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346 results on '"Park, Jeong‐Gun"'

1. Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit.

Author

Kadosh, Bernard, Berg, David, Bohula, Erin, Park, Jeong-Gun, Baird-Zars, Vivian, Alviar, Carlos, Alzate, James, Barnett, Christopher, Barsness, Gregory, Burke, James, Chaudhry, Sunit-Preet, Daniels, Lori, DeFilippis, Andrew, Delicce, Anthony, Fordyce, Christopher, Ghafghazi, Shahab, Gidwani, Umesh, Goldfarb, Michael, Katz, Jason, Keeley, Ellen, Kenigsberg, Benjamin, Kontos, Michael, Lawler, Patrick, Leibner, Evan, Menon, Venu, Metkus, Thomas, Miller, P, OBrien, Connor, Papolos, Alexander, Prasad, Rajnish, Shah, Kevin, Sinha, Shashank, Snell, R, So, Derek, Solomon, Michael, Ternus, Bradley, Teuteberg, Jeffrey, Toole, Joseph, van Diepen, Sean, Morrow, David, and Roswell, Robert

Subjects
cardiac intensive care, pulmonary artery catheter, shock, Humans, Pulmonary Artery, Heart Failure, Intensive Care Units, Hospitalization, Hospital Mortality, Catheters
Abstract

BACKGROUND: The appropriate use of pulmonary artery catheters (PACs) in critically ill cardiac patients remains debated. OBJECTIVES: The authors aimed to characterize the current use of PACs in cardiac intensive care units (CICUs) with attention to patient-level and institutional factors influencing their application and explore the association with in-hospital mortality. METHODS: The Critical Care Cardiology Trials Network is a multicenter network of CICUs in North America. Between 2017 and 2021, participating centers contributed annual 2-month snapshots of consecutive CICU admissions. Admission diagnoses, clinical and demographic data, use of PACs, and in-hospital mortality were captured. RESULTS: Among 13,618 admissions at 34 sites, 3,827 were diagnosed with shock, with 2,583 of cardiogenic etiology. The use of mechanical circulatory support and heart failure were the patient-level factors most strongly associated with a greater likelihood of the use of a PAC (OR: 5.99 [95% CI: 5.15-6.98]; P < 0.001 and OR: 3.33 [95% CI: 2.91-3.81]; P

Published
2023

2. Continuum of Preshock to Classic Cardiogenic Shock in the Critical Care Cardiology Trials Network Registry

Author

Patel, Siddharth M., Berg, David D., Bohula, Erin A., Baird-Zars, Vivian M., Park, Jeong-Gun, Barnett, Christopher F., Daniels, Lori B., Fordyce, Christopher B., Ghafghazi, Shahab, Goldfarb, Michael J., Gorder, Kari, Kwon, Younghoon, Leibner, Evan, Menon, Venu, Potter, Brian J., Prasad, Rajnish, Solomon, Michael A., Teuteberg, Jeffrey J., Thompson, Andrea D., Zakaria, Sammy, Katz, Jason N., van Diepen, Sean, and Morrow, David A.

Published
2024
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3. Characteristics and Outcomes of Adults With Congenital Heart Disease in the Cardiac Intensive Care Unit

Author

Keane, Ryan R., Carnicelli, Anthony P., Loriaux, Daniel B., Kendsersky, Payton, Krasuski, Richard A., Brown, Kelly M., Arps, Kelly, Baird-Zars, Vivian, Dixson, Jeffrey A., Echols, Emily, Granger, Christopher B., Harrison, Robert W., Kontos, Michael, Newby, L. Kristin, Park, Jeong-Gun, Shah, Kevin S., Ternus, Bradley W., Van Diepen, Sean, Katz, Jason N., and Morrow, David A.

Published
2024
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4. Early Serial Assessment of Aggregate Vasoactive Support and Mortality in Cardiogenic Shock: Insights From the Critical Care Cardiology Trials Network Registry

Author

Patel, Siddharth M., Berg, David D., Bohula, Erin A., Baird-Zars, Vivian M., Barsness, Gregory W., Chaudhry, Sunit-Preet, Chonde, Meshe D., Cooper, Howard A., Ginder, Curtis, Jentzer, Jacob C., Kontos, Michael C., Miller, P. Elliott, Newby, L. Kristin, O’Brien, Connor G., Park, Jeong-Gun, Pierce, Matthew J., Pisani, Barbara A., Potter, Brian J., Shah, Kevin S., Teuteberg, Jeffrey J., Katz, Jason N., van Diepen, Sean, and Morrow, David A.

Published
2024
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5. Variation in risk-adjusted cardiac intensive care unit (CICU) length of stay and the association with in-hospital mortality: An analysis from the Critical Care Cardiology Trials Network (CCCTN) registry

Author

Koerber, Daniel M., Katz, Jason N., Bohula, Erin, Park, Jeong-Gun, Dodson, Mark W., Gerber, Daniel A., Hillerson, Dustin, Liu, Shuangbo, Pierce, Matthew J., Prasad, Rajnish, Rose, Scott W., Sanchez, Pablo A., Shaw, Jeffrey, Wang, Jeffrey, Jentzer, Jacob C., Kristin Newby, L., Daniels, Lori B., Morrow, David A., and van Diepen, Sean

Published
2024
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6. Prognostic performance of the IABP-SHOCK II Risk Score among cardiogenic shock subtypes in the critical care cardiology trials network registry

Author

Alviar, Carlos L., Li, Boyangzi K., Keller, Norma M., Bohula-May, Erin, Barnett, Christopher, Berg, David D., Burke, James A., Chaudhry, Sunit-Preet, Daniels, Lori B., DeFilippis, Andrew P., Gerber, Daniel, Horowitz, James, Jentzer, Jacob C., Katrapati, Praneeth, Keeley, Ellen, Lawler, Patrick R., Park, Jeong-Gun, Sinha, Shashank S., Snell, Jeffrey, Solomon, Michael A., Teuteberg, Jeffrey, Katz, Jason N., van Diepen, Sean, and Morrow, David A.

Published
2024
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16. Estimating and presenting hazard ratios and absolute risks from a Cox model with complex nonlinear interactions.

Author

Bellavia, Andrea, Melloni, Giorgio E M, Park, Jeong-Gun, Discacciati, Andrea, and Murphy, Sabina A

Subjects
STATISTICAL models, MATHEMATICAL variables, RISK assessment, DATA analysis, RESEARCH, SURVIVAL analysis (Biometry), CONFIDENCE intervals, PROPORTIONAL hazards models, REGRESSION analysis
Abstract

Interaction analysis is a critical component of clinical and public health research and represents a key topic in precision health and medicine. In applied settings, however, interaction assessment is usually limited to the test of a product term in a regression model and to the presentation of results stratified by levels of additional covariates. Stratification of results often relies on categorizing or making linearity assumptions for continuous covariates, with substantial loss of precision and of relevant information. In time-to-event analysis, moreover, interaction assessment is often limited to the multiplicative hazard scale by inclusion of a product term in a Cox regression model, disregarding the clinically relevant information that is captured by the absolute risk scale. In this paper we present a user-friendly procedure, based on the prediction of individual absolute risks from the Cox model, for the estimation and presentation of interactive effects on both the multiplicative and additive scales in survival analysis. We describe how to flexibly incorporate interactions with continuous covariates, which potentially operate in a nonlinear fashion, provide software for replicating our procedure, and discuss different approaches to deriving CIs. The presented approach will allow clinical and public health researchers to assess complex relationships between multiple covariates as they relate to a clinical endpoint, and to provide a more intuitive and precise depiction of the results in applied research papers focusing on interaction and effect stratification. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Application of the Win Ratio Method in the ENGAGE AF-TIMI 48 Trial Comparing Edoxaban With Warfarin in Patients With Atrial Fibrillation.

Author

Bergmark, Brian A., Park, Jeong-Gun, Hamershock, Rose A., Melloni, Giorgio E. M., De Caterina, Raffaele, Antman, Elliott M., Ruff, Christian T., Rutman, Howard, Mercuri, Michele F., Lanz, Hans-Joachim, Braunwald, Eugene, and Giugliano, Robert P.

Abstract

BACKGROUND: Cardiovascular trials often use a composite end point and a time-to-first event model. We sought to compare edoxaban versus warfarin using the win ratio, which offers data complementary to time-to-first event analysis, emphasizing the most severe clinical events. METHODS: ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind, randomized trial in which patients with atrial fibrillation were assigned 1:1:1 to a higher dose edoxaban regimen (60/30 mg daily), a lower dose edoxaban regimen (30/15 mg daily), or warfarin. In an exploratory analysis, we analyzed the trial outcomes using an unmatched win ratio approach. The win ratio for each edoxaban regimen was the total number of edoxaban wins divided by the number of warfarin wins for the following ranked clinical outcomes: 1: death; 2: hemorrhagic stroke; 3: ischemic stroke/systemic embolic event/epidural or subdural bleeding; 4: noncerebral International Society on Thrombosis and Haemostasis major bleeding; and 5: cardiovascular hospitalization. RESULTS: 21 105 patients were randomized to higher dose edoxaban regimen (N=7035), lower dose edoxaban regimen (N=7034), or warfarin (N=7046), yielding >49 million pairs for each treatment comparison. The median age was 72 years, 38% were women, and 59% had prior vitamin K antagonist use. The win ratio was 1.11 (95% CI, 1.05-1.18) for higher dose edoxaban regimen versus warfarin and 1.11 (95% CI, 1.05-1.18) for lower dose edoxaban regimen versus warfarin. The favorable impacts of edoxaban on death (34% of wins) and cardiovascular hospitalization (41% of wins) were the major contributors to the win ratio. Results consistently favored edoxaban in subgroups based on creatine clearance and dose reduction at baseline, with heightened benefit among those without prior vitamin K antagonist use. CONCLUSIONS: In a win ratio analysis of the ENGAGE AF-TIMI 48 trial, both dose regimens of edoxaban were superior to warfarin for the net clinical outcome incorporating ischemic and bleeding events. As the win ratio emphasizes the most severe clinical events, this analysis supports the superiority of edoxaban over warfarin in patients with atrial fibrillation. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Hepatic Fat Changes with Antisense Oligonucleotide Therapy Targeting ANGPTL3

Author

Zimerman, Andre, primary, Wiviott, Stephen D., additional, Park, Jeong-Gun, additional, Murphy, Sabina A., additional, Ran, Xinhui, additional, Bramson, Candace R., additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia F., additional, Verma, Subodh, additional, Wojakowski, Wojtek, additional, Terra, Steven G., additional, Sabatine, Marc S., additional, Bergmark, Brian A., additional, and Marston, Nicholas A., additional

Published
2023
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24. 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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25. Novel Dosing Strategies Increase Exposures of the Potent Antituberculosis Drug Rifapentine but Are Poorly Tolerated in Healthy Volunteers

Author

Dooley, Kelly E, Savic, Radojka M, Park, Jeong-Gun, Cramer, Yoninah, Hafner, Richard, Hogg, Evelyn, Janik, Jennifer, Marzinke, Mark A, Patterson, Kristine, Benson, Constance A, Hovind, Laura, Dorman, Susan E, Haas, David W, and Team, ACTG A5311 Study

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Patient Safety, Infectious Diseases, Clinical Research, Emerging Infectious Diseases, Rare Diseases, Prevention, Orphan Drug, Clinical Trials and Supportive Activities, Tuberculosis, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Antitubercular Agents, Drug Administration Schedule, Female, Healthy Volunteers, Humans, Male, Middle Aged, Rifampin, Young Adult, ACTG A5311 Study Team, Microbiology, Medical Microbiology, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

Rifapentine is a potent antituberculosis drug currently in phase III trials. Bioavailability decreases with increasing dose, yet high daily exposures are likely needed to improve efficacy and shorten the tuberculosis treatment duration. Further, the limits of tolerability are poorly defined. The phase I multicenter trial in healthy adults described here investigated two strategies to increase rifapentine exposures: dividing the dose or giving the drug with a high-fat meal. In arm 1, rifapentine was administered at 10 mg/kg of body weight twice daily and 20 mg/kg once daily, each for 14 days, separated by a 28-day washout; the dosing sequence was randomized. In arm 2, 15 mg/kg rifapentine once daily was given with a high-fat versus a low-fat breakfast. Sampling for pharmacokinetic analysis was performed on days 1 and 14. Population pharmacokinetic analyses were performed. This trial was stopped early for poor tolerability and because of safety concerns. Of 44 subjects, 20 discontinued prematurely; 11 of these discontinued for protocol-defined toxicity (a grade 3 or higher adverse event or grade 2 or higher rifamycin hypersensitivity). Taking rifapentine with a high-fat meal increased the median steady-state area under the concentration-time curve from time zero to 24 h (AUC0-24ss) by 31% (relative standard error, 6%) compared to that obtained when the drug was taken with a low-fat breakfast. Dividing the dose increased exposures substantially (e.g., 38% with 1,500 mg/day). AUC0-24ss was uniformly higher in our study than in recent tuberculosis treatment trials, in which toxicity was rare. In conclusion, two strategies to increase rifapentine exposures, dividing the dose or giving it with a high-fat breakfast, successfully increased exposures, but toxicity was common in healthy adults. The limits of tolerability in patients with tuberculosis remain to be defined. (AIDS Clinical Trials Group study A5311 has been registered at ClinicalTrials.gov under registration no. NCT01574638.).

Published
2015

26. Depot Medroxyprogesterone Acetate in Combination with a Twice-Daily Lopinavir-Ritonavir-Based Regimen in HIV-Infected Women Showed Effective Contraception and a Lack of Clinically Significant Interactions, with Good Safety and Tolerability: Results of the ACTG 5283 Study

Author

Luque, Amneris E, Cohn, Susan E, Park, Jeong-Gun, Cramer, Yoninah, Weinberg, Adriana, Livingston, Elizabeth, Klingman, Karin L, Aweeka, Francesca, and Watts, D Heather

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, HIV/AIDS, Infectious Diseases, Clinical Research, Contraception/Reproduction, Sexually Transmitted Infections, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Contraceptives, Oral, Synthetic, Delayed-Action Preparations, Drug Interactions, Female, HIV Infections, HIV Protease Inhibitors, Humans, Lopinavir, Medroxyprogesterone Acetate, Middle Aged, Ovulation, Progesterone, Ritonavir, Young Adult, Microbiology, Pharmacology and Pharmaceutical Sciences, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

We conducted an open-label, steady-state pharmacokinetic (PK) study of drug-drug interactions between depot medroxyprogesterone acetate (DMPA) and twice-daily lopinavir (LPV) plus low-dose ritonavir (RTV) (LPV/r) among 24 HIV-infected women and compared the results to those for HIV-infected women receiving DMPA while on no antiretroviral therapy or on nucleosides only (n = 14 subjects from the control arm of AIDS Clinical Trials Group [ACTG] study 5093). The objectives of the study were to address the effect of LPV/r on DMPA and to address the effect of DMPA on LPV/r therapy. PK parameters were estimated using noncompartmental analysis with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of LPV and RTV PKs before and 4 weeks after DMPA dosing. Plasma progesterone concentrations were measured every 2 weeks after DMPA dosing through week 12. Although the MPA area under the concentration-time curve and maximum concentration of drug in plasma were statistically significantly increased in the study women on LPV/r compared to those in the historical controls, these increases were not considered clinically significant. There were no changes in LPV or RTV exposure after DMPA. DMPA was well tolerated, and suppression of ovulation was maintained. (This study has been registered at ClinicalTrials.gov under registration no. NCT01296152.).

Published
2015

27. Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study

Author

Barr, Liz, Blanchard-Horan, Christina, Connick, Elizabeth, Cermak, Mary Allegra, Chakhtoura, Nahida, Chang-Ching, Cecelia, Fox, Andee, Haas, David W., Landay, Alan, Leon, Mey, Park, Jeong-Gun, Patterson, Kristine, Sise, Thucuma, Spear, Greg, Shugarts, David, Tshandu, Pamela, Wira, Charles R, Scarsi, Kimberly K, Cramer, Yoninah S, Rosenkranz, Susan L, Aweeka, Francesca, Berzins, Baiba, Coombs, Robert W, Coughlin, Kristine, Moran, Laura E, Zorrilla, Carmen D, Akelo, Victor, Aziz, Mariam, Friedman, Ruth K, Gingrich, David, Swaminathan, Shobha, Godfrey, Catherine, and Cohn, Susan E

Published
2019
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32. Phase I Safety, Pharmacokinetics, and Pharmacogenetics Study of the Antituberculosis Drug PA-824 with Concomitant Lopinavir-Ritonavir, Efavirenz, or Rifampin

Author

Dooley, Kelly E, Luetkemeyer, Anne F, Park, Jeong-Gun, Allen, Reena, Cramer, Yoninah, Murray, Stephen, Sutherland, Deborah, Aweeka, Francesca, Koletar, Susan L, Marzan, Florence, Bao, Jing, Savic, Rada, and Haas, David W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Alkynes, Antitubercular Agents, Antiviral Agents, Benzoxazines, Cyclopropanes, Drug Combinations, Drug Therapy, Combination, Female, Humans, Lopinavir, Male, Middle Aged, Nitroimidazoles, Pharmacogenetics, Rifampin, Ritonavir, Young Adult, AIDS Clinical Trials Group A5306 Study Team, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

There is an urgent need for new antituberculosis (anti-TB) drugs, including agents that are safe and effective with concomitant antiretrovirals (ARV) and first-line TB drugs. PA-824 is a novel antituberculosis nitroimidazole in late-phase clinical development. Cytochrome P450 (CYP) 3A, which can be induced or inhibited by ARV and antituberculosis drugs, is a minor (∼20%) metabolic pathway for PA-824. In a phase I clinical trial, we characterized interactions between PA-824 and efavirenz (arm 1), lopinavir/ritonavir (arm 2), and rifampin (arm 3) in healthy, HIV-uninfected volunteers without TB disease. Participants in arms 1 and 2 were randomized to receive drugs via sequence 1 (PA-824 alone, washout, ARV, and ARV plus PA-824) or sequence 2 (ARV, ARV with PA-824, washout, and PA-824 alone). In arm 3, participants received PA-824 and then rifampin and then both. Pharmacokinetic sampling occurred at the end of each dosing period. Fifty-two individuals participated. Compared to PA-824 alone, plasma PA-824 values (based on geometric mean ratios) for maximum concentration (Cmax), area under the concentration-time curve from 0 to 24 h (AUC0-24), and trough concentration (Cmin) were reduced 28%, 35%, and 46% with efavirenz, 13%, 17%, and 21% with lopinavir-ritonavir (lopinavir/r) and 53%, 66%, and 85% with rifampin, respectively. Medications were well tolerated. In conclusion, lopinavir/r had minimal effect on PA-824 exposures, supporting PA-824 use with lopinavir/r without dose adjustment. PA-824 exposures, though, were reduced more than expected when given with efavirenz or rifampin. The clinical implications of these reductions will depend upon data from current clinical trials defining PA-824 concentration-effect relationships. (This study has been registered at ClinicalTrials.gov under registration no. NCT01571414.).

Published
2014

34. Model-Based Estimates of the Effects of Efavirenz on Bedaquiline Pharmacokinetics and Suggested Dose Adjustments for Patients Coinfected with HIV and Tuberculosis

Author

Svensson, Elin M, Aweeka, Francesca, Park, Jeong-Gun, Marzan, Florence, Dooley, Kelly E, and Karlsson, Mats O

Subjects
Pharmacology and Pharmaceutical Sciences, Medical Microbiology, Biomedical and Clinical Sciences, Tuberculosis, Clinical Trials and Supportive Activities, HIV/AIDS, Orphan Drug, Rare Diseases, Clinical Research, Emerging Infectious Diseases, Sexually Transmitted Infections, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Alkynes, Anti-HIV Agents, Antitubercular Agents, Benzoxazines, Cyclopropanes, Diarylquinolines, Dose-Response Relationship, Drug, Drug Interactions, Drug Therapy, Combination, HIV Infections, Humans, Middle Aged, Models, Biological, Quinolines, Stochastic Processes, Treatment Outcome, Young Adult, Microbiology, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

Safe, effective concomitant treatment regimens for tuberculosis (TB) and HIV infection are urgently needed. Bedaquiline (BDQ) is a promising new anti-TB drug, and efavirenz (EFV) is a commonly used antiretroviral. Due to EFV's induction of cytochrome P450 3A4, the metabolic enzyme responsible for BDQ biotransformation, the drugs are expected to interact. Based on data from a phase I, single-dose pharmacokinetic study, a nonlinear mixed-effects model characterizing BDQ pharmacokinetics and interaction with multiple-dose EFV was developed. BDQ pharmacokinetics were best described by a 3-compartment disposition model with absorption through a dynamic transit compartment model. Metabolites M2 and M3 were described by 2-compartment models with clearance of BDQ and M2, respectively, as input. Impact of induction was described as an instantaneous change in clearance 1 week after initialization of EFV treatment and estimated for all compounds. The model predicts average steady-state concentrations of BDQ and M2 to be reduced by 52% (relative standard error [RSE], 3.7%) with chronic coadministration. A range of models with alternative structural assumptions regarding onset of induction effect and fraction metabolized resulted in similar estimates of the typical reduction and did not offer a markedly better fit to data. Simulations to investigate alternative regimens mitigating the estimated interaction effect were performed. The results suggest that simple adjustments of the standard regimen during EFV coadministration can prevent reduced exposure to BDQ without increasing exposures to M2. However, exposure to M3 would increase. Evaluation in clinical trials of adjusted regimens is necessary to ensure appropriate dosing for HIV-infected TB patients on an EFV-based regimen.

Published
2013

35. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial

Author

Giugliano, Robert P, Pedersen, Terje R, Park, Jeong-Gun, De Ferrari, Gaetano M, Gaciong, Zbigniew A, Ceska, Richard, Toth, Kalman, Gouni-Berthold, Ioanna, Lopez-Miranda, Jose, Schiele, François, Mach, François, Ott, Brian R, Kanevsky, Estella, Pineda, Armando Lira, Somaratne, Ransi, Wasserman, Scott M, Keech, Anthony C, Sever, Peter S, and Sabatine, Marc S

Published
2017
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39. Advanced Respiratory Support in the Contemporary Cardiac ICU

Author

Metkus, Thomas S., Miller, P. Elliott, Alviar, Carlos L., Baird-Zars, Vivian M., Bohula, Erin A., Cremer, Paul C., Gerber, Daniel A., Jentzer, Jacob C., Keeley, Ellen C., Kontos, Michael C., Menon, Venu, Park, Jeong-Gun, Roswell, Robert O., Schulman, Steven P., Solomon, Michael A., van Diepen, Sean, Katz, Jason N., and Morrow, David A.

Published
2020
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40. Clinical Practice Patterns in Temporary Mechanical Circulatory Support for Shock in the Critical Care Cardiology Trials Network (CCCTN) Registry

Author

Berg, David D., Barnett, Christopher F., Kenigsberg, Benjamin B., Papolos, Alexander, Alviar, Carlos L., Baird-Zars, Vivian M., Barsness, Gregory W., Bohula, Erin A., Brennan, Joseph, Burke, James A., Carnicelli, Anthony P., Chaudhry, Sunit-Preet, Cremer, Paul C., Daniels, Lori B., DeFilippis, Andrew P., Gerber, Daniel A., Granger, Christopher B., Hollenberg, Steven, Horowitz, James M., Gladden, James D., Katz, Jason N., Keeley, Ellen C., Keller, Norma, Kontos, Michael C., Lawler, Patrick R., Menon, Venu, Metkus, Thomas S., Miller, P. Elliott, Nativi-Nicolau, Jose, Newby, L. Kristin, Park, Jeong-Gun, Phreaner, Nicholas, Roswell, Robert O., Schulman, Steven P., Sinha, Shashank S., Snell, R. Jeffrey, Solomon, Michael A., Teuteberg, Jeffrey J., Tymchak, Wayne, van Diepen, Sean, and Morrow, David A.

Published
2019
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41. HEPATIC FAT CHANGES AFTER AN ANTISENSE OLIGONUCLEOTIDE THERAPY TARGETING ANGPTL3: A TRANSLATE-TIMI 70 ANALYSIS

Author

Zimerman, André, primary, Wiviott, Stephen, additional, Park, Jeong-Gun, additional, Murphy, Sabina, additional, Ran, Xinhui, additional, Bramson, Candace, additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia, additional, Verma, Subodh, additional, Wojakowski, Wojciech, additional, Terra, Steven G., additional, Sabatine, Marc Steven, additional, Bergmark, Brian, additional, and Marston, Nicholas, additional

Published
2023
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43. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE

Author

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

Published
2023
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44. Epidemiology of Shock in Contemporary Cardiac Intensive Care Units: Data From the Critical Care Cardiology Trials Network Registry

Author

Berg, David D., Bohula, Erin A., van Diepen, Sean, Katz, Jason N., Alviar, Carlos L., Baird-Zars, Vivian M., Barnett, Christopher F., Barsness, Gregory W., Burke, James A., Cremer, Paul C., Cruz, Jennifer, Daniels, Lori B., DeFilippis, Andrew P., Haleem, Affan, Hollenberg, Steven M., Horowitz, James M., Keller, Norma, Kontos, Michael C., Lawler, Patrick R., Menon, Venu, Metkus, Thomas S., Ng, Jason, Orgel, Ryan, Overgaard, Christopher B., Park, Jeong-Gun, Phreaner, Nicholas, Roswell, Robert O., Schulman, Steven P., Jeffrey Snell, R., Solomon, Michael A., Ternus, Bradley, Tymchak, Wayne, Vikram, Fnu, and Morrow, David A.

Published
2019
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45. Association of Serial High-Sensitivity Cardiac Troponin T With Subsequent Cardiovascular Events in Patients Stabilized After Acute Coronary Syndrome

Author

Patel, Siddharth M., primary, Qamar, Arman, additional, Giugliano, Robert P., additional, Jarolim, Petr, additional, Marston, Nicholas A., additional, Park, Jeong-Gun, additional, Blazing, Michael A., additional, Cannon, Christopher P., additional, Braunwald, Eugene, additional, and Morrow, David A., additional

Published
2022
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46. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT

Author

Bohula, Erin A., primary, Berg, David D., additional, Lopes, Mathew S., additional, Connors, Jean M., additional, Babar, Ijlal, additional, Barnett, Christopher F., additional, Chaudhry, Sunit-Preet, additional, Chopra, Amit, additional, Ginete, Wilson, additional, Ieong, Michael H., additional, Katz, Jason N., additional, Kim, Edy Y., additional, Kuder, Julia F., additional, Mazza, Emilio, additional, McLean, Dalton, additional, Mosier, Jarrod M., additional, Moskowitz, Ari, additional, Murphy, Sabina A., additional, O’Donoghue, Michelle L., additional, Park, Jeong-Gun, additional, Prasad, Rajnish, additional, Ruff, Christian T., additional, Shahrour, Mohamad N., additional, Sinha, Shashank S., additional, Wiviott, Stephen D., additional, Van Diepen, Sean, additional, Zainea, Mark, additional, Baird-Zars, Vivian, additional, Sabatine, Marc S., additional, Morrow, David A., additional, Im, Kyung Ah, additional, Saxena, Retu, additional, Wiley, Brandon, additional, Benson, Carina, additional, Delamed, Roman, additional, Skeik, Nedaa, additional, Chopra, Ami, additional, Judson, Marc, additional, Beegle, Scott, additional, Shkolnik, Boris, additional, Tiwari, Anupama, additional, Wu, Gregory, additional, Raval, Abhijit, additional, Branch, Emerald, additional, Rischard, Franz, additional, Hypes, Cameron, additional, Bixby, Billie, additional, Bime, Christian, additional, Sundaram, Madhan, additional, Sweitzer, Nancy, additional, Sandoval, Alfredo Vazquez, additional, White, Heath, additional, Berg, Katherine, additional, Shaefi, Shahzad, additional, Donnino, Michael, additional, Carroll, Brett, additional, Ieong, Michael, additional, Ackerbauer, Kimberly, additional, Murphy, Jaime, additional, Bhatt, Ankeet, additional, Blood, Alexander, additional, Patel, Siddharth, additional, Luu, Victor, additional, Narechania, Shraddha, additional, Lorganger, Austin, additional, Plambeck, Robert, additional, Nayfeh, Ali, additional, Sanley, Michael, additional, Del Cor, Michel, additional, Hegg, AJ, additional, Nara, Winston, additional, Snyder, Michael, additional, Khan, Faisal, additional, Shawa, Imad, additional, Larned, Joshua, additional, Collado, Elias, additional, Al Faiyumi, Mohammed, additional, Mehta, Rajeev, additional, Komanapalli, Sudarshan, additional, Muppidi, Vijayadershan, additional, Desai, Mehul, additional, Flanagan, Casey, additional, Genovese, Leonard, additional, Haddad, Tariq, additional, King, Christopher, additional, Peterson, Amber, additional, Htun, Thane, additional, Pionk, Elizabeth, additional, Mouawad, Nicolas, additional, Kumar, Chintalapudi, additional, Nguyen, Kevin, additional, Mughal, Majid, additional, Malek, Ryan, additional, Parekh, Akarsh, additional, Provenzano, Christopher, additional, Ianitelli, Melissa, additional, Prentice-Gaytan, Nicole, additional, Bykowski, Adam, additional, Tait, Don, additional, Schendel, Shelley, additional, Yalamanchili, Varun, additional, Lala, Vasim, additional, Hunyadi, Victor, additional, Papolos, Alexander, additional, Kenigsberg, Benjamin, additional, Shenoy, Aarthi, additional, Stuckey, Thomas, additional, McQuaid, Douglas, additional, Mannam, Praveen, additional, McClung, Jeffrey, additional, Nilsson, Kent, additional, McKown, Andrew, additional, Wells, Jason, additional, Hotchkin, David, additional, Jacobs, Marc, additional, Strauss, Wayne, additional, Balestra, Rick, additional, Sahni, Vikram, additional, Snell, R. Jeffrey, additional, Suradi, Hussam, additional, Sungurlu, Sarah, additional, Kuppy, Jessica, additional, Gajo, Eileen, additional, Adams, Foster, additional, Shehadeh, Abbas, additional, Suleiman, Addi, additional, Nandigam, Harish, additional, Slim, Jihad, additional, Babar, Sardar Ijlal, additional, Baral, Dipti, additional, Nawaz, Talha, additional, Waheed, Syed Abdullah, additional, Roth, Randy, additional, Sitaula, Subhas, additional, Hayat, Shahid, additional, Babu, Jooby, additional, Caberto, Jason, additional, Hsu, Victor, additional, Chang, Robert, additional, Bochan, Markian, additional, Garcia-Cortes, Rafael, additional, Skopicki, Hal, additional, Chen, On, additional, Pilato, Lauren, additional, Richman, Paul, additional, Adler, Alexander, additional, Sudhindra, Praveen, additional, Beversdorf, Jamie, additional, Kashyap, Ravindra, additional, Mehta, Parth, additional, Mehrad, Borna, additional, Ataya, Ali, additional, Lascano, Jorge, additional, Brantly, Mark, additional, Austin, Adam, additional, Koman, Eduard, additional, Galski, Thomas, additional, Kumar, Vijaya, additional, Soubani, Ayman, additional, Harrison, Nicolas, additional, Reddy, Vineet, additional, and Fonkam, Audrey, additional

Published
2022
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49. Prevention of Stroke with the Addition of Ezetimibe to Statin Therapy in Patients With Acute Coronary Syndrome in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)

Author

Bohula, Erin A., Wiviott, Stephen D., Giugliano, Robert P., Blazing, Michael A., Park, Jeong-Gun, Murphy, Sabina A., White, Jennifer A., Mach, Francois, Van de Werf, Frans, Dalby, Anthony J., White, Harvey D., Tershakovec, Andrew M., Cannon, Christopher P., and Braunwald, Eugene

Published
2017
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