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1. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.

Author

Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, and Nissen SE

Subjects
Aged, Anticholesteremic Agents adverse effects, Benzodiazepines adverse effects, Biomarkers blood, Cardiovascular Diseases blood, Cardiovascular Diseases drug therapy, Cholesterol, HDL blood, Cholesterol, LDL blood, Diabetes Mellitus drug therapy, Double-Blind Method, Female, Humans, Intracranial Arteriosclerosis drug therapy, Male, Middle Aged, Myocardial Ischemia drug therapy, Peripheral Vascular Diseases drug therapy, Risk, Treatment Failure, Anticholesteremic Agents therapeutic use, Benzodiazepines therapeutic use, Cardiovascular Diseases prevention & control, Cholesterol Ester Transfer Proteins antagonists & inhibitors
Abstract

Background: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease., Methods: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina., Results: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91)., Conclusions: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .).

Published
2017
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2. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author

L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. Alexopoulos, E. Duronto, S. Car, O. Bashkirtsev, J. Mandak, V. Papademetriou, David O. Williams, Oscar Pereira Dutra, R. Baman, T. J. Hong, J. O. Ibañez, D. L. Gomez, R. K. Jain, R. Jozwa, L. Di Lorenzo, Matthew Wilson, Christian W. Hamm, A. Buakhamsri, Nikitas Moschos, Ashok Kumar, A. Kadiiski, C. Y. Lee, M. Opazo, J. Tang, E. Ferrari, P. Colon-Hernandez, Jean-Pierre Déry, B. Goloborodko, L. Gimple, Diego Ardissino, M. Bergovec, S. Thew, Dariusz Dudek, K. Tang, P. A.G. Zwart, A. Deshpande, S. Sathe, Yves Cottin, V. Pai, O. Koval, J. Lesnik, Pavan S. Reddy, A. Espinoza, Rungroj Krittayaphong, Carisi Anne Polanczyk, E. Kukuy, L. Tejada, J. Nobel, Renato D. Lopes, J. Bagatin, A. Manolova, E. Boudriot, A. Godoy, N. Perepech, Christopher D. Olympios, A. E. Guimarães, James Harris, Aref Rahman, D. Foley, H. J. Kruik, J. Bruguera I Cortada, I. Fotiadis, A. Bharani, Petar Otasevic, Eileen Brown, N. Gratsiansky, J. E. Poulard, Vladimir Gašparović, Habib Haouala, A. de Belder, J. Schmedtje, Lilia Nigro Maia, J. Cobos, Werner Benzer, E. Korban, A. U. Quraishi, X. Hong, A. Bazzi, P. Kotha, L. Gubolino, H. Ingersoll, Debra Marshall, Udo Sechtem, Sandipan Dutta, G. Frago, Anthony Mathur, Shaun G. Goodman, William Bachinsky, A. Hamer, Jaime Gomez, Patrizio Lancellotti, Vance Wilson, L. White, P.P. Mohanan, Aleksandar Knezevic, Sorin J. Brener, Susanna R. Stevens, H. Luquez, S. K. Lee, P. E. Leaes, P. Benjarge, T. Tu, Z. Coufal, N. Koliopoulos, Mahmut Şahin, X. Huang, S. Boldueva, J. De Souza, N. Chidambaram, S. Zolyomi, K. G. Shyu, H. Montecinos, A. Piombo, Wladmir Faustino Saporito, R. L. Kulkarni, I. Szakal, G. Arminio, M. Elbaz, Samir Pancholy, Jang Ho Bae, Giuseppe Musumeci, S. B. Zouari, A. Chois, D. Wojciechowski, A. Bakbak, E. Bozkurt, Kenneth J. Winters, R. Raugaliene, D. Sarkar, J. M. Alegret, Hubertus Heuer, E. Bobescu, E. Roncallo, R. Carlsson, R. Craig McLendon, L K Newby, K. Zrazhevskiy, João Pedro Ferreira, A. Haidar, D. Tellez, Robert Olszewski, Shmuel Gottlieb, H. Jure, A. Garcia Escudero, S. Sengupta, V. Ochean, W. Kostuk, G. Range, F. Leroy, G. Parale, R. Fernandez, M. Fulwani, M. Padovan, Y. Dovgalevskiy, Kreton Mavromatis, H. Hart, Y. G. Ko, F. Seixo, V. Bisne, J. McGarvey, Kimberly L. Blackwell, John H. Strickler, Sanjay Kumar, A. Bordonava, L. Egorova, C. Patocchi, A. Karczmarczyk, Chiara Melloni, Piyamitr Sritara, M. Anastasiou-Nana, Roman Szełemej, K. Penchev, D. Morales, M. Tokmakova, Krzysztof Zmudka, Rakesh Yadav, E. Bressollette, D. Nul, A. L. Astesiano, M. Urban, Abdulhay Albirini, C. T. Chin, F. Moulin, I. M. Coman, R. Watkin, J. Abanilla, J. Brønnum-Schou, J. Anusauskiene, P. Andrade Lotufo, Joseph G. Rogers, M. Bessen, P. C. Sartori, Paulo Roberto Ferreira Rossi, K. Atassi, H. V. Anderson, B. Klugherz, Bateshwar Prasad Singh, Mirza S. Baig, Z. Yusof, J. H. Geertman, A. Labroo, P. Nash, Freek W.A. Verheugt, Nancy J. Brown, M. A. Alcocer, A. Neskovic, L. Francek, Judith S. Hochman, A. Hoffmann, R. Dran, A. Podczeck-Schweighofer, Jeffry Katz, Josh Roberts, Roger E. McLendon, Ronald Rodriguez, T. Downes, A. Roth, L. E. Mayorga, Armagan Altun, José-Luis López-Sendón, M. Krotin, N. van der Merwe, O. Gigliotti, C. Park, G. Brigden, M. Kumbla, D. C G Basart, D. Erdogan, R. van Kranen, J. Beloscar, Johny Joseph, Pierluigi Tricoci, J. Marino, N. Mahon, S. Dani, I. Kovalskyy, Ioannis Nanas, V. Volkov, M. I. Edmilao, J. Kruells-Muench, F. Alamgir, R. Rinaldi, W. E. Mogrovejo, J. Mirat, C. Staniloae, S. Borromeo, H. Kozman, H. Zhang, Y. Zhou, S. Shurmur, A. Manari, M. A. Barrera, A. Vasylenko, D. Keedy, Paul A. Gurbel, Ali Oto, Charles R. Lambert, V. G. Ribeiro, A. Quintero, H. Joshi, L. Tang, J. Allan, C. S. Díaz, F. Carvalho Neuenschwander, Mircea Cintezǎ, M. Kokles, G. Piovaccari, Z. Kovacs, W. Li, C. Beauloye, E. J. Ramos, D. Bertolim Precoma, J. Burstein, G. Covelli, E. C. Zambrano, Assen Goudev, A. Tang, F. Henriquez, S. Tangsuntornwiwat, C. Kirma, GR Aycock, Kenneth W. Mahaffey, M. Ardnt, Jose C. Nicolau, O. Barbarash, E. K. Shin, P. Potapenko, T. Supryadkina, Asok Venkataraman, W. Mogrovejo, M. Acikel, R. Bohorquez, M. Syvänne, M. Chan, H. Mardikar, H. Berlin, O. Quintana, K. Heintz, J. M. Bastos, Guillermo Llamas Esperon, G. Aroney, J. Chen, Nancy H. Collins, C. Ahsan, G. Heins, F. Baer, V. Kondle, Nicholas Danchin, G. Shetty, Sergio Berti, Philip E. Aylward, James Cotton, G. S. Vallejo, Massimo Volpe, Z. Vasiljevic-Pokrajcic, C. Bugueño, Seung Woon Rha, S. Ilic, G. E. Stanciulescu, Z. Li, D. Nassiacos, R. Sciberras, S. Kuanprasert, Denilson Campos de Albuquerque, M. Pavlovic, Craig S. Barr, Mohammed R. Essop, John G. Canto, David T. Roberts, M. Ozdemir, Jacquelyn Miller, T. K. Ong, Sian E. Harding, V. Bose, J. Yoon, R. Syan, M. A. Paz, O. Maskon, Dennis V. Cokkinos, L. Kraus, Z. Masud, K. Amosova, M. Boyarkin, L. Mos, Dmitry Zamoryakhin, Arif Anis Khan, Jeffrey A. Breall, A. Gallino, Ivo Petrov, F. A. Alves da Cost, Saul Vizel, Hugo Vargas Filho, P. Kaewsuwanna, G. Antonelli, Chuen Den Tseng, I. Vakaliuk, J. Miklin, A. El Hawary, Ashok Jacob, D. Gumm, Kurt Huber, G. Pajes, N. Jathappa, Stanislaw Bartus, P. V. Lavhe, C. Romero, J. Balkin, T. Gould, R. Durgaprasad, Felipe Martinez, Henning Ebelt, A. Puri, D. K. Agarwal, E. E. Buyukoner, R. Mora Junior, P. Poliacik, A. Dande, X. Zhao, J. Floro, A. Bagriy, Yuliya Lokhnygina, M. Atieh, V. Batushkin, Valentin Markov, O. Karpenko, Peter Clemmensen, P. Castro, L. Paloscia, F. Florenzano, J. L. Accini, Tony Schibler, J. Arneja, W. Wu, B. Andruszkiewicz, Michael A. Morse, P. Vojtisek, D. Sadler, S. Frischwasser, M. Cayli, W N Leimbach, E. Flores, B. Wang, A Sosa Liprandi, Y. Michalaros, H. C. Finimundi, Raul D. Santos, N. Vijay, E. Magnus Ohman, Y. Karpenko, J. Sirotiakova, Z. Shogenov, D A Zateyshchikov, Eric P. Viergever, R. Bach, Gary S. Niess, D. C. Acosta, G. Piegari, J. B. Gupta, J. Shanes, E. Ronner, J. Arter, Claudio Cavallini, M. A. Hominal, V. Bugan, S. D. Varini, K. Nyman, B. G. Castillo, Sinan Aydoğdu, N. Novikova, D. Wang, P. Simpson, Y. Huang, Taral Patel, Gabriel Tatu-Chitoiu, D. Silva Junior, H. Theron, C. Alvarez, Anikó Ilona Nagy, T. Chua, P. Georgiev, D. Rittoo, G. De Luca, R. Blonder, Alberto Caccavo, D. Koganti, E. Manenti, N. Ghaisas, G. Letcher, D. Platogiannis, Arshed A. Quyyumi, J. Dy, Z. Ples, W. Kunz Sebba Barroso de Souza, Hamid Taheri, S. Kammoun, A. Salvioni, B. Stockins, K. Sutalo, J. C. Post, Merih Kutlu, Vijay K. Chopra, C. Mathis, Stephen M. Schwartz, Manish Jain, D. Coisne, A. Goudev, A. Dalby, João Morais, P. van Kalmthout, Andrzej Budaj, I. Dotani, L. Mircoli, R. Vicari, J. P. Herrman, M. Moran, G. Lupkovics, Alexander Parkhomenko, J. Heath, Andrew Moriarty, C. Pop, J. Y. Hwang, S. Kassam, R. Martingano, I. Nikolskaya, Z. Zheng, Johann S. de Bono, M. Izzo, R. Labonte, E. H. Forte, W. Moleerergpoom, Piera Angelica Merlini, D. Lee, W. Macias, G. Syan, S. Zhou, S. W. Kim, T. Duris, E. Shaoulian, Andreas U. Wali, Marco Antonio Mota Gomes, Pritibha Singh, M. Ovize, M. Del Core, W. Bowden, B. Xu, Ravi Bhagwat, C. Wongvipaporn, J. Vojacek, Steven Lindsay, F. McGrew, J. Gorny, J. D. Pappas, R. Vuyyuru, J. Chahin, Ashraf Reda, T. Lau, E. Conn, J. Meisner, S. Meymandi, A. D. Hrabar, M. Slanina, D. Jarasuniene, C. Lang, A. Vo, Christian Hamm, H. Gogia, Z. Yuan, T. Mathew, A. Van Dorpe, J. Kettner, M. Barbiero, Harvey D. White, L. Rudenko, V. Jain, M. Carter, David Erlinge, G. Ma, V. Sierkova, D. K. Kim, Steven O. Smith, R. K. Premchand, P. Jetty, J. Y. Hou, V. Simanenkov, T. Kaelsch, David P. Foley, A. Francis, Piotr Ponikowski, Ramón Corbalán, D. Connolly, J. Tuma, R. Zambahari, Miodrag Ostojic, R. Lamich, A. Rabelo Alves, V. Tseluyko, G. Moises Azize, L. Khaisheva, G. Pencheva, C. Ingram, J. Cooke, A. Prado, M. De Tollenaere, M. Kim, Alan Rees, Melanie B. Turner, Mark B. Abelson, H. L. Luciardi, L. Illyes, R. Sarma, L. Manriquez, J. A. Marin Neto, D. Iordachescu-Petica, G. Hoedemaker, Victor S. Gurevich, F. Ridocci, J. Grman, F. Waxman, Jorge F. Saucedo, E. Boughzala, B. S. Jagadesa, Heba Abdullah, A. Weiss, N. Bichan, L. Tami, Y. Bouzid, N. I. Gomez, Zafar Sy, Béla Merkely, J. P. Albisu, L. Rodriguez-Ospina, John C. Chambers, L. L. Lobo Marquez, R. Guan, Steven Georgeson, M. K. Sarna, L. Nogueira Liberato de Sousa, Mika Laine, P. Pimentel Filho, Teresa Kawka-Urbanek, G P Arutyunov, S. Elhadad, A. Dambrauskaite, R. Leon de la Fuente, Audes D. M. Feitosa, P. Baetslé, Abraham Al Ahmad, José Francisco Kerr Saraiva, Roland P.T. Troquay, J. Berlingieri, Margaret Arstall, J. L. Coronado, K. Yang, S. V. Shalaev, Bernard J. Gersh, A. El-Etreby, Elżbieta Zinka, F. De Valais, John E.A. Blair, P. Fajardo, M. Rodriguez, R. Boujnah, H. Hammerman, Y. S. Chong, Stigi Joseph, M. H. Jeong, J. Ge, Q. He, Robert S Iwaoka, Bimal R. Shah, J. Sawhney, T. Sakulsaengprapha, G. Werner, Jill Anderson, M. Hondl, Meinrad Gawaz, Gilmar Reis, M. Dalkowski, Tomáš Janota, M. Damiao Gomes Seabra, A. Dharmadhikari, Aleš Linhart, John Elliott, Kodangudi B. Ramanathan, Doron Zahger, Dilek Ural, L. Regos, F. R. Bolohan, Marcello Galvani, B. Zakhary, N. Qureshi, D. Deac, Maria Emília Figueiredo Teixeira, T. Venter, Santosh Gupta, W. Wright, P. Telekes, A. Furber, V. Nykonov, Zhu Junren, M. Cinteza, I. Lang, S. Junejo, D. Martins, Mauro Esteves Hernandes, G. Ishmurzin, Anthony J. Dalby, R. Scioli, P. Babu, R. Habaluyas, V. Mendoza, G. B. Scaro, Matthew T. Roe, M. Senaratne, D. J. van der Heijden, T. Pillay, Yoav Turgeman, J. Moreira, C. Cuccia, C. Astarita, S. De Servi, Robert G. Wilcox, M. C. Constantinescu, Kardiyoloji, Roe Matthew, T., Armstrong Paul, W., Fox Keith, A. A., White Harvey, D., Prabhakaran, Dorairaj, Goodman Shaun, G., Cornel Jan, H., Bhatt Deepak, L., Clemmensen, Peter, Martinez, Felipe, Ardissino, Diego, Nicolau Jose, C., Boden William, E., Gurbel Paul, A., Ruzyllo, Witold, Dalby Anthony, J., McGuire Darren, K., Leiva Pons Jose, L., Parkhomenko, Alexander, Gottlieb, Shmuel, Topacio Gracita, O., Hamm, Christian, Pavlides, Gregory, Goudev Assen, R., Oto, Ali, Tseng Chuen, Den, Merkely, Bela, Gasparovic, Vladimir, Corbalan, Ramon, Cinteza, Mircea, McLendon R., Craig, Winters Kenneth, J., Brown Eileen, B., Lokhnygina, Yuliya, Aylward Philip, E., Huber, Kurt, Hochman Judith, S., Ohman E., Magnu, and Golino, Paolo

Subjects
Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012

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