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4. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Author

Adir, Yochai, Baillie, Timothy, Baratz, David, Burger, Charles, Chakinala, Murali M., Cifrián Martínez, Jose Manual, Delcroix, Marion, Dwyer, Nathan, Elwing, Jean M., Fisher, Micah, Franco, Veronica, Grünig, Ekkehard, Highland, Kristin, Hill, Nicholas, Hirani, Naushad, Hoeper, Marius, Jansa, Pavel, Keogh, Anne, Kingrey, John, Lopez-Meseguer, Manuel, McConnell, John W., Mehta, Sanjay, Melendres-Groves, Lana, Opitz, Christian, Pepke-Zaba, Joanna, Pillutla, Priya, Rahaghi, Franck, Raina, Amresh, Raviv, Yael, Robinson, Jeffrey, Ryan, John, Sager, Jeffrey, Shapiro, Shelley, Simon, Marc, Smith, Kerri, Sobol, Irina R., Sood, Namita, Spikes, Leslie A., Stadler, Stefan, Stevens, Wendy, Sulica, Roxana, White, R. James, Frantz, Robert P, McLaughlin, Vallerie V, Sahay, Sandeep, Escribano Subías, Pilar, Zolty, Ronald L, Benza, Raymond L, Channick, Richard N, Chin, Kelly M, Hemnes, Anna R, Howard, Luke S, Sitbon, Olivier, Vachiéry, Jean-Luc, Zamanian, Roham T, Cravets, Matt, Roscigno, Robert F, Mottola, David, Osterhout, Robin, Bruey, Jean-Marie, Elman, Erin, Tompkins, Cindy-ann, Parsley, Ed, Aranda, Richard, Zisman, Lawrence S, and Ghofrani, Hossein-Ardeschir

Published
2024
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13. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial.

Author

Frantz, Robert P, McLaughlin, Vallerie V, Sahay, Sandeep, Escribano Subías, Pilar, Zolty, Ronald L, Benza, Raymond L, Channick, Richard N, Chin, Kelly M, Hemnes, Anna R, Howard, Luke S, Sitbon, Olivier, Vachiéry, Jean-Luc, Zamanian, Roham T, Cravets, Matt, Roscigno, Robert F, Mottola, David, Osterhout, Robin, Bruey, Jean-Marie, Elman, Erin, and Tompkins, Cindy-ann

Subjects
PULMONARY arterial hypertension, C-kit protein, MACROPHAGE colony-stimulating factor, PLATELET-derived growth factor receptors, VASCULAR remodeling, COUGH, PULMONARY hypertension
Abstract

Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory, proliferative, and fibrotic pathways driving pulmonary vascular remodelling in PAH. Seralutinib, an inhaled kinase inhibitor, targets these pathways. We aimed to evaluate the efficacy and safety of seralutinib in patients with PAH receiving standard background therapy. The TORREY trial was a phase 2, randomised, multicentre, multinational, double-blind, placebo-controlled study. Patients with PAH from 40 hospital and community sites were randomly assigned 1:1 via interactive response technologies to receive seralutinib (60 mg twice daily for 2 weeks, then increased to 90 mg twice daily as tolerated) or placebo by dry powder inhaler twice daily for 24 weeks. Randomisation was stratified by baseline pulmonary vascular resistance (PVR; <800 dyne·s/cm5 and ≥800 dyne·s/cm5). Patients were eligible if classified as WHO Group 1 PH (PAH), WHO Functional Class II or III, with a PVR of 400 dyne·s/cm5 or more, and a 6 min walk distance of between 150 m and 550 m. The primary endpoint was change in PVR from baseline to 24 weeks. Analyses for efficacy endpoints were conducted in randomly assigned patients (intention-to-treat population). Safety analyses included all patients who received the study drug. TORREY was registered with ClinicalTrials.gov (NCT04456998) and EudraCT (2019-002669-37) and is completed. From Nov 12, 2020, to April 20, 2022, 151 patients were screened for eligibility, and following exclusions, 86 adults receiving PAH background therapy were randomly assigned to seralutinib (n=44; four male, 40 female) or placebo (n=42; four male, 38 female), and comprised the intention-to-treat population. At baseline, treatment groups were balanced except for a higher representation of WHO Functional Class II patients in the seralutinib group. The least squares mean change from baseline to week 24 in PVR was 21·2 dyne·s/cm5 (95% CI −37·4 to 79·8) for the placebo group and −74·9 dyne·s/cm5 (−139·7 to −10·2) for the seralutinib group. The least squares mean difference between the seralutinib and placebo groups for change in PVR was −96·1 dyne·s/cm5 (95% CI −183·5 to −8·8; p=0·03). The most common treatment-emergent adverse event in both treatment groups was cough: 16 (38%) of 42 patients in the placebo group; 19 (43%) of 44 patients in the seralutinib group. Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH. Gossamer Bio. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Safety and tolerability of transition from inhaled treprostinil to oral selexipag in pulmonary arterial hypertension: Results from the TRANSIT-1 study

Author

Frost, Adaani, Janmohamed, Munir, Fritz, Jason S., McConnell, John W., Poch, David, Fortin, Terry Ann, Miller, Chad E., Chin, Kelly M., Fisher, Micah, Eggert, Michael, McEvoy, Colleen, Benza, Raymond L., Farber, Harrison W., Kim, Nick H., Pfister, Thomas, Shiraga, Yoko, and McLaughlin, Vallerie

Published
2019
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17. The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study

Author

Kerr, Kim M, Elliott, C Greg, Benza, Raymond L, Channick, Richard N, Chin, Kelly M, Davis, R Duane, Jain, Sonia, LaCroix, Andrea Z, Madani, Michael M, McLaughlin, Vallerie V, Park, Myung H, Tapson, Victor F, and Auger, William R

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundChronic thromboembolic pulmonary hypertension (CTEPH) is a rare sequela of acute pulmonary embolism that is treatable when recognized. Awareness of this disease has increased with recent advancements in therapeutic options, but delays in diagnosis remain common, and diagnostic and treatment guidelines are often not followed. Data gathered from international registries have improved our understanding of CTEPH, but these data may not be applicable to the US population owing to differences in demographics and medical practice patterns. ObjectiveThe US CTEPH Registry (US-CTEPH-R) was developed to provide essential information to better understand the demographics, risk factors, evaluation, and treatment of CTEPH in the United States, as well as the short- and long-term outcomes of surgical and nonsurgical therapies in the modern treatment era. MethodsThirty sites throughout the United States enrolled 750 subjects in this prospective, longitudinal, observational registry of patients newly diagnosed with CTEPH. Enrollment criteria included a mean pulmonary artery pressure ≥25 mmHg by right heart catheterization and radiologic confirmation of CTEPH by a multidisciplinary adjudication committee. Following enrollment, subjects were followed biannually until the conclusion of the study. Quality of life surveys were administered at enrollment and biannually, and all other testing was at the discretion of the treating clinician. Details regarding surgical therapy, balloon pulmonary angioplasty, and medical therapy were collected at enrollment and at follow-up, as well as information related to health care utilization and survival. ResultsData from this registry will improve understanding of the demographics, risk factors, and treatment patterns of patients with CTEPH, and the longitudinal impact of therapies on quality of life, health care utilization, and survival. ConclusionsThis manuscript details the methodology and design of the first large, prospective, longitudinal registry of patients with CTEPH in the United States. Trial RegistrationClinicalTrials.gov NCT02429284; https://www.clinicaltrials.gov/ct2/show/NCT02429284 International Registered Report Identifier (IRRID)DERR1-10.2196/25397

Published
2021
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18. Disease characteristics, treatments, and outcomes of patients with pulmonary arterial hypertension treated with selexipag in real-world settings from the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry)

Author

McLaughlin, Vallerie, primary, Farber, Harrison W., additional, Highland, Kristin B., additional, Hemnes, Anna R., additional, Chakinala, Murali M., additional, Chin, Kelly M., additional, Han, Michelle, additional, Cho, Michelle, additional, Tobore, Tobore, additional, Rahman, Mohammad, additional, and Kim, Nick H., additional

Published
2023
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19. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality

Author

McLaughlin, Vallerie V., Hoeper, Marius M., Channick, Richard N., Chin, Kelly M., Delcroix, Marion, Gaine, Sean, Ghofrani, Hossein-Ardeschir, Jansa, Pavel, Lang, Irene M., Mehta, Sanjay, Pulido, Tomás, Sastry, B.K.S., Simonneau, Gérald, Sitbon, Olivier, Souza, Rogério, Torbicki, Adam, Tapson, Victor F., Perchenet, Loïc, Preiss, Ralph, Verweij, Pierre, Rubin, Lewis J., and Galiè, Nazzareno

Published
2018
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22. Early selexipag initiation and long-term outcomes: insights from randomised controlled trials in pulmonary arterial hypertension

Author

Coghlan, J. Gerry, primary, Gaine, Sean, additional, Channick, Richard, additional, Chin, Kelly M., additional, du Roure, Camille, additional, Gibbs, J. Simon R., additional, Hoeper, Marius M., additional, Lang, Irene M., additional, Mathai, Stephen C., additional, McLaughlin, Vallerie V., additional, Mitchell, Lada, additional, Simonneau, Gérald, additional, Sitbon, Olivier, additional, Tapson, Victor F., additional, and Galiè, Nazzareno, additional

Published
2022
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23. Safety of macitentan for the treatment of pulmonary hypertension: Real‐world experience from the OPsumit® USers Registry (OPUS) and OPsumit® Historical USers cohort (OrPHeUS)

Author

McLaughlin, Vallerie V., primary, Channick, Richard, additional, Kim, Nick H., additional, Frantz, Robert P., additional, McConnell, John W., additional, Melendres‐Groves, Lana, additional, Miller, Chad, additional, Ravichandran, Ashwin, additional, Rodriguez‐Lopez, Josanna, additional, Brand, Monika, additional, Leroy, Sandrine, additional, Wetherill, Graham, additional, and Chin, Kelly M., additional

Published
2022
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29. Reply

Author

Chin, Kelly M., primary, Doelberg, Martin, additional, Martin, Nicolas, additional, Perchenet, Loïc, additional, and Galie, Nazzareno, additional

Published
2022
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31. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study

Author

Gaine, Sean, Sitbon, Olivier, Channick, Richard N., Chin, Kelly M., Sauter, Rafael, Galiè, Nazzareno, Hoeper, Marius M., McLaughlin, Vallerie V., Preiss, Ralph, Rubin, Lewis J., Simonneau, Gérald, Tapson, Victor, Ghofrani, Hossein-Ardeschir, Lang, Irene, Gaine, Sean, Sitbon, Olivier, Channick, Richard N., Chin, Kelly M., Sauter, Rafael, Galiè, Nazzareno, Hoeper, Marius M., McLaughlin, Vallerie V., Preiss, Ralph, Rubin, Lewis J., Simonneau, Gérald, Tapson, Victor, Ghofrani, Hossein-Ardeschir, and Lang, Irene

Subjects
pulmonary arterial hypertensionselexipagtime from diagnosis
Abstract

BACKGROUND: Early initiation of pulmonary arterial hypertension (PAH) therapies is associated with improved long-term outcomes, yet data on the early use of prostacyclin pathway agents are limited. In these post hoc analyses of the Prostacyclin (PGI(2)) Receptor Agonist In Pulmonary Arterial Hypertension (GRIPHON) study, the largest randomized controlled trial for PAH to date, the prognostic value of time from diagnosis and its impact on treatment response were examined. RESEARCH QUESTION: How does time from diagnosis impact morbidity/mortality events and response to selexipag treatment in patients with PAH? STUDY DESIGN AND METHODS: The GRIPHON study randomly assigned 1,156 patients with PAH to selexipag or placebo treatment. Patients were categorized post hoc into a time from diagnosis of≤ 6months and > 6months at randomization. Hazard ratios (selexipag vsplacebo) were calculated for the primary end point of morbidity/mortality by time from diagnosis using Cox proportional hazard models. RESULTS: Time from diagnosis was≤ 6months in 34.9%and > 6months in 65.1%of patients. Time from diagnosis was prognostic of morbidity/mortality, with newly diagnosed patients having a poorer long-term outcome than patients diagnosed for longer. Compared with placebo, selexipag reduced the risk of morbidity/mortality in patients with a time from diagnosis of≤ 6months and > 6months, with a more pronounced effect in newly diagnosed patients (hazard ratio, 0.45 [95%CI, 0.33-0.63] and 0.74 [95%CI, 0.57-0.96], respectively; P= .0219 for interaction). INTERPRETATION: In the GRIPHON study, newly diagnosed PAH patients had a worse prognosis than patients with a longer time from diagnosis. The benefit of selexipag treatment on disease progression was more pronounced in patients treated earlier than in patients treated later. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01106014; URL: www.clinicaltrials.gov.

Published
2021

32. The impact of comorbidities on selexipag treatment effect in patients with pulmonary arterial hypertension: insights from the GRIPHON study

Author

Rosenkranz, Stephan, primary, Channick, Richard, additional, Chin, Kelly M., additional, Jenner, Bartosz, additional, Gaine, Sean, additional, Galiè, Nazzareno, additional, Ghofrani, Hossein‐Ardeschir, additional, Hoeper, Marius M., additional, McLaughlin, Vallerie V., additional, Du Roure, Camille, additional, Rubin, Lewis J., additional, Sitbon, Olivier, additional, Tapson, Victor, additional, and Lang, Irene M., additional

Published
2021
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33. Selexipag for the Treatment of Pulmonary Arterial Hypertension

Author

Sitbon, Olivier, Channick, Richard, Chin, Kelly M., Frey, Aline, Gaine, Sean, Galiè, Nazzareno, Ghofrani, Hossein-Ardeschir, Hoeper, Marius M., Lang, Irene M., Preiss, Ralph, Rubin, Lewis J., Di Scala, Lilla, Tapson, Victor, Adzerikho, Igor, Liu, Jinming, Moiseeva, Olga, Zeng, Xiaofeng, Simonneau, Gérald, and McLaughlin, Vallerie V.

Published
2015
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34. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension

Author

Galiè, Nazzareno, primary, Gaine, Sean, additional, Channick, Richard, additional, Coghlan, J. Gerry, additional, Hoeper, Marius M., additional, Lang, Irene M., additional, McLaughlin, Vallerie V., additional, Lassen, Cheryl, additional, Rubin, Lewis J., additional, Hsu Schmitz, Shu-Fang, additional, Sitbon, Olivier, additional, Tapson, Victor F., additional, and Chin, Kelly M., additional

Published
2021
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36. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension

Author

Gaine, Sean, primary, Sitbon, Olivier, additional, Channick, Richard N., additional, Chin, Kelly M., additional, Sauter, Rafael, additional, Galiè, Nazzareno, additional, Hoeper, Marius M., additional, McLaughlin, Vallerie V., additional, Preiss, Ralph, additional, Rubin, Lewis J., additional, Simonneau, Gérald, additional, Tapson, Victor, additional, Ghofrani, Hossein-Ardeschir, additional, and Lang, Irene, additional

Published
2021
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37. Additional file 1 of Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study

Author

Klose, Hans, Chin, Kelly M., Ewert, Ralf, Gall, Henning, Parambil, Joseph, Poch, David, Hans-Jürgen Seyfarth, Axelsen, Lene N., Schmitz, Shu-Fang Hsu, Stein, Claudia, and Preston, Ioana R.

Subjects
Data_FILES
Abstract

Additional file 1: Additional figures and tables.

Published
2021
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42. The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study (Preprint)

Author

Kerr, Kim M, primary, Elliott, C Greg, additional, Benza, Raymond L, additional, Channick, Richard N, additional, Chin, Kelly M, additional, Davis, R Duane, additional, Jain, Sonia, additional, LaCroix, Andrea Z, additional, Madani, Michael M, additional, McLaughlin, Vallerie V, additional, Park, Myung H, additional, Tapson, Victor F, additional, and Auger, William R, additional

Published
2020
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44. Colaboradores

Author

Adams, Lewis, Adamson, Rosemary, Adler, Dan E., Akoumianaki, Evangelia, Albert, Tyler J., Albertine, Kurt H., Alexander, Barbara D., Amos, Christopher I., Arenberg, Douglas A., Argento, A. Christine, Atif, Shaikh M., Ayas, Najib T., Babik, Jennifer M., Badlam, Jessica B., Balmes, John Randolph, Banaei, Niaz, Barnett, Christopher F., Bartolome, Sonja D., Baughman, Robert P., Beers, Michael F., Benditt, Joshua O., Benowitz, Neal L., Bhakta, Nirav R., Bhatnagar, Rahul, Bhatt, Surya P., Bibby, Anna C., Binnie, Alexandra, Blanc, Paul D., Borok, Zea, Bradley, T. Douglas, Broaddus, V. Courtney, Brochard, Laurent J., Brody, Steven L., Brown, Kevin K., Brunetta, Paul G., Cadranel, Jacques, Carr, Shamus R., Carr, Tara F., Cattamanchi, Adithya, Chalabreysse, Lara, Chan, Edward D., Chan, Ken K.P., Chastre, Jean, Cheng, Guang-Shing, Chin, Kelly M., Cho, Michael H., Christiani, David C., Chung, Kian Fan, Clive, Amelia O., Cohen, Robert A., Colby, Thomas V., Cool, Carlyne D., Cordioli, Ricardo Luiz, Corte, Tamera J., Cottin, Vincent, Crothers, Kristina, Curtis, Jeffrey L., Daley, Charles L., Davidson, Bruce L., Davies, Helen E., Davis, J. Lucian, De Marco, Teresa, Deresinski, Stanley C., Deroose, Christophe M., Dixon, Anne E., Dockrell, David H., Dooms, Christophe, Downey, Gregory P., DuBrock, Hilary, El-Chemaly, Souheil, Elliott, C. Gregory, Ernst, Joel D., Evans, Christopher M., Fahy, John V., Fajardo, Elaine, Fan, Eddy, Faughnan, Marie E., Feller-Kopman, David, Fenster, Brett E., Fernandes, Timothy M., Fernández Pérez, Evans R., Fischer, William A., II, Fontenot, Andrew P., Frank, James, Frankel, Stephen K., Friedberg, Joseph, Fung, Monica, Gao, Yuansheng, Garpestad, Erik, Gartman, Eric J., Gebhart, G.F., George, Gautam, Gesthalter, Yaron B., Gladwin, Mark T., Go, Leonard H.T., Gidwani, Nisha H., Girard, Nicolas, Glenny, Robb W., Goligher, Ewan C., Gomez, Antonio, Gonzalez, Anne V., Gordon, Stephen B., Gossot, Dominique, Gotts, Jeffrey E., Gotway, Michael B., Gould, Michael, Graney, Bridget A., Grasselli, Giacomo, Greenland, John R., Griffith, David E., Gupta, Nishant, Hallifax, Rob, Han, Meilan K., Hansel, Nadia N., Hatipoğlu, Umur, Henderson, William R., Herold, Susanne, Herridge, Margaret S., Hiensch, Robert, Hilbert, Janet, Hill, Nicholas S., Ho, Antonia, Holm, Stephanie M., Hoover, Wynton, Hopewell, Philip C., Horne, David J., Horner, Richard L., Hsia, Connie C.W., Huang, Laurence, Huddleston, Lindsey L., Hyzy, Robert C., Inoue, Yoshikazu, Jakubzick, Claudia V., Jia, Shijing, Johannson, Kerri A., Johnson, Meshell, Jokerst, Clinton E., Jones, Kirk D., Judson, Marc A., Kalil, Andre C., Kaminska, Marta, Kaminsky, David A., Kato-Maeda, Midori, Kaufman, David A., Kerr, Kim M., Keshavjee, Shaf, Kheir, Fayez, Kidson, Kristen M., Kim, Kami, Kim, Suil, Kimoff, R. John, King, Talmadge E., Jr., Kitsios, Georgios, Klein, Jeffrey S., Konopka, Kristine, Koth, Laura L., Kotloff, Robert M., Kraft, Monica, Krishnan, Vidya, Kroon, Lisa, Kuebler, Wolfgang M., Küpeli, Elif, Kuschner, Ware G., Lambrecht, Bart N., Lammi, Matthew R., Lapinsky, Stephen E., Lazarus, Stephen C., Lee, Jarone, Lee, Joyce S., Lee, Warren L., Lee, Won Y., Lee, Y. C. Gary, Lee-Chiong, Teofilo L., Jr., Lehman, Jonathan M., Lemière, Catherine, Lentz, Robert J., Light, Richard W., Limper, Andrew H., Lipnick, Michael S., Liu, Stanley Yung-Chuan, Loyd, James E., Lugogo, Njira, Luks, Andrew M., Lurie, Nicole, Luyt, Charles-Edouard, Lyon, Stuart M., Machado, Roberto F., Maier, Lisa A., Malhotra, Atul, Martin, Thomas R., Maskell, Nick A., Massion, Pierre P., Mathai, Stephen C., Matson, Scott M., Matthay, Michael A., Matthay, Richard A., May, Anna M., Mayer, Annyce S., Mazzone, Peter J., Mazzone, Stuart B., McCarthy, Cormac, McCool, F. Dennis, McCormack, Francis X., McCormack, Meredith C., McCulley, David, McVerry, Bryan J., Mehra, Reena, Mehta, Atul C., Metersky, Mark L., Meyer, Nuala J., Mira-Avendano, Isabel C., Mody, Gita N., Mokhlesi, Babak, Morris, Alison, Morris, Amy E., Morris, Timothy A., Morty, Rory E., Mudambi, Lakshmi, Munger, John S., Munavvar, Mohammed, Nahid, Payam, Nelson-Piercy, Catherine, Nici, Linda, Nishimura, Stephen L., Nosanchuk, Joshua D., O’Riordan, Thomas G., Ortega, Victor Enrique, Ortiz, Justin R., Pamidi, Sushmita, Pastis, Nicholas J., Patel, Sanjay R., Patroniti, Nicolò, Pergam, Steven A., Pesenti, Antonio, Peters, Michael C., Pfeifer, Kurt, Philips, Jennifer A., Pinsky, Benjamin A., Pletcher, Steven D., Prabhudesai, Vikramaditya, Que, Loretta G., Quick, Bryon D., Rahman, Najib M., Raj, J. Usha, Ramirez, Maria I., Reddy, Rishindra M., Redente, Elizabeth F., Reed, Hasina Outtz, Reinhardt, R. Lee, Riches, David W.H., Rivera, M. Patricia, Rochester, Carolyn L., Roman, Jesse, Rose, Alexandra, Rosen, Clark A., Routes, John M., Rowe, Steven M., Ryan, Clodagh M., Ryu, Jay H., Sanghavi, Sarah, Sarmiento, Kathleen F., Saullo, Jennifer L., Schoene, Robert B., Schumaker, Gregory L., Schwartz, David A., Schwartzstein, Richard M., Schwarz, Marvin I., Selman, Moisés, Shah, Neomi, Shah, Rupal J., Shete, Priya B., Shojaee, Samira, Silvestri, Gerard A., Singer, Jonathan P., Slatore, Christopher G., Smaldone, Gerald C., Smetana, Gerald W., Solomon, George M., Sorscher, Eric J., Stapleton, Renee D., Sterman, Daniel, Stewart, Shelby J., Stoller, James K., Sun, Xin, Sunwoo, Bernie Y., Sweeney, Daniel A., Swenson, Erik R., Tanner, Nichole T., Tanoue, Lynn, Thompson, George R., III, Trapnell, Bruce C., Triplette, Matthew, Tukey, Melissa H., Tzelepis, George E., Urisman, Anatoly, Vandenplas, Olivier, Van Hoesen, Karen B., Varghese, Thomas K., Jr., Vassallo, Robert, Verbsky, James W., Wagh, Ajay, Walsh, Ryan, Weber, David J., Weiner, Ashley A., Weiss, Louis M., Wells, Athol U., West, John B., West, T. Eoin, White, Douglas B., Winthrop, Kevin L., Wohl, David A., Wolfe, Lisa F., Woodruff, Prescott G., Worodria, William, Yeh, D. Dante, Yoon, Christina, Young, VyVy N., Zacharias, William J., and Zanella, Alberto

Published
2023
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47. Two formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study☆

Author

Chin, Kelly M., Badesch, David B., Robbins, Ivan M., Tapson, Victor F., Palevsky, Harold I., Kim, Nick H., Kawut, Steven M., Frost, Adaani, Benton, Wade W., Lemarie, Jean-Christophe, Bodin, Frederic, Rubin, Lewis J., and McLaughlin, Vallerie

Published
2014
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49. List of Contributors

Author

Ahya, Vivek N., primary, Archer-Chicko, Christine, additional, Ashare, Alix, additional, Carroll, James, additional, Chin, Kelly M., additional, Elliott, C. Gregory, additional, Friedman, Eliot B., additional, Fedullo, Peter F., additional, Fishman, Alfred P., additional, Gerke, Alicia, additional, Gladwin, Mark T., additional, Groskreutz, Dayna J., additional, Housten-Harris, Traci, additional, Ivy, D. Dunbar, additional, Jeffery, Maren E., additional, Jones, Peter Lloyd, additional, Kotloff, Robert M., additional, Krowka, Michael J., additional, Machado, Roberto F., additional, Mandel, Jess, additional, Mazza, Emilio, additional, Netzer, Giora, additional, Palevsky, Harold I., additional, Pietra, Giuseppe G., additional, Rashid, Asrar, additional, Sager, Jeffrey S., additional, Snow, Jennifer L., additional, Swanson, Karen L., additional, Taichman, Darren B., additional, and Thomas, Karl W., additional

Published
2006
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50. The impact of comorbidities on selexipag treatment effect in patients with pulmonary arterial hypertension: insights from the GRIPHON study.

Author

Rosenkranz, Stephan, Channick, Richard, Chin, Kelly M., Jenner, Bartosz, Gaine, Sean, Galiè, Nazzareno, Ghofrani, Hossein‐Ardeschir, Hoeper, Marius M., McLaughlin, Vallerie V., Du Roure, Camille, Rubin, Lewis J., Sitbon, Olivier, Tapson, Victor, and Lang, Irene M.

Subjects
PULMONARY arterial hypertension, TREATMENT effectiveness, COMORBIDITY, CORONARY artery disease, ESSENTIAL hypertension
Abstract

Aims: The number of pulmonary arterial hypertension (PAH) patients with comorbidities is increasing and there are limited data on response to PAH‐targeted therapies in this population. These post hoc analyses explored the effect of selexipag in PAH patients with cardiovascular comorbidities in the GRIPHON study. Methods and results: Randomized patients (n = 1156) were classified using three methods: (i) by subgroups defined according to previously published comorbidity count and restrictive haemodynamic criteria: Subgroup A (<3 comorbidities and haemodynamic criteria met; n = 962) and Subgroup B (≥3 comorbidities and/or haemodynamic criteria not met; n = 144); comorbidities included body mass index ≥30 kg/m2, essential hypertension, diabetes, history of coronary artery disease; (ii) by number of comorbidities, with addition of atrial fibrillation (0, 1, 2, 3, 4, or 5); (iii) by presence of individual comorbidities. Selexipag to placebo hazard ratios (HR) and 95% confidence intervals (CI) for morbidity/mortality (primary composite endpoint) were estimated using Cox regression adjusting selexipag effect for baseline covariates. Approximately half of the patients in GRIPHON (n = 584; 50.5%) had comorbidities. Selexipag reduced the risk of a morbidity/mortality event compared with placebo in both Subgroup A (HR 0.66, 95% CI 0.53, 0.82) and Subgroup B (HR 0.50, 95% CI 0.26, 0.96), with no evidence of an inconsistent treatment effect between subgroups (interaction p = 0.432). Consistent results were observed in analyses by number and by specific type of comorbidity. Conclusion: Selexipag reduces the risk of a morbidity/mortality event vs. placebo irrespective of patient comorbidity status, suggesting that comorbidity status does not influence the treatment effect of selexipag. [ABSTRACT FROM AUTHOR]

Published
2022
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