Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .
Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia.
BACKGROUND Serum proprotein convertase subtilisin/kexin 9 ( PCSK9 ) binds to low-density lipoprotein ( LDL ) receptors , increasing the degradation of LDL receptors and reducing the rate at which LDL cholesterol is removed from the circulation . REGN727/SAR236553 ( design ated here as SAR236553 ) , a fully human PCSK9 monoclonal antibody , increases the recycling of LDL receptors and reduces LDL cholesterol levels . METHODS We performed a phase 2 , multicenter , double-blind , placebo-controlled trial involving 92 patients who had LDL cholesterol levels of 100 mg per deciliter ( 2.6 mmol per liter ) or higher after treatment with 10 mg of atorvastatin for at least 7 weeks . Patients were r and omly assigned to receive 8 weeks of treatment with 80 mg of atorvastatin daily plus SAR236553 once every 2 weeks , 10 mg of atorvastatin daily plus SAR236553 once every 2 weeks , or 80 mg of atorvastatin daily plus placebo once every 2 weeks and were followed for an additional 8 weeks after treatment . RESULTS The least-squares mean ( ±SE ) percent reduction from baseline in LDL cholesterol was 73.2±3.5 with 80 mg of atorvastatin plus SAR236553 , as compared with 17.3±3.5 with 80 mg of atorvastatin plus placebo ( P<0.001 ) and 66.2±3.5 with 10 mg of atorvastatin plus SAR236553 . All the patients who received SAR236553 , as compared with 52 % of those who received 80 mg of atorvastatin plus placebo , attained an LDL cholesterol level of less than 100 mg per deciliter , and at least 90 % of the patients who received SAR236553 , as compared with 17 % who received 80 mg of atorvastatin plus placebo , attained LDL cholesterol levels of less than 70 mg per deciliter ( 1.8 mmol per liter ) . CONCLUSIONS In a r and omized trial involving patients with primary hypercholesterolemia , adding SAR236553 to either 10 mg of atorvastatin or 80 mg of atorvastatin result ed in a significantly greater reduction in LDL cholesterol than that attained with 80 mg of atorvastatin alone . ( Funded by Sanofi and Regeneron Pharmaceuticals ; Clinical Trials.gov number , NCT01288469 . )
Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .