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Cardiovascular efficacy and safety of bococizumab in high-risk patients

Title:	Cardiovascular efficacy and safety of bococizumab in high-risk patients
Authors:	Ridker, P. M.; Revkin, J.; Amarenco, P.; Brunell, R.; Civeira, F.; Flather, M.; Glynn, R. J.; Gregoire, J.; Jukema, J. W.; Karpov, Y.; Kastelein, J. J. P.; Koenig, W.; Lorenzatti, A.; Manga, P.; Masiukiewicz, U.; Miller, M.; Mosterd, A.; Murin, J.; Nicolau, J. C.; Nissen, S.; Ponikowski, P.; Santos, R. D.; Schwartz, P. F.; Soran, H.; White, H.; Wright, R. S.; Vrablik, M.; Yunis, C.; Shear, C. L.; Tardif; J. -C. Conde D; Colquhoun D; Missault L; Grégoire J; Gao R; Urina M; Solar M; Jensen HK; Grobbee D; Savolainen M; Schiele FN; Montalescot G; Edes I; Blake G; Lotan C; Maggioni A; Savonitto S; Lee CW; Leiva Pons JL; Dan GA; Cortada JB; Mellbin L; Kahan T; Noble S; Hwang JJ; Sritara P; Tökgozoğlu L; Tarasenko L; Borer JS; Black H; Carmena R; Furie KL; McMurray J; Neaton J; Zannad F; O’Neill B; Welty F; McNamara R; Chun H; Abbott JD; Jacoby D; McPherson C; Jadbabaie F; Pinto D; McCullough L; Silverman IE; Sansing LH; Dearborn-Tomazos J; Foody J; Schindler J; Piazza G; Chakrabarti A; Pride Y; Gelfand E; Baultrukonis D; Chaudhuri S; Frederich R; Johnson M; Mridha K; Powell C; Wang E; Wei C; Anderson P; Buonanno M; Epsley C; Evans B; Frolova M; Goetsch M; Hessinger D; Ikehara E; Ivanac K; Kizko J; Le K; McNally-Dufort C; Morocco T; Nadkarni S; Nissen T; Nye R; Pak R; Pence D; Redifer P; Schwartz W; Sattler C; Schade R; Sullivan B; Wegner J; Alvarez CA; Budassi N; Vogel DR; Avaca H; Conde DG; Estol CC; Gelersztein E; Glenny JA; Hershson AR; Bruno RL; Maffei LE; Soler JM; Zaidman CJ; Carnero GS; Colombo HR; Jure HO; Luquez HA; Ramos HR; Resk JH; Rusculleda MM; Ulla MR; Caccavo A; Farias EF; Wenetz LM; Cabella PR; Cuadrado JA; Chahin M; Mackinnon IJ; Zarandon RB; Schmidberg J; Fernandez AA; Montana O; Codutti OR; Gorosito VM; Maldonado N; Sala J; De La Fuente RA; Casabella TE; Di Gennaro JP; Guerrero RA; Alvarez MS; Berli M; Botta CE; Montenegro EE; Vico ML; Begg A; Lehman R; Gilfillan CP; d'Emden M; Markovic TP; Sullivan D; Aroney C; Stranks SN; Crimmins DS; Arstall M; Van Gaal W; Davis T; Aylward PE; Amerena J; William M; Proietto J; Purnell PW; Singh B; Arya KW; Dart AM; Thompson P; Davis SM; Carroll PA; De Looze F; Jayasinghe R; Bhindi R; Buysschaert I; Sarens T; van de Borne P; Scott BP; Roosen J; Cools F; Missault LH; Debroye C; Schoors DF; Hollanders G; Schroe HH; De Sutter J; Hermans K; Carlier M; van Landegem P; Verwerft J; Mulleners T; Delforge MD; Soufflet V; Elegeert I; Descamps OS; Janssens S; Lemmens RC; Desfontaines P; Scheen A; Heijmans S; Capiau L; Vervoort G; Carlier SG; Faes D; Alzand B; Keuleers S; De Wolf L; Thoeng J; De Bruyne L; de Santos MO; Felicio JS; Areas CA; Figueiredo EL; Michalaros YL; Neuenschwander FC; Reis G; Saad JA; Kormann AP; Nascimento CV; Precoma DB; Abib E Jr; dos Santos FR; Mello YG; Saraiva JF; Rech RL; Cerci R; Fortes JA; Rossi PR; de Lima e Silva FA; Hissa M; Silva RP; de Souza WK; Guimarães Filho FV; Mangili OC; de Oliveira Paiva MS; Tumelero R; Abrantes JA; Caramori PR; Dutra OP; Leaes PE; Manenti ER; Polanczyk CA; Bandeira e Farias FA; de Moraes Junior JB; Russo LA; Alves AR Jr; Dracoulakis MD; Ritt LE; Saporito WF; Herdy AH; Maia LN; Sternieri MV; Ayoub JC; Bianco HT; da Costa FA; Eliaschewitz FG; Fonseca FA; Nakandakare ER; Bonansea TC; Castro NM; de Barros e Silva PG; Smith P; Botelho RV; Resende ES; Barbieri DS; Hernandes ME; Bajaj H; Beaudry P; Berlingieri JC; Salter TJ; Ajala B; Anderson TJ; Nanji A; Ross S; Pandey S; Desrosiers D; Gaudet D; Moran G; Csanadi MA; St-Amour E; Cusimano S; Halperin FA; Babapulle M; Vizel S; Petrella J; Spence JD; Gupta N; Tellier G; Bourgeois R; Gregóire JC; Wesson T; Zadra R; Twum-Barima DY; Cha JY; Hartleib MC; Bergeron J; Chouinard G; McPherson TP; Searles G; Peterson SR; Mukherjee A; Lepage S; Conway JR; Kouz SM; Dion D; Pesant Y; Cheung SS; Goldenberg RM; Aronson R; Gupta AK; O’Mahoney M; Pliamm L; Teitelbaum I; Hoag GN; Nadra IJ; Yared Z; Yao LC; Nguyen T; Saunders KK; Potthoff S; Varleta P; Assef V; Godoy JG; Olivares C; Roman O; Vejar M; Montecinos H; Pincetti C; Li Y; Wang D; Li J; Yang X; Du Y; Wang G; Yang P; Zhang X; Xu P; Zhao Y; Chen J; Li S; Li W; Zhang L; Zhu Y; Zhang Y; Zhou C; Wang Y; Liu F; Ma Y; Ti Z; Zeng X; Zhou Y; Cui G; Li D; Xue L; Jiang J; Lian Y; He Y; Mendoza JA; Bonfanti JA; Dada FA; Urina-Triana MA; Rodriguez WR; Sanchez ML; Lozno HY; Triana EH; Arambula RM; Rico-Carrillo AE; Gallo HJ; Catano JS; Jattin FG; Plazas JA; Gomez JE; Botero-Lopez R; Gomez NI; Munoz CF; Pelaez SV; Eraso AM; Goyes AR; Elbl L; Fiserova N; Vesely J; Wasserburger B; Blaha V; Vojacek J; Maskova P; Hutyra M; Vrkoc J; Hala T; Vodnansky P; Bocek P; Cifkova R; Bufka V; Ceska R; Machkova M; Zidkova E; Lukac M; Mikusova T; Kellnerova I; Kuchar L; Ferkl R; Cech V; Zemek S; Monhart Z; Davidsen F; Joensen A; Lihn AS; Rasmussen TK; Wiggers H; Lindgren LM; Schmidt U; Galatius S; Sillesen H; Bronnum Schou J; Thomsen KK; Urhammer S; Jeppensen J; Schou M; May O; Steffensen R; Nielsen WB; Nielesen T; Jepsen JM; Rai A; Sykulski R; Andersen LT; Rickers H; Frost L; Lomholdt J; Egstrup K; Wermuth S; Klausen L; Lassus J; Palomaki A; Khari J; Tatlisumak T; Kekki S; Vanttinen E; Strandberg A; Valtonen M; Sia SM; Nerg O; Puhakka M; Strand J; Timonen M; Levola J; Arstila L; Taurio J; Kantola I; Suomi J; Humaloja K; Askonen K; Schiele F; Sibon I; Zemour G; Goube P; Petit C; Chati Z; Range G; Rabahi F; Rihani R; Bergerot C; Roubille F; Boye A; Probst V; Ferrari E; Cayla G; Thouvenot E; Delarche N; Couffinhal T; Coisne D; Paillard F; Elbaz M; Decoulx E; Angoulvant D; Agraou B; Caudmont S; Berrouschot J; Lauer B; Schoell I; Trenk D; Derwahl KM; Khariouzov A; Proepper F; Stawowy P; Da Stephan U; Stoessel J; Voehringer HF; Dorsel T; Stellbrink C; Rinke A; Northroff J; Bourhaial H; Stratmann M; Wetzel T; Axthelm C; Guenzel A; Weigmann I; Faghih M; Hagemann D; Schaefer A; Weber D; Luedemann J; Contzen C; Kornmann MO; Winkelmann B; Simon J; Felix S; Brauer C; Laufs U; Schmidt E; Marten I; Licka M; Heisters J; Appel KF; Kleinecke-Pohl U; Klein C; von Hodenberg EF; Maus O; Sigal H; Taeschner H; Schwimmbeck P; Lemke B; Perings C; Illies G; Pfuetzner A; Salbach P; Hengstenberg C; Kohler A; Mudra H; Behnke T; Baar M; Jeserich M; Scholz G; Naudts I; Voller H; Herrmann HJ; von Engelhardt CB; Gerke S; Pohlmeier L; Schaufele T; Woehrle J; Al-Zoebi A; Horacek T; Peterfai E; Kemeny V; Lakatos F; Bod E; Andrassy P; Andreka P; Balo T; Davidovits Z; Laszlo Z; Nagy K; Papp A; Somogyi A; Toldy-Schedel E; Vertes A; Voros P; Paragh G; Martyin T; Hajdu C; Deak L; Farago K; Nagy A; Kirschner R; Koszegi Z; Zilahi Z; Toth K; Wittmann I; Bajcsi D; Reiber I; Toth L; Benczur B; Nagy L; Sydo T; Lupkovics G; Oroszlan T; Crean P; Mahon NG; McAdam B; MacNeill B; Katz A; Tsalihin D; Vazan A; Eitan A; Lewis BS; Gavish D; Wainstein J; Mosenzon O; Mosseri M; Vishlitzky V; Atar S; Nseir WB; Brenner H; Elis A; Fuchs S; Shimon I; Solodky A; Goldhaber A; Tanne D; Knobler H; Kracoff OH; Hussein O; Auriel E; Chorin E; Sharir T; Bitzur R; Shechter M; Antonicelli R; Franceschini E; Porcu M; Sesti G; Maggiolini S; Salvioni A; Filardi PP; Trimarco B; Averna M; Pasqualini L; Pirro M; Pantaleoni M; Piovaccari G; Arca M; Fedele Francesco; Roncon L; Anselmi M; Sganzerla P; Morocutti G; Bonora E; Dimas AL; Esperon GA; Morales-Villegas E; Isunza JM; Beltran LG; Molina CA; Garcia DK; Ruiz LA; Reyna LS; De los Rios Ibarra MO; Soto JR; Gonzalez-Ortiz M; Herrera-Marmolejo M; Ramos SA; Ramos-Lopez GA; Stobschinski CA; AguilarSalinas CA; 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van Kempen WW; Zoet-Nugteren SK; van Daele ME; Swart HP; van der Zwaan CT; Hermans WR; Magro M; van de Wal RM; Hassink RJ; Visseren F; Veenendaal A; De Nooijer C; Troquay RP; Imholz BP; van der Meer P; Visser RP; van Leendert RJ; Gosselink MA; Baker J; Benatar JR; Kerr J; Pryke JR; Scott RS; Millar-Corte GD; Williams M; Montgomery B; Venter DJ; Ternouth IF; DeCaigney SC; Hart HH; Corin A; Garden PI; Sheahan D; Harding SA; Korecki J; Supronik J; Styczkiewicz M; Bijata-Bronisz R; Rusicka T; Walczak M; Krolikowski Z; Ostrowski J; Lukaszewicz M; Przekwas-Jaruchowska M; Zieba B; Miekus P; Orkwiszewska-Nalewajko A; Piepiorka M; Kubalski P; Wychota K; Blach E; Ochala A; Okopien B; Wronska D; Janion M; Czarnecka D; Kolodziejczyk J; Konieczynska M; Landa K; Mirek-Bryniarska E; Necki M; Pasternak DA; Rozpondek P; Trebacz J; Walczewska J; Sidor M; Broncel M; Drozdz J; Kosmider M; Saryusz-Wolska M; Kucharska D; Opalinska E; Pijanowski Z; Wozniak I; Banaszkiewicz K; Klecha A; Horodecki M; Piskorz-Wapinska J; Kobielusz-Gembala I; Kim MH; Kim DK; Cho BR; Kim KS; Her SH; Lee SY; Rhee MY; Kim K; Kang WC; Kim DH; Cho YS; Kim SH; Rim SJ; Tahk SJ; Jeon HK; Yoon J; Mociran M; Pop CF; Minescu B; Andrei LD; Radoi M; Calin A; Ciomag RM; Copaci I; Fruntelata AG; Popescu M; Tivadar S; Roman G; Avram RI; Mistodie CV; Morosanu M; Popa AR; Popescu ML; Popoviciu MS; Tase A; Busegeanu M; Popescu A; Szilagyi I; Sitterli-Natea CN; Maximov DM; Munteanu M; Negrisanu GD; Kuzin A; Popov D; Shapovalova J; Vishneva E; Shutemova E; Pasechnik E; Bogdanov E; Khasanov N; Barbarash OL; Shangina OA; Tarasov N; Solonev O; Kosmacheva E; Chernyatina MA; Ginzburg M; Blokhin A; Bulanova N; Drapkina OM; Gordeev IG; Libov IA; Lomakin N; Panchenko E; Shogenov ZS; Zateyshchikov D; Klein G; Motylev I; Belenkiy DI; Demin A; Nikolaev KY; Oleynikov V; Zrazhevskiy K; Katelnitskiy I; Khaisheva L; Aksentiev S; Nedoshivin A; Popova VB; Agafina AS; Ballyuzek M; Baranova E; Burova N; Eryshev S; Filippov A; Goloshchekin BM; Konstantinov V; 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Contributors:	Ridker, P. M.; Revkin, J.; Amarenco, P.; Brunell, R.; Civeira, F.; Flather, M.; Glynn, R. J.; Gregoire, J.; Jukema, J. W.; Karpov, Y.; Kastelein, J. J. P.; Koenig, W.; Lorenzatti, A.; Manga, P.; Masiukiewicz, U.; Miller, M.; Mosterd, A.; Murin, J.; Nicolau, J. C.; Nissen, S.; Ponikowski, P.; Santos, R. D.; Schwartz, P. F.; Soran, H.; White, H.; Wright, R. S.; Vrablik, M.; Yunis, C.; Shear, C. L.; Tardif; J. -C., Conde D; Colquhoun, D; Missault, L; Grégoire, J; Gao, R; Urina, M; Solar, M; Jensen, Hk; Grobbee, D; Savolainen, M; Schiele, Fn; Montalescot, G; Edes, I; Blake, G; Lotan, C; Maggioni, A; Savonitto, S; Lee, Cw; Leiva Pons, Jl; Dan, Ga; Cortada, Jb; Mellbin, L; Kahan, T; Noble, S; Hwang, Jj; Sritara, P; Tökgozoğlu, L; Tarasenko, L; Borer, J; Black, H; Carmena, R; Furie, Kl; Mcmurray, J; Neaton, J; Zannad, F; O’Neill, B; Welty, F; Mcnamara, R; Chun, H; Abbott, Jd; Jacoby, D; Mcpherson, C; Jadbabaie, F; Pinto, D; Mccullough, L; Silverman, Ie; Sansing, Lh; Dearborn-Tomazos, J; Foody, J; Schindler, J; Piazza, G; Chakrabarti, A; Pride, Y; Gelfand, E; Baultrukonis, D; Chaudhuri, S; Frederich, R; Johnson, M; Mridha, K; Powell, C; Wang, E; Wei, C; Anderson, P; Buonanno, M; Epsley, C; Evans, B; Frolova, M; Goetsch, M; Hessinger, D; Ikehara, E
Publisher Information:	Massachussetts Medical Society; Waltham
Publication Year:	2017
Collection:	Sapienza Università di Roma: CINECA IRIS
Subject Terms:	Antibodie; antibodies monoclonal humanized; anticholesteremic agent; cardiovascular disease; cholesterol; LDL; double-blind method; female; follow-up studie; human; hypercholesterolemia; injections; subcutaneou; lipid; male; middle aged; proprotein convertase 9; risk factor; treatment failure; medicine (all)
Description:	BACKGROUND Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P
Document Type:	article in journal/newspaper
Language:	English
Relation:	info:eu-repo/semantics/altIdentifier/pmid/28304242; info:eu-repo/semantics/altIdentifier/wos/WOS:000399534600007; volume:376; issue:16; firstpage:1527; lastpage:1539; numberofpages:13; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11573/1150632
DOI:	10.1056/NEJMoa1701488
Availability:	http://hdl.handle.net/11573/1150632; https://doi.org/10.1056/NEJMoa1701488
Rights:	info:eu-repo/semantics/openAccess
Accession Number:	edsbas.9ED1A8
Database:	BASE