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We reviewed data from Phase 3 studies to evaluate the efficacy and safety of these antibodies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We systematically reviewed Phase 3 English\u2010language 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We identified 12 studies of alirocumab and nine of evolocumab, including over 10\u2009000 patients overall. Most studies enrolled patients with hypercholesterolaemia and used anti\u2010PCSK9 antibodies with statins. The ODYSSEY FH I, FH II and HIGH FH alirocumab studies and the RUTHERFORD\u20102 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\u2010study); only those data for HoFH are reported here. All comparator studies demonstrated a reduction in LDL cholesterol (LDL\u2010C) with the anti\u2010PCSK9 antibodies. No head\u2010to\u2010head studies were conducted between alirocumab and evolocumab. Up to 87% of patients receiving alirocumab and up to 98% receiving evolocumab reached LDL\u2010C 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Using anti\u2010PCSK9 antibodies as add\u2010on therapy to other lipid\u2010lowering treatments or as monotherapy for patients unable to tolerate statins may help patients with high cardiovascular risk to achieve their LDL\u2010C goals.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13066","type":"journal-article","created":{"date-parts":[[2016,8,2]],"date-time":"2016-08-02T16:03:29Z","timestamp":1470153809000},"page":"1412-1443","source":"Crossref","is-referenced-by-count":40,"title":["Systematic review of published Phase 3 data on anti\u2010PCSK9 monoclonal antibodies in patients with hypercholesterolaemia"],"prefix":"10.1111","volume":"82","author":[{"given":"Ioanna","family":"Gouni\u2010Berthold","sequence":"first","affiliation":[{"name":"Center for Endocrinology, Diabetes and Preventive Medicine (ZEDP) University of Cologne  Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier S.","family":"Descamps","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Centres Hospitaliers Jolimont  Haine Saint\u2010Paul Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Fraass","sequence":"additional","affiliation":[{"name":"Amgen GmbH  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Hartfield","sequence":"additional","affiliation":[{"name":"Oxford PharmaGenesis Ltd  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6556-2002","authenticated-orcid":false,"given":"Kim","family":"Allcott","sequence":"additional","affiliation":[{"name":"Oxford PharmaGenesis Ltd  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Dent","sequence":"additional","affiliation":[{"name":"Amgen (Europe) GmbH  Zug Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winfried","family":"M\u00e4rz","sequence":"additional","affiliation":[{"name":"Clinical Institute of Medical and Chemical Laboratory Diagnostics Medical University Graz  Graz Austria"},{"name":"Medical Clinic V (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim University of Heidelberg  Germany"},{"name":"Synlab Academy Synlab Holding Deutschland GmbH  Mannheim and Augsburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,10,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkv1037"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13354"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13347"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-2251"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr158"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61350-5"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/2047487315569401"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2014.971151"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1P150"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.5114\/aoms.2015.49807"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2796.2003.01070.x"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.ATV.11.2.290"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature09270"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-94-007-1147-1"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/ng1161"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.2174\/13816128113199990313"},{"key":"e_1_2_9_18_1","unstructured":"Amgen.Repatha\u00ae (evolocumab) prescribing information 2015. 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