(HealthDay News) – Addition of the fully human serum proprotein convertase subtilisin/kexin 9 monoclonal antibody, SAR236553, to atorvastatin is associated with greater reductions in low-density lipoprotein (LDL) cholesterol levels compared with atorvastatin alone, according to a study published online Oct 31 in the New England Journal of Medicine.
Eli M. Roth, MD, from the Sterling Research Group in Cincinnati, and colleagues performed a Phase 2 trial involving 92 patients with LDL cholesterol levels ≥100mg/dL after at least seven weeks of treatment with 10mg atorvastatin. Participants were randomized to three groups to receive eight weeks of 10mg or 80mg daily atorvastatin, plus SAR236553 once every two weeks, or eight weeks of 80mg atorvastatin with placebo once every two weeks.
The researchers found that there was a significantly greater least-squares mean percent reduction from baseline in LDL cholesterol for treatment with 80mg atorvastatin plus SAR236553 (73.2±3.5) compared with 10mg atorvastatin plus SAR236553 (66.2±3.5) or atorvastatin plus placebo (17.3±3.5). All patients who received SAR236553 attained an LDL cholesterol level <100mg/dL, compared with 52% of those receiving 80mg atorvastatin plus placebo. At least 90% of patients who received SAR236553 attained LDL levels <70mg/dL, compared with 17% of those who received 80mg atorvastatin plus placebo.
“In a randomized trial involving patients with primary hypercholesterolemia, adding SAR236553 to either 10mg of atorvastatin or 80mg of atorvastatin resulted in a significantly greater reduction in LDL cholesterol than that attained with 80mg of atorvastatin alone,” the authors write.
The study was funded by Sanofi and Regeneron Pharmaceuticals, both of which manufacture SAR236553; several authors are employed by Sanofi.