1. Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes
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Roe, Matthew T, Li, Qian H, Bhatt, Deepak L, Bittner, Vera A, Diaz, Rafael, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Lopez-Jaramillo, Patricio, Lopes, Renato D, Louie, Michael J, Moriarty, Patrick M, Szarek, Michael, Vogel, Robert, White, Harvey D, Zeiher, Andreas M, Baccara-Dinet, Marie T, Steg, Ph Gabriel, Schwartz, Gregory G, Tricoci, Pierluigi, Mahaffey, Kenneth W, Edelberg, Jay M, Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angele, Pordy, Robert, Sasiela, William J, Tamby, Jean-Francois, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Gotcheva, Nina N, Prieto, Juan-Carlos, Yong, Huo, Pecin, Ivan, Reiner, Zeljko, Ostadal, Petr, Poulsen, Steen Hvitfeldt, Viigimaa, Margus, Nieminen, Markku S, Danchin, Nicolas, Chumburidze, Vakhtang, Marx, Nikolaus, Liberopoulos, Evangelos, Valdovinos, Pablo Carlos Montenegro, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Kedev, 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Radovanovic, Slavica, Balinovac, Jovan, Dincic, Dragan V, Seferovic, Petar, Dodic, Slobodan, Dimkovic, Sinisa, Poh, Kian-Keong, Ong, Hean Yee, Micko, Karol, Nociar, Jan, Pella, Daniel, Fulop, Peter, Hranai, Marian, Palka, Juraj, Mazur, Juraj, Majercak, Ivan, Dzupina, Andrej, Fazekas, Frantisek, Gonsorcik, Jozef, Bugan, Viliam, Selecky, Juraj, Kamensky, Gabriel, Strbova, Jaroslava, Smik, Rudolf, Dukat, Andrej, Olexa, Peter, Zuran, Ivan, Poklukar, Janez, Suligoj, Natasa Cerni, Cevc, Matija, Cyster, Henry P, Ranjith, Naresh, Corbett, Clive, Bayat, Junaid, Makotoko, Ellen Makoali, Kapp, Ilse E, Basson, Matthys M de V, Lottering, Hanlie, Van Zyl, Louis J, Sebastian, Peter J, Pillay, Thayabran, Saaiman, Jan A, Commerford, Patrick J, Cassimjee, Soraya, Ebrahim, Iftikhar O, Sarvan, Mahomed, Mynhardt, Joseph H, Reuter, Helmuth, Moodley, Rajendran, Vida, Manuel, Cequier Fillat, Angel R, Peris, Vicente Bodi, Jimenez, Francisco Fuentes, Marin, Francisco, Cruz Fernandez, Jose M, Gil-Extremera, Blas, Diz, Fernando Worner, Garcia-Dorado, David, Iniguez, Andres, Tunon Fernandez, Jose, Gonzalez-Juanatey, Jose R, Fernandez Portales, Javier, Civeira Murillo, Fernando, Matas Pericas, Laia, Luis Zamorano, Jose, De Mora Martin, Manuel, Bruguera Cortada, Jordi, Alonso Martin, Joaquin J, De Berrazueta Fernandez, Jose R, Diaz Fernandez, Jose Francisco, Garcia Lledo, Jose Alberto, Cosin Sales, Juan, Botas Rodriguez, Javier, Gusi Tragant, Gabriel, Benedicto, Amparo, Gonzalez-Juanatey, Carlos, Camprubi Potau, Mercedes, Plaza Perez, Ignacio, Moris De La Tassa, Cesar, Loma-Osorio Rincon, Pablo, Balaguer Recena, Javier, Escudier, Juan M, Coca Payeras, Antonio, Alonso Orcajo, Norberto, Valdivielso, Pedro, Constantine, Godwin, Haniffa, Ruvaiz, Tissera, Nirmali, Amarasekera, Stanley, Fernando, Nimali, Jayawardena, Jayanthimala, Santharaj, Wijeyasingam, Ekanayaka, Ruvan, Mendis, Sepalika, Senaratne, Vajira, Mayurathan, Gnanamoorthy, Sirisena, Thilak, Rajapaksha, Ajantha, Herath, Jagath I, Amarasena, Naomali, Berglund, Stefan, Rasmanis, Gundars, Witt, Nils, Mourtzinis, Georgios, Nicol, Peter, Hansen, Ole, Romeo, Stefano, Jensen, Steen Agergaard, Torstensson, Ingemar, Ahremark, Ulf, Sundelin, Torbjorn, Moccetti, Tiziano, Mach, Francois, Binder, Ronald, Tsai, Wei-Chuan, Ueng, Kwo-Chang, Lai, Wen-Ter, Liu, Ming-En, Hwang, Juey-Jen, Yin, Wei-Hsian, Hsieh, I-Chang, Lin, Wei Hsiang, Kuo, Jen-Yuan, Huang, Tsuei-Yuan, Fang, Chih-Yuan, Kaewsuwanna, Pinij, Soonfuang, Wasant, Jintapakorn, Woravut, Sukonthasarn, Apichard, Wongpraparut, Nattawut, Sastravaha, Krisada, Sansanayudh, Nakarin, Kehasukcharoen, Wirash, Piyayotai, Dilok, Chotnoparatpat, Paiboon, Camsari, Ahmet, Kultursay, Hakan, Mutlu, Bulent, Ersanli, Murat, Demirtas, Mustafa, Kirma, Cevat, Ural, Ertan, Koldas, Lale, Karpenko, Oleksandr, Prokhorov, Alexander, Vakaluyk, Ihor, Myshanych, Halyna, Reshotko, Dmytro, Batushkin, Valeriy, Rudenko, Leonid, Kovalskyi, Ihor, Kushnir, Mykola, Tseluyko, Vira, Mostovoy, Yuriy, Stanislavchuk, Mykola, Kyiak, Yulian, Karpenko, Yuriy, Malynovsky, Yaroslav, Klantsa, Andriy, Kutniy, Oles, Amosova, Ekaterina, Tashchuk, Viktor, Leshchuk, Oleh, Rishko, Mykola, Kopytsya, Mykola, Yagensky, Andriy, Vatutin, Mykola, Bagriy, Andriy, Barna, Olga M, Ushakov, Olexiy, Dzyak, Georgiy, Goloborodko, Borys, Rudenko, Anatolii, Zheleznyy, Volodymyr, Trevelyan, Jasper, Zaman, Azfar, Lee, Kaeng, Moriarty, Andrew, Aggarwal, Rajesh K, Clifford, Piers, Wong, Yuk-Ki, Iqbal, Syed MR, Subkovas, Eduardas, Braganza, Denise, Sarkar, David, Storey, Robert, Griffiths, Huw, Mcclure, Sam, Muthusamy, Rangasamy, Kurian, John, Levy, Terry, Barr, Craig, Kadr, Honer, Gerber, Robert, Simaitis, Audrius, Soran, Handrean, Mathur, Anthony, Brodison, Adrian, Oliver, Richard, Mudawi, Telal, Reynolds, Timothy, Sharman, David, Butler, Rob, Wilkinson, Peter, Lip, Gregory YH, Halcox, Julian, Vardi, Gil, Baldari, Duccio, Brabham, David, Treasure, Charles, Dahl, Charles, Palmer, Bruce, Wiseman, Alan, Khan, Abul, Puri, Sanjeev, Mohart, Ann Elizabeth, Ince, Carlos, Flores, Enrique, Wright, Scott, Cheng, Shi-Chi, Rosenberg, Michael, Rogers, William, Kosinski, Edward, Forgosh, Les, Waltman, Jonathan, Khan, Misal, Shoukfeh, Mohammad, Dagher, Georges, Lieber, Ira, Kumar, Priya, East, Cara, Krichmar, Perry, White, Lindsey, Knickelbine, Thomas, Haldis, Thomas, Gillespie, Eve, Suh, David, Arif, Imran, Akhter, Faiq, Carlson, Eric, D'Urso, Michael, El-Ahdab, Fadi, Nelson, William, Harris, Barry, Cohen, Steven, Carter, Luther, Sabatino, Kenneth, Haddad, Tariq, Malik, Amir, Rao, Sunder, Mulkay, Angel, Jovin, Ion, Klancke, Kim, Malhotra, Vinay, Devarapalli, Sai K, Koren, Michael, Chandna, Harish, Dodds, George, Janik, Matthew, Moran, Joseph, Sumner, Andrew, Kobayashi, John, Davis, William, Yazdani, Shahram, Pasquini, John, Thakkar, Maitreya, Vedere, Amarnath, Leimbach, Wayne, Rider, James, Singh, Narendra, Shah, Anil V, Janosik, Denise, Pepine, Carl, Berman, Brett, Gelormini, Joseph, Daniels, Christopher, Keating, Friederike, Kondo, Nicholas I, Shetty, Sanjay, Waider, Winfried, Takata, Theodore, Abu-Fadel, Mazen, Shah, Vipul, Aggarwal, Rahul, Izzo, Mark, Kumar, Anil, Hattler, Brack, Link, Chad, Bortnick, Anna, Kinzfogl, George, Ghitis, Arnold, Larry, John, Teufel, Edward, Kuhlman, Peter, Mclaurin, Brent, Zhang, Wenwu, Thew, Stephen, Abbas, Jalal, White, Matthew, Ranadive, Nandkishore, Gring, Christian, Henderson, David, Schuchard, Timothy, Farhat, Naim, Kline, Geoffrey, Mahal, Sharan, Whitaker, Jack, Speirs, Shawn, Andersen, Rolf, Daboul, Nizar, Horwitz, Phillip, Ponce, George, Jafar, Zubair, Mcgarvey, Joseph, Panchal, Vipul, Voyce, Stephen, Blok, Thomas, Sheldon, William, Azizad, Masoud M, Schmalfuss, Carsten, Picone, Mark, Herzog, William, Lindsey, Jason, Nowins, Rosemary, Lepor, Norman, El Shahawy, Mahfouz, Weintraub, Howard, Irimpen, Anand, May, Wade, Galski, Thomas, Chu, Alan, Mody, Freny, Hodes, Zachary, Rose, Gregory, Fairlamb, James, Lambert, Charles, Raisinghani, Ajit, Abbate, Antonio, King, Marilyn, Carey, Charles, Gerber, Jaime, Younis, Liwa, Park, Hyeun Tom, Vidovich, Mladen, Knutson, Thomas, Friedman, Dennis, Chaleff, Fred, Loussararian, Arthur, Rozeman, Phillip, Kimmelstiel, Carey, Silver, Kevin, Foster, Malcolm, Tonnessen, Glen, Amlani, Mohamadali, Wali, Andreas, Malozzi, Christopher, Wattanakit, Keattiyoat, O'Donnell, Philip J, Singal, Dinesh, Jaffrani, Naseem, Banuru, Sridhar, Fisher, Daniel, Xenakis, Mark, Perlmutter, Neal, Bhagwat, Ravi, Strader, James, Akyea-Djamson, Ayim, Labroo, Ajay, Lee, Kwan, Marais, H John, Claxton, Edmund, Berk, Martin, Rossi, Peter, Joshi, Parag, Khaira, Ajit S, Kumkumian, Greg, Lupovitch, Steven, Purow, Joshua, Welka, Stephen, Hoffman, David, Fischer, Stuart, Soroka, Eugene, Eagerton, Donald, Pancholy, Samir, Ray, Michael, Farrar, Michael, Pollock, Stewart, French, William J, Diamantis, Steve, Gimple, Lawrence, Neustel, Mark, Schwartz, Steven, Pereira, Edward, Spriggs, Douglas, Strain, Janet, Vo, Anthony, Chane, Majed, Hall, Jason, Vijay, Nampalli, Lotun, Kapildeo, Lester, F Martin, Nahhas, Ahed, Pope, Theodore, Nager, Paul, Vohra, Rakesh, Bashir, Riyaz, Ahmed, Hinan, Berlowitz, Michael, Fishberg, Robert, Barrucco, Robert, Yang, Eric, Radin, Michael, Sporn, Daniel, Eisenberg, Steven, Landzberg, Joel, Mcgough, Martin, Turk, Samir, Schwartz, Michael, Sundram, P Sandy, Jain, Diwakar, Zainea, Mark, Bayron, Carlos, Karlsberg, Ronald, Lui, Henry, Keen, William, Westerhausen, Donald, Khurana, Sandeep, Agarwal, Himanshu, Birchem, Jessica, Penny, William, Chang, Mark, Murphy, Sherrill, Schifferdecker, Branislav, Gilbert, John M, Chalavarya, Gopal, Eaton, Charles, Schmedtje, John F, Christenson, Stuart, Denham, Douglas, Macdonell, Alexander, Gibson, Paul, Rahman, Aref, Al Joundi, Tammam, Conrad, Gary, Kotha, Purushotham, Love, Michael, Giesler, Gregory, Rubenstein, Howard, Akright, Laura, Krawczyk, Justine, Wells, Terry, Welker, James, Foster, Robert, Gilmore, Richard, Anderson, Jay, Jacoby, Douglas, Harris, Bill, Gardner, Geraldine, Dandillaya, Ramprasad, Vora, Kishor, Kostis, John, Hunter, John, Laxson, David, Ball, Eric, Camp, Alan, Lopes, Renato, Egydio, Flavia, Kawakami, Anelise, Oliveira, Janaina, Wozniak, Julianna, Matthews, Alexander, Ratky, Caroline, Valiris, Janine, Berdan, Lisa, Hepditch, Anita, Quintero, Kirby, Rorick, Tyrus, Westbrook, Melissa, Pascual, Andrea, Rovito, Carla, Bezault, Madeleine, Drouet, Elodie, Simon, Tabassome, Alsweiler, Caroline, Luyten, Anne, Aylward, Phil, Butters, Julie, Griffith, Liddy, Shaw, Michelle, Grunberg, Lena, Islam, Shahidul, Bregeault, Marie-France, Bougon, Nathalie, Faustino, Douglas, Fontecave, Sylvie, Murphy, Judith, Verrier, Melanie, Agnetti, Veronique, Andersen, Dorthe, Badreddine, Emmy, Bekkouche, Mhamed, Bouancheau, Cecile, Brigui, Imane, Brocklehurst, Maddy, Cianciarulo, Joseph, Devaul, Dawn, Domokos, Szilvia, Gache, Cecile, Gobillot, Caroline, Guillou, Severine, Healy, Jan, Heath, Megan, Jaiwal, Gayatri, Javierre, Carine, Labeirie, Julien, Monier, Myriam, Morales, Ulises, Mrabti, Asmaa, Mthombeni, Bicky, Okan, Betim, Smith, Lucile, Sheller, Jennifer, Sopena, Sebastien, Pellan, Valerie, Benbernou, Fadela, Bengrait, Nafissa, Lamoureux, Maud, Kralova, Katarina, Scemama, Michel, Bejuit, Raphael, Coulange, Anthony, Berthou, Christelle, Repincay, Jerome, Lorenzato, Christelle, Etienne, Alexis, Gouet, Valerie, Loizeau, Virginie, Normand, Mickael, Ourliac, Anne, Rondel, Christelle, Adamo, Antony, Beltran, Pascale, Barraud, Pauline, Dubois-Gache, Helene, Halle, Benjamin, Metwally, Lamia, Mourgues, Maxime, Sotty, Marc, Vincendet, Marion, Cotruta, Raluca, Zhu, Chengyue, Fournie-Lloret, Dominique, Morrello, Christine, Perthuis, Aurelie, Picault, Patrick, Zobouyan, Isabelle, Everest, ODYSSEY OUTCOMES Investigators, İÜC, Ege Üniversitesi, Cardiology, and Internal Medicine
- Subjects
Male ,Time Factors ,Cardiac & Cardiovascular Systems ,STATIN THERAPY ,alirocumab ,acute coronary syndrome ,dyslipidemias ,guideline ,Guideline ,PCSK9 ,chemistry.chemical_compound ,Recurrence ,Risk Factors ,Original Research Articles ,Secondary Prevention ,Cardiac and Cardiovascular Systems ,BENEFIT ,03.02. Klinikai orvostan ,ADDING EZETIMIBE ,1102 Cardiorespiratory Medicine and Haematology ,Cholesterol management ,Secondary prevention ,Kardiologi ,Anticholesteremic Agents ,PCSK9 Inhibitors ,American Heart Association ,Middle Aged ,Cholesterol ,Treatment Outcome ,Practice Guidelines as Topic ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Female ,Acute coronary syndrome ,Proprotein Convertase 9 ,Cardiology and Cardiovascular Medicine ,Risk assessment ,Life Sciences & Biomedicine ,medicine.medical_specialty ,Serine Proteinase Inhibitors ,Antibodies, Monoclonal, Humanized ,Risk Assessment ,CARDIOVASCULAR OUTCOMES ,1117 Public Health and Health Services ,EVENTS ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,Alirocumab ,Aged ,Dyslipidemias ,Science & Technology ,business.industry ,1103 Clinical Sciences ,medicine.disease ,United States ,chemistry ,Peripheral Vascular Disease ,Cardiovascular System & Hematology ,Cardiovascular System & Cardiology ,Human medicine ,business ,Biomarkers - Abstract
Gislason, Gunnar H/0000-0002-0548-402X; Leonardi, Sergio/0000-0002-4800-6132; Sherwood, Matthew/0000-0002-4305-5883; Abbate, Antonio/0000-0002-1930-785X; Muenzel, Thomas/0000-0001-5503-4150; Taskinen, Marja-Riitta/0000-0002-6229-3588; Chumakova, Galina A/0000-0002-2810-6531; Ersanli, Murat/0000-0003-1847-3087; Reshetko, Olga/0000-0003-3107-7636; Nikolaev, Konstantin/0000-0003-4601-6203; Raffel, Owen C/0000-0001-5470-7050; Podoleanu, Cristian/0000-0001-9987-2519; bastos, jose/0000-0002-9526-3123; Tse, Hung Fat/0000-0002-9578-7808; Lopez-Jaramillo, Patricio/0000-0002-9122-8742, WOS: 000494805400011, PubMed: 31475572, Background: the 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol >= 70 mg/dL or non-high-density lipoprotein cholesterol >= 100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Methods: in the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. the primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. in the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; P-interaction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; P-interaction=0.672). the absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P-interaction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P-interaction=0.661). Conclusions: the US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab., Sanofi; Regeneron Pharmaceuticals, This work was supported by Sanofi and Regeneron Pharmaceuticals.
- Published
- 2019