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7. Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study

Author

Mautalén, Carlos Alfredo, Man, Zulema, Zanchetta, Jose Ruben, Magaril, Clelia Haydee, Sambrook, Philip, Reginster, Jean-Yves, Geusens, Piet, Goemaere, Stefan, Albergaria, Ben Hur, Zerbini, Cristiano Augusto de Freitas, Castro, Marise Lazaretti, Gregorio, Luiz Henrique, Stoilov, Rumen, Borissova, Anna-Maria I, Hristozov, Kiril Hristov, Temelkova, Nataliya L, Daskalova, Ivona Kirilova, Kuzmanova, Stefka Ivanova, Yaneva-Bichovska, Daniela, Batalov, Anastas Zgurov, Riedemann, Pablo, Rodriguez Portales, José Adolfo, Tang, Hai, Zhu, hanmin, Zhang, Zhenlin, Chao, Aijun, Hu, Yali, Liu, Zhiming, Lu, Juming, Qiu, Mingcai, Gao, Xin, Zhang, Shaofen, Xu, Ling, Xia, Weibo, Liao, Eryuan, Yang, Wenying, Wu, Wen, Dai, Kerong, Hu, Renming, Jaller, Juan Jose, Cabal, Francisco, Molina, José Fernando, Cure Cure, Carlos A, Yupanqui-Lozno, Hernan, Chalem, Philippe, Londono, John, Abello, Mauricio, Tobias, Edgardo D, Otero, William, Nikolic, Tatjana, Miskic, Blazenka, Stepan, Jan, Vyskocil, Vaclav, Novosad, Libor, Slesinger, Jan, Novosad, Pavel, Vlckova, Erika, Bortlik, Ladislav, Dokoupilova, Eva, Hala, Tomas, Jensen, Jens-Erik Beck, Brixen, Kim Torsten, Langdahl, Bente Lomholt, Schwarz, Peter, Eskildsen, Peter Claes, Eiken, Pia Agnete, Hermann, Anne Pernille, Gram, Jeppe, Schou, Maiken Brix, Alexandersen, Peter, Nedergaard, Bettina, Mejía, Dolores Magdalena, Estrella De Henriquez, Lourdes, Páez, Norka, Velazco, Casimiro, Valter, Ivo, Vahula, Kadri-Liina, Kull, Ingrid, Maasalu, Katre, Chapurlat, Roland, Fardellone, Patrice, Benhamou, Claude Laurent, Roux, Christian, Weryha, Georges, Herkt, Volkmar, Martz, Rene, Nischik, Ruth, Spieler, Wolfgang, Contzen, Christel, Felsenberg, Dieter, Frieling, Isolde, Frahm, Eike, Briones, Henry, Sandoval, Boris, Barrios, Patricia, García, Abraham, Avendaño, Carlos, González, Magdalena, Guerra, Jeremías, Tuna, Maria, Díaz, Olga Marina, Samayoa, Eduardo, López, Edgar, Barrera, José Raúl, Palencia, Mainor, Cifuentes, Mayra, Alvarado, Georgina, López, Miriam, Chavez, Nilmo, Haase, Franklin, Rivera, Ruddy, González, Claudio, Tan, Kathryn, Leung, Ping Chung, Mandalam, Sheshadri, Pitale, Shailesh Umakant, Bantwal, Ganapathi, Ammini, Ariachery Chinamma, Shaikh, Shehla Sajid Akhta, Kanakatte Mylariah, Prasanna Kumar, Dharmalingam, Mala, Mukhopadhyay, Satinath, Jain, Arpit, Singh, Parminder, Shetty, Naresh, Sathyanarayana, Srikanta Shamanna, Shah, Nalini, Chadha, Manoj Dharam, Bhandankar, Rajendra, Velayutham, Kumaravel, Marwah, Sudha, John, Mathew, Sahay, Rakesh Kumar, Adami, Silvano, Nuti, Ranuccio, Bianchi, Gerolamo, Brandi, Maria Luisa, Minisola, Salvatore, Fiore, Carmelo Erio, Rubinacci, Alessandro, Miyajima, Hisayuki, Yamane, Hiroo, Nakatani, Yuji, Okamoto, Sumiaki, Kuroda, Koji, Fujimori, Motoaki, Itabashi, Akira, Katayama, Kuniaki, Nakajo, Satoru, Somekawa, Yoshiaki, Ohsawa, Yoshimitsu, Tajima, Wataru, Mizuno, Katsunori, Mori, Shigeru, Kanabuchi, Takato, Hashizume, Hiroyuki, Oka, Nobuyuki, Hamada, Kazutoshi, Yamaguchi, Motoi, Hirahara, Fumiki, Atobe, Masaaki, Ohtake, Yoshiharu, Ichikawa, Shuichi, Onishi, Tomoyuki, Matsumoto, Kou, Nakamura, Tetsuro, Shirasawa, Eishi, Katayama, Ko, Takahashi, Mitsugu, Oguma, Tadanori, Matsui, Hideo, Katoh, Yoshiharu, Shigenobu, Keiichi, Onishi, Tsutomu, Shibukawa, Masato, Ikeda, Satoshi, Osaka, Kazuhiro, Kanda, Ryosuke, Inobe, Yoshito, Shigenobu, Masaharu, Hasegawa, Morimasa, Yamaji, Tetsuo, Miyazaki, Yu, Ito, Takayasu, Nakamura, Eisuke, Nagai, Shinji, Lim, Sung-Kil, Chung, Yoon-Sok, Shin, Chan-Soo, Min, Yong-Ki, Kim, Ghi Su, Yoon, Hyun Koo, Kang, Moo-Il, Yang, Kyu-Hyun, Park, Hyoung Moo, Kim, In Joo, Chung, Dong Jin, Chung, Ho Yeon, Jaundzeikare, Sandra, Andersone, Dace, Medne, Agita, Yaghi, Yasser, Alekna, Vidmantas, Kasiulevicius, Vytautas, Purtokaite - Labutiniene, Irina, Krasauskiene, Aurelija, Varanaviciene, Jurate, Basijokiene, Vida, Abraitiene, Agne, Radzeviciene, Lina, Walliser, Jesus, García Hernández, Pedro Alberto, Araujo, Maria Frida, Avila Armengol, Hilario Ernesto, De la Peña, Pilar, Tamayo, Juan, Zazueta, Beatriz, Cons, Fidencio, Gilchrist, Nigel Leslie, Reid, Ian Reginald, Leikis, Robert, Jones, Peter, Singh, Joe Gragrath Pradeep, Halse, Johan Inge, Syversen, Unni, Høivik, Hans Olav, Øfjord, Erik Snorre, Gulseth, Hans Christian, Elle, Sigbjørn, Norheim, Paal Dag, Calvo Quiroz, Armando A., Cesar Augusto, Pastor A., León Portocarrero, Manuel Gustavo, Vidal Neira, Luis Fernando, Chavez, Jose, Garro Barrera, Boris, Kuroiwa Sampei, Rita, Luis Fernando, Bellatín V., Oquelis Cabredo, Rogger, Castillo, Sonia, Morales, Agustin Miguel G, Tan, Perry Pua, Leagogo, Liberato Antonio C, Jr., Wang, Edward HM, Li-Yu, Julie T, Sawicki, Andrzej Z, Stasiuk, Barbara, Kania, Grzegorz, Lorenc, Roman, Sidorowicz-Bialynicka, Anna, Szczepanski, Leszek, Franek, Edward, Filip, Rafal, Sekula, Jan, Blicharski, Tomasz, Leszczynski, Piotr, Sewerynek, Ewa, Miazgowski, Tomasz, Milewicz, Andrzej, Dabrowska, Magda, Romaszko, Jerzy, Pluskiewicz, Wojciech, Wojnowski, Lukasz, Codreanu, Catalin, Bolosiu, Horatiu, Ionescu, Ruxandra, Zosin, Ioana, Macovei, Liviu, Bojinca, Mihai, Radulescu, Florin, Pop, Simona, Sarbu, Adrian, Benevolenskaya, Lidia I, Nasonov, Evgeny L, Rozhinskaya, Lyudmila Ya, Oganov, Raphael G, Rodionova, Svetlana S, Shlyakhto, Eugeny Vladimirovich, Trofimov, Vasiliy, Zotkin, Eugeny G, Zazerskaya, Irina E, Grineva, Elena N, Ershova, Olga, Lesnyak, Olga, Ostroumova, Olga D, Malichenko, Svetlana B, Pikhlak, Eduard G, Pilyaev, Valery G, Raskina, Tatiana, Zonova, Elena V, Shirinsky, Valery S, Dimic, Aleksandar N, Cobeljic, Goran, Vujovic, Svetlana, Ellis, Graham Charlston, Lipschitz, Stanley, De Villiers, Tobias Johannes, De Weerd, Albert Jan, Vally, Tasneem, Trinder, Yvonne, Coetsee, Jacobus Ludewikus, Davis, Charles Pierre, Nayiager, Savithree, Hough, Frans Stephanus, Oelofse, Louis F, van der Walt, Eugene, Lombaard, Johannes Jurgens, Blignaut, Suzanne, Govind, Uttam, Fouche, Leon Frederik, Kruger, Dawid Stephanus, Dalmeyer, Johannes Paul, Ferreira, Mada M, Escudero-Contreras, Alejandro, Muñoz Torres, Manuel, Hawkins Carranza, Federico, Perez Castrillon, Jose Luis, García Meijide, Juan Antonio, Jodar Gimeno, Esteban, Palacios Gil-Antuñana, Santiago, de Teresa Parreno, Luis, Martín Mola, Emilio, Alvarez Sanchez, Carmen, Lippuner, Kurt, Tsai, Keh-Sung, Tu, Shih-Te, Chen, Jung-Fu, Lee, Oscar Kuang-Sheng, Hsu, Wen-Wei, Grygorieva, Natalia Viktorivna, Povoroznyuk, Vladyslav Volodymyrovych, Korzh, Mykola Oleksiiovych, Loskutov, Oleksandr Levgeniiovych, Chukov, Andriy Borysovych, Sarmiento, Rex, Thomas, Hawys, Donnachie, Hugh, Pavel-Knox, Irina, Shaw, Hilary, Hassanin, Hana, Abdulhakim, Essam Eldin Ahmed, Savani, Naren, Bachmann, Gloria A, Barrett-Connor, Elizabeth, Binkley, Neil C, Bone, Henry G, Brandon, Donald M, Checketts, Darin David, Fraser, Neil J, Watts, Nelson B, Geller, Steven A, Gimbel, Joseph S, Greenwald, Maria White, Holt, Peter A, Johnston, Cyrus Conrad, Fang, Chien, Kiel, Douglas P, Klashman, David J, Lewiecki, E. Michael, Lowenstein, Mitchell B, McClung, Michael Roy, Nattrass, Susan M, Odio, Alberto, Levengood, Julie, Romaguera, Josefina, Saag, Kenneth G, Sebai, Mohamed Bassam, Snyder, Brian, Kutner, Mark Eliot, Streja, Dan, Schwartz, Elliott P, Christiansen, Mark G, McClung, Michael R, O'Donoghue, Michelle L, Papapoulos, Socrates E, Bone, Henry, Langdahl, Bente, Reid, Ian R, Cavallari, Ilaria, Bonaca, Marc P, Wiviott, Stephen D, de Villiers, Tobias, Ling, Xu, Nakamura, Toshitaka, Rodriguez-Portales, Jose Adolfo, Zanchetta, José, Zerbini, Cristiano A F, Park, Jeong-Gun, Im, KyungAh, Cange, Abby, Grip, Laura T, Heyden, Norman, DaSilva, Carolyn, Cohn, Dosinda, Massaad, Rachid, Scott, Boyd B, Verbruggen, Nadia, Gurner, Deborah, Miller, Deborah L, Blair, Micki L, Polis, Adam B, Stoch, S Aubrey, Santora, Arthur, Lombardi, Antonio, Leung, Albert T, Kaufman, Keith D, and Sabatine, Marc S

Published
2019
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10. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease

Author

Bansilal, Sameer, Bonaca, Marc P., Cornel, Jan H., Storey, Robert F., Bhatt, Deepak L., Steg, Ph. Gabriel, Im, Kyungah, Murphy, Sabina A., Angiolillo, Dominick J., Kiss, Robert G., Parkhomenko, Alexander N., Lopez-Sendon, Jose, Isaza, Daniel, Goudev, Assen, Kontny, Frederic, Held, Peter, Jensen, Eva C., Braunwald, Eugene, Sabatine, Marc S., and Oude Ophuis, A.J.

Published
2018
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11. Abstract 16139: A Targeted Proteomic Approach to Identify Circulating Biomarkers of Heart Failure Risk in Patients With Type 2 Diabetes Mellitus in DECLARE-TIMI 58

Author

Berg, David, Wiviott, Stephen D, RAZ, Itamar, Kamanu, Frederick, Im, KyungAh, Cahn, Avivit, Mosenzon, ofri, Bhatt, Deepak L, Jarolim, Petr, Leiter, Lawrence A, McGuire, Darren K, WILDING, JOHN, Huo, Yong, Lopez-sendon, Jose L, Ardissino, Diego, Gause-nilsson, Ingrid A, Sabatine, Marc S, and Morrow, David A

Published
2020
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16. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Cardiovascular Outcomes Trials

Author

Zelniker, Thomas A., Wiviott, Stephen D., Raz, Itamar, Im, KyungAh, Goodrich, Erica L., Furtado, Remo H.M., Bonaca, Marc P., Mosenzon, Ofri, Kato, Eri T., Cahn, Avivit, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., and Sabatine, Marc S.

Published
2019
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18. Abstract 15100: Reduction in Total Cardiovascular Events With the PCSK9 Inhibitor Evolocumab in Patients With Cardiovascular Disease in the FOURIER Trial

Author

Murphy, Sabina A, Pedersen, Terje R, Gaciong, Zbigniew A, Ceska, Richard, Ezhov, Marat V, Connolly, Derek, Kraydashenko, Oleg, Jukema, J. Wouter, Toth, Kalman, Tikkanen, Matti J, Im, Kyungah, Wiviott, Stephen D, Kurtz, Christopher, Honarpour, Narimon, Giugliano, Robert P, Keech, Anthony C, Sever, Peter S, and Sabatine, Marc S

Published
2017

20. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE.

Author

Gaba, Prakriti, O'Donoghue, Michelle L., Park, Jeong-Gun, Wiviott, Stephen D., Atar, Dan, Kuder, Julia F., Im, KyungAh, Murphy, Sabina A., De Ferrari, Gaetano M., Gaciong, Zbigniew A., Toth, Kalman, Gouni-Berthold, Ioanna, Lopez-Miranda, Jose, Schiele, François, Mach, François, Flores-Arredondo, Jose H., López, J. Antonio G., Elliott-Davey, Mary, Wang, Bei, and Monsalvo, Maria Laura

Published
2023
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22. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54

Author

Bonaca, Marc P., Bhatt, Deepak L., Steg, P. Gabriel, Storey, Robert F., Cohen, Marc, Im, Kyungah, Oude Ophuis, Ton, Budaj, Andrej, Goto, Shinya, López-Sendón, José, Diaz, Rafael, Dalby, Anthony, Van de Werf, Frans, Ardissino, Diego, Montalescot, Gilles, Aylward, Philip, Magnani, Giulia, Jensen, Eva C., Held, Peter, Braunwald, Eugene, and Sabatine, Marc S.

Published
2016
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23. Efficacy and safety of ticagrelor for long-term secondary prevention of atherothrombotic events in relation to renal function: insights from the PEGASUS-TIMI 54 trial

Author

Magnani, Giulia, Storey, Robert F., Steg, Gabriel, Bhatt, Deepak L., Cohen, Marc, Kuder, Julia, Im, Kyungah, Aylward, Philip, Ardissino, Diego, Isaza, Daniel, Parkhomenko, Alexander, Goudev, Assen R., Dellborg, Mikael, Kontny, Frederic, Corbalan, Ramon, Medina, Felix, Jensen, Eva C., Held, Peter, Braunwald, Eugene, Sabatine, Marc S., and Bonaca, Marc P.

Published
2016
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24. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54.

Author

Bonaca, Marc P, Im, KyungAh, Magnani, Giulia, Bansilal, Sameer, Dellborg, Mikael, Storey, Robert F, Bhatt, Deepak L, Steg, P Gabriel, Cohen, Marc, Johanson, Per, Braunwald, Eugene, and Sabatine, Marc S

Subjects
PATIENT selection, SECONDARY prevention, TICAGRELOR, CARDIOVASCULAR disease related mortality, MYOCARDIAL infarction
Abstract

Aim In patients with prior myocardial infarction (MI) on aspirin, the addition of ticagrelor reduces ischaemic risk but increases bleeding risk. The simultaneous assessment of baseline ischaemic and bleeding risk may assist clinicians in selecting patients who are most likely to have a favourable risk/benefit profile with long-term ticagrelor. Methods and results PEGASUS-TIMI 54 randomized 21 162 prior MI patients, 13 956 of which to the approved 60 mg dose or placebo and who had all necessary data. The primary efficacy endpoint was cardiovascular death, MI, or stroke, and the primary safety outcome was TIMI major bleeding; differences in Kaplan–Meier event rates at 3 years are presented. Post-hoc subgroups based on predictors of bleeding and ischaemic risk were merged into a selection algorithm. Patients were divided into four groups: those with a bleeding predictor (n = 2721, 19%) and then those without a bleeding predictor and either 0–1 ischaemic risk factor (IRF; n = 3004, 22%), 2 IRF (n = 4903, 35%), or ≥3 IRF (n = 3328, 24%). In patients at high bleeding risk, ticagrelor increased bleeding [absolute risk difference (ARD) +2.3%, 95% confidence interval (CI) 0.6, 3.9] and did not reduce the primary efficacy endpoint (ARD +0.08%, 95% CI −2.4 to 2.5). In patients at low bleeding risk, the ARDs in the primary efficacy endpoint with ticagrelor were −0.5% (−2.2, 1.3), −1.5% (−3.1, 0.02), and −2.6% (−5.0, −0.24, P = 0.03) in those with ≤1, 2, and 3 risk factors, respectively (P = 0.076 for trend across groups). There were significant trends for greater absolute risk reductions for cardiovascular death (P -trend 0.018), all-cause mortality (P -trend 0.027), and net outcomes (P -trend 0.037) with ticagrelor across these risk groups. Conclusion In a post-hoc exploratory analysis of patients with prior MI, long-term ticagrelor therapy appears to be best suited for those with prior MI with multiple IRFs at low bleeding risk. Clinical Trial Registration NCT01225562 ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

Published
2022
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27. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

Author

Cannon, Christopher P., Blazing, Michael A., Giugliano, Robert P., McCagg, Amy, White, Jennifer A., Theroux, Pierre, Darius, Harald, Lewis, Basil S., Ophuis, Ton Oude, Jukema, J. Wouter, De Ferrari, Gaetano M., Ruzyllo, Witold, De Lucca, Paul, Im, KyungAh, Bohula, Erin A., Reist, Craig, Wiviott, Stephen D., Tershakovec, Andrew M., Musliner, Thomas A., Braunwald, Eugene, and Califf, Robert M.

Published
2015
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28. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction

Author

Bonaca, Marc P., Bhatt, Deepak L., Cohen, Marc, Steg, Philippe Gabriel, Storey, Robert F., Jensen, Eva C., Magnani, Giulia, Bansilal, Sameer, Fish, M. Polly, Im, Kyungah, Bengtsson, Olof, Ophuis, Ton Oude, Budaj, Andrzej, Theroux, Pierre, Ruda, Mikhail, Hamm, Christian, Goto, Shinya, Spinar, Jindrich, Nicolau, José Carlos, Kiss, Robert G., Murphy, Sabina A., Wiviott, Stephen D., Held, Peter, Braunwald, Eugene, and Sabatine, Marc S.

Published
2015
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29. Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial

Author

Udell, Jacob A., Bhatt, Deepak L., Braunwald, Eugene, Cavender, Matthew A., Mosenzon, Ofri, Steg, Ph. Gabriel, Davidson, Jaime A., Nicolau, Jose C., Corbalan, Ramon, Hirshberg, Boaz, Frederich, Robert, Im, KyungAh, Umez-Eronini, Amarachi A., He, Ping, McGuire, Darren K., Leiter, Lawrence A., Raz, Itamar, and Scirica, Benjamin M.

Published
2015
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32. Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome: The SOLID-TIMI 52 Randomized Clinical Trial

Author

O’Donoghue, Michelle L., Braunwald, Eugene, White, Harvey D., Steen, Dylan P., Lukas, Mary Ann, Tarka, Elizabeth, Steg, Gabriel P., Hochman, Judith S., Bode, Christoph, Maggioni, Aldo P., Im, KyungAh, Shannon, Jennifer B., Davies, Richard Y., Murphy, Sabina A., Crugnale, Sharon E., Wiviott, Stephen D., Bonaca, Marc P., Watson, David F., Weaver, Douglas W., Serruys, Patrick W., and Cannon, Christopher P.

Published
2014
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34. Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors

Author

Scirica, Benjamin M., Im, KyungAh, Murphy, Sabina A., Kuder, Julia F., Rodriguez, Dolly A., Lopes, Renato D., Green, Jennifer B., Ruff, Christian T., and Sabatine, Marc S.

Subjects
CD26 antigen, HEART failure, SITAGLIPTIN, TYPE 2 diabetes, IVABRADINE, HOSPITAL care
Abstract

Background: Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re‐adjudicate a prespecified set of originally adjudicated events. Methods: TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study‐level meta‐analysis of four randomized, placebo‐controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP‐4) inhibitors was then performed. Results: After re‐adjudication of potential HHF events in the intent‐to‐treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person‐years) and 239 patients in the placebo arm (1.13/100 person‐years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78–1.13, p =.49). Concordance between the outcome of the original adjudication and the re‐adjudication for HHF events was 82.7%. The meta‐analysis of CV outcomes trials with DPP‐4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83–1.39), with moderate heterogeneity (p =.45, I2 = 62.07%). Conclusion: The results of this independent re‐adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study‐level meta‐analysis showed no overall significant risk for HHF with DPP‐4 inhibitors, but with statistical heterogeneity. [ABSTRACT FROM AUTHOR]

Published
2022
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35. REDUCTION IN TOTAL CARDIOVASCULAR EVENTS WITH THE PCSK9 INHIBITOR EVOLOCUMAB IN PATIENTS WITH CARDIOVASCULAR DISEASE IN THE COMBINED FOURIER AND FOURIER OPEN-LABEL EXTENSION (OLE) STUDIES

Author

Murphy, Sabina, O'Donoghue, Michelle L., Wiviott, Stephen, Atar, Dan, Keech, Anthony C., Kuder, Julia, Im, KyungAh, Flores-Arredondo, Jose, Antonio, J., Lopez, G., Elliott, Mary, Wang, Bei, Monsalvo, Maria Laura, Abbasi, Siddique A., Giugliano, Robert P., and Sabatine, Marc Steven

Published
2023
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37. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk

Author

O'Donoghue, Michelle L., Fazio, Sergio, Giugliano, Robert P., Stroes, Erik S. G., Kanevsky, Estella, Gouni-Berthold, Ioanna, Im, KyungAh, Lira Pineda, Armando, Wasserman, Scott M., Češka, Richard, Ezhov, Marat V., Jukema, J. Wouter, Jensen, Henrik K., Tokgözoğlu, S. Lale, Mach, François, Huber, Kurt, Sever, Peter S., Keech, Anthony C., Pedersen, Terje R., Sabatine, Marc S., Experimental Vascular Medicine, Vascular Medicine, and ACS - Atherosclerosis & ischemic syndromes

Abstract

BACKGROUND: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined. METHODS: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration. RESULTS: The median (interquartile range) baseline Lp(a) concentration was 37 (13-165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01-1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%-46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r=0.37; 95% CI, 0.36-0.39; Pmedian, and by 7% (hazard ratio, 0.93; 95% CI, 0.80-1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively. CONCLUSIONS: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633.

Published
2019

46. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Author

Zelniker, Thomas A., Raz, Itamar, Mosenzon, Ofri, Dwyer, Jamie P., Heerspink, Hiddo H. J. L., Cahn, Avivit, Goodrich, Erica L., Im, Kyungah, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P. H., Gause-Nilsson, Ingrid, Langkilde, Anna Maria, Sabatine, Marc S., and Wiviott, Stephen D.

Published
2021
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47. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction.

Author

Magnani, Giulia, Ardissino, Diego, Im, KyungAh, Budaj, Andrzej, Storey, Robert F., Gabriel Steg, P., Bhatt, Deepak L., Cohen, Marc, Ophius, Ton Oude, Goudev, Assen, Parkhomenko, Alexander, Kamensky, Gabriel, Angiolillo, Dominick J., López-Sendón, José, Johanson, Per, Braunwald, Eugene, Sabatine, Marc S., Bonaca, Marc P., Steg, P Gabriel, and Oude Ophius, Ton

Published
2021
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49. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54.

Author

Furtado, Remo H M, Nicolau, Jose C, Magnani, Giulia, Im, Kyungah, Bhatt, Deepak L, Storey, Robert F, Steg, P Gabriel, Spinar, Jindrich, Budaj, Andrzej, Kontny, Frederic, Corbalan, Ramon, Kiss, Robert G, Abola, Maria Teresa, Johanson, Per, Jensen, Eva C, Braunwald, Eugene, Sabatine, Marc S, and Bonaca, Marc P

Abstract

Aims PEGASUS-TIMI 54 demonstrated that long-term dual antiplatelet therapy (DAPT) with aspirin and ticagrelor reduced the risk of major adverse cardiovascular events (MACE), with an acceptable increase in bleeding, in patients with prior myocardial infarction (MI). While much of the discussion around prolonged DAPT has been focused on stented patients, patients with prior MI without prior coronary stenting comprise a clinically important subgroup. Methods and results This was a pre-specified analysis from PEGASUS-TIMI 54, which randomized 21 162 patients with prior MI (1–3 years) and additional high-risk features to ticagrelor 60 mg, 90 mg, or placebo twice daily in addition to aspirin. A total of 4199 patients had no history of coronary stenting at baseline. The primary efficacy outcome (MACE) was the composite of cardiovascular death, MI, or stroke. Patients without history of coronary stenting had higher baseline risk of MACE [13.2% vs. 8.0%, adjusted hazard ratio (HR) 1.41, 95% confidence interval (CI) 1.15–1.73, in the placebo arm]. The relative risk reduction in MACE with ticagrelor (pooled doses) was similar in patients without (HR 0.82, 95% CI 0.68–0.99) and with prior stenting (HR 0.85, 95% CI 0.75–0.96; P for interaction = 0.76). Conclusion Long-term ticagrelor reduces thrombotic events in patients with prior MI regardless of whether they had prior coronary stenting. These data highlight the benefits of DAPT in prevention of spontaneous atherothrombotic events and indicate that long-term ticagrelor may be considered in high-risk patients with prior MI even if they have not been treated with stenting. ClinicalTrials.gov Identifier NCT01225562. Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]

Published
2020
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50. Interleukin-6 (IL-6) haplotypes and the response to therapy of chronic hepatitis C virus infection

Author

Yee, Leland J., Im, KyungAh, Borg, Brian, Yang, Huiying, and Liang, T. Jake

Subjects
Adult, Male, Genotype, Interleukin-6, Interferon-alpha, Hepacivirus, Hepatitis C, Chronic, Interferon alpha-2, Middle Aged, Polymorphism, Single Nucleotide, Article, Recombinant Proteins, Polyethylene Glycols, Cohort Studies, Gene Expression Regulation, Gene Frequency, Haplotypes, Multivariate Analysis, Humans, Female, Alleles
Abstract

Chronic hepatitis C virus (HCV) infection affects nearly 170 million individuals worldwide. Treatment of HCV with pegylated interferon-alpha-2a is successful in eradicating virus from only 30 to 80% of those treated. Interleukin-6 (IL-6) is an important cytokine involved in the immune response to infectious agents and in vitro studies suggest that host genetic variation, particularly haplotypes, may affect IL-6 expression. We examined the contribution of haplotypes in the IL-6 gene on sustained viral response (SVR) to the therapy for chronic HCV infection. We observed the IL-6 T-T-G-G-G-G-C-A-G-A haplotype to be associated with a lower risk of achieving SVR among Caucasian Americans (CAs) ((relative risk) RR=0.80; 95% CI: 0.66-0.98; P=0.0261). Using a sliding window approach, the rs1800797-(G)-rs1800796-(G)-rs1800795-(G) haplotype was associated with a reduced chance of SVR (RR=0.79; 95% CI: 0.66-0.94; P=0.0081), as was the rs1800796-(G)-rs1800795-(G)-rs2069830-(C) haplotype (RR=0.78; 95% CI: 0.66-0.94; P=0.0065) among CAs. Overall, the rs1800797-(G)-rs1800796-(G)-rs1800795-(G) haplotype was independently associated with a reduced chance of SVR (RR=0.78; 95% CI: 0.62-1.0; P=0.0489) after adjustment for potential confounding factors. Our findings further illustrate the complexity of IL-6 genetic regulation and the potential importance of haplotypes on IL-6 expression. Our findings provide additional support for the potential importance of genetic variation in the IL-6 gene and the response to HCV therapy.

Published
2009

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