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N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.

Darapladib for preventing ischemic events in stable coronary heart disease.

Collaborators (921)

White HD, Wallentin L, Budaj A, Cannon CP, Harrington RA, Steg PG, Davies RY, Tarka E, White HD, Wallentin L, Held C, Stewart R, Bucan O, Elfström C, Brown R, Hegg L, Jarosz M, Krug-Gourley S, Rudman J, Smith P, Tarka E, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Held C, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, López-Sendón J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Sritara P, Stewart R, Swart HP, Sy RG, Teramoto T, Tse HF, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Collins R, Anderson J, DeMets D, Ganz P, Sandercock P, Weber M, Fisher M, Buhr K, Diegel S, Schultz M, Held C, Mahaffey KW, Alexander JH, Al-Khatib S, Baron T, Bergström O, Bushnell C, Christersson C, Eggers K, Fredlund BO, Hagström E, Hijazi Z, Örndahl LH, James SK, Jernberg T, Johnston N, Lopez RD, Mehta RH, Newby KL, Nordmark Ö, Oldgren J, Roe MT, Saldéen K, Stenborg A, Szummer K, Varenhorst C, Åkerblom A, Elfström C, Bodén U, Holmgren P, Alm C, Hallberg T, Forsman M, Ljung H, Svanberg C, Loebs PF, Atwater K, Baldwin R, Butts M, Chan T, Connolly P, Esposito G, Hillier JB, Jordan M, Lane K, Eckart D, O'Malia K, Ryan G, Smitheran P, Tait M, Vyas S, Frazilus J, Bucan O, Douglas S, Alsweiler C, Ball L, Bucan A, Mackay L, Wiviott S, Gignac G, Goessling W, Hochberg E, Lane A, Rosenberg C, Wagner A, Wolpin BM, Lowe C, Mills K, Alkhalil M, Ruvido J, Rehman MQ, Shimmer M, Stebletsova I, Elfström C, Bodén U, Holmgren P, Alm C, Hallberg T, Forsman M, Ljung H, Svanberg C, Loebs PF, Atwater K, Baldwin R, Butts M, Chan T, Connolly P, Esposito G, Hillier JB, Jordan M, Lane K, Eckart D, O'Malia K, Ryan G, Smitheran P, Tait M, Vyas S, Frazilus J, Bucan O, Douglas S, Alsweiler C, Ball L, Bucan A, Mackay L, Barnes A, Brown R, Chiswell K, Davies RY, Stebbins A, Bustamante Labarta M, Cartasegna LR, Chekherdemian S, Cuello JL, Elías P, Giordano J, Hirschson A, Hominal MA, Ibañez JO, Jure HO, Litvak M, Macin SM, MacKinnon IJ, Maffei LE, Montaña OR, Prado AD, Sala JM, Sanchez RA, Brieger D, Chew D, Cross D, De Looze FJ, Farshid A, Hall S, Krum H, Lane GK, Oqueli Flores E, Stickland J, Purnell PW, Szto GY, Thompson PL, Waites J, William M, Beauloye C, Boland J, Charlier F, De Raedt HJ, Dens JA, Dujardin K, Friart A, Scheen A, Schröder E, Sinnaeve PR, Verheye S, Vranckx P, Abrantes JA, Albuquerque D, Ardito WR, Baracioli LM, Bertolami MC, Bodanese LC, Dos Santos Filho RD, Maia LN, Manenti ER, Marino RL, Ogawa Indio do Brasil CK, Paiva MS, Rabelo Alves Junior Á, Rassi S, Reis G, Rossi PR, Saraiva JF, Benov H, Chompalova B, Denchev S, Goudev A, Grigorova V, Mihov A, Mincheva V, Petrova S, Staneva A, Raev D, Tisheva S, Aronson R, Bedard J, Bhargava RK, Borts D, Constance C, Cusson J, Davies RF, Ducas J, Ferguson ME, Goldenberg RM, Grondin F, Gyenes G, Halperin F, Kornder J, Kouz S, Lainesse AY, Leader R, Leiter LA, Lonn EM, Milot A, Pearce ME, Pliamm L, Powell CN, Rose BF, Rupka DW, Siega AJ, Klinke PW, St-Amour E, Talbot P, Tardif JC, Tishler SJ, Title L, Wong GC, Buller CE, Acevedo Blanco MA, Albornoz Alarcon FJ, Escobar E, Florenzano Urzua F, Pedemonte Villablanca OA, Prieto Dominguez JC, Sanhueza Cardemil P, Varleta Olivares PE, Chen H, Chen J, Dong Y, Ge J, He B, Huo Y, Li W, Li XL, Liao Y, Wei M, Yan X, Ye P, Yuan Z, Zhang Y, Zhu J, Cermak O, Dedek V, Francek L, Grunfeldova H, Hubac J, Franc P, Kellnerova I, Klimsa Z, Kroupa J, Kuchar L, Linhart A, Malecha J, Povolny J, Velimsky T, Volf R, Jirka V, Bang L, Grande P, Frost L, Husted SE, Laursen RV, Nielsen T, Hedman A, Muda P, Planken U, Barnay C, Bauters C, Bayet G, Bonnet J, Bruckert E, Cottin Y, Courreges JP, Danchin N, Decoulx E, Demarcq JM, Dubois-Rande JL, Elbaz M, Khalife K, Krempf M, Maupas E, Ovize M, Roul JG, Schiele F, Bassand JP, Steg G, Vaisse B, Aigner UM, Bavendiek U, Fischer D, Benedix G, Boeneke H, Bott J, Brado B, Buhr M, Butter C, Fischer S, Foerster AP, Grad MO, Grosskopf J, Hanefeld M, Hoeltz S, Frick HM, Illies G, Jung TW, Kademann B, Kahrmann G, Bourrat A, Horacek T, Reusch R, Klausmann G, Klein C, Koenig W, Krause KH, Kuesters D, Mellwig KP, Menke T, Mueller S, Neumann G, Nischik R, Preusche A, Prohaska M, Regner SF, Rein W, Rummel R, Samer H, Schaefer T, Schenkenberger I, Schmidt E, Schoen N, Schreckenberg A, Schulze U, Wunderlich J, Sohn HY, Klauss V, Toursarkissian N, Voigt JG, Weber D, Winkelmann BR, Zuechner D, Alexopoulos D, Anastasiou-Nana M, Kremastinos D, Elisaf M, Geleris P, Kallikazaros I, Kranidis A, Manolis A, Mantas I, Olympios C, Tziakas D, Voudris V, Lam YY, Yip WK, Siu CW, Benczúr B, Hornyik A, László Z, Papp A, Papp A, Plés Z, Piros A, Szakál I, Túri T, Sereg M, Vértes A, Abraham S, Banker DN, Chandwani P, Gupta R, Hiremath J, Jayadev S, Joseph S, Menon J, Keshavamurth C, Srinivas A, Parikh K, Pothineni RB, Sathe SP, Sawhney JP, Sethi S, Chandra PK, Varma S, Ardissino D, Bobbio M, Bongo AS, Cipollone F, Mezzetti A, Colivicchi F, Santini M, Esposito G, Chiariello M, Marzilli M, Merlini P, Moretti L, Olivari Z, Patrizi G, Valgimigli M, Amemiya H, Ando K, Iwabuchi M, Endo M, Nagashima H, Kametani R, Koike A, Kuramochi T, Nakamura Y, Oku K, Okutsu M, Sueyoshi A, Takahashi W, Sasaki Y, Tanabe J, Tanaka H, Kashima K, Tanaka Y, Takeshita S, Teranishi J, Betsuyaku T, Yamamoto T, Yamazaki S, Yano S, Yoshida K, Chae JK, Chae SC, Cho MC, Choi DH, Choi DJ, Hong TJ, Jeon HK, Jeong M, Kim HS, Kim HJ, Ryu KH, Kim WS, Kim KS, Lee SH, Lim DS, Park SW, Seung KB, Cervantes-Escárcega JL, Hernández-Santamaría I, Sánchez-Díaz CJ, Uribe-Rios MA, Alvarado-Ruiz R, De Winter RJ, Dijkgraaf R, Jansen RM, Knufman NM, Frederiks J, Kuijper A, Post JC, Michels HR, Roeters van Lennep HW, Liem A, Smits PC, Swart HP, Van Boven AJ, Van Daele ME, Van der Zwaan C, Von Birgelen C, Westendorp IC, Davidson L, Devlin GP, Elliott JM, Hamer AW, Harrison NA, Rankin RJ, Hart HH, Hills MJ, O'Meeghan TJ, Scott DS, Stewart RA, Tisch JG, Williams MJ, Chen VH, Berge C, Istad H, Pedersen TR, Sirnes PA, Hanif B, Ishaq R, Kayani AM, Qureshi MB, Siddique S, Yaqub Z, Doig R, Britto F, Yanac P, Horna M, Valdivia J, Zubiate MC, Abelardo NS, Abola MT, Añonuevo JC, Atilano AA, Cheng FC, Gaspar-Trinidad EY, Sison JA, Sulit DJ, Sy RG, Uy NL, Budaj A, Chmielinski A, Czepiel A, Guzniczak EM, Siminiak T, Kania G, Kincel K, Kopaczewski J, Kubica J, Lysek R, Miekus P, Mlodziankowski A, Napora P, Prochaczek F, Ruscika T, Tarchalski J, Tracz W, Wrzosek B, Basarab GV, Benedek I, Cinteza M, Cristea MI, Dimulescu DR, Dragusin D, Gabor I, Ginghina CD, Macarie CE, Sinescu C, Tatu-Chitoiu G, Vinereanu D, Andryushina NA, Baum SR, Arkhipov MV, Barbarash OL, Boldueva S, Boyarkin MV, Demko AP, Freydlin MS, Golitsyn SP, Gordeev I, Gratsiansky N, Karpov YA, Kobalava Z, Konstantinov V, Kuimov AD, Kukharchuk VV, Panov A, Ruda MY, Sayganov SA, Simanenkov V, Smolenskaya OG, Tsyba LP, Vishnevsky AY, Yakhontova PK, Yakushin SS, Zateyshchikov DA, Gaspar L, Hranai M, Kokles M, Pella D, Badat A, Sliwa-Hahnle K, Blignaut S, Burgess L, Dalby A, Dawood SY, Gray T, Horak AR, Mabin T, Manga P, Moodley R, Pretorius MM, Hough FS, Roodt A, Saaiman J, Theron HD, Alonso Karlezi R, Mata López P, Aranda Granados P, Berrazueta Fernández JR, Carnevali Ruiz D, Castro Conde A, Cruz Fernández JM, De Teresa Galván E, De Teresa Parreño L, Díaz Buschmann I, Domínguez Escribano JR, Garcia Puig J, Gil Extremera B, Gómez Cerezo J, Macaya CM, Mostaza Prieto JM, Muñoz Aguilera R, Pérez Muñoz C, Querejeta Iraola R, Romero Hinojosa JA, Ruilope Urioste LM, Sabán Ruiz J, Sobrino Martínez J, Suárez Suárez EC, Lozano Martínez-Luengas I, Al-Khalili F, Bandh S, Bennermo M, Dellborg M, Held C, Herlitz J, Johanson P, Hjelmaeus L, Landergren K, Linderfalk C, Lindholm CJ, Lindmark K, Mooe T, Nilsson J, Wodlin P, Ho YL, Hou C, Hsia CH, Lin SJ, Tsai LM, Wang KY, Chotinaiwattarakul C, Kuanprasert S, Sansanayudh N, Sritara P, Suithichaiyakul T, Andriyevska S, Basylevych AY, Denesiuk VI, Kononenko LG, Korzh OM, Kovalenko VM, Kraiz IG, Lishnevska VY, Lutay MI, Parkhomenko OM, Rudenko LV, Telyatnikova ZY, Tseluyko VY, Vatutin MT, Vizir VA, Bakhai A, Bijral HS, Stewart E, Dargie H, Barlow MG, Dutka DP, Findlay IN, Fisher M, Gorog DA, Jacques AM, Beeton I, Logie B, Pepper JR, Flather MD, Purcell IF, Scullion W, Thompson JF, Senior R, Simpson DA, Thackray SD, Alamgir MF, Wilding JP, Wong YK, Ahmed AM, Antonishen MC, Atassi K, Azocar J, Ball EM, Ballantyne CM, Bays HE, Beavins JE, Benjamin SA, Benson MR, Berger PB, Buckley JW, Betz WR, Biederman RW, Bisher EW 3rd, Bittner VA, Breton CF, Buttaci S, Changlani M, Patterson JB, Byrd LJ, Canaday DB, Cashion WR Jr, Chandna H, Chang AR, Chin J, Claybrook HP, Martin FA, Cohen KR, Colan DR, Coodley GO, Corson MA, Knopp RH, Paramsothy P, Cottiero RA, Dandona P, Davidson MH, Kamaradt KT, Davuluri AK, Desai VS, Garson GD, East C, Ebrahimi R, Ellison HS, Erickson BR, Fernandes VL, Flores AR, Folkerth SD, Foster RE, Gaona RE Sr, Gardner TJ, George WH, Gessler CJ Jr, Gill SK, Go AS, Go AS, Goldberg AC, Goldschmidt ME, Gorman TA, Brautigam DF, Guyton JR, Haffey T, Henry SD, Hermany PR, Hoekstra JA, Hudson M, Iteld BJ, Jack DB, Johnson FP Jr, Joswig BC, Kaissar AJ, Karns AD, Karns RM, Kaster SR, Kerzner B, Khan MS, Ahmed IS, Kieval J, Kim E, Klaff LJ, Klein EJ, Koren MJ, Kosinski EJ, Krumian R, Portnoy EB, Kuvin JT, Langer MM, Letts DP, Lipetz RS, Long WJ, Thomas I, Lopes-Virella M, Lubin BC, Martin RA, Masri B, Matthews G, Corbelli JC, McCullum K, Meholick AW, Mitchell JR, Modares F, Mohler E, Morcos CN, Murdock DK, Narayan P, Oberoi MS, O'Connor T, Schnecker RJ, O'Donnell PJ, Ong ST, Parang P, Pasquini JA, Patel RJ, Patlola R, Penny W, Pepine CJ, Pierce CH, Stein EA, Popeil LR, Pratt SE, Price RW, Raikhel M, Ravi RC, Cho D, Rhyne JM, Richards MK, Rivera E, Robinson JG, Roth EM, Rubenstein CJ, Sandoval JD, Sangrigoli RA, Schramm EL, Schwartzbard A, Serfer GT, Shah DH, Shalek MS, Shanes JG, Sharma MS, Bretton EM, Sheikh Z, Sklaver NL, Solano Mdel P, Goldberg RB, Srivastava NK, Staniloae CS, Staub JS, Stillabower ME, Suresh DP, Szulawski I, Thompson P, Polk DM, Tinkel JL, Pandya UH, Toth PT, Traboulssi M, Tuohy ER 4th, Uusinarkaus KT, Vijay NK, Voyce S, Wainwright W, Rhancock H, Walder JS, Wang TY, Watkins SP, Weiss RJ, Whitney EJ, Wickemeyer WJ, Willis JG, Wilson DF, Abrams C, Wiseman A, Wolfson E, Wright D, Zawada ET Jr, Verma S.

Abstract

BACKGROUND:

Elevated lipoprotein-associated phospholipase A2 activity promotes the development of vulnerable atherosclerotic plaques, and elevated plasma levels of this enzyme are associated with an increased risk of coronary events. Darapladib is a selective oral inhibitor of lipoprotein-associated phospholipase A2.

METHODS:

In a double-blind trial, we randomly assigned 15,828 patients with stable coronary heart disease to receive either once-daily darapladib (at a dose of 160 mg) or placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the components of the primary end point as well as major coronary events (death from coronary heart disease, myocardial infarction, or urgent coronary revascularization for myocardial ischemia) and total coronary events (death from coronary heart disease, myocardial infarction, hospitalization for unstable angina, or any coronary revascularization).

RESULTS:

During a median follow-up period of 3.7 years, the primary end point occurred in 769 of 7924 patients (9.7%) in the darapladib group and 819 of 7904 patients (10.4%) in the placebo group (hazard ratio in the darapladib group, 0.94; 95% confidence interval [CI], 0.85 to 1.03; P=0.20). There were also no significant between-group differences in the rates of the individual components of the primary end point or in all-cause mortality. Darapladib, as compared with placebo, reduced the rate of major coronary events (9.3% vs. 10.3%; hazard ratio, 0.90; 95% CI, 0.82 to 1.00; P=0.045) and total coronary events (14.6% vs. 16.1%; hazard ratio, 0.91; 95% CI, 0.84 to 0.98; P=0.02).

CONCLUSIONS:

In patients with stable coronary heart disease, darapladib did not significantly reduce the risk of the primary composite end point of cardiovascular death, myocardial infarction, or stroke. (Funded by GlaxoSmithKline; STABILITY ClinicalTrials.gov number, NCT00799903.).

PMID:
24678955
DOI:
10.1056/NEJMoa1315878
[Indexed for MEDLINE]
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