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ARTICLE | Clinical News

SAR236553: Additional Phase II data

April 2, 2012 7:00 AM UTC

Additional data from the double-blind, placebo-controlled, U.S. Phase II DFI11566 trial in 92 patients showed that subcutaneous REGN727 plus 80 mg atorvastatin significantly reduced mean LDL-C from baseline to week 8, the primary endpoint, by 73% vs. 17% for 80 mg atorvastatin alone (p<0.001). Additionally, REGN727 plus 10 mg atorvastatin significantly reduced mean LDL-C from baseline to week 8 by 66% vs. atorvastatin alone. The trial enrolled patients with elevated LDL-C (>=100 mg/dL) who were receiving a 10 mg dose of atorvastatin for at least 6 weeks or who had LDL-C levels >=100 mg/dL after a run-in period with 10 mg atorvastatin to receive REGN727 plus 10 or 80 mg atorvastatin or placebo plus 80 mg atorvastatin. Data were presented at the American College of Cardiology meeting in Chicago. ...