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N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.

Effects of dalcetrapib in patients with a recent acute coronary syndrome.

Collaborators (1041)

Schwartz GG, Olsson AG, Ballantyne CM, Barter P, Chaitman BR, Holme IM, Kallend D, Leiter L, Leitersdorf E, McMurray JJ, Nicholls S, Shah PK, Tardif JC, Chaitman BR, Bach R, Cruz-Flores S, Fintel D, Gosselin G, Sila CA, Thygesen K, Vetrovec GW, Pfeffer M, DeMets D, Carmena R, Pedersen TR, Rouleau J, Schumi J, Diaz R, White H, Barter P, Maurer G, Vanoverschelde JL, Marin-Neto JA, Leiter L, Tardif JC, Gao R, Ostadal P, Larsen M, Niskanen L, Steg PG, Koenig W, Edes I, Crean P, Leitersdorf E, Lotan C, Bramucci E, Maggione A, Park SJ, Jukema J, White H, Ponikowski P, Murin J, Manga P, Lopez-Sendon J, Al-Khalili F, Erne P, Brady A, Farkouh M, Kaul S, Miller M, Nicholls S, Wright R, Branco C, Burdeska A, de Grandpre Gde B, De Sampaio G, Fuhrer S, Greulich S, Haigh T, Hegedus A, Hertig C, Hynes A, Jonkanski I, Kaehny MR, Kaewphluk M, Kirchner P, Lim L, Morillo J, Murphy C, Okay-Emaviwe E, Parusel C, Pimenta N, Ponten A, Schmitt-Welker R, Thiebaud E, van der Laan M, Whitfield K, Ziesel K, Zoschg M, Abbs M, Aulgur S, Chapin L, Coffee L, Galtry P, Geyer G, Macari A, Miller C, Scheer T, Stone P, Prcela L, Strzelecki M, Boucher MC, Daigneault L, Johnson D, Laforest M, Villeneuve MC, Gadaleta F, Caruso O, Caccavo A, Alvarez C, Giacomi G, Macin S, Cartasegna L, Mackinnon I, Cuneo C, Hominal M, Labarta GB, Garrido M, Muntaner J, Sanchez AS, Vico ML, Bono J, Hasbani E, Llanos J, Stisman DJ, Chekherdemian S, Covelli G, Piskorz D, Santos D, Snitman MJ, Berli M, Amuchastegui M, Porcile R, Dran R, Fernandez AA, Caime G, Fuselli J, Luciardi H, Gonzalez M, Pelagagge MJ, Iglesias RM, Litvak BM, Manuale O, Schygiel PO, van Gaal W, Amerena J, Tan R, Colquhoun D, Kritharides L, Garrahy P, Thompson P, Ziffer R, Lee A, New G, Aroney C, Ardill J, Waites J, Challa P, Purnell P, Siostrzonek P, Drexel H, Pieske B, Berger R, Schuchlenz H, Beauloye C, Stammen F, De Raedt H, De Wolf L, Missault L, Vrolix M, Leone A, de Moraes Junior JB, Botelho RV, Dutra OP, Saad JA, Paiva MS, Abrantes JA, Mendes DA, Ramos RF, Rossi PR, Feitosa FG, da Costa FA, dos Santos Filho RD, Michalaros YL, Motta MS, Bodanese LC, Manenti ER, Maia LN, da Silva Junior DG, Saporito WF, Gomes MA, Saraiva JF, Sousa AC, de Souza Neto JD, Braile MC, Fonseca FA, Précoma DB, Fortes JA, de Souza WK, Teixeira MS, Zago AJ, Schmidt A, Pastore CA, de Albuquerque DC, Pittella FJ, Ardito WR, Leães PE, Abreu LM, Tardif JC, Lavoie JP, Kouz S, Hess A, Pouliot J, Pandey A, Gosselin G, Bourgeois R, Rodes-Cabau J, Lainesse A, Diaz A, Fadlallah H, Baird M, Lonn E, Dion D, Lepage S, Roy A, Bergeron J, Pesant Y, Huynh T, St-Amour É, Klinke W, Schampaert E, Fay D, Houde G, Hui W, Sussex B, Chehayeb R, Nawaz S, Nigro F, Senaratne MP, Le May M, Title L, Ducas J, Leader R, Sabe-Affaki G, Bhargava R, Labonté R, Rupka D, Mymin D, Vizel S, Bédard J, Berlingieri J, Kornder J, Savard D, Constance C, Lalani A, Maranda C, Bernstein V, Ma P, Gagné C, Johnston J, Gupta M, O'Keefe D, Abramson B, Ahmed S, Bose S, Dzavik V, Lasko B, Sabbah É, Mansour S, Lai K, Paulin C, Chen J, Li Z, Yang X, Hong X, Hao Y, Ke Y, Wu Z, Yuan Z, Fu G, Zhang H, Gan X, Hu D, Su H, Li J, Yang K, Cao K, Ge J, Li H, Zhou S, Chen Y, Qu P, Zhao F, Ma S, Yang Y, Wang X, Xu B, Wang J, Wei M, Hu T, Jiang X, Chen J, Bai F, Lu Q, Yu B, Wang M, Yang X, Huang Y, Hornacek I, Bufka V, Groch L, Ferkl R, Ramik C, Simek S, Stasek J, Monhart Z, Jelinek P, Kotik I, Sabl P, Coufal Z, Naplava R, Ballek L, Hubac J, Cermak O, Ostadal P, Reichert P, Jandik J, Schee A, Vodnansky P, Kaislerova M, Klarlund K, Brønnum-Schou J, Kaiser-Nielsen P, Egstrup K, Torp-Pedersen C, Jensen G, Skagen K, Urhammer S, May O, Zeuthen E, Nyman K, Niskanen L, Koskela E, Agraou B, Decoulx E, Probst V, Galinier M, Coste P, Aleil B, Steg G, Cattan S, Houdain FD, Roul G, Cottin Y, Kirkorian G, Furber A, Aliot E, Coisne D, Lafont A, Cohen A, Levai L, Henry P, Dibie A, Heuer H, Stellbrink C, Voeller H, Koenig W, Muegge A, Tiroch K, vom Dahl J, Katus H, Anker S, Hauf G, Worth H, Laufs U, Genth-Zotz S, Voehringer HF, Kamke W, Schoeller R, Hoffmann S, Sueselbeck T, Kadel C, Werner G, Franz N, Richardt G, Steiner S, Ebelt H, Mueller-Wieland D, Horacek T, Brachmann J, Winkelmann B, Erbel R, Koenig HJ, Horvath I, Forster T, Edes I, Lupkovics G, Zolyomi S, Csikász J, Kovacs Z, Turi T, Keltai M, Szalai G, Janosi A, Kis E, Toth K, Zámolyi K, Barsi B, Laszlo Z, Vértes A, Regos L, Fejer C, Foley D, Crean P, Sugrue D, Klutstein M, Shechter M, Atar S, Lotan C, Hasin Y, Kobal S, Shochat M, Vered Z, Aronson D, Weiss A, Kracoff O, Francis A, Lewis B, Halkin A, Rauchfleisch S, Mosseri M, Turgeman Y, Solodky A, Hayek T, Zeltser D, Dicker D, Lahav M, Musumeci G, Bramucci E, Bernabò P, Salvioni A, Cernigliaro C, Rossi ML, Villani GQ, Caso P, Boccanelli A, Esposito G, Benassi A, Catapano O, De Caterina R, Olivari Z, Marinucci L, Zerboni SC, Anselmi M, Golino P, Patrizi G, Sheiban I, Lok DJ, Alings AM, Basart DC, Kragten JA, Trip MD, Hamraoui K, Pos L, Freericks MP, Willems F, Tans J, Cornel JH, Herrman JP, Hermans W, Mannaerts HF, Remmen JJ, Kuijper A, Ronner E, ten Berg J, van 't Hof AW, Jukema JW, Ilhan M, Nierop PR, Hamer B, Linssen GC, Van den Berg BJ, van der Heijden DJ, van Lennep HW, Bronzwaer P, Plomp J, Bruning TA, Posma J, van Wijk LM, Bokern MJ, Oomen A, Visser J, van Eck JW, van Vlies B, Koolen JJ, Veen G, Hoedemaker G, Klomps HC, Louwerenburg JW, Doevendans PA, Troughton R, Scott D, Benatar J, Hamer A, Devlin G, Ternouth I, Wilkins G, Harding S, Ostrowski J, Drzewiecki A, Zmudka K, Rynkiewicz A, Kosmider M, Dluzniewski M, Stopinski M, Ponikowski P, Konieczny M, Mazurek W, Kubica J, Ujda M, Szwed H, Derlaga B, Jaworska K, Loboz-Grudzien K, Piwowarska W, Trojnar R, Szpajer M, Wita K, Szelemej R, Kornacewicz-Jach Z, Krzyzanowski M, Piepiorka M, Kuc K, Bronisz M, Gil R, Swiatek J, Miekus P, Kawka-Urbanek T, Dobrzycki S, Krauze-Wielicka M, Gasior Z, Zarebinski M, Hiczkiewicz J, Grajek S, Sokolowski K, Bychowski J, Comulada Rivera A, Ortiz-Carrasquillo R, Franco E, Matta-Fontanet E, Barranco E, Camilo-Vazquez E, Poliacik P, Micko K, Belicova M, Dzupina A, Sulej P, Murin J, Margoczy R, Spisak V, Stevlik J, Naidoo D, Dawood S, Theron H, Venter TP, Bayat J, Rossouw J, Essop M, Lloyd E, Snyders FA, Engelbrecht JM, Manga P, Saaiman JA, Badenhorst JC, Klug E, Gebka MK, Cho YH, Kim SH, Park SJ, Yoon D, Cho BR, Jeong MH, Park JS, Hur SH, Hyon MS, Kim MH, Jeon DW, Shin E, Namgung J, Park JI, Chung NS, Garcia-Aranda VL, Juanatey JR, Aviles FF, Antorrena I, Arroyo R, Coronado JL, Garcia JM, Quiles J, Elbal LM, Nodar JM, Aros F, de Miguel CM, Alvarez MG, Berrazueta JR, Goicolea F, Paz MA, Bruguera i Cortada J, Salvador A, Juanatey CG, Romo AI, Viklund J, Berglund S, Samad B, Witt N, Saldeen-Niléhn K, Moccetti T, Mach F, Erne P, Pieper M, Hayoz D, Peter M, Widmer F, Butler R, Mathur A, Watkin R, Smith D, Newby D, Travill C, Brady A, Pell A, Lewis P, Lindsay S, Bridges A, Connolly E, Lip G, Venkataraman A, Gupta S, Fath-Ordoubadi F, Martin S, Purvis J, Findlay I, Wilkinson P, Bakhai A, Chauhan A, Hudson I, de Belder M, Murdoch D, Purdy D, Gogia H, Zelman R, Siegel C, Herrington D, Humiston D, Berman K, Korban E, Kotlaba D, Dave K, Khan M, Schwartz G, Benton R, Lui H, Singh J, Blonder R, Krishnaswami A, Shah A, Varma J, Bertolet B, Kassas S, Khaira A, Carter E, Dykstra G, Georgeson S, Hotchkiss D, Zaroff J, Hunter J, Asbill B Jr, Pederson R, Nadar V, Sullenberger L, Dotani I, Erickson B, Weinstein D, Eilen S, McMahon J, Wiseman A, Eaton G, Izzo M, Rama B, Budoff M Jr, Klancke K, Moustoukas N, Rider J, Samal A, Schoondyke J, Traboulssi M, Treat S, Zakhary B, Burtt D, Gaither N, Hinchman D, Jan M, Polk D, Zarka A, Bloom S, Chodnicki D, Collard C, Heiman M, Kosinski E, Krantzler J, Lualdi J, McLellan B, Stein B, Treasure C, Weiss M, Burchenal J, Cambier P, Dean J, Fields R, Fischell T, McClure J 2nd, Jaffrani N, Kabour A, Meckel C, Pearson J, Raisinghani A, Rezkalla S, Taheri H, Jardula M, Kennett J, Kovacich D, Pickens W, Thomas G, Bhatti Z, Chiu A, Colan D, Fastabend C, Herzog W, Kakavas P, Kotha P, Minor S, Younis L, Herndon W, Iteld B, McFarlane S, Moses D, Naidu J, Roberts J, Tekler L, Thomas J, Berkery W, Bilazarian S, Bittner V, Cohen Y, Duprez D, Gillespie E, Goldstein M, Graham S, Guarnieri T, Schmedtje J Jr, Gilbert J Jr, Khan M, Knapp J, Kobayashi J, Kopecky S, Malinowski T, Mathew T, Miller C, Roan P, Schwartz M, Seals A, Tak T, Cowan L, Gerber J, Goldner D, Kershner D, Meholick A, Mowdy M, Nguyen T, Norwood P, Patel D, Rogers C, Rowe W, Shanes J, Simpfendorfer C, Solanki R, Altschuller A, Alzohaili O, Brilakis E, Chandna H, Cottiero R, Felten W, Forgosh L, Quinlan E 3rd, Ibarra J, Kaluski E, Kersh R, Kesselbrenner M, Lambert C, Leimgruber P, McGough M, Moses J, Norris R, Reeves R, Schmalfuss C, Sumpter M, Turk S, Vijay N, Zebrack J, Blackmore R, Byars W, Chandrashekar Y, Del Core M, Eisenberg S, Forker A, Gips S, Gress J, Gruberg L, Habib G, Hearne S, Howard L, Jovin I, Kruse K, Landzberg J, Mandviwala M, Patel M, Pillai K, Quadrel M, Sahar D, Sarikonda K, Schwartz S, Sharma M, Simpson P, Smith KM, Solano M, Stys T, Akmal M, Arora D, Chandrasekaran S, Corl J, Devireddy K, Edwards A, Forman S, Fung G, Goldberg R, Hanlon S, Held J, Borromeo S 3rd, Koren M, Kukuy E, Leppo J, Littlefield R, Loh I, Marar I, Mathis C, Mirro M, Myla S, Revtyak G, Srinivas V, Strain J, Timmapuri S, Almassi H, Bishop A, Barrett-Connor E, Davis B, Flores A, Gilchrist I, Handel F, Hemphill J, Henderson D, Hurst P, Bhagwat R Jr, Mandak J, Rivas E, Varma S, Vora K, White J, Yasuda T, Adolphe A, Wera-Archakul W, Ashchi M, Brown D, Caputo R, Cromer M, Dadkhah S, Desai A, Doucette J, Duvernoy C, Fishberg R, Fortuin FD, Fuleihan D, Ghai A, Giesler G, Jackson B, Jaffe C, Jarmukli N, Jetty P, Jones M, Goytia-Leos D, Lillestol M, Matar F, McKenzie M, Miller M, Nelson C, Saucedo J, Schoenwalder D, Staab P, Trevino M, Voyce S, Yousuf K, Abbott R, Albirini A, Apostol J, Barnum O, Brown A, Burckhartt B, Carstens J, Delafontaine P, Desai P, Edris M, Elkin G, Emlein G, Felker D, Haidar A, Hanke F, Hilton T, Hodes Z, Klugherz B, Masri B, Murphy J, Quyyumi A, Raikhel M, Sangrigoli R, Scott C, Shammas N, Springer M, Stegemoller R, Tadros G, Welka S, Alwine L, Arif A, Arif I, Bains S, Bedoya R, Doherty J, Eisenberg D, Ervin W, Feldman R, Gudmundsson G, Harris J, Herrod J, Portelli J 3rd, Jauch W, Jinich D, Johnson D, Baine S Jr, Kai W, Kashou H, Kashyap M, Kaul S, Levenson L, Litt M, Lowe J, Martin L, Rashid HU, Raybuck B, Rogal P, Rozanski J, Sutherland J, Tahirkheli N, Tami L, Teniola S, Viswanath D, Waxman F, Adkins K, Agaiby J, Cannon L, Chang M, Cole J, DeGregorio M, Ellis J, Foster M, George A, Goyal N, Gupta A, Herzog E, Barbel-Johnson K, Bareket Y Jr, Karns A, Karunaratne H, Kramer N, Lasala G, McGlynn S, Mehta A, Moscoso R, Nguyen T, Real M, Roehll W, Sayeed S, Seto T, El-Sherif T, Shu W, Singh V, Smith W, Taghizadeh B, Wilcox M, Williams R, Baker S, Bazzi A, Beavins J, Egbujiobi L, Gassler J, Gimple L, Homan J, House B, Hussain M, Jamal N, Lovell C Jr, Chambers J Jr, Chesebro J Jr, Bestermann W Jr, Keller A, Koura F, Larson D, Lewis S, Little T, Lorber D, Mavromatis K, Mouhaffel A, Panzarella P, Rusche R, Schaefer S, Seaworth J, Singh N, Smith D, Srinivasan V, Srivastava N, Weinberg B, Weiss D, Yasin M, Ziada K.

Abstract

BACKGROUND:

In observational analyses, higher levels of high-density lipoprotein (HDL) cholesterol have been associated with a lower risk of coronary heart disease events. However, whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain. Inhibition of cholesteryl ester transfer protein (CETP) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes.

METHODS:

We randomly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib, at a dose of 600 mg daily, or placebo, in addition to the best available evidence-based care. The primary efficacy end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, unstable angina, or cardiac arrest with resuscitation.

RESULTS:

At the time of randomization, the mean HDL cholesterol level was 42 mg per deciliter (1.1 mmol per liter), and the mean low-density lipoprotein (LDL) cholesterol level was 76 mg per deciliter (2.0 mmol per liter). Over the course of the trial, HDL cholesterol levels increased from baseline by 4 to 11% in the placebo group and by 31 to 40% in the dalcetrapib group. Dalcetrapib had a minimal effect on LDL cholesterol levels. Patients were followed for a median of 31 months. At a prespecified interim analysis that included 1135 primary end-point events (71% of the projected total number), the independent data and safety monitoring board recommended termination of the trial for futility. As compared with placebo, dalcetrapib did not alter the risk of the primary end point (cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P=0.52) and did not have a significant effect on any component of the primary end point or total mortality. The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo (P<0.001 for both comparisons).

CONCLUSIONS:

In patients who had had a recent acute coronary syndrome, dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events. (Funded by F. Hoffmann-La Roche; dal-OUTCOMES ClinicalTrials.gov number, NCT00658515.).

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