TUESDAY, March 27 (HealthDay News) -- For statin-treated patients with high levels of low-density lipoprotein (LDL) cholesterol, concomitant treatment with a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) is associated with a further reduction in LDL cholesterol, according to a study published in online March 26 in the Journal of the American College of Cardiology to coincide with presentation at the annual meeting of the American College of Cardiology, held from March 24 to 27 in Chicago.
Noting that statin therapy stimulates production of PCSK9, James McKenney, Pharm.D., from Virginia Commonwealth University in Richmond, and colleagues investigated the effect of blocking PCSK9 using the monoclonal antibody SAR236553/REGN727. A total of 183 patients with an LDL cholesterol reading of 100 mg/dL or higher who had already been treated with atorvastatin for more than six weeks were randomly allocated to six groups: placebo; SAR236553/REGN727 every two weeks (Q2W) at a dose of 50, 100, or 150 mg; or SAR236553/REGN727 every four weeks (Q4W) at 200 or 300 mg, alternating with placebo for 12 weeks.
The researchers found that there was a dose-response to SAR236553/REGN727 injections. Patients assigned to 50, 100, and 150 mg Q2W had a 40, 64, and 72 percent reduction, respectively, in circulating LDL cholesterol. Patients who received 200 or 300 mg injections Q4W had reductions of 43 and 48 percent, respectively. There was a 5 percent reduction seen in the placebo group.
"These encouraging results suggest the need for further evaluation of SAR236553 in larger, even more diverse patient populations, and with different background therapies, to fully assess its efficacy and safety," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron Pharmaceuticals, both of which funded the study and together manufacture SAR236553/REGN727.
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