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10.1111/bcp.13066

http://scihub22266oqcxt.onion/10.1111/bcp.13066
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suck abstract from ncbi


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pmid27478094
      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]


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