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LDL reductions greater with statin plus PCSK9 monoclonal antibody vs. statin alone
Patients with primary hypercholesterolemia who added a fully human PCSK9 monoclonal antibody to their statin regimen experienced greater reductions in LDL than with statin alone, according to phase 2 trial results.
Compared with baseline, the least-squares mean percent reduction in LDL at 8 weeks was 73.2% for patients assigned 80 mg atorvastatin plus the PCSK9 monoclonal antibody, REGN727/SAR236553 (Sanofi/Regeneron Pharmaceuticals); 66.2% for patients assigned 10 mg atorvastatin plus REGN727/SAR236553; and 17.3% for patients assigned 80 mg atorvastatin plus placebo.
All patients who received REGN727/SAR236553 attained an LDL level of <100 mg/dL and at least 90% attained a level of <70 mg/dL, compared with 52% and 17% of patients assigned statin plus placebo, respectively.
The multicenter, double blind, placebo-controlled trial was designed to compare the effects of REGN727/SAR236553 plus high- or low-dose atorvastatin with high-dose atorvastatin alone. Researchers randomly assigned 92 patients to 8 weeks of treatment with 80 mg atorvastatin daily plus REGN727/SAR236553 once every 2 weeks; 10 mg atorvastatin daily plus REGN727/SAR236553 once every 2 weeks; or 80 mg atorvastatin daily plus placebo once every 2 weeks. Prior to enrollment, all patients had LDL levels >100 mg/dL after treatment with 10 mg atorvastatin for at least 7 weeks.
The researchers observed similar changes in levels of apolipoprotein B, non-HDL and total cholesterol, and a modest increase in HDL with high-dose atorvastatin plus REGN727/SAR236553.
Additional follow-up for 8 weeks after treatment revealed that lipid levels were “consistent” with levels expected after withdrawing lipid-lowering medications after week 8, the researchers wrote in the study.
No safety issues were identified. However, the researchers said “larger studies will be necessary to assess the potential risk of adverse effects of REGN727/SAR236553.”
“Although the results of this trial are preliminary, they suggest that administration of REGN727/SAR236553 with statins may benefit patients in whom LDL has not been reduced to recommended levels, either because of an inadequate lipid-lowering response with high-dose statins alone or because of unacceptable side effects with high-dose statins,” the researchers concluded.
Disclosure: The trial was funded by Sanofi and Regeneron Pharmaceuticals.