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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Br+J+Clin+Pharmacol
2016 ; 82
(6
): 1412-1443
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Systematic review of published Phase 3 data on anti-PCSK9 monoclonal antibodies
in patients with hypercholesterolaemia
#MMPMID27478094
Gouni-Berthold I
; Descamps OS
; Fraass U
; Hartfield E
; Allcott K
; Dent R
; März W
Br J Clin Pharmacol
2016[Dec]; 82
(6
): 1412-1443
PMID27478094
show ga
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.
|*Clinical Trials, Phase III as Topic
[MESH]
|*PCSK9 Inhibitors
[MESH]
|Antibodies, Monoclonal, Humanized
[MESH]
|Antibodies, Monoclonal/*therapeutic use
[MESH]
|Cholesterol, LDL/blood
[MESH]
|Humans
[MESH]
|Hyperlipoproteinemia Type II/*drug therapy/metabolism
[MESH]