDL-C levels with alirocumab compared to a 15.6% reduction with ezetimibe. Furthermore, only a minority of patients were titrated upwards on alirocumab thus supporting the effectiveness of the low-dose treatment. The trial at hand is the first of twelve phase 3 trials being conducted to establish the therapeutic use of alirocumab. What are your thoughts on this new drug and the new class it belongs to? How do you think it will affect future treatment of cholesterol if approved?
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