Unknown

Dataset Information

0

Systematic review of published Phase 3 data on anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia.


ABSTRACT: AIMS: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. We reviewed data from Phase 3 studies to evaluate the efficacy and safety of these antibodies. METHODS:We systematically reviewed Phase 3 English-language studies in patients with hypercholesterolaemia, published between 1 January 2005 and 20 October 2015. Congress proceedings from 16 November 2012 to 16 November 2015 were also reviewed. RESULTS:We identified 12 studies of alirocumab and nine 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 those 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. CONCLUSIONS: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.

SUBMITTER: Gouni-Berthold I 

PROVIDER: S-EPMC5099564 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

altmetric image

Publications

Systematic review of published Phase 3 data on anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia.

Gouni-Berthold Ioanna I   Descamps Olivier S OS   Fraass Uwe U   Hartfield Elizabeth E   Allcott Kim K   Dent Ricardo R   März Winfried W  

British journal of clinical pharmacology 20161004 6


<h4>Aims</h4>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. We reviewed data from Phase 3 studies to evaluate the efficacy and safety of these antibodies.<h4>Methods</h4>We systematically reviewed Phase 3 English-language studies in patients with hypercholesterolaemia, published between 1 January 2005 and 20 October 2015. Congress proceedings from 1  ...[more]

Similar Datasets

| S-EPMC5601297 | biostudies-other
| S-EPMC6790354 | biostudies-literature
| S-EPMC7470150 | biostudies-literature
| S-EPMC6173233 | biostudies-literature
| S-EPMC7157865 | biostudies-literature
| S-EPMC6478267 | biostudies-literature
| S-EPMC6319316 | biostudies-literature
| S-EPMC5126212 | biostudies-literature
2024-05-30 | E-MTAB-13507 | biostudies-arrayexpress
| S-EPMC7545799 | biostudies-literature