(HealthDay)—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, M.D., from the Sterling Research Group in Cincinnati, and colleagues performed a phase 2 trial involving 92 patients with LDL cholesterol levels ≥100 mg/dL after at least seven weeks of treatment with 10 mg atorvastatin. Participants were randomized to three groups to receive eight weeks of 10 or 80 mg daily atorvastatin, plus SAR236553 once every two weeks, or eight weeks of 80 mg 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 80 mg atorvastatin plus SAR236553 (73.2 ± 3.5) compared with 10 mg 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 <100 mg/dL, compared with 52 percent of those receiving 80 mg atorvastatin plus placebo. At least 90 percent of patients who received SAR236553 attained LDL levels <70 mg/dL, compared with 17 percent of those who received 80 mg atorvastatin plus placebo.
"In a randomized trial involving patients with primary hypercholesterolemia, adding SAR236553 to either 10 mg of atorvastatin or 80 mg of atorvastatin resulted in a significantly greater reduction in LDL cholesterol than that attained with 80 mg 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.