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6. Contemporary guideline‐directed medical therapy in de novo, chronic, and worsening heart failure patients: First data from the TITRATE‐HF study

Author

Malgie, Jishnu, primary, Wilde, Mariëlle I., additional, Clephas, Pascal R.D., additional, Emans, Mireille E., additional, Koudstaal, Stefan, additional, Schaap, Jeroen, additional, Mosterd, Arend, additional, van Ramshorst, Jan, additional, Wardeh, Alexander J., additional, van Wijk, Sandra, additional, van den Heuvel, Mieke, additional, Wierda, Eric, additional, Borleffs, C. Jan Willem, additional, Saraber, Colette, additional, Beeres, Saskia L.M.A., additional, van Kimmenade, Roland, additional, Jansen Klomp, Wouter, additional, Denham, Robert, additional, da Fonseca, Carlos A., additional, Klip, IJsbrand T., additional, Manintveld, Olivier C., additional, van der Boon, Robert M.A., additional, van Ofwegen, Clara E.E., additional, Yilmaz, Ayten, additional, Pisters, Ron, additional, Linssen, Gerard C.M., additional, Faber, Nikola, additional, van Heerebeek, Loek, additional, van de Swaluw, Julio E.C., additional, Bouhuijzen, Lex J., additional, Post, Marco C., additional, Kuijper, Aaf F.M., additional, Wu, Ka wai, additional, van Beek, Eugène A., additional, Hesselink, Tim, additional, Kleijn, Lennaert, additional, Kurvers, Maurice J.M., additional, Tio, René A., additional, Langerveld, Jorina, additional, van Dalen, Bas M., additional, van Eck, J.W. Martijn, additional, Handoko, M. Louis, additional, Hermans, Walter R.M., additional, Koornstra‐Wortel, Hetty J.J., additional, Szymanski, Mariusz K., additional, Rooker, Dennis, additional, Tandjung, Kenneth, additional, Eijsbouts, Sabine C.M., additional, Asselbergs, Folkert W., additional, van der Meer, Peter, additional, Brunner‐La Rocca, Hans‐Peter, additional, de Boer, Rudolf A., additional, and Brugts, Jasper J., additional

Published
2024
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7. Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Author

Joseph, Richard W, Elassaiss-Schaap, Jeroen, Kefford, Richard, Hwu, Wen-Jen, Wolchok, Jedd D, Joshua, Anthony M, Ribas, Antoni, Hodi, F Stephen, Hamid, Omid, Robert, Caroline, Daud, Adil, Dronca, Roxana, Hersey, Peter, Weber, Jeffrey S, Patnaik, Amita, de Alwis, Dinesh P, Perrone, Andrea, Zhang, Jin, Kang, S Peter, Ebbinghaus, Scot, Anderson, Keaven M, and Gangadhar, Tara C

Subjects
Cancer, Clinical Research, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose: The purpose of this study was to assess the association of baseline tumor size (BTS) with other baseline clinical factors and outcomes in pembrolizumab-treated patients with advanced melanoma in KEYNOTE-001 (NCT01295827).Experimental Design: BTS was quantified by adding the sum of the longest dimensions of all measurable baseline target lesions. BTS as a dichotomous and continuous variable was evaluated with other baseline factors using logistic regression for objective response rate (ORR) and Cox regression for overall survival (OS). Nominal P values with no multiplicity adjustment describe the strength of observed associations.Results: Per central review by RECIST v1.1, 583 of 655 patients had baseline measurable disease and were included in this post hoc analysis. Median BTS was 10.2 cm (range, 1-89.5). Larger median BTS was associated with Eastern Cooperative Oncology Group performance status 1, elevated lactate dehydrogenase (LDH), stage M1c disease, and liver metastases (with or without any other sites; all P ≤ 0.001). In univariate analyses, BTS below the median was associated with higher ORR (44% vs. 23%; P < 0.001) and improved OS (HR, 0.38; P < 0.001). In multivariate analyses, BTS below the median remained an independent prognostic marker of OS (P < 0.001) but not ORR. In 459 patients with available tumor programmed death ligand 1 (PD-L1) expression, BTS below the median and PD-L1-positive tumors were independently associated with higher ORR and longer OS.Conclusions: BTS is associated with many other baseline clinical factors but is also independently prognostic of survival in pembrolizumab-treated patients with advanced melanoma. Clin Cancer Res; 24(20); 4960-7. ©2018 AACR See related commentary by Warner and Postow, p. 4915.

Published
2018

8. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Auer, Johann, Hubauer, Martin, Pandzic, Sead, Preishuber, Eva, Primus-Grabscheit, Carina, Reitgruber, Dietmar, Schmalzer, Florian, Adlbrecht, Christopher, Schober, Andreas, Hajos, Johannes, Keil, Christoph, Schratter, Alexandra, Frick, Matthias, Benda, Magdalena Anna, Mächler, Maximilian, Mutschlechner, Beatrix, Saely, Christoph, Sprenger, Lukas, Lichtenauer, Michael, Eber, Miriam, Hoppe, Uta, Kolbitsch, Tobias, Jirak, Peter Michael, Mirna, Moritz, Schönbauer, Robert, Bergler-Klein, Jutta, Hengstenberg, Christian, Stojkovic, Stefan, Scherr, Daniel, Manninger-Wünscher, Martin, Rohrer, Ursula, Stühlinger, Markus, Schgoer, Wilfried, Schwarzl, Jana, Pürerfellner, Helmut, Derndorfer, Michael, Ebner, Christian, Eder, Veronika, Kollias, Georgios, Sturmberger, Thomas, Sieghartsleitner, Stefan, Vijgen, Johan, Koopman, Peter, Dujardin, Karl, Anné, Wim, De Ceuninck, Michel, Tavernier, Rene, Duytschaever, Mattias, Knecht, Sébastien, Missault, Luc, Vandekerckhove, Yves, Rossenbacker, Tom, Ector, Bavo, Charlier, Filip, Debruyne, Philippe, Dewilde, Willem, Janssens, Luc, Roosen, John, Vankelecom, Bart, Heidbuchel, Hein, Delesie, Michiel, Vervoort, Gert, Rombouts, Hans, Vanassche, Thomas, Engelen, Matthias, Verhamme, Peter, Willems, Rik, Constance, Christian, Pranno, Nicolas, Cox, Jafna, Bata, Iqbal, Macle, Laurent, Aguilar, Martin, Tourigny, Julia Cadrin, Dubuc, Marc, Dyrda, Katia, Guerra, Peter, Khairy, Paul, Mondésert, Blandine, Rivard, Léna, Roy, Denis, Tadros, Rafik, Talajic, Mario, Thibault, Bernard, Nault, Isabelle, Blier, Louis, Champagne, Jean, Molin, Franck, O'Hara, Gilles, Philippon, François, Plourde, Benoit, Sarrazin, Jean-François, Steinberg, Christian, Coufal, Zdenek, Balazsik, David, Mikulica, Michal, Zapeca, Jakub, Cermak, Ondrej, Drasnar, Tomas, Falc, Matej, Hornof, Josef, Racz, Blazej, Weissova, Danica, Linkova, Hana, Paskova, Eva, Petr, Robert, Sirakova, Andrea, Kettner, Jiri, Benak, Ales, Holek, Martin, Podpera, Ivo, Podperova, Monika, Vancura, Vlastimil, Jandik, Tomas, Smid, Jiri, Dedek, Vratislav, Banik, Jan, Durdil, Vaclav, Hnat, Tomas, Lellouche, Nicolas, Rouffiac, Ségolène, Taldir, Guillaume, Bridonneau, Valentin, Couffon, Philippe, Daudin, Magalie, Hamon, Cécile, Lacaze, Jonathan, Quentin, Anne, Thebault, Christophe, Boiffard, Emmanuel, Billon, Olivier, Miette, Fabien, Pouliquen, Hervé, Turlotte, Guillaume, Gorka, Hervé, Albert, Franck, Bayle, Sandrine, Bensaid, Reda, Dasoveanu, Madalina, Demichili, Thibaud, Dutoiu, Teodora, Khalil, Cliff, Loghin, Caterina, Range, Grégoire, Roussel, Laurent, Socié, Pierre, Thuaire, Christophe, Extramiana, Fabrice, Algalarrondo, Vincent, Boughanmi, Haten, El Mansour, Noreddine, Mohammad, Usman, Sellier, Romain, Elbaz, Meyer, Laperche, Clémence, Maury, Philippe, Kiss, Robert, Borsanyi, Tunde, Gingl, Zoltan, Polgar, Balaza, Benczur, Bela, Bodor, Alexandra, Hepp, Tamas, Malati, Eva, Nagy, Laszlo, Erdei, Norbert, Kapus, Jozsef, Kapus, Katalin, Toth, Brigitta, Matoltsy, Andras, Kiss, Tunde, Merkely, Bela, Herczeg, Szilvia, Kiss, Orsolya, Sallo, Zoltan, Toth, Kalman, Habon, Tamas, Rabai, Miklos, Totsimon, Kinga, Zilahi, Zsolt, Bencze, Gabriella, Santa, Janos, Aradi, Daniel, Kelemen, Barbara, Bolognese, Leonardo, Nesti, Martina, Notarstefano, Pasquale Giovanni, D'Orazio, Simona, Cosmi, Franco, Becattini, Cecilia, Agnelli, Giancarlo, Broccatelli, Belinda, Mosconi, Maria Giulia, Paciaroni, Maurizio, Urbini, Chiara, Parato, Vito Maurizio, Notaristefani, Camilla, Scarano, Michele, Ameri, Pietro, Ghigliotti, Giorgio, Guglielmi, Giulia, Lotti, Roberta, Merlo, Andrea Carlo, Muiesan, Maria Lorenza, Abondio, Andrea, Berasi, Caterina, Mattiuzzo, Elena, Mutti, Claudio, Salvetti, Massimo, Pignatelli, Pasquale, Menichelli, Danilo, Pastori, Daniele, Tamiya, Eiji, Matsumoto, Takahiro, Takabe, Tomosato, Yamamoto, Shoichi, Yamashita, Haruyo, Higashiue, Shinichi, Furuya, Onichi, Hiramatsu, Norihiko, Kasuga, Kensuke, Kojima, Saburo, Komooka, Masatoshi, Kuroyanagi, Satoshi, Matsuura, Makoto, Takemoto, Tetsushi, Yamamoto, Shuji, Saito, Katusmi, Abe, Takuro, Ishida, Issei, Iwanami, Yuji, Kataoka, Shohei, Moriyama, Tetsu, Murohashi, Akira, Sasaki, Akihito, Nakamura, Yuichiro, Ueno, Tetsuya, Shimane, Akira, Hamana, Tomoyo, Ichibori, Hirotoshi, Inoue, Tomohiro, Itoh, Mitsuaki, Iwane, Seigo, Kawai, Hiroya, Kokawa, Tatsuya, Masumoto, Akiko, Matsuo, Koki, Miyata, Taishi, Nakano, Shinsuke, Oishi, Shogo, Onishi, Tetsuari, Sawada, Takahiro, Saito, Takayuki, Shoda, Mitsuhiko, Takahashi, Nobuyuki, Takaya, Tomofumi, Taniguchi, Yasuyo, Tsukamoto, Shota, Tsukishiro, Yasue, Tsukiyama, Yoshiro, Tsunamoto, Hiroshi, Uzu, Kenzo, Yamamoto, Hiroyuki, Yamamoto, Tetsuya, Yokoi, Kiminobu, Yoshida, Chiaki, Watanabe, Nobuhiro, Betsuyaku, Tetsuo, Adachi, Kumiko, Awane, Kouichi, Goto, Daisuke, Sakakibara, Mamoru, Watanabe, Masashi, Ueno, Hideki, Hiroe, Yoshitaka, Matsuo, Koshi, Ayata, Kenji, Fukuda, Ko, Hata, Yoshiki, Hashimoto, Katsushi, Matsumi, Hiroaki, Nikaido, Akira, Okamoto, Shuichi, Sime, Iveta, Stirna, Valters, Reinholde, Ilze, Hansone, Silvija, Kozlovska, Anita, Romanova, Janina, Klincare, Dace, Pontaga, Natalja, Dirmans, Igors, Kalnins, Artis, Upite, Dana, Gersamija, Arcils, Teleznikovs, Arturs, Rozkova, Nadezda, Safro, Jelena, Anguera Camós, Ignasi, Domenico Dallaglio, Paolo, Salguero Bodes, Rafael, Arnbas, Fernando, Borrego, Luis, Marco, Alvaro, Jimenez, Javier Ramos, Gómez-Doblas, Juan José, Pérez Cabeza, Alejandro, Ferreira Gonzålez, Ignacio, Limeres Freire, Javier, Lopez Grau, Merce, Viñolas Prat, Xavier, Moreno Weidmann, Zoraida, Guerra Ramos, Jose Maria, Alonso Martin, Maria Concepcion, Campos Garcia, Bieito, Mogro Carranza, Javier Mauricio, Mendez Zurita, Francisco Javier, Rodriguez Font, Enrique, Gonzales Matos, Carlos Eduardo, García Hernando, Víctor, Lindholm, Carl-Johan, Thulin, Jörgen, Wallén, Håkan, Hagwall, Kristina, Eliasson, Ken, Lundvall, Martin, Olsson, Jens, Kjellman, Björn, Lind, Markus, Johansson, Lars, Svedberg, Niclas, Berglund, Stefan, Söderberg, Julia, Zedigh, Christer, Mooe, Thomas, Axelsson, Mattias, Binsell, Emil, Huber, Daniel, Müller, Christian, Danier, Isabelle, Kühne, Michael, Okamura, Bernhard, Schoepfer, Hadrien, Simmen, Cornelia, Reichlin, Tobias, Chollet, Laurève, Lam, Anna, Wittmer, Severin, Rickli, Hans, Gall, Christian, Hametner, Greta, Intorp, Stephanie, Luescher, Daniel, Haegeli, Laurent, Berg, Jan Christopher, Ebrahimi, Ramin, Auricchio, Angelo, Crljenica, Carmela, Moccetti, Tizziano, Monti, Cristina, Pasotti, Elena, Petrova, Iveta, Rossi, Mariagrazia, Mach, François, Namdar, Mehdi, de Groot, Joris, Proost, Virginnio, Neefs, Joline, Linz, Dominik, van Stipdonk, Twan, den Uijl, Dennis, Alings, Marco, Schaap, Jeroen, Segers, Dolf, Wouters, Noemi, Bartels, Louis, Tieleman, Robert, Pisters, Ron, de Vries, Tim, Selig, Jaap, Kuijper, Aaf, Bot, Pieter, Keijzers, Mitran, Verdel, Gerardus, Tukkie, Raymond, van den Bos, Ewout, Kauer, Floris, Oemrawsingh, Rohit, Stevenhagen, Jeroen, van Es, Jan, Lip, Gregory, Gupta, Dhiraj, Kotalczyk, Agnieszka, Gunstone, Anthony, Brixey, Richard David, Gorog, Diana, Dinarvand, Danial, Gue, Ying, Kanji, Rahim, Memtsas, Vassilios, Senior, Roxy, Bioh, Gabriel, Wong, Yuk-Ki, Child, Nick, Piccini, Jonathan P, Caso, Valeria, Connolly, Stuart J, Fox, Keith A A, Oldgren, Jonas, Jones, W Schuyler, Gorog, Diana A, Durdil, Václav, Viethen, Thomas, Neumann, Christoph, Mundl, Hardi, and Patel, Manesh R

Published
2022
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11. RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands

Author

van Eijk, Jorna, primary, Luijken, Kim, additional, Jaarsma, Tiny, additional, Reitsma, Johannes B, additional, Schuit, Ewoud, additional, Frederix, Geert W J, additional, Derks, Lineke, additional, Schaap, Jeroen, additional, Rutten, Frans H, additional, Brugts, Jasper, additional, de Boer, Rudolf A, additional, Asselbergs, Folkert W, additional, and Trappenburg, Jaap C A, additional

Published
2024
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13. Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE‐HF

Author

Clephas, Pascal R. D., primary, Malgie, Jishnu, additional, Schaap, Jeroen, additional, Koudstaal, Stefan, additional, Emans, Mireille, additional, Linssen, Gerard C. M., additional, de Boer, Grytsje A., additional, van Heerebeek, Loek, additional, Borleffs, C. Jan Willem, additional, Manintveld, Olivier C., additional, van Empel, Vanessa, additional, van Wijk, Sandra, additional, van den Heuvel, Mieke, additional, da Fonseca, Carlos, additional, Damman, Kevin, additional, van Ramshorst, Jan, additional, van Kimmenade, Roland, additional, van de Ven, Arjen R. T., additional, Tio, René A., additional, van Veghel, Dennis, additional, Asselbergs, Folkert W., additional, de Boer, Rudolf A., additional, van der Meer, Peter, additional, Greene, Stephen J., additional, Brunner‐La Rocca, Hans‐Peter, additional, and Brugts, Jasper J., additional

Published
2023
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16. 1-Year Outcomes of Delayed Versus Immediate Intervention in Patients With Transient ST-Segment Elevation Myocardial Infarction

Author

Janssens, Gladys N., van der Hoeven, Nina W., Lemkes, Jorrit S., Everaars, Henk, van de Ven, Peter M., Marques, Koen M.J., Nap, Alexander, van Leeuwen, Maarten A.H., Appelman, Yolande, Knaapen, Paul, Verouden, Niels J.W., Allaart, Cornelis P., Brinckman, Stijn L., Saraber, Colette E., Plomp, Koos J., Timmer, Jorik R., Kedhi, Elvin, Hermanides, Renicus S., Meuwissen, Martijn, Schaap, Jeroen, van der Weerdt, Arno P., van Rossum, Albert C., Nijveldt, Robin, and van Royen, Niels

Published
2019
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17. The different risk of new‐onset, chronic, worsening, and advanced heart failure: A systematic review and meta‐regression analysis.

Author

Shakoor, Abdul, Abou Kamar, Sabrina, Malgie, Jishnu, Kardys, Isabella, Schaap, Jeroen, de Boer, Rudolf A., van Mieghem, Nicolas M., van der Boon, Robert M.A., and Brugts, Jasper J.

Subjects
HEART failure, PROGNOSIS, MORTALITY, DEATH rate, SCIENTIFIC observation, CONFIDENCE intervals
Abstract

Aims: Heart failure (HF) is a chronic and progressive syndrome associated with a poor prognosis. While it may seem intuitive that the risk of adverse outcomes varies across the different stages of HF, an overview of these risks is lacking. This study aims to determine the risk of all‐cause mortality and HF hospitalizations associated with new‐onset HF, chronic HF (CHF), worsening HF (WHF), and advanced HF. Methods and results: We performed a systematic review of observational studies from 2012 to 2022 using five different databases. The primary outcomes were 30‐day and 1‐year all‐cause mortality, as well as 1‐year HF hospitalization. Studies were pooled using random effects meta‐analysis, and mixed‐effects meta‐regression was used to compare the different HF groups. Among the 15 759 studies screened, 66 were included representing 862 046 HF patients. Pooled 30‐day mortality rates did not reveal a significant distinction between hospital‐admitted patients, with rates of 10.13% for new‐onset HF and 8.11% for WHF (p = 0.10). However, the 1‐year mortality risk differed and increased stepwise from CHF to advanced HF, with a rate of 8.47% (95% confidence interval [CI] 7.24–9.89) for CHF, 21.15% (95% CI 17.78–24.95) for new‐onset HF, 26.84% (95% CI 23.74–30.19) for WHF, and 29.74% (95% CI 24.15–36.10) for advanced HF. Readmission rates for HF at 1 year followed a similar trend. Conclusions: Our meta‐analysis of observational studies confirms the different risk for adverse outcomes across the distinct HF stages. Moreover, it emphasizes the negative prognostic value of WHF as the first progressive stage from CHF towards advanced HF. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE‐HF.

Author

Clephas, Pascal R. D., Malgie, Jishnu, Schaap, Jeroen, Koudstaal, Stefan, Emans, Mireille, Linssen, Gerard C. M., de Boer, Grytsje A., van Heerebeek, Loek, Borleffs, C. Jan Willem, Manintveld, Olivier C., van Empel, Vanessa, van Wijk, Sandra, van den Heuvel, Mieke, da Fonseca, Carlos, Damman, Kevin, van Ramshorst, Jan, van Kimmenade, Roland, van de Ven, Arjen R. T., Tio, René A., and van Veghel, Dennis

Subjects
HEART failure, DESIGN failures, DRUG therapy, VENTRICULAR ejection fraction, DIURETICS, DRUGS
Abstract

Aims: Current heart failure (HF) guidelines recommend to prescribe four drug classes in patients with HF with reduced ejection fraction (HFrEF). A clear challenge exists to adequately implement guideline‐directed medical therapy (GDMT) regarding the sequencing of drugs and timely reaching target dose. It is largely unknown how the paradigm shift from a serial and sequential approach for drug therapy to early parallel application of the four drug classes will be executed in daily clinical practice, as well as the reason clinicians may not adhere to new guidelines. We present the design and rationale for the real‐world TITRATE‐HF study, which aims to assess sequencing strategies for GDMT initiation, dose titration patterns (order and speed), intolerance for GDMT, barriers for implementation, and long‐term outcomes in patients with de novo, chronic, and worsening HF. Methods and results: A total of 4000 patients with HFrEF, HF with mildly reduced ejection fraction, and HF with improved ejection fraction will be enrolled in >40 Dutch centres with a follow‐up of at least 3 years. Data collection will include demographics, physical examination and vital parameters, electrocardiogram, laboratory measurements, echocardiogram, medication, and quality of life. Detailed information on titration steps will be collected for the four GDMT drug classes. Information will include date, primary reason for change, and potential intolerances. The primary clinical endpoints are HF‐related hospitalizations, HF‐related urgent visits with a need for intravenous diuretics, all‐cause mortality, and cardiovascular mortality. Conclusions: TITRATE‐HF is a real‐world multicentre longitudinal registry that will provide unique information on contemporary GDMT implementation, sequencing strategies (order and speed), and prognosis in de novo, worsening, and chronic HF patients. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.

Author

Hamid, Omid, Robert, Caroline, Daud, Adil, Hodi, F Stephen, Hwu, Wen-Jen, Kefford, Richard, Wolchok, Jedd D, Hersey, Peter, Joseph, Richard W, Weber, Jeffrey S, Dronca, Roxana, Gangadhar, Tara C, Patnaik, Amita, Zarour, Hassane, Joshua, Anthony M, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Algazi, Alain, Mateus, Christine, Boasberg, Peter, Tumeh, Paul C, Chmielowski, Bartosz, Ebbinghaus, Scot W, Li, Xiaoyun Nicole, Kang, S Peter, and Ribas, Antoni

Subjects
Humans, Melanoma, Brain Neoplasms, Skin Neoplasms, Antineoplastic Agents, Antibodies, Monoclonal, Drug Administration Schedule, Dose-Response Relationship, Drug, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Antibodies, Monoclonal, Humanized, Programmed Cell Death 1 Receptor, Human Genome, Genetics, Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cancer, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma.MethodsWe administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks.ResultsA total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months.ConclusionsIn patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.).

Published
2013

23. Figure S1 from Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Author

Joseph, Richard W., primary, Elassaiss-Schaap, Jeroen, primary, Kefford, Richard, primary, Hwu, Wen-Jen, primary, Wolchok, Jedd D., primary, Joshua, Anthony M., primary, Ribas, Antoni, primary, Hodi, F. Stephen, primary, Hamid, Omid, primary, Robert, Caroline, primary, Daud, Adil, primary, Dronca, Roxana, primary, Hersey, Peter, primary, Weber, Jeffrey S., primary, Patnaik, Amita, primary, de Alwis, Dinesh P., primary, Perrone, Andrea, primary, Zhang, Jin, primary, Kang, S. Peter, primary, Ebbinghaus, Scot, primary, Anderson, Keaven M., primary, and Gangadhar, Tara C., primary

Published
2023
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24. Table S1 from Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Author

Joseph, Richard W., primary, Elassaiss-Schaap, Jeroen, primary, Kefford, Richard, primary, Hwu, Wen-Jen, primary, Wolchok, Jedd D., primary, Joshua, Anthony M., primary, Ribas, Antoni, primary, Hodi, F. Stephen, primary, Hamid, Omid, primary, Robert, Caroline, primary, Daud, Adil, primary, Dronca, Roxana, primary, Hersey, Peter, primary, Weber, Jeffrey S., primary, Patnaik, Amita, primary, de Alwis, Dinesh P., primary, Perrone, Andrea, primary, Zhang, Jin, primary, Kang, S. Peter, primary, Ebbinghaus, Scot, primary, Anderson, Keaven M., primary, and Gangadhar, Tara C., primary

Published
2023
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25. Figure Legends from Baseline Tumor Size Is an Independent Prognostic Factor for Overall Survival in Patients with Melanoma Treated with Pembrolizumab

Author

Joseph, Richard W., primary, Elassaiss-Schaap, Jeroen, primary, Kefford, Richard, primary, Hwu, Wen-Jen, primary, Wolchok, Jedd D., primary, Joshua, Anthony M., primary, Ribas, Antoni, primary, Hodi, F. Stephen, primary, Hamid, Omid, primary, Robert, Caroline, primary, Daud, Adil, primary, Dronca, Roxana, primary, Hersey, Peter, primary, Weber, Jeffrey S., primary, Patnaik, Amita, primary, de Alwis, Dinesh P., primary, Perrone, Andrea, primary, Zhang, Jin, primary, Kang, S. Peter, primary, Ebbinghaus, Scot, primary, Anderson, Keaven M., primary, and Gangadhar, Tara C., primary

Published
2023
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26. Figure S1 from Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Author

Patnaik, Amita, primary, Kang, S. Peter, primary, Rasco, Drew, primary, Papadopoulos, Kyriakos P., primary, Elassaiss-Schaap, Jeroen, primary, Beeram, Muralidhar, primary, Drengler, Ronald, primary, Chen, Cong, primary, Smith, Lon, primary, Espino, Guillermo, primary, Gergich, Kevin, primary, Delgado, Liliana, primary, Daud, Adil, primary, Lindia, Jill A., primary, Li, Xiaoyun Nicole, primary, Pierce, Robert H., primary, Yearley, Jennifer H., primary, Wu, Dianna, primary, Laterza, Omar, primary, Lehnert, Manfred, primary, Iannone, Robert, primary, and Tolcher, Anthony W., primary

Published
2023
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27. Supplementary Tables S1-2, Figure 1 from Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Author

Patnaik, Amita, primary, Kang, S. Peter, primary, Rasco, Drew, primary, Papadopoulos, Kyriakos P., primary, Elassaiss-Schaap, Jeroen, primary, Beeram, Muralidhar, primary, Drengler, Ronald, primary, Chen, Cong, primary, Smith, Lon, primary, Espino, Guillermo, primary, Gergich, Kevin, primary, Delgado, Liliana, primary, Daud, Adil, primary, Lindia, Jill A., primary, Li, Xiaoyun Nicole, primary, Pierce, Robert H., primary, Yearley, Jennifer H., primary, Wu, Dianna, primary, Laterza, Omar, primary, Lehnert, Manfred, primary, Iannone, Robert, primary, and Tolcher, Anthony W., primary

Published
2023
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29. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial

Author

Robert, Caroline, Ribas, Antoni, Wolchok, Jedd D, Hodi, F Stephen, Hamid, Omid, Kefford, Richard, Weber, Jeffrey S, Joshua, Anthony M, Hwu, Wen-Jen, Gangadhar, Tara C, Patnaik, Amita, Dronca, Roxana, Zarour, Hassane, Joseph, Richard W, Boasberg, Peter, Chmielowski, Bartosz, Mateus, Christine, Postow, Michael A, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Li, Xiaoyun Nicole, Iannone, Robert, Ebbinghaus, Scot W, Kang, S Peter, and Daud, Adil

Published
2014
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30. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Piccini, Jonathan P, primary, Caso, Valeria, additional, Connolly, Stuart J, additional, Fox, Keith A A, additional, Oldgren, Jonas, additional, Jones, W Schuyler, additional, Gorog, Diana A, additional, Durdil, Václav, additional, Viethen, Thomas, additional, Neumann, Christoph, additional, Mundl, Hardi, additional, Patel, Manesh R, additional, Auer, Johann, additional, Hubauer, Martin, additional, Pandzic, Sead, additional, Preishuber, Eva, additional, Primus-Grabscheit, Carina, additional, Reitgruber, Dietmar, additional, Schmalzer, Florian, additional, Adlbrecht, Christopher, additional, Schober, Andreas, additional, Hajos, Johannes, additional, Keil, Christoph, additional, Schratter, Alexandra, additional, Frick, Matthias, additional, Benda, Magdalena Anna, additional, Mächler, Maximilian, additional, Mutschlechner, Beatrix, additional, Saely, Christoph, additional, Sprenger, Lukas, additional, Lichtenauer, Michael, additional, Eber, Miriam, additional, Hoppe, Uta, additional, Kolbitsch, Tobias, additional, Jirak, Peter Michael, additional, Mirna, Moritz, additional, Schönbauer, Robert, additional, Bergler-Klein, Jutta, additional, Hengstenberg, Christian, additional, Stojkovic, Stefan, additional, Scherr, Daniel, additional, Manninger-Wünscher, Martin, additional, Rohrer, Ursula, additional, Stühlinger, Markus, additional, Schgoer, Wilfried, additional, Schwarzl, Jana, additional, Pürerfellner, Helmut, additional, Derndorfer, Michael, additional, Ebner, Christian, additional, Eder, Veronika, additional, Kollias, Georgios, additional, Sturmberger, Thomas, additional, Sieghartsleitner, Stefan, additional, Vijgen, Johan, additional, Koopman, Peter, additional, Dujardin, Karl, additional, Anné, Wim, additional, De Ceuninck, Michel, additional, Tavernier, Rene, additional, Duytschaever, Mattias, additional, Knecht, Sébastien, additional, Missault, Luc, additional, Vandekerckhove, Yves, additional, Rossenbacker, Tom, additional, Ector, Bavo, additional, Charlier, Filip, additional, Debruyne, Philippe, additional, Dewilde, Willem, additional, Janssens, Luc, additional, Roosen, John, additional, Vankelecom, Bart, additional, Heidbuchel, Hein, additional, Delesie, Michiel, additional, Vervoort, Gert, additional, Rombouts, Hans, additional, Vanassche, Thomas, additional, Engelen, Matthias, additional, Verhamme, Peter, additional, Willems, Rik, additional, Constance, Christian, additional, Pranno, Nicolas, additional, Cox, Jafna, additional, Bata, Iqbal, additional, Macle, Laurent, additional, Aguilar, Martin, additional, Tourigny, Julia Cadrin, additional, Dubuc, Marc, additional, Dyrda, Katia, additional, Guerra, Peter, additional, Khairy, Paul, additional, Mondésert, Blandine, additional, Rivard, Léna, additional, Roy, Denis, additional, Tadros, Rafik, additional, Talajic, Mario, additional, Thibault, Bernard, additional, Nault, Isabelle, additional, Blier, Louis, additional, Champagne, Jean, additional, Molin, Franck, additional, O'Hara, Gilles, additional, Philippon, François, additional, Plourde, Benoit, additional, Sarrazin, Jean-François, additional, Steinberg, Christian, additional, Coufal, Zdenek, additional, Balazsik, David, additional, Mikulica, Michal, additional, Zapeca, Jakub, additional, Cermak, Ondrej, additional, Drasnar, Tomas, additional, Falc, Matej, additional, Hornof, Josef, additional, Racz, Blazej, additional, Weissova, Danica, additional, Linkova, Hana, additional, Paskova, Eva, additional, Petr, Robert, additional, Sirakova, Andrea, additional, Kettner, Jiri, additional, Benak, Ales, additional, Holek, Martin, additional, Podpera, Ivo, additional, Podperova, Monika, additional, Vancura, Vlastimil, additional, Jandik, Tomas, additional, Smid, Jiri, additional, Dedek, Vratislav, additional, Banik, Jan, additional, Durdil, Vaclav, additional, Hnat, Tomas, additional, Lellouche, Nicolas, additional, Rouffiac, Ségolène, additional, Taldir, Guillaume, additional, Bridonneau, Valentin, additional, Couffon, Philippe, additional, Daudin, Magalie, additional, Hamon, Cécile, additional, Lacaze, Jonathan, additional, Quentin, Anne, additional, Thebault, Christophe, additional, Boiffard, Emmanuel, additional, Billon, Olivier, additional, Miette, Fabien, additional, Pouliquen, Hervé, additional, Turlotte, Guillaume, additional, Gorka, Hervé, additional, Albert, Franck, additional, Bayle, Sandrine, additional, Bensaid, Reda, additional, Dasoveanu, Madalina, additional, Demichili, Thibaud, additional, Dutoiu, Teodora, additional, Khalil, Cliff, additional, Loghin, Caterina, additional, Range, Grégoire, additional, Roussel, Laurent, additional, Socié, Pierre, additional, Thuaire, Christophe, additional, Extramiana, Fabrice, additional, Algalarrondo, Vincent, additional, Boughanmi, Haten, additional, El Mansour, Noreddine, additional, Mohammad, Usman, additional, Sellier, Romain, additional, Elbaz, Meyer, additional, Laperche, Clémence, additional, Maury, Philippe, additional, Kiss, Robert, additional, Borsanyi, Tunde, additional, Gingl, Zoltan, additional, Polgar, Balaza, additional, Benczur, Bela, additional, Bodor, Alexandra, additional, Hepp, Tamas, additional, Malati, Eva, additional, Nagy, Laszlo, additional, Erdei, Norbert, additional, Kapus, Jozsef, additional, Kapus, Katalin, additional, Toth, Brigitta, additional, Matoltsy, Andras, additional, Kiss, Tunde, additional, Merkely, Bela, additional, Herczeg, Szilvia, additional, Kiss, Orsolya, additional, Sallo, Zoltan, additional, Toth, Kalman, additional, Habon, Tamas, additional, Rabai, Miklos, additional, Totsimon, Kinga, additional, Zilahi, Zsolt, additional, Bencze, Gabriella, additional, Santa, Janos, additional, Aradi, Daniel, additional, Kelemen, Barbara, additional, Bolognese, Leonardo, additional, Nesti, Martina, additional, Notarstefano, Pasquale Giovanni, additional, D'Orazio, Simona, additional, Cosmi, Franco, additional, Becattini, Cecilia, additional, Agnelli, Giancarlo, additional, Broccatelli, Belinda, additional, Mosconi, Maria Giulia, additional, Paciaroni, Maurizio, additional, Urbini, Chiara, additional, Parato, Vito Maurizio, additional, Notaristefani, Camilla, additional, Scarano, Michele, additional, Ameri, Pietro, additional, Ghigliotti, Giorgio, additional, Guglielmi, Giulia, additional, Lotti, Roberta, additional, Merlo, Andrea Carlo, additional, Muiesan, Maria Lorenza, additional, Abondio, Andrea, additional, Berasi, Caterina, additional, Mattiuzzo, Elena, additional, Mutti, Claudio, additional, Salvetti, Massimo, additional, Pignatelli, Pasquale, additional, Menichelli, Danilo, additional, Pastori, Daniele, additional, Tamiya, Eiji, additional, Matsumoto, Takahiro, additional, Takabe, Tomosato, additional, Yamamoto, Shoichi, additional, Yamashita, Haruyo, additional, Higashiue, Shinichi, additional, Furuya, Onichi, additional, Hiramatsu, Norihiko, additional, Kasuga, Kensuke, additional, Kojima, Saburo, additional, Komooka, Masatoshi, additional, Kuroyanagi, Satoshi, additional, Matsuura, Makoto, additional, Takemoto, Tetsushi, additional, Yamamoto, Shuji, additional, Saito, Katusmi, additional, Abe, Takuro, additional, Ishida, Issei, additional, Iwanami, Yuji, additional, Kataoka, Shohei, additional, Moriyama, Tetsu, additional, Murohashi, Akira, additional, Sasaki, Akihito, additional, Nakamura, Yuichiro, additional, Ueno, Tetsuya, additional, Shimane, Akira, additional, Hamana, Tomoyo, additional, Ichibori, Hirotoshi, additional, Inoue, Tomohiro, additional, Itoh, Mitsuaki, additional, Iwane, Seigo, additional, Kawai, Hiroya, additional, Kokawa, Tatsuya, additional, Masumoto, Akiko, additional, Matsuo, Koki, additional, Miyata, Taishi, additional, Nakano, Shinsuke, additional, Oishi, Shogo, additional, Onishi, Tetsuari, additional, Sawada, Takahiro, additional, Saito, Takayuki, additional, Shoda, Mitsuhiko, additional, Takahashi, Nobuyuki, additional, Takaya, Tomofumi, additional, Taniguchi, Yasuyo, additional, Tsukamoto, Shota, additional, Tsukishiro, Yasue, additional, Tsukiyama, Yoshiro, additional, Tsunamoto, Hiroshi, additional, Uzu, Kenzo, additional, Yamamoto, Hiroyuki, additional, Yamamoto, Tetsuya, additional, Yokoi, Kiminobu, additional, Yoshida, Chiaki, additional, Watanabe, Nobuhiro, additional, Betsuyaku, Tetsuo, additional, Adachi, Kumiko, additional, Awane, Kouichi, additional, Goto, Daisuke, additional, Sakakibara, Mamoru, additional, Watanabe, Masashi, additional, Ueno, Hideki, additional, Hiroe, Yoshitaka, additional, Matsuo, Koshi, additional, Ayata, Kenji, additional, Fukuda, Ko, additional, Hata, Yoshiki, additional, Hashimoto, Katsushi, additional, Matsumi, Hiroaki, additional, Nikaido, Akira, additional, Okamoto, Shuichi, additional, Sime, Iveta, additional, Stirna, Valters, additional, Reinholde, Ilze, additional, Hansone, Silvija, additional, Kozlovska, Anita, additional, Romanova, Janina, additional, Klincare, Dace, additional, Pontaga, Natalja, additional, Dirmans, Igors, additional, Kalnins, Artis, additional, Upite, Dana, additional, Gersamija, Arcils, additional, Teleznikovs, Arturs, additional, Rozkova, Nadezda, additional, Safro, Jelena, additional, Anguera Camós, Ignasi, additional, Domenico Dallaglio, Paolo, additional, Salguero Bodes, Rafael, additional, Arnbas, Fernando, additional, Borrego, Luis, additional, Marco, Alvaro, additional, Jimenez, Javier Ramos, additional, Gómez-Doblas, Juan José, additional, Pérez Cabeza, Alejandro, additional, Ferreira Gonzålez, Ignacio, additional, Limeres Freire, Javier, additional, Lopez Grau, Merce, additional, Viñolas Prat, Xavier, additional, Moreno Weidmann, Zoraida, additional, Guerra Ramos, Jose Maria, additional, Alonso Martin, Maria Concepcion, additional, Campos Garcia, Bieito, additional, Mogro Carranza, Javier Mauricio, additional, Mendez Zurita, Francisco Javier, additional, Rodriguez Font, Enrique, additional, Gonzales Matos, Carlos Eduardo, additional, García Hernando, Víctor, additional, Lindholm, Carl-Johan, additional, Thulin, Jörgen, additional, Wallén, Håkan, additional, Hagwall, Kristina, additional, Eliasson, Ken, additional, Lundvall, Martin, additional, Olsson, Jens, additional, Kjellman, Björn, additional, Lind, Markus, additional, Johansson, Lars, additional, Svedberg, Niclas, additional, Berglund, Stefan, additional, Söderberg, Julia, additional, Zedigh, Christer, additional, Mooe, Thomas, additional, Axelsson, Mattias, additional, Binsell, Emil, additional, Huber, Daniel, additional, Müller, Christian, additional, Danier, Isabelle, additional, Kühne, Michael, additional, Okamura, Bernhard, additional, Schoepfer, Hadrien, additional, Simmen, Cornelia, additional, Reichlin, Tobias, additional, Chollet, Laurève, additional, Lam, Anna, additional, Wittmer, Severin, additional, Rickli, Hans, additional, Gall, Christian, additional, Hametner, Greta, additional, Intorp, Stephanie, additional, Luescher, Daniel, additional, Haegeli, Laurent, additional, Berg, Jan Christopher, additional, Ebrahimi, Ramin, additional, Auricchio, Angelo, additional, Crljenica, Carmela, additional, Moccetti, Tizziano, additional, Monti, Cristina, additional, Pasotti, Elena, additional, Petrova, Iveta, additional, Rossi, Mariagrazia, additional, Mach, François, additional, Namdar, Mehdi, additional, de Groot, Joris, additional, Proost, Virginnio, additional, Neefs, Joline, additional, Linz, Dominik, additional, van Stipdonk, Twan, additional, den Uijl, Dennis, additional, Alings, Marco, additional, Schaap, Jeroen, additional, Segers, Dolf, additional, Wouters, Noemi, additional, Bartels, Louis, additional, Tieleman, Robert, additional, Pisters, Ron, additional, de Vries, Tim, additional, Selig, Jaap, additional, Kuijper, Aaf, additional, Bot, Pieter, additional, Keijzers, Mitran, additional, Verdel, Gerardus, additional, Tukkie, Raymond, additional, van den Bos, Ewout, additional, Kauer, Floris, additional, Oemrawsingh, Rohit, additional, Stevenhagen, Jeroen, additional, van Es, Jan, additional, Lip, Gregory, additional, Gupta, Dhiraj, additional, Kotalczyk, Agnieszka, additional, Gunstone, Anthony, additional, Brixey, Richard David, additional, Gorog, Diana, additional, Dinarvand, Danial, additional, Gue, Ying, additional, Kanji, Rahim, additional, Memtsas, Vassilios, additional, Senior, Roxy, additional, Bioh, Gabriel, additional, Wong, Yuk-Ki, additional, and Child, Nick, additional

Published
2022
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33. CCTA for Improved Assessment of Patients with Acute Chest Pain and Non-Conclusive Elevated High-Sensitivity Troponins

Author

Arslan, Murat, primary, Schaap, Jeroen, additional, Van Gorsel, Bart, additional, Aubanell, Anton, additional, Budde, Ricardo P.J., additional, Hirsch, Alexander, additional, Smulders, Martijn W., additional, Mihl, Casper, additional, Damman, Peter, additional, Sliwicka, Olga, additional, Habets, Jesse, additional, Dubois, Eric A., additional, and Dedic, Admir, additional

Published
2022
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34. Risk, Clinical Course, and Outcome of Ischemic Stroke in Patients Hospitalized With COVID-19: A Multicenter Cohort Study

Author

Sluis, Wouter M., primary, Linschoten, Marijke, additional, Buijs, Julie E., additional, Biesbroek, J. Matthijs, additional, den Hertog, Heleen M., additional, Ribbers, Tessa, additional, Nieuwkamp, Dennis J., additional, van Houwelingen, Reinier C., additional, Dias, Andreas, additional, van Uden, Ingeborg W.M., additional, Kerklaan, Joost P., additional, Bienfait, H. Paul, additional, Vermeer, Sarah E., additional, de Jong, Sonja W., additional, Ali, Mariam, additional, Wermer, Marieke J.H., additional, de Graaf, Marieke T., additional, Brouwers, Paul J.A.M., additional, Asselbergs, Folkert W., additional, Kappelle, L. Jaap, additional, van der Worp, H. Bart, additional, Algra, Annemijn M., additional, Donders, Richard C.J.M., additional, Pruissen, D. Martijn O., additional, Kuijper, Aaf F.M., additional, van Ofwegen-Hanekamp, Clara E.E., additional, Hermanides, Rik S., additional, Haerkens-Arends, Hortence E., additional, Anthonio, Rutger L., additional, Emans, Mireille E., additional, Tio, René A., additional, ten Berg, Jur M., additional, Groenemeijer, Björn E., additional, Pisters, Ron, additional, van der Zee, P. Marc, additional, Siebelink, Hans-Marc J., additional, Verschure, Derk O., additional, Meijs, Matthijs F.L., additional, Schut, Astrid, additional, Tieleman, Robert G., additional, Hermans-van Ast, Wanda, additional, Schaap, Jeroen, additional, Jewbali, Lucia S., additional, Smits, Peter C., additional, van der Harst, Pim, additional, van Smeden, Maarten, additional, and van Gilst, Wiek H., additional

Published
2021
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35. Coronary CT angiography for improved assessment of patients with acute chest pain and low-range positive high-sensitivity troponins: study protocol for a prospective, observational, multicentre study (COURSE trial)

Author

Arslan, Murat, primary, Schaap, Jeroen, additional, Van Gorsel, Bart, additional, Budde, Ricardo PJ, additional, Bekkers, Sebastiaan CAM, additional, Van Cauteren, Yvonne JM, additional, Damman, Peter, additional, Habets, Jesse, additional, Dubois, Eric A, additional, and Dedic, Admir, additional

Published
2021
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36. Drug Distribution in Brain and Cerebrospinal Fluids in Relation to IC50 Values in Aging and Alzheimer's Disease, Using the Physiologically Based LeiCNS-PK3.0 Model.

Author

Saleh, Mohammed A. A., Bloemberg, Julia S., Elassaiss-Schaap, Jeroen, and de Lange, Elizabeth C. M.

Subjects
ALZHEIMER'S disease, CEREBROSPINAL fluid examination, ALZHEIMER'S patients, CEREBROSPINAL fluid, BLOOD-brain barrier, SUBARACHNOID space, AGING
Abstract

Background: Very little knowledge exists on the impact of Alzheimer's disease on the CNS target site pharmacokinetics (PK). Aim: To predict the CNS PK of cognitively healthy young and elderly and of Alzheimer's patients using the physiologically based LeiCNS-PK3.0 model. Methods: LeiCNS-PK3.0 was used to predict the PK profiles in brain extracellular (brainECF) and intracellular (brainICF) fluids and cerebrospinal fluid of the subarachnoid space (CSFSAS) of donepezil, galantamine, memantine, rivastigmine, and semagacestat in young, elderly, and Alzheimer's patients. The physiological parameters of LeiCNS-PK3.0 were adapted for aging and Alzheimer's based on an extensive literature search. The CNS PK profiles at plateau for clinical dose regimens were related to in vitro IC50 values of acetylcholinesterase, butyrylcholinesterase, N-methyl-D-aspartate, or gamma-secretase. Results: The PK profiles of all drugs differed between the CNS compartments regarding plateau levels and fluctuation. BrainECF, brainICF and CSFSAS PK profile relationships were different between the drugs. Aging and Alzheimer's had little to no impact on CNS PK. Rivastigmine acetylcholinesterase IC50 values were not reached. Semagacestat brain PK plateau levels were below the IC50 of gamma-secretase for half of the interdose interval, unlike CSFSAS PK profiles that were consistently above IC50. Conclusion: This study provides insights into the relations between CNS compartments PK profiles, including target sites. CSFSAS PK appears to be an unreliable predictor of brain PK. Also, despite extensive changes in blood-brain barrier and brain properties in Alzheimer's, this study shows that the impact of aging and Alzheimer's pathology on CNS distribution of the five drugs is insignificant. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo‐Leiro, Maria G., Dahlström, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cândida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Besada, Diego Alejandro, Majul, Claudio Rodolfo, Bruno, Marco Raul Litvak, Sassone, Sonia, Avaca, Horacio Alberto, Rasmussen, Mariela, Aiub, Jorge Roberto, Hominal, Miguel Angel, Perna, Eduardo, Duran, Ruben Omar Garcia, Schiavi, Lilia, Marquez, Lilia Luz Lobo, Vilamajo, Oscar Alberto Gomez, Mackinnon, Ignacio, Fuente, Ricardo Alfonso Leon, Montana, Oscar Romano, Novaretto, Leonardo, Guerrero, Rodolfo Andres Ahuad, Brasca, Daniela Garcia, Prado, Aldo, Garrido, Marcelo Alejandro, Luquez, Hugo, Martinez, Diego Felipe, Nicolosi, Liliana, Parody, Maria Leonor, Zaidman, Cesar, Berra, Fernando Colombo, Ibañez, Julio, Zapata, Gerardo, Caccavo, Alberto, Colque, Roberto, Diez, Mirta, Poy, Carlos, Salomone, Oscar Alejandro, Vogel, Daniel, Bordonava, Anselmo Paulino, Fernandez, Alberto, French, John, Atherton, John, Hamilton, Andrew, Begg, Alistair, Abhayaratna, Walter, Judkins, Christopher, De Pasquale, Carmine, McKenzie, Scott, Amerena, John, Szto, Gregory, Kearney, Leighton, Zimmet, Hendrik, Sverdlov, Aaron, Beltrame, John, Korczyk, Dariusz, Sindone, Andrew, Moertl, Deddo, Huber, Kurt, Huelsmann, Martin, Ablasser, Klemens, Ebner, Christian, Siostrzonek, Peter, Drexel, Heinz, Poelzl, Gerhard, Dujardin, Karl, Dupont, Matthias, Buysschaert, Ian, Lancellotti, Patrizio, Droogne, Walter, Chouchane, Iman, Silveira, Fabio, Rassi, Salvador, Reis, Gilmar, Filho, Pedro Pimentel, Simoes, Marcus Vinicius, Braga, Joao Carlos, Giorgeto, Flavio Eduardo, Ferraz, Almir, Jaeger, Cristiano Pederneiras, Saraiva, Jose Francisco, Tognon, Alexandre, Cardoso, Juliano, Greco, Oswaldo, Paiva, Maria Sanali, Paolino, Bruno, Filho, Otavio Coelho, Maia, Lilia Nigro, Silva, Rodrigo, Canesin, Manoel, Rossi, Paulo Roberto Ferreira, Fortes, Jose Augusto Ribas, Cerci, Rodrigo Julio, Manenti, Euler Roberto Fernandes, Leaes, Paulo Ernesto, Silva Neto, Luis Beck, Souza, Weimar Kunz Barroso, Bacal, Fernando, Chaves, Renato, Ramires, Felix, Vidotti, Maria Helena, Barros e Silva, Pedro Gabriel Melo, Piegas, Leopoldo Soares, Todorov, Georgi, Tzekova, Maria, Goudev, Assen, Mincheva, Valentina, Vasilev, Ivaylo, Tisheva‐ Gospodinova, Snezhanka, Petrov, Ivo, Postadzhiyan, Arman, Velikov, Chavdar, Dimov, Bojidar, Constance, Christian, Phaneuf, Denis‐Carl, Mielniczuk, Lisa, Pandey, A Shekhar, Senaratne, Manohara, Zieroth, Shelley, Savard, Daniel, Stewart, Robert, Huynh, Thao, Giannetti, Nadia, Moe, Gordon, Bourgeois, Ronald, Ezekowitz, Justin, Hartleib, Michael, Sussex, Bruce, Babapulle, Mohan, Chehayeb, Raja, Gaudet, Daniel, McKelvie, Robert, Nguyen, Viviane, Roth, Sherryn, Gupta, Milan, Pesant, Yves, Rupka, Dennis, Bhargava, Rakesh, Costa‐Vitali, Atilio, Proulx, Guy, Vega, Mario, Potthoff, Sergio, Cid, Maria Cristina Schnettler, Sepulveda, Alex Mauricio Villablanca, Zanetti, Fernando Tomas Lanas, Gajardo, Victor Areli Saavedra, Kindel, Carlos Conejeros, Jofre, Christian Paolo Pincetti, Segarra, Jorge Leonardo Cobos, Venegas, Manuel Eduardo Rodriguez, Hidalgo, Mario Yanez, Jalaf, Margarita Gertrudis Vejar, Li, Weimin, Zhang, Jinguo, Fu, Xin, Zhang, Xuelian, Li, Dongye, Wang, Zhifang, Qu, Yanling, Zheng, Zhe, Tang, Huifang, Yang, Ping, Zhang, Yuhui, Zheng, Yang, Mi, Yafei, Huang, He, Bu, Peili, Chen, Guoqin, Chen, Jiyan, Han, Yajun, Li, Zhangquan, Ma, Shumei, Yang, Xuming, Yuan, Zuyi, Dong, Yugang, Li, Zhaoping, Mahemuti, Ailiman, Niu, Wentang, Yang, Zhenyu, Zhang, Yuqing, Sun, Yuemin, Wu, Weiheng, Liu, Feng, Yan, Jing, Li, Yinjun, Wang, Yi, Zhang, Shouyan, Zhou, Changyong, Cui, Hanbin, Li, Jianjun, Li, Tianfa, Han, Qinghua, Wei, Yu, Correa, Luis Eduardo Echeverria, Mendoza, Jose Luis Accini, Jattin, Fernando Manzur, Osorio, Wilder Castaño, Luengas, Carlos Alberto, Arroyo, Julian Alonso Coronel, Corredor, Miguel Alfredo Moncada, Giraldo, Clara Ines Saldarriaga, Lopez, Rodrigo Botero, Salazar, Dora Ines Molina, Triana, Miguel Urina, Lopez, Luis Horacio Atehortua, Rojas, Pastor Olaya, Pelaez, Sebastian Velez, Pareja, Monica Lopez, Bonfanti, Alberto Cadena, Polasek, Rostislav, Monhart, Zdenek, Sochor, Karel, Motovska, Zuzana, Belohlavek, Jan, Busak, Ladislav, Krupicka, Jiri, Tyl, Petr, Jerabek, Ondrej, Podpera, Ivo, Skrobakova, Janka, Peterka, Karel, Spacek, Rudolf, Cech, Vladimir, Kellnerova, Ivana, Nechvatal, Libor, Pozdisek, Zbynek, Houra, Marek, Kryza, Radim, Machova, Vilma, Cepelak, Michal, Stepek, David, Zeman, Kamil, Klimsa, Zdenek, Koleckar, Pavel, Schee, Alexandr, Spinarova, Lenka, Coufal, Zdenek, Jeppesen, Jorgen, Vraa, Soren, Wiggers, Henrik, Nyvad, Ole, Nielsen, Tonny, Kaiser‐Nielsen, Peter, Videbaek, Lars, Galinier, Michel, Lefebvre, Jean‐Marie, Tartiere, Jean‐Michel, De Geeter, Guillaume, Roubille, Francois, Ricci, Jean Etienne, Salvat, Muriel, Gueffet, Jean‐Pierre, Decoulx, Eric, Berdague, Philippe, Jondeau, Guillaume, Ovize, Michel, Groote, Pascal De, Donal, Erwan, Isnard, Richard, Sabatier, Rémi, Trochu, Jean Noel, Damy, Thibaud, Georges, Jean‐Louis, Rosamel, Yann, Picard, François, Aboyans, Victor, Laperche, Thierry, Mitrovic, Veselin, Taggeselle, Jens, Störk, Stefan, Ebelt, Henning, Genth‐Zotz, Sabine, Rassaf, Tienush, Duengen, Hans‐Dirk, Mittag, Marcus, Menck, Niels, Zeymer, Uwe, Haehling, Stephan, Boehm, Michael, Frankenstein, Lutz, Killat, Holger, Bourhaial, Hakima, Beug, Daniel, Horacek, Thomas, Pfister, Roman, Sandri, Marcus, Westenfeld, Ralf, Kadel, Christoph, Karvounis, Haralambos, Patsilinakos, Sotirios, Mantas, Ioannis, Karavidas, Apostolos, Giamouzis, Grigorios, Tsioufis, Konstantinos, Naka, Katerina, Tziakas, Dimitrios, Parissis, John, Styliadis, Ioannis, Barbetseas, Ioannis, Manolis, Athanasios, Kochiadakis, George, Herczeg, Bela, Nagy, Laszlo, Nyolczas, Noemi, Toth, Kalman, Merkely, Bela, Laszlo, Zoltan, Mark, Laszlo, Szakal, Imre, Papp, Andras, Bezzegh, Katalin, Lakatos, Ferenc, Hajko, Erik, Papp, Aniko, Forster, Tamas, Lupkovics, Geza, Mohacsi, Attila, Salamon, Csaba, Aradi, Daniel, Andreka, Peter, Szasz, Gyula, Zilahi, Zsolt, Kazinczy, Rita, Margonato, Alberto, Agostoni, Piergiuseppe, Fucili, Alessandro, Piovaccari, Giancarlo, Senni, Michele, Carluccio, Erberto, Bilato, Claudio, Frigerio, Maria, Indolfi, Ciro, Sinagra, Gianfranco, Brunetti, Natale Daniele, Perna, Gianpiero, Pini, Daniela, Volterrani, Maurizio, Leonardi, Sergio, Mortara, Andrea, Friz, Hernan Emilio Francisco Polo, Rossini, Roberta, Tocchetti, Carlo Gabriele, Vincenzi, Antonella, Cavallini, Claudio, Floresta, Agata Marina, Zaca, Valerio, Giudici, Vittorio, Villani, Giovanni Quinto, Higashino, Yorihiko, Oishi, Shogo, Wada, Atsuyuki, Fukuzawa, Shigeru, Onoue, Kenji, Koike, Akihiro, Koizumi, Tomomi, Masuda, Seigo, Mitsuo, Kazuhisa, Takahashi, Natsuki, Takenaka, Takashi, Tanabe, Jun, Watanabe, Naoki, Yoshida, Takeshi, Amano, Tetsuya, Ishikawa, Masahiro, Kida, Keisuke, Kubota, Toru, Nakamura, Kentaro, Sakamoto, Tomohiro, Shimomura, Mitsuhiro, Yuge, Masaru, Doi, Masayuki, Domae, Hiroshi, Ebato, Mio, Fujii, Kenshi, Fujiwara, Wakaya, Gohara, Seiichiro, Hata, Yoshiki, Kanda, Junji, Kitaoka, Hiroaki, Matsumoto, Takashi, Michishita, Ichiro, Miura, Shinichiro, Miyazaki, Tetsuro, Nakamura, Akihiro, Ogawa, Tomohiro, Okumura, Takahiro, Okumura, Yasuo, Sakai, Tetsuo, Sato, Yukihito, Shimizu, Wataru, Sugino, Hiroshi, Suzuki, Masahiro, Takagi, Atsutoshi, Takaishi, Hiroshi, Tanaka, Takahiro, Terasaki, Toshiro, Tsujimoto, Mitsuru, Ueda, Yasunori, Ujino, Keiji, Usui, Makoto, Yamamoto, Mitsutaka, Yoshikawa, Masaki, Ando, Kenji, Asakura, Masanori, Asano, Hiroshi, Fujii, Shigeru, Hara, Hisao, Inomata, Takayuki, Isshiki, Takaaki, Kadokami, Toshiaki, Kai, Hisashi, Kasai, Toshio, Kawamitsu, Katsunori, Kawasaki, Tomohiro, Koga, Tokushi, Komiyama, Nobuyuki, Maejima, Yasuhiro, Manita, Mamoru, Miyamoto, Nobuhide, Node, Koichi, Numaguchi, Kotaro, Sakata, Yasushi, Serikawa, Takeshi, Takama, Noriaki, Tatebe, Shunsuke, Ueno, Hideki, Hidaka, Takayuki, Hiroi, Shitoshi, Iseki, Harukazu, Ito, Hiroshi, Kajinami, Kouji, Kawakami, Hideo, Momiyama, Yukihiko, Mori, Masuki, Morita, Yukiko, Okishige, Kaoru, Sakagami, Satoru, Takeishi, Yasuchika, Terasawa, Akihiro, Utsu, Noriaki, Badariene, Jolita, Celutkiene, Jelena, Slapikas, Rimvydas, Jarasuniene, Dalia, Castillo, Armando Garcia, De los Rios Ibarra, Manuel Odin, Lopez, Gabriel Arturo Ramos, Llamas, Edmundo Alfredo Bayram, Esperon, Guillermo Antonio Llamas, Vazquez, Eduardo Salcido, Gonzalez, Ricardo Garcia, Leon, Jose Luis Arenas, Gonzalez, Salvador Leon, Mendoza, Maria Alexandra Arias, Rodriguez, Alicia Contreras, Machado, Gustavo Francisco Mendez, Salazar, Melchor Alpizar, Ruiz, Alberto Esteban Bazzoni, Flores, Ana Maria De Leon, Carrasco, Jose Alfredo Pagola, Araiza, Raul Reyes, Römer, Tjeerd, Remmen, Johannes, Van Eck, Jacob, Elvan, Arif, Smilde, Tom, Voors, Adriaan, Wal, Ruud, Schaap, Jeroen, Sluis, Aize, Linssen, Gerardus, Magro, Michael, Willems, Frank, Hal, John, Zwaan, Coenraad, Beelen, Driek, Boswijk, Dirk, Hermans, Walter, Van Kesteren, Henricus, Scott, Russell, Hart, Hamish, Lund, Marianne, Szczasny, Marcin, Blicharski, Tomasz, Kafara, Mariusz, Stankiewicz, Anna, Skonieczny, Grzegorz, Zabowka, Maciej, Kania, Grzegorz, Kopaczewski, Jerzy, Pawlowicz, Lidia, Spyra, Janusz, Wlodarczyk, Aleksander, Sciborski, Ryszard, Balsam, Pawel, Drozdz, Jaroslaw, Sobkowicz, Bozena, Konieczynska, Malgorzata, Lelonek, Malgorzata, Bednarkiewicz, Zbigniew, Trebacz, Jaroslaw, Jankowski, Piotr, Sidor, Mateusz, Berkowski, Piotr, Chmielak, Zbigniew, Lenartowska, Lucyna, Nessler, Jadwiga, Straburzynska‐Migaj, Ewa, Kalarus, Zbigniew, Kowalski, Robert, Kalecinska‐Krystkiewicz, Ewa, Gola, Zbigniew, Pijanowski, Zbigniew, Wozakowska‐Kaplon, Beata, Cymerman, Krzysztof, Rynkiewicz, Andrzej, Miekus, Pawel, Monteiro, Pedro, Sarmento, Pedro Morais, Almeida, Filipa, Duarte, Tatiana, Fonseca, Candida, Oliveira, Luis, Santos, Luis, Brito, Dulce, Stanciulescu, Gabriela, Spiridon, Marilena Renata, Militaru, Constantin, Podoleanu, Cristian Gheorghe, Zdrenghea, Dumitru, Popescu, Mircea Ioachim, Macarie, Cezar‐Eugen, Giuca, Alina, Mitu, Florin, Voicu, Olga‐Cristina, Dorobantu, Maria, Lighezan, Daniel, Stamate, Sorin, Bykov, Alexander, Kobalava, Zhanna, Zrazhevskiy, Konstantin, Semenova, Irina, Vishnevsky, Alexander, Shutemova, Elena, Tereschenko, Sergey, Shvarts, Yury, Barbarash, Olga, Lukyanov, Yury, Voevoda, Mikhail, Dovgolis, Svetlana, Dronov, Dmitry, Goloshchekin, Boris, Sitnikova, Maria, Ezhov, Marat, Tarasov, Nikolay, Kotelnikov, Mikhail, Kostenko, Viktor, Solovev, Oleg, Goncharov, Ivan, Myasnikov, Roman, Rafalskiy, Vladimir, Ryabov, Vyacheslav, Kosmacheva, Elena, Motylev, Igor, Nosov, Vladimir, Osipova, Irina, Salukhov, Vladimir, Belenkiy, Dmitriy, Bolshakova, Olga, Pimenov, Leonid, Shilkina, Nataliya, Kulibaba, Elena, Repin, Alexey, Timofeev, Alexander, Mitrokhin, Vladislav, Sherenkov, Alexander, Arbolishvili, Georgy, Antalik, Lubomir, Dzupina, Andrej, Fulop, Peter, Majercak, Ivan, Gonsorcik, Jozef, Vinanska, Daniela, Lenner, Egon, Lukacova, Jana, Margoczy, Roman, Smik, Rudolf, Stevlik, Jan, Uhliar, Rudolf, Burgess, Lesley, Badat, Aysha, Klug, Eric, Van Zyl, Louis, Abelson, Mark, Moodley, Rajendran, Tsabedze, Nqoba, Fourie, Nyda, Bonet, Luis Almenar, Prado, Jose Maria Arizon, Oliveira Soares, Manue Martinez‐Selles D, Villota, Julio Eduardo Nuñez, Leiro, Maria Generosa Crespo, Juanatey, Jose Ramon Gonzalez, Figal, Domingo Andres Pascual, Palomas, Juan Luis Bonilla, Perez, Sonia Mirabet, Jimenez, Juan Francisco Delgado, Padron, Antonio Lara, Diaz, Victor Alfonso Jimenez, Cubero, Javier Segovia, Paya, Vicente Eduardo Climent, Mayoral, Alejandro Recio, Fuente Galan, Luis, Doblas, Juan Jose Gomez, Freire, Ramon Bover, Peiro, Maria Teresa Blasco, Molina, Beatriz Diaz, Martinez, Laura Jordan, Vilchez, Francisco Gonzalez, Boman, Kurt, Karlstrom, Patric, Berglund, Stefan, Szabo, Barna, Peterson, Magnus, Wodlin, Peter, Lindholm, Carl‐Johan, Moccetti, Tiziano, Mueller, Christian, Suter, Thomas, Hullin, Roger, Meyer, Philippe, Noll, Georg, Yigit, Zerrin, Turgut, Okan Onur, Bekar, Lutfu, Sahin, Tayfun, Koldas, Zehra Lale, Celik, Ahmet, Cavusoglu, Yuksel, Demir, Mesut, Onrat, Ersel, Duzenli, Mehmet, Cosansu, Kahraman, Muderrisoglu, Ibrahim Haldun, Tuncer, Mustafa, Badak, Ozer, Nalbantgil, Sanem, Kirma, Cevat, Okuyan, Ertugrul, Guray, Umit, Prokhorov, Oleksandr, Karpenko, Oleksandr, Vakaliuk, Igor, Yagensky, Andriy, Kracz, Igor, Stanislavchuk, Mykola, Kulynych, Oleksii, Rishko, Mykola, Stets, Roman, Tseluyko, Vira, Mishchenko, Larysa, Rudenko, Leonid, Rudyk, Iurii, Alieksieieva, Liudmyla, Korzh, Oleksii, Mostovoy, Yuriy, Parkhomenko, Oleksandr, Rasputina, Lesya, Voronkov, Leonid, Lymar, Yurii, Vasilyeva, Larysa, Keeling, Philip, Barr, Craig, Wong, Kenneth, Price, Dallas, Skaria, Binoy, Clark, Andrew, Chandrasekaran, Badrinathan, Trevelyan, Jasper, Gordon, Brian, Donnelly, Patrick, Glover, Jason, Ryding, Alisdair, Weir, Robin, Lang, Chim, Roy, Debashis, Adhya, Shaumik, Clifford, Piers, Ludman, Andrew, Kalra, Paul, Lynch, Mary, Mahmood, Shahid, Al Mohammad, Abdallah, Asubiaro, Joshua, Elmahi, Einas, Muthumala, Amal, Taylor, Justin, Gupta, Dinesh, Nadar, Venkatesh, Henderson, David, Zolty, Ronald, Sauer, Andrew, Adams, Kirkwood, Chandra, Lokesh, Jaffrani, Naseem, Grewal, Gurinder, Mancini, Donna, McLean, Dalton, Vasallo, Javier, Gottlieb, Stephen, Joseph, Susan, Barua, Rajat, Gorodeski, Eiran, Mouhaffel, Asad, Chung, Eugene, Desai, Pratik, Portnay, Edward, Rama, Bhola, Shandling, Adrian, Stahl, Llyod, Heilman, Karl, Jacob, Binu, Londono, Juan, Almousalli, Omar, Ashcom, Thomas, Bauerlein, Eugene Joseph, Koo, Charles, McGrew, Frank, Rajagopalan, Navin, Robinson, Shawn, Schultz, David, Starling, Randall, Ambardekar, Amrut, Bhagwat, Ravi, Boehmer, John, Bouza, Manuel, Farris, Neil, Feitell, Scott, Ganji, Jagadeesh, Geltman, Edward, Javier, Julian, Morrow, John Andrew, Pianko, Leonard, Smart, Frank, Adler, Alexander, Brinkley, Douglas, Cardona, Jose, Coletti, Andrew, Harris, John, Hunter, Vernon, Krantz, Mori, Lang, Christopher, Lovell, Charles, Murray, David, Pillutla, Priya, Shah, Amit, Bogaev, Roberta, Dauber, Ira, Franchi, Francesco, Fremont, Richard, Hart, Terence, Hattler, Brack, Janik, Matthew, Khalife, Wissam, Malhotra, Sanjay, Mamdani, Shafiq, Nelson, William, Orgera, Marisa, Ortiz, Aurelio, Rahko, Peter, Rennyson, Stephen, Shin, Jooyoung, Tsao, Lana, Uretsky, Barry, Wahid, Faisal, Wilkett, Matt, Amanullah, Aman, Baker, Mathue, Berk, Martin, Boccalandro, Fernando, Cruz, Kimberly, Doyle, Timothy, Gianfagna, Robert, Jones, Alonzo, King, Anthony, Lepor, Norman, Martinez‐Castrillon, Melvin, Pham, Michael, Radin, Michael, Radojevic, Joseph, Ramanathan, Kodangudi, Schmalfuss, Carsten, Schnitzler, Robert, Shah, Keyur, Takata, Theodore, Bertolet, Barry, Bostick, Brian, Civitello, Andrew, Collins, John, Dib, Nabil, Fang, James, Gilmore, Richard, Gray, Wayne, Grazette, Luanda, Haddad, Tariq, Hearne, Steven, Janmohamed, Munir, Katz, Richard, Kazemi, Navid, Llerena, Sara, Lohr, Nicole, Marzouka, George, Mignone, John, Ooi, Henry, Paszczuk, Anna, Pickett, Christopher, Sampognaro, Gregory, Sawyer, Douglas, Shayani, Steven, Treasure, Charles, Vaz, Garth, Vijay, Nampalli, Williams, Celeste, Yeoman, Gary, Zhang, Lily, Aaronson, Keith, Abo‐Auda, Wael, Alharethi, Rami, Anderson, William, Ariani, Mehrdad, Banerji, Sourin, Baweja, Paramdeep, Carson, Peter, Eberly, Arthur, Elliott, James, Fernando, Ronald, Fisher, Daniel, Forman, Steven, Gabriel, George, Gogia, Harinder, Hametz, Craig, Houston, Brian, Ibrahim, Hassan, Jadbabaie, Farid, Kassiotis, Christos, Krishnamoorthy, Arun, Kwan, Michael, Lupovitch, Steven, Macias, Leonardo, Malik, Adnan, Martinez, Luis, Miyamoto, Michael, Mody, Freny, Patel, Devesh, Peart, Brenda, Pisani, Barbara, Ramos, Mark, Rivero, Mariel, Shah, Anil, Sharma, Mukesh, Sichrovsky, Tina, Simon, Marc, Singh, Deovrat, Tallet, Julio, Vaccari, Christopher, Villoch, Mario, Wheeler, Matthew, Yousuf, Kabir, Abadier, Rafik, Abdullah, Shuaib, Arora, Raveen, Aslam, Shamaila, Buynak, Robert, Chang, David, Contreras, Johanna, Halpern, Stephen, Handel, Franklin, Heitner, John, Herzog, William, Jackson, Bruce, Kao, John, Kondo, Nicholas, Koren, Michael, LeWinter, Martin, Martindale, Jeffrey, Martinez‐Arraras, Joaquin, Olsen, Stephanie, Piatek, Marek, Ranadive, Nandkishore, Randall, William, Rao, Sunder, Rawitscher, David, Rider, James, Sokos, George, Strader, J Russell, Sulemanjee, Nasir, Tahirkheli, Naeem, Trichon, Benjamin, Vanhecke, Thomas, Whellan, David, Abuannadi, Mohammad, Aggarwala, Gaurav, Ahmad, Saad, Artis, Andre, Cheirif, Jorge, Cotarlan, Vladimir, Cox, Jeremy, Eaton, Charles, Florea, Viorel, Frank, Theodore, Friedman, Keith, Ganeshram, Vedampattu, Gass, Alan, Gemignani, Anthony, Hasni, Syed, Hedgepeth, Chester, Itchhaporia, Dipti, Kaluski, Edo, Karim, Amin, Kono, Alan, Lader, Ellis, Lakshminarayanan, Batlagundu, Lewis, Neil, Malhotra, Vinay, Mayer, Nolan, Mohapatra, Robert, Nair, Nandini, O'Brien, Terrence, Pauwaa, Sunil, Rowan, Christopher, Saxena, Sanjeev, Seto, Arnold, Shah, Nishant, Singh, Pradeep, Skopicki, Hal, Stoddard, Marcus, and Sweitzer, Nancy

Subjects
R1
Abstract

Aims:\ud The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.\ud \ud Methods and Results:\ud Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure

Published
2020

41. Colchicine in Patients with Chronic Coronary Disease

Author

Nidorf, Stefan M., primary, Fiolet, Aernoud T.L., additional, Mosterd, Arend, additional, Eikelboom, John W., additional, Schut, Astrid, additional, Opstal, Tjerk S.J., additional, The, Salem H.K., additional, Xu, Xiao-Fang, additional, Ireland, Mark A., additional, Lenderink, Timo, additional, Latchem, Donald, additional, Hoogslag, Pieter, additional, Jerzewski, Anastazia, additional, Nierop, Peter, additional, Whelan, Alan, additional, Hendriks, Randall, additional, Swart, Henk, additional, Schaap, Jeroen, additional, Kuijper, Aaf F.M., additional, van Hessen, Maarten W.J., additional, Saklani, Pradyot, additional, Tan, Isabel, additional, Thompson, Angus G., additional, Morton, Allison, additional, Judkins, Chris, additional, Bax, Willem A., additional, Dirksen, Maurits, additional, Alings, Marco, additional, Hankey, Graeme J., additional, Budgeon, Charley A., additional, Tijssen, Jan G.P., additional, Cornel, Jan H., additional, and Thompson, Peter L., additional

Published
2020
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42. 814 MCLA-145 (CD137xPD-L1): a potent CD137 agonist and immune checkpoint inhibitor that that does not show signs of peripheral toxicity

Author

Bol, Kees, primary, Marissen, Wilfred, additional, Elaissais-Schaap, Jeroen, additional, Tacken, Paul, additional, Engels, Steef, additional, Wang, Liang-Chuan, additional, Mondal, Arpita, additional, Throsby, Mark, additional, Roberts, Alan, additional, Mayes, Patrick, additional, and Geuijen, Cecile, additional

Published
2020
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43. [Untitled]

Author

Schaap, Jeroen, de Groot, Joris A H, Nieman, Koen, Meijboom, W Bob, Boekholdt, S Matthijs, Post, Martijn C, Van der Heyden, Jan A, de Kroon, Thom L, Rensing, Benno J W M, Moons, Karel GM, and Verzijlbergen, J Fred

Published
2013
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47. Diurnal modulation of pacemaker potentials and calcium current in the mammalian circadian clock

Author

Pennartz, Cyriel M. A., de Jeu, Marcel T. G., Bos, Nico P. A., Schaap, Jeroen, and Geurtsen, Alwin M. S.

Subjects
Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Author(s): Cyriel M. A. Pennartz (corresponding author); Marcel T. G. de Jeu; Nico P. A. Bos; Jeroen Schaap; Alwin M. S. Geurtsen It has long been known that neurons in [...]

Published
2002
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50. TEXT-MINING IN ELECTRONIC HEALTHCARE RECORDS FOR EFFICIENT RECRUITMENT AND DATA-COLLECTION IN CARDIOVASCULAR TRIALS: A MULTICENTER VALIDATION STUDY

Author

Dijk, Wouter Van, primary, Fiolet, Aernoud, additional, Schuit, Ewoud, additional, Sammani, Arjan, additional, Groenhof, Katrien, additional, van der Graaf, Rieke, additional, de Vries, Martine, additional, Alings, Marco, additional, Schaap, Jeroen, additional, Asselbergs, Folkert, additional, Grobbee, Diederick, additional, Groenwold, Rolf, additional, and Mosterd, Arend, additional

Published
2020
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