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Anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia: systematic review of published phase 3 data

Two anti-proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies, Alirocumab and Evolocumab, have been approved for the treatment of hypercholesterolaemia in certain patients.
Data from phase 3 studies to evaluate the efficacy and safety of these antibodies were reviewed.

Researchers identified 12 studies of Alirocumab and 9 of Evolocumab, including over 10 000 patients overall. Most studies enrolled patients with hypercholesterolaemia and used anti-PCSK9 antibodies with statins.

The ODYSSEY FH I, FH II and HIGH FH Alirocumab studies and the RUTHERFORD-2 Evolocumab study exclusively recruited patients with heterozygous familial hypercholesterolaemia.

Two Evolocumab studies focused mainly on homozygous familial hypercholesterolaemia ( HoFH ): TESLA Part B and TAUSSIG ( a TESLA sub-study ); only data for HoFH are reported here.

All comparator studies demonstrated a reduction in LDL cholesterol ( LDL-C ) with the anti-PCSK9 antibodies.

No head to head studies were conducted between Alirocumab and Evolocumab.

Up to 87% of patients receiving Alirocumab and up to 98% receiving Evolocumab reached LDL-C goals.

Both antibodies were effective and well tolerated across a broad population of patients and in specific subgroups, such as those with type 2 diabetes.

In conclusion, using anti-PCSK9 antibodies as add-on therapy to other lipid-lowering treatments or as monotherapy for patients unable to tolerate statins may help patients with high cardiovascular risk to achieve their LDL-C goals. ( Xagena )

Gouni-Berthold I et al, Br J Clin Pharmacol 2016; Epub ahead of print