LDL-C reductions for Roszet are calculated as 64%, 66% and 72% for the 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg doses respectively based on the LDL-C reductions of rosuvastatin and ezetimibe.
LDL-C reductions for placebo arms were 7% vs. rosuvastatin and 4% vs. ezetimibe in the respective studies.
- Rosuvastatin 5mg showed a LDL-C reduction of 45%.
- Ezetimibe LDL-C reductions were generally consistent across all statins in baseline therapy.
In a multicenter, double-blind, placebo-controlled, dose-ranging study1, in patients with hyperlipidemia, rosuvastatin given as a single daily dose for 6 weeks significantly reduced Total-C, LDL-C, non HDL-C, and ApoB, across the dose range.
In an 8-week, double-blind study2 in patients with primary
hypercholesterolemia, known coronary heart disease, or multiple
cardiovascular risk factors, adding ezetimibe to ongoing statin therapy
provided an additional 25% mean LDL-C reduction from treated baseline (post statin treatment) vs. 4% when adding placebo across the statins studied (p<0.001). LDL-C reductions attributable to ezetimibe were generally consistent across all statins studied.
- Roszet (rosuvastatin and ezetimibe) Prescribing Information; Morristown, NJ; Althera Pharmaceuticals
- Gagne C, Bays HE, Weiss SR, et al. Efficacy and Safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary
hypercholesterolemia. Am J Cardiol. 2002;90:1084-1091.