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113 results on '"Honarpour, Narimon"'

1. A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings

Author

Véniant, Murielle M., Lu, Shu-Chen, Atangan, Larissa, Komorowski, Renee, Stanislaus, Shanaka, Cheng, Yuan, Wu, Bin, Falsey, James R., Hager, Todd, Thomas, Veena A., Ambhaikar, Malhar, Sharpsten, Lucie, Zhu, Yineng, Kurra, Vamsi, Jeswani, Rohini, Oberoi, Rajneet K., Parnes, Jane R., Honarpour, Narimon, Neutel, Joel, and Strande, Jennifer L.

Published
2024
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3. Heart Failure With Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials

Author

Parikh, Kishan S., Sharma, Kavita, Fiuzat, Mona, Surks, Howard K., George, Jyothis T., Honarpour, Narimon, Depre, Christopher, Desvigne-Nickens, Patrice, Nkulikiyinka, Richard, Lewis, Gregory D., Gomberg-Maitland, Mardi, O’Connor, Christopher M., Stockbridge, Norman, Califf, Robert M., Konstam, Marvin A., Januzzi, James L., Jr., Solomon, Scott D., Borlaug, Barry A., Shah, Sanjiv J., Redfield, Margaret M., and Felker, G. Michael

Published
2018
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4. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial

Author

Sabatine, Marc S, Leiter, Lawrence A, Wiviott, Stephen D, Giugliano, Robert P, Deedwania, Prakash, De Ferrari, Gaetano M, Murphy, Sabina A, Kuder, Julia F, Gouni-Berthold, Ioanna, Lewis, Basil S, Handelsman, Yehuda, Pineda, Armando Lira, Honarpour, Narimon, Keech, Anthony C, Sever, Peter S, and Pedersen, Terje R

Published
2017
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5. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study

Author

Raal, Frederick J, Hovingh, G Kees, Blom, Dirk, Santos, Raul D, Harada-Shiba, Mariko, Bruckert, Eric, Couture, Patrick, Soran, Handrean, Watts, Gerald F, Kurtz, Christopher, Honarpour, Narimon, Tang, Lihua, Kasichayanula, Sree, Wasserman, Scott M, and Stein, Evan A

Published
2017
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8. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial

Author

Teerlink, John R, Felker, G Michael, McMurray, John J V, Solomon, Scott D, Adams, Kirkwood F, Jr, Cleland, John G F, Ezekowitz, Justin A, Goudev, Assen, Macdonald, Peter, Metra, Marco, Mitrovic, Veselin, Ponikowski, Piotr, Serpytis, Pranas, Spinar, Jindrich, Tomcsányi, János, Vandekerckhove, Hans J, Voors, Adriaan A, Monsalvo, Maria Laura, Johnston, James, Malik, Fady I, and Honarpour, Narimon

Published
2016
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13. Evaluation of Large-Scale Proteomics for Prediction of Cardiovascular Events.

Author

Helgason, Hannes, Eiriksdottir, Thjodbjorg, Ulfarsson, Magnus O., Choudhary, Abhishek, Lund, Sigrun H., Ivarsdottir, Erna V., Hjorleifsson Eldjarn, Grimur, Einarsson, Gudmundur, Ferkingstad, Egil, Moore, Kristjan H. S., Honarpour, Narimon, Liu, Thomas, Wang, Huei, Hucko, Thomas, Sabatine, Marc S., Morrow, David A., Giugliano, Robert P., Ostrowski, Sisse Rye, Pedersen, Ole Birger, and Bundgaard, Henning

Subjects
DYSLIPIDEMIA, DISEASE risk factors, CARDIOVASCULAR diseases, MAJOR adverse cardiovascular events, MONOGENIC & polygenic inheritance (Genetics), PROTEOMICS, BLOOD proteins
Abstract

Key Points: Question: How does risk prediction based on proteomics data compare with clinical risk factors and polygenic risk scores? Findings: In a retrospective analysis using measurements of thousands of plasma proteins in primary- and secondary-event populations, a protein risk score, developed using more than 4900 plasma protein levels to predict major atherosclerotic cardiovascular disease events, stratified risk as well as a risk factor score and was slightly better than polygenic risk scores for coronary artery disease and stroke. The protein score modestly improved discriminative accuracy (measured by C index) and risk classification (measured by category-free net reclassification improvement and integrated discrimination improvement) when added to a model using clinical risk factors. Meaning: A protein risk score, derived from large-scale proteomics, yielded a modest improvement in discrimination when added to models based on clinical risk factors. Importance: Whether protein risk scores derived from a single plasma sample could be useful for risk assessment for atherosclerotic cardiovascular disease (ASCVD), in conjunction with clinical risk factors and polygenic risk scores, is uncertain. Objective: To develop protein risk scores for ASCVD risk prediction and compare them to clinical risk factors and polygenic risk scores in primary and secondary event populations. Design, Setting, and Participants: The primary analysis was a retrospective study of primary events among 13 540 individuals in Iceland (aged 40-75 years) with proteomics data and no history of major ASCVD events at recruitment (study duration, August 23, 2000 until October 26, 2006; follow-up through 2018). We also analyzed a secondary event population from a randomized, double-blind lipid-lowering clinical trial (2013-2016), consisting of individuals with stable ASCVD receiving statin therapy and for whom proteomic data were available for 6791 individuals. Exposures: Protein risk scores (based on 4963 plasma protein levels and developed in a training set in the primary event population); polygenic risk scores for coronary artery disease and stroke; and clinical risk factors that included age, sex, statin use, hypertension treatment, type 2 diabetes, body mass index, and smoking status at the time of plasma sampling. Main Outcomes and Measures: Outcomes were composites of myocardial infarction, stroke, and coronary heart disease death or cardiovascular death. Performance was evaluated using Cox survival models and measures of discrimination and reclassification that accounted for the competing risk of non-ASCVD death. Results: In the primary event population test set (4018 individuals [59.0% women]; 465 events; median follow-up, 15.8 years), the protein risk score had a hazard ratio (HR) of 1.93 per SD (95% CI, 1.75 to 2.13). Addition of protein risk score and polygenic risk scores significantly increased the C index when added to a clinical risk factor model (C index change, 0.022 [95% CI, 0.007 to 0.038]). Addition of the protein risk score alone to a clinical risk factor model also led to a significantly increased C index (difference, 0.014 [95% CI, 0.002 to 0.028]). Among White individuals in the secondary event population (6307 participants; 432 events; median follow-up, 2.2 years), the protein risk score had an HR of 1.62 per SD (95% CI, 1.48 to 1.79) and significantly increased C index when added to a clinical risk factor model (C index change, 0.026 [95% CI, 0.011 to 0.042]). The protein risk score was significantly associated with major adverse cardiovascular events among individuals of African and Asian ancestries in the secondary event population. Conclusions and Relevance: A protein risk score was significantly associated with ASCVD events in primary and secondary event populations. When added to clinical risk factors, the protein risk score and polygenic risk score both provided statistically significant but modest improvement in discrimination. This study of 13 540 individuals in Iceland (aged 40-75 years) evaluated the utility of protein risk scores for prediction of atherosclerotic cardiovascular disease events compared to risk prediction using polygenic risk scores in addition to risk scores based on clinical risk factors [ABSTRACT FROM AUTHOR]

Published
2023
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15. Abstract 15100: Reduction in Total Cardiovascular Events With the PCSK9 Inhibitor Evolocumab in Patients With Cardiovascular Disease in the FOURIER Trial

Author

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

Published
2017

17. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency

Author

Anker, Stefan D., Schroeder, Stefan, Atar, Dan, Bax, Jeroen J., Ceconi, Claudio, Cowie, Martin R., Crisp, Adam, Dominjon, Fabienne, Ford, Ian, Ghofrani, Hossein-Ardeschir, Gropper, Savion, Hindricks, Gerhard, Hlatky, Mark A., Holcomb, Richard, Honarpour, Narimon, Jukema, Wouter J., Kim, Albert M., Kunz, Michael, Lefkowitz, Martin, Le Floch, Chantal, Landmesser, Ulf, McDonagh, Theresa A., McMurray, John J., Merkely, Bela, Packer, Milton, Prasad, Krishna, Revkin, James, Rosano, Giuseppe M.C., Somaratne, Ransi, Stough, Wendy Gattis, Voors, Adriaan A., and Ruschitzka, Frank

Published
2016
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20. Loss of Apaf-1 leads to partial rescue of the HAND2-null phenotype

Author

Aiyer, Aparna R., Honarpour, Narimon, Herz, Joachim, and Srivastava, Deepak

Subjects
Apoptosis -- Research, Biological sciences
Abstract

HAND2 is an essential transcription factor for cardiac, pharyngeal arch, and limb development. Apoptosis in the HAND2-null embryo causes hypoplasia of the right ventricle and pharyngeal arches leading to lethality by embryonic day (E)10.0 from heart failure. In order to investigate the role of apoptosis in inducing the HAND2-null phenotype, we generated mouse embryos lacking both HAND2 and Apaf-1, a central downstream mediator of mitochondrial damage-induced apoptosis. In contrast to HAND[2.sup.-/-] embryos, HAND[2.sup./-] [Apaf-1.sup.-/-] embryos at E10.5-11.0 had well-developed pharyngeal arches, aortic arch arteries, and no signs of cardiac failure. TUNEL analysis through pharyngeal arches of [HAND2.sup.-/-] [Apaf-1.sup.-/-] embryos revealed decreased apoptosis and the embryos had clearly patent aortic arch arteries. However, ventricular hypoplasia and cell death were unchanged in these animals compared to [HAND2.sup.-/-] embryos, resulting in growth arrest at E11.0. Our study suggests that loss of HAND2 in the pharyngeal arch mesenchyme leads to apoptosis in an Apaf-1-dependent fashion and that, while loss of aortic arch integrity contributes to the early lethality, the ventricular defects are independent of arch development. Keywords: Apaf-1; HAND2-null phenotype; Pharyngeal arches

Published
2005

22. The effect of the cardiac myosin activator, omecamtiv mecarbil, on right ventricular structure and function in chronic systolic heart failure (COSMIC‐HF).

Author

Biering‐Sørensen, Tor, Minamisawa, Masatoshi, Liu, Jiankang, Claggett, Brian, Papolos, Alexander I., Felker, G. Michael, McMurray, John J.V., Legg, Jason C., Malik, Fady I., Honarpour, Narimon, Kurtz, Christopher E., Teerlink, John R., and Solomon, Scott D.

Subjects
HEART failure, IVABRADINE, MYOSIN, RIGHT ventricular dysfunction, CARDIAC patients, CARDIAC pacing, HEART failure patients
Abstract

In addition, the RV-ESA and PASP together with parameters of RV-PA coupling (TAPSE/PASP ratio and RVOT-VTI/PASP ratio) improved significantly in the PK-titration group as compared to the placebo group ( I Table i 1 and I Figure i 1). Our analyses demonstrated that 20 weeks of OM treatment in patients with HFrEF improved RV-SET, RV-VTI in both OM groups, and improved RV-ESA, RV afterload and RV-PA coupling only in the PK-titration group, whereas OM did not significantly improve TAPSE or RV-FAC. Right ventricular (RV) dysfunction due to post-capillary pulmonary hypertension is a common sequela of elevated left ventricular (LV) filling pressures in patients with heart failure (HF) which has been demonstrated to be associated with poor clinical outcomes.1-3 Measures of RV-pulmonary artery (RV-PA) coupling that evaluate indices of RV function and pulmonary hypertension severity have been shown to be associated with clinical outcomes.4,5 A phase 2 trial, COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, NCT01786512) demonstrated that treatment with omecamtiv mecarbil (OM), a selective cardiac myosin activator, known as a myotrope, was related to an improved LV systolic function, beneficial reverse remodelling, sympathetic withdrawal and a reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with HF with reduced ejection fraction (HFrEF).6 In this research letter, we report the treatment effect of OM on RV structure and function together with RV-PA coupling in patients with HFrEF. [Extracted from the article]

Published
2021
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24. Evolocumab and clinical outcomes in patients with cardiovascular disease

Author

Sabatine, Marc S., Giugliano, Robert P., Keech, Anthony C., Honarpour, Narimon, Wiviott, Stephen D., Murphy, Sabina A., Kuder, Julia F., Wang, Huei, Liu, Thomas, Wasserman, Scott M., Sever, Peter S., Pedersen, Fish MP, Terje R., Abrahamsen, Te, Im, K, Kanevsky, E, Bonaca, Mp, Lira Pineda, A, Hanlon, K, Knusel, B, Somaratne, R, Kurtz, C, Scott, R, Accini Mendoza JL, Amerena, J, Badariene, J, Burgess, L, Ceska, R, Charng, Mj, Choi, D, Cobos, Jl, Dan, Ga, De Ferrari GM, Deedwania, Pc, Chopra, Vk, Erglis, A, Ezhov, Mv, Ferreira, J, Filipová, S, Gaciong, Za, Pasierski, T, Georgiev, Bg, Gonzalez-Galvez, G, Gouni-Berthold, I, Schäufele, T, Hirayama, A, Huber, K, Rammer, M, Kjaerulf Jensen, H, Wermuth, S, Jiang, L, Jukema, Jw, Kraydashenko, O, Leiter, La, Lewis, Bs, López-Miranda, J, Lorenzatti, Aj, Mach, F, Mcadam, B, Nilsson, L, Olsson, Å, Rallidis, L, Rogelio, Gg, Kerr Saraiva JF, Scheen, A, Schiele, F, Scott, Rs, Connolly, D, Siu, Cw, Tay, L, Thorgeirsson, G, Tikkanen, Mj, Tokgozoglu, Sl, Toth, K, Viigimaa, M, Wan Ahmad WA, Hennekens, Ch, Andreotti, F, Baigent, C, Brown, Wv, Davis, Br, Newcomer, Jw, Wood, Sk, Larosa, J, Ansell, B, Olsson, A, Lowe, C, Zahn, L, Awtry, E, Berger, C, Croce, K, Desai, A, Gelfand, E, Ho, C, Leeman, D, Link, M, Norden, A, Pande, A, Rost, N, Ruberg, F, Silverman, S, Singhal, A, Vita, J, Mackinnon, I, Vogel, Dr, Leon de la Fuente, R, Perna, E, Amuchastegui, M, Pacora, F, Hershson, A, Blumberg, E, Glenny, Ja, Colombo, H, Cuadrado, Ja, Nicolosi, L, Rojas, Cg, Ulla, Mr, Hasbani, Eg, Cuneo, C, Lopez Santi RG, Sanabria, Hd, Hrabar, A, Lozada, A, Begg, A, Lehman, S, Wittert, G, Juergens, C, Kostner, K, Beltrame, J, Simpson, R, Sinhal, A, Adams, M, Kritharides, L, Roberts Thomson, P, Cross, D, Thompson, P, Van Gaal, W, Cox, N, Farshid, A, Hammett, C, Garrahy, P, Prasan, A, Horrigan, M, Ebenbichler, C, Hanusch, U, Prager, R, Schernthaner, G, Luger, A, Siostrzonek, P, Toplak, H, Bergler-Klein, J, Paulweber, B, Sinzinger, H, Buysschaert, I, Thoeng, J, Vandekerckhove, H, Catez, E, Verheye, S, Descamps, O, Hoffer, E, Wollaert, B, Chenu, P, van de Borne, P, De Meulemeester, M, Friart, A, Charlier, F, De Raedt, H, Rietzschel, E, Roelandt, R, Lalmand, J, Tavares Russo LA, Reis, G, Duarte Barbosa EC, Vidotti, Mh, Fernandes Manenti ER, Dutra, O, Leaes, Pe, Rech, Rl, Bertolim Precoma, D, Nicolau, Jc, Amoedo, R, Eliaschewitz, Fg, Pereira, A, Kurtz Lisboa HR, Soares Piegas, L, Cunha Borges JL, Ferreira Rossi PR, Pimentel Filho, P, Bodanese, Lc, de Sa Cunha, R, Moura Jorge JC, Ardito, Wr, Barroso de Souza WK, Hissa, M, Izar, Mc, Manolova, A, Kitova, L, Kinova, E, Tzekova, M, Velchev, V, Tarnovska-Kadreva, R, Gotchev, D, Petrov, I, Raev, D, Trendafilova-Lazarova, D, Yotov, Y, Lazov, P, Rahimi, S, St Amour, E, Constance, C, Pesant, Y, Hess, A, Anderson, T, Sussex, B, Henein, S, Tsoukas, G, Pandey, As, Bergeron, J, Hart, R, Gosselin, G, Chehayeb, R, Hamet, P, Hartleib, M, Mukherjee, A, Halperin, F, Petrella, R, Bhargava, R, Lonn, E, Sabbah, E, Bata, I, Cha, J, Gaudet, D, Chapman, K, Murthy, D, Nigro, F, Rupka, D, Gossard, D, Gupta, M, Dowell, A, Mansour, S, Baass, A, Geadah, C, Huynh, T, Peterson, S, Poirier, P, Sabe-Affaki, G, Vertes, G, Crowley, D, Duchesne, L, Pincetti Jofre CP, Potthoff Cardenas, S, Conejeros Kindel, C, Saavedra Gajardo VA, Lanas Zanetti, F, Sepulveda Varela PA, Stockins Fernandez BA, Li, W, Li, D, Zhao, S, Li, Z, Wang, J, Yang, Y, Zhang, L, Yang, P, Zhang, X, Huang, H, Xue, L, Zheng, Z, Huang, W, Dai, H, Su, H, Zeng, X, Zheng, Y, Tang, Y, Yao, Z, Sun, Y, Du, Y, Ge, Z, Yan, J, Chen, X, Liu, F, Pei, H, Yang, X, Cui, H, Gu, Y, Yang, Z, Li, J, Lian, Y, Cui, Y, Wang, D, Jiang, J, Li, X, Chen, J, Mo, Z, Xu, P, He, Y, Zhou, C, Qu, P, Zhu, Y, Liu, Y, Shen, X, Gao, X, Terront Lozano MA, Moncada Corredor MA, Hernandez Triana, E, Botero Lopez, R, Coronel Arroyo JA, Quintero Baiz AE, Sanchez Vallejo, G, Arana Londoño, C, Molina de Salazar DI, Castellanos Bueno, R, Manzur Jattin, F, Cure Cure CA, Sotomayor Herazo, A, Spinar, J, Hala, T, Machkova, M, Klimsa, Z, Polasek, R, Jerabek, O, Kazdera, P, Pozdisek, Z, Vaclavik, J, Frana, P, Elbl, L, Kucera, D, Kryza, R, Malecha, J, Reichert, P, Sochor, K, Ludka, O, Kellnerova, I, Peterka, K, Zidkova, E, Cech, V, Brabec, T, Fiserova, N, Kvasnicka, J, Rosolova, H, Nemecek, E, Adamkova, V, Dunaj, M, Pojsl, S, Cepelak, M, Podpera, I, Kuchar, L, Rysava, D, Burianova, H, Spinarova, L, Skrobakova, J, Charvat, J, Homza, M, Zemanek, J, Koleckar, P, Karen, I, Krupicka, J, Blaha, V, Matuska, J, Brotanek, J, Cifkova, R, Kuchar, R, Vomacka, Z, Kosek, Z, Hulinsky, V, Krejcova, H, Kuchar, J, Jelinek, Z, Jelinek, P, Markdanner Lindgren, L, Saetre Lihn, A, Korsgaard Thomsen, K, Bronnum-Schou, J, Nielsen, H, Nielsen, T, Egstrup, K, Klausen, Ic, Mickley, H, Hove, J, Jeppesen, J, Melchior, T, Schmidt, Eb, Valter, I, Rosenthal, A, Kaik, J, Kork, A, Alt, I, Strand, J, Nieminen, S, Kahri, J, Suomi, J, Nyman, K, Strandberg, Te, Piippo, T, Savolainen, M, Vikman, S, Pucheu, Y, Cariou, B, Henry, P, Ferrari, E, Montalescot, G, Ferrieres, J, Roubille, F, Bonnet, B, Angoulvant, D, Range, G, Bammert, A, Delarche, N, Mariat, C, Cayla, G, Durlach, V, Coisne, D, Paillard, F, Rouzier, R, Goralski, M, Khanoyan, P, Cottin, Y, Ziegler, O, Khalife, K, Le Corvoisier, P, Motreff, P, Spaulding, C, Vanbelle, E, Bourhaial, H, Opitz, C, Kahrmann, G, Contzen, C, Appel, K, Schenkenberger, I, Rinke, A, Trenk, D, Maus, O, Karakas, M, Hanefeld, M, Darius, H, Hetzel, G, Münzel, T, Wöhrle, J, Stawowy, P, Marten, I, Isermann, B, Kast, P, Vorpahl, M, Bosiljanoff, P, Hengstenberg, C, Kassner, U, Salbach, P, Fischer, M, Steiner, S, Wagner, S, Kraatz, U, von Hodenberg, E, Weyland, K, Mantas, I, Tziakas, D, Bousboulas, S, Patsilinakos, S, Mertzanos, G, Panagoulis, C, Bilianou, H, Skoumas, I, Elisaf, M, Manolis, A, Moschos, N, Kochiadakis, G, Ntaios, G, Richter, D, Athyros, V, Kolovou, G, Danias, P, Melidonis, A, Fan, Kyy, Siu, Sc, Hornyik, A, Lakatos, F, Zilahi, Z, Nagy, K, Laszlo, Z, Peterfai, E, Lupkovics, G, Andreka, P, Merkely, B, Herczeg, B, Piros, Ga, Salamon, C, Mark, L, Papp, A, Szakal, I, Edes, I, Mohacsi, A, Tomcsanyi, J, Hajko, E, Nagy, A, Papp, E, Kiss, R, Karadi, I, Sigurdsson, A, Jain, A, Pai, R, Kothiwale, V, Kulkarni, G, Mahajan, A, Aggarwal, S, Mehta, V, Rajadhyaksha, G, Joshi, A, Khandait, V, Parmar, M, Tyagi, S, Airody Govinda, R, Dwivedi, Sk, Parikh, K, Pothineni, Rb, Solanki, B, O’Donnell, M, Crean, P, Barton, J, Shechter, M, Shotan, A, Klutstein, M, Chorin, E, Gavish, D, Kracoff, O, Atar, S, Rigler, S, Hasin, Y, Schiff, E, Merlini, P, Rapezzi, C, Pirro, M, Gonnelli, S, Floresta, Am, Mennuni, M, Ardissino, D, Senni, M, Marenzi, G, Marcucci, R, Sampietro, T, Cosmi, F, Perrone Filardi, P, De Caterina, R, Fedele, Francesco, Moretti, L, Biasucci, Lm, Ferri, C, Go, Y, Kiyosue, A, Higashi, Y, Tokunaga, T, Kawasaki, T, Sakagami, S, Namba, S, Saku, K, Oku, K, Arakawa, T, Iida, H, Nakamura, Y, Yamamoto, K, Hata, Y, Katsuda, Y, Koga, Y, Shimizu, M, Uehara, H, Kajiyama, S, Okamoto, H, Shinozaki, T, Fujino, Y, Funazaki, T, Higa, N, Kaigawa, K, Koike, A, Nakane, H, Sato, K, Satoh, Y, Shirasawa, K, Sugino, H, Tanabe, J, Uemura, O, Yoshimichi, G, Akai, A, Himeno, H, Inage, T, Inoko, M, Kadokami, T, Noguchi, Y, Yamashita, K, Yasumura, Y, Yuge, M, Hosokawa, S, Kawamitsu, K, Kozuma, K, Matsuo, H, Nakashima, E, Okada, M, Wada, A, Yokoya, K, Iwade, K, Kawabata, K, Tanno, H, Ako, J, Fujita, H, Izumiya, Y, Kanno, M, Nunohiro, T, Ohmura, H, Ueno, T, Kakurina, N, Jasinkevica, I, Stukena, I, Veze, I, Eglite, R, Teterovska, D, Sime, I, Strazdiene, V, Venceviciene, L, Gustiene, O, Radzeviciene-Jurgute, R, Kucinskiene, A, Maskon, O, Lee, Cy, Erng, T, Gan, Hw, Mohamed Yusof AK, Ramanathan, Gl, Liew, H, Lopez Alvarado, A, Nevarez Ruiz LA, De los Rios Ibarra MO, Bazzoni Ruiz AE, Ramos Lopez GA, Llamas Esperon GA, De la Peña Topete GDJ, Violante Ortiz RM, Illescas Diaz JJ, Leon Gonzalez, S, Sanchez Diaz CJ, Mendez Machado GF, Venegas Carrillo LA, Aldrete Velasco JA, Cardona Muñoz EG, Leiva Pons JL, Perez Alva JC, van der Zwaan, C, Oomen, A, van de Wal, R, Magro, M, Boswijk, D, Janus, C, Groutars, R, Tonino, W, Cornel, Jh, Oude Ophuis, A, Troquay, R, Liem, A, Westendorp, I, Van Hessen, M, Lok, D, De Nooijer, C, Den Hartog, F, Van Beek, E, Bendermacher, P, Jansen, R, Römer, T, Rensing, B, Hersbach, F, Herrman, J, Ladyjanskaia, G, Karalis, I, Linssen, G, Bokern, M, Visman, A, Kooij, A, Monajemi, H, Lieverse, A, Baker, J, Tie, S, Risberg, K, Hysing, J, Pedersen, T, Hoivik, Ho, Norheim, P, Solnor, L, Hovland, A, Kjaernli, T, Jocson, G, Coching, Rm, Batalla, E, Go, A, Habaluyas, R, Barcinas, R, Sy, Ra, Estepar, Ra, Germar, A, Trebacz, J, Szymkowiak, K, Wnetrzak-Michalska, R, Kopaczewski, J, Przekwas-Jaruchowska, M, Kania, G, Zabowka, M, Mirek-Bryniarska, E, Dabrowska, M, Napora, P, Konieczny, M, Spyra, J, Lysek, R, Pijanowski, Z, Grzegorzewski, B, Bednarkiewicz, Z, Kinasz, L, Antkowiak-Piatyszek, K, Stania, K, Szpajer, M, Staneta, P, Skonieczny, G, Ksiezycka-Majczynska, E, Blicharski, T, Piepiorka, M, Wozakowska-Kaplon, B, Zechowicz, T, Ilkowski, J, Lubiszewska, B, Hiczkiewicz, J, Wierzbicka, K, Kosior, D, Garbocz, P, Kubica, J, Raczak, G, Wozniak, I, Cygler, J, Kramarczuk, E, Bystryk, L, Pentela-Nowicka, J, Dabrowski, M, Podolec, P, Zieba, B, Mosiewicz, J, Dubaniewicz, W, Banach, M, Tyszecka, G, Lepich, T, Rychlewska-Hanczewska, A, Guzik, T, Monteiro, P, Pereira, H, Oliveira, L, Matos, P, Soares Goncalves, S, Leitao, A, Vasco Salgado, A, Timoteo, At, Pintilei, E, Badila, E, Militaru, C, Tudoran, M, Arsenescu-Georgescu, C, Mitu, F, Zdrenghea, D, Lighezan, D, Teodorescu, I, Popescu, Mi, Coman, I, Vintila, Mm, Vishnevsky, A, Lukyanov, Y, Blokhin, A, Kostenko, V, Shvarts, Y, Markov, V, Motylev, I, Dronov, D, Sherenkov, A, Barbarash, O, Shutemova, E, Bolshakova, O, Kobalava, Z, Voevoda, M, Treshkur, T, Zrazhevskiy, K, Pimenov, L, Solovev, O, Tarasov, N, Arkhipov, M, Freidlin, M, Shalaev, S, Yakhontova, P, Shustov, S, 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Yamashita, K, Yasumura, Y, Yuge, M, Hosokawa, S, Kawamitsu, K, Kozuma, K, Matsuo, H, Nakashima, E, Okada, M, Wada, A, Yokoya, K, Iwade, K, Kawabata, K, Tanno, H, Ako, J, Fujita, H, Izumiya, Y, Kanno, M, Nunohiro, T, Ohmura, H, Ueno, T, Kakurina, N, Jasinkevica, I, Stukena, I, Veze, I, Eglite, R, Teterovska, D, Sime, I, Strazdiene, V, Venceviciene, L, Gustiene, O, Radzeviciene-Jurgute, R, Kucinskiene, A, Maskon, O, Lee, C, Erng, T, Gan, H, Mohamed Yusof, A, Ramanathan, G, Liew, H, Lopez Alvarado, A, Nevarez Ruiz, L, De los Rios Ibarra, M, Bazzoni Ruiz, A, Ramos Lopez, G, Llamas Esperon, G, De la Pena Topete, G, Violante Ortiz, R, Illescas Diaz, J, Leon Gonzalez, S, Sanchez Diaz, C, Mendez Machado, G, Venegas Carrillo, L, Aldrete Velasco, J, Cardona Munoz, E, Leiva Pons, J, Perez Alva, J, van der Zwaan, C, Oomen, A, van de Wal, R, Magro, M, Boswijk, D, Janus, C, Groutars, R, Tonino, W, Cornel, J, Oude Ophuis, A, Troquay, R, Liem, A, Westendorp, I, Van Hessen, M, Lok, D, De Nooijer, C, 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Dabrowski, M, Podolec, P, Zieba, B, Mosiewicz, J, Dubaniewicz, W, Banach, M, Tyszecka, G, Lepich, T, Rychlewska-Hanczewska, A, Guzik, T, Monteiro, P, Pereira, H, Oliveira, L, Matos, P, Soares Goncalves, S, Leitao, A, Vasco Salgado, A, Timoteo, A, Pintilei, E, Badila, E, Militaru, C, Tudoran, M, Arsenescu-Georgescu, C, Mitu, F, Zdrenghea, D, Lighezan, D, Teodorescu, I, Popescu, M, Coman, I, Vintila, M, Vishnevsky, A, Lukyanov, Y, Blokhin, A, Kostenko, V, Shvarts, Y, Markov, V, Motylev, I, Dronov, D, Sherenkov, A, Barbarash, O, Shutemova, E, Bolshakova, O, Kobalava, Z, Voevoda, M, Treshkur, T, Zrazhevskiy, K, Pimenov, L, Solovev, O, Tarasov, N, Arkhipov, M, Freidlin, M, Shalaev, S, Yakhontova, P, Shustov, S, Goloshchekin, B, Panov, A, Bart, B, Bubnova, M, Gordeev, I, Osipova, I, Tereshenko, S, Solovieva, E, Meshkov, A, Zateyshchikov, D, Tan, J, Subramaniam, T, Pella, D, Fulop, P, Antalik, L, Dzupina, A, Banikova, A, Sosovec, D, Urgeova, L, Mazur, J, Hranai, M, Banik, M, Vinanska, D, Lennerova, J, Kovar, F, Pastrnakova, E, Uhliar, R, Blasko, P, Gonsorcik, J, Lukacova, J, Oriesek, R, Hatalova, K, du Toit, M, Ebrahim, I, Vawda, G, Lipschitz, S, Blignaut, S, Engelbrecht, J, Coetzer, T, Pretorius, M, Urbach, D, Badat, A, Pillay, S, Van Zyl, L, Abelson, M, van der Walt, E, Moodley, R, Jacovides, A, Oosthuysen, W, Klug, E, Lottering, H, Kok, J, Saaiman, J, Dawood, S, De Jong, D, Kapp, C, Makotoko, E, Bayat, J, Sarvan, M, Vally, T, Stapelberg, A, Kim, M, Bae, J, Cho, Y, Kim, S, Han, K, Her, S, Kim, B, Lee, S, Hong, B, Kim, W, Rha, S, Jeong, M, Shin, G, Vida Gutierrez, M, Valdes Chavarri, M, Pinto Sala, X, Gonzalez Juanatey, J, Civeira Murillo, F, Zamorano Gomez, J, Lekuona Goya, I, Iniguez Romo, A, Cordero Fort, A, Ascaso Gimilio, J, Millan Nunez-Cortes, J, Lindholm, C, Soderberg, S, Suutari, A, Berglund, S, Mooe, T, Kusiak, D, Bandh, S, Dahlen, G, Olsson, S, Witt, N, Tyden, P, Johansson, P, Cizinsky, S, Falck, G, Pettersson, S, Rasmanis, G, Ostergren, J, Moccetti, T, Beer, H, Eberli, F, Krahenbuhl, S, Linka, A, Ackermann, D, Michel, P, Yeh, H, Tsai, C, Wu, C, Hsia, C, Juang, J, Hsieh, I, Lai, W, Huang, C, Hsieh, Y, Sahin, T, Duzenli, M, Yigit, Z, Demir, M, Yilmaz, M, Muderrisoglu, I, Kirma, C, Ercan, E, Kayikcioglu, L, Balbay, Y, Lymar, I, Kulynych, O, Prokhorov, O, Karpenko, O, Kraіz, I, Vakaliuk, I, Stanislavchuk, M, Korzh, O, Rudyk, I, Zhurba, S, Svishchenko, Y, Tseluyko, V, Gyrina, O, Reshotko, D, Kopytsya, M, Volkov, V, Myshanych, G, Rebrov, B, Rishko, M, Rudenko, L, Shatylo, V, Parkhomenko, O, Yena, L, Golovchenko, O, Sorokina, I, Malynovsky, Y, Ivan, P, Blagden, M, Dear, H, Mathew, A, Lagocki, S, Kondagunta, V, Ahsan, A, Mckinnon, C, Douglas, F, Thom, S, Fiore, G, Caulfield, M, Lynch, M, Thomas, H, Bain, S, Hall, A, Mcnally, D, Fisher, M, Keeling, P, Al-Bahrani, A, Lip, G, Ellery, A, Purohit, J, Travill, C, Cappuccio, F, Davis, G, Gaunt, R, Adlam, D, Asamoah, N, Jaafar, F, Mccormack, T, Jupp, B, Pye, M, Ainsworth, P, Chauhan, A, Paul, N, Fairlie, H, Fox, C, Muzulu, S, Trevelyan, J, Aggarwal, R, Issa, B, Saravanan, P, Cruickshank, K, Gorog, D, Heller, S, Newby, D, Nicolson, A, Hare, P, Donnelly, P, Rutherfurd, S, de Belder, M, Finlayson, J, Harvey, J, Hoye, A, Kingston, D, Sarkar, D, Negahban, A, Webster, J, Wyatt, N, Muir, S, Cummings, M, Mackenzie, I, Senior, R, Capps, N, Fotherby, K, Mcintyre, H, Aldegather, J, Dixon, L, Saksena, R, Butler, R, Ramstad, D, Pierpont, B, Levinson, D, Mohammed, A, Haddad, T, Goel, A, Dave, K, Haught, W, Desire, A, Hershon, K, Napoli, M, Tami, L, Rothschild, R, Khurana, S, Gupta, D, Cheung, D, Hearne, S, Grubb, S, Miller, A, Baird, I, Marcus, A, Srivastava, S, Forgosh, L, Fritz, R, Mays, M, Bertolet, B, Reddy, J, Khan, M, Nakhle, S, Dill, S, Fishbein, G, Khan, B, Marais, H, Reschak, M, Malone, M, Nadar, V, Whitney, R, Reichman, A, Reyes, H, El Shahawy, M, Rabinowitz, A, Weinstein, D, Farhat, N, Onyema, D, Potu, R, Runquist, L, Barnum, O, Crater, T, Fialkow, J, Shah, A, Thompson, C, Wiseman, A, Doyle, T, Henderson, D, Herzog, W, Schnitzler, R, Carr, K, Davis, M, Nagajothi, N, Olsen, S, Rogers, W, Rubino, J, Singh, I, Tarleton, G, Bhagwat, R, Clardy, D, Jardula, M, Robinson, J, Torres, M, Vijay, N, Farris, N, Lillo, J, Moriarty, P, Recknor, C, Berlacher, P, Christensen, T, Gabra, N, Issa, M, Janik, M, Lawless, A, Molter, D, Stout, E, Brezina, B, Claxton, E, Linsky, R, Poock, J, Remler, R, Roseman, H, Schramm, E, Al-Joundi, T, Amin, J, Hitchcock, J, Isserman, S, Kirstein, J, Rider, J, Shalek, M, Sherman, H, Bernstein, M, Chandra, L, Hatharasinghe, R, Ibrahim, H, Iteld, B, Linzmeyer, K, Seaton, B, Zeig, S, Christofides, E, Dunbar, R, Griffin, S, Kohli, N, Koren, M, Pharr, W, Purdy, D, Spencer, R, Yeoman, G, Banerjee, S, Cheek, H, Engel, E, Hamroff, G, Huling, R, Kozlowski, L, Levin, P, Makam, S, Meengs, M, Bhushan, R, Erickson, B, Herman, L, Lo, E, Mcdowell, E, Mcgrew, F, Miller, M, Ord, J, Webel, R, Wilhoit, G, Wise, J, Yang, E, Budoff, M, Collins, J, Dauber, I, Dobkin, L, Focil, A, Gandy, W, Pasquini, J, Ramos, M, Rodriguez, D, Rosenson, R, Sanford, K, Schlau, A, Snyder, B, Stonesifer, L, Tang, A, De Souza, J, Elam, M, French, J, Guyton, J, Hage Korban, E, Kereiakes, D, King, M, Loh, I, Navarro, J, Simons, R, Tobin, T, Younis, L, Aboufakher, R, Baldari, D, Ballantyne, C, Broughton, R, Eaton, C, Johnston, J, Simon, W, Thomson, S, Vora, K, Youngman, D, Alzohaili, O, Auerbach, E, Brown, C, Burrough, B, Chen, Y, Gilpatrick, M, Landzberg, J, Mitchell, C, Rice, L, Rubenfire, M, Sofley, C, Strobl, D, Atassi, K, Davila, W, Diogo, J, Fagan, T, Joffe, I, Krishna, J, Osea, E, Penny, W, Rowe, W, Shapiro, M, Welker, J, Benton, R, Dobratz, D, Fortuin, F, Graham, J, Henry, B, Kusnick, B, Lutskiy, M, Mcrae, A, Saway, W, Scott, J, Shah, M, Weinberg, B, Zarich, S, Acheatel, R, Case, C, Earl, J, Fernandez, S, Giugliano, G, Handelsman, Y, Hermany, P, Holder, S, Kashyap, M, Khan, A, Lader, E, Peniston, J, Raoof, T, Sacco, J, Shore, K, Spriggs, D, Stringam, S, Tahirkheli, N, Delgado, E, Derian, W, Greenwald, J, Harris, M, Jackson, R, Marhefka, G, Mcelveen, W, Mooss, A, Morris, P, Murray, J, Pearlstein, P, Raisinghani, A, Rezkalla, S, Sakhrani, L, Schreibman, D, Shaoulian, E, Steinsapir, J, Yataco, A, De La Cruz, A, Fredrick, M, Goldenberg, E, Lee, D, Mccullum, K, Mclellan, B, Stephens, L, Wilson, S, Alfieri, A, Mandviwala, M, Orourke, D, Samal, A, Schmedtje, J, Waxman, F, Carhart, R, Clements, B, Dyke, C, Ghali, J, Gruberg, L, Hack, T, Jehle, A, Pogue, B, Schooley, C, and Shifrin, G

Subjects
Male, STATIN THERAPY, 2700 General Medicine, Disease, Cardiovascular, PLACEBO-CONTROLLED TRIAL, Gastroenterology, 0302 clinical medicine, Anticholesteremic Agent, Medicine, Myocardial infarction, 11 Medical and Health Sciences, ddc:616, Incidence, Antibodies, Monoclonal, General Medicine, Cholesterol, Cardiovascular Diseases, Monoclonal, Drug Therapy, Combination, Proprotein Convertase 9, Antibody, Aged, Anticholesteremic Agents, Atherosclerosis, Cholesterol, LDL, Double-Blind Method, Female, Follow-Up Studies, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Least-Squares Analysis, Middle Aged, Medicine (all), REDUCING LIPIDS, Human, medicine.medical_specialty, Evinacumab, Clinical Trials and Supportive Activities, PCSK9 INHIBITION, Follow-Up Studie, LDL, 03 medical and health sciences, Drug Therapy, Clinical Research, LDL-C, Least-Squares Analysi, Science & Technology, Unstable angina, PCSK9, medicine.disease, chemistry, Clinical Biochemistry, 030204 cardiovascular system & hematology, Bococizumab, FOURIER Steering Committee and Investigators, Medical and Health Sciences, chemistry.chemical_compound, Antibodies monoclonal, Cardiovascular Disease, 030212 general & internal medicine, Stroke, Humanized, RISK, biology, PCSK9 Inhibitors, 10051 Rheumatology Clinic and Institute of Physical Medicine, Heart Disease, Atherosclerosi, 6.1 Pharmaceuticals, Combination, Cardiology, Life Sciences & Biomedicine, Antibodies, Monoclonal, Humanized, EZETIMIBE, 610 Medicine & health, Antibodies, Medicine, General & Internal, General & Internal Medicine, Internal medicine, CORONARY-HEART-DISEASE, In patient, Heart Disease - Coronary Heart Disease, Alirocumab, Ldl cholesterol, business.industry, Evaluation of treatments and therapeutic interventions, Evolocumab, Good Health and Well Being, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, biology.protein, MODERATE, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business
Abstract

Background Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. Methods We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. Results At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P

Published
2017

27. Association between systolic ejection time and outcomes in heart failure by ejection fraction.

Author

Patel, Priyesh A., Ambrosy, Andrew P., Phelan, Matthew, Alenezi, Fawaz, Chiswell, Karen, Van Dyke, Melissa K., Tomfohr, Jennifer, Honarpour, Narimon, and Velazquez, Eric J.

Subjects
HEART failure, LOGISTIC regression analysis, AFRICAN Americans
Abstract

Aims: Worsening heart failure (HF) is associated with shorter left ventricular systolic ejection time (SET), but there are limited data describing the relationship between SET and clinical outcomes. Thus, the objective was to describe the association between SET and clinical outcomes in an ambulatory HF population irrespective of ejection fraction (EF).Methods and Results: We identified ambulatory patients with HF with reduced EF (HFrEF) and HF with preserved EF (HFpEF) who had an outpatient transthoracic echocardiogram performed between August 2008 and July 2010 at a tertiary referral centre. Multivariable logistic regression was used to evaluate the association between SET and 1-year outcomes. A total of 545 HF patients (171 HFrEF, 374 HFpEF) met eligibility criteria. Compared with HFpEF, HFrEF patients were younger [median age 60 years (25th-75th percentiles 50-69) vs. 64 years (25th-75th percentiles 53-74], with fewer females (30% vs. 56%) and a similar percentage of African Americans (36% vs. 35%). Median (25th-75th percentiles) EF with HFrEF was 30% (25-35%) and with HFpEF was 54% (48-58%). Median SET was shorter (280 ms vs. 315 ms, P < 0.001), median pre-ejection period was longer (114 ms vs. 89 ms, P < 0.001), and median relaxation time was shorter (78.7 ms vs. 93.3 ms, P < 0.001) among patients with HFrEF vs. HFpEF. Death or HF hospitalization occurred in 26.9% (n = 46) HFrEF and 11.8% (n = 44) HFpEF patients. After adjustment, longer SET was associated with lower odds of the composite of death or HF hospitalization at 1 year among HFrEF but not HFpEF patients.Conclusion: Longer SET is independently associated with improved outcomes among HFrEF patients but not HFpEF patients, supporting a potential role for normalizing SET as a therapeutic strategy with systolic dysfunction. [ABSTRACT FROM AUTHOR]

Published
2020
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30. Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial.

Author

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

Published
2019
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33. List of Contributors

Author

Alturkistani, Abrar, An, Juanjuan, Benda, Norbert, Bienfait, Karina, Blackler, Adele R., Bøgsted, Martin, Brindley, David, Broich, Karl, Brøndum, Rasmus F., Brunhoeber, Patrick, Bureau, Matthew, Car, Josip, Carter, Alison, Clarke, Tara, Clements, June, Cross, Darren, Doble, Brett, Dolled-Filhart, Marisa, Domazetoski, Elena, Duncan, Mark W., ElGabry, Ehab A., Ellison, Aaron R., Emancipator, Kenneth, Enzmann, Harald, Farooq, Maria, Feng, Janine, Foley, Kimberley, Generalov, Evgenii, Go, Ning Fei, Goltsov, Alexey, Green, George A., IV, Hersom, Maria, Honarpour, Narimon, Iddamalgoda, Lahiru, Ikeda, Masayuki, Jenkins, Suzanne, Jørgensen, Jan Trøst, Kapadia, Monesh, Karwowska, Sylwia, Kuzulugil, Sebnem S., Lam, Ching, Lewis, Jason S., Li, Jinbo, Liesenfeld, Oliver, Lopes, Gilberto, Luo, Dee, Meinert, Edward, Meyer, Ralf, Mistry, Amita, Mitsakakis, Nicholas, Mollerup, Jens, Montalto, Michael C., Murata, Lauren B., Murtaza, Muhammed, Nielsen, Karsten Bork, Pant, Saumya, Parker, Jayson L., Pereira, Patrícia M.R., Ramarao, Manjunath, Rigl, Ted, Schildgen, Oliver, Schildgen, Verena, Scholl, Catharina, Scudder, Sidney A., Seyfried, Donna, Sharma, Abha, Shimazawa, Rumiko, Simon, Richard, Singh, Shalini, Sobol, Nicholas B., Stanforth, David A., Stingl, Julia, Sundararajan, Vijayaraghava Seshadri, Suravajhala, Prashanth, Tosolini, Alessandra, Tsou, Jeff, Tully, Kathryn M., Walk, Eric E., Wu, Dianna, Xu, Xiaolei, and Yu, Karen

Published
2019
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35. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

Author

Cowie, Martin R., Filippatos, Gerasimos S., Alonso Garcia, Maria de los Angeles, Anker, Stefan D., Baczynska, Anna, Bloomfield, Daniel M., Borentain, Maria, Bruins Slot, Karsten, Cronin, Maureen, Doevendans, Pieter A., El‐Gazayerly, Amany, Gimpelewicz, Claudio, Honarpour, Narimon, Janmohamed, Salim, Janssen, Heidi, Kim, Albert M., Lautsch, Dominik, Laws, Ian, Lefkowitz, Martin, and Lopez‐Sendon, Jose

Subjects
THERAPEUTICS, HEART failure, LIFE expectancy, HOSPITAL care, HEART diseases, CARDIOVASCULAR agents, CLINICAL trials, CONSENSUS (Social sciences), HEALTH outcome assessment, DRUG approval
Abstract

Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way. [ABSTRACT FROM AUTHOR]

Published
2017
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36. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial

Author

Giugliano, Robert P., Mach, Francois, Zavitz, Kenton, Kurtz, Christopher, Schneider, Jingjing, Wang, Huei, Keech, Anthony, Pedersen, Terje R., Sabatine, Marc S., Sever, Peter S., Honarpour, Narimon, Wasserman, Scott M., and Ott, Brian R.

Published
2017
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41. Effect of the Proprotein Convertase Subtilisin/Kexin 9 Monoclonal Antibody, AMG 145, in Homozygous Familial Hypercholesterolemia.

Author

Stein, Evan A., Honarpour, Narimon, Wasserman, Scott M., Feng Xu, Scott, Rob, and Raal, Frederick J.

Subjects
*HYPERCHOLESTEREMIA, *PROPROTEIN convertases, *SUBTILISINS, *MONOCLONAL antibodies, *GENETIC disorder treatment, *PHYSIOLOGICAL effects of cholesterol
Abstract

Background--Homozygous familial hypercholesterolemia is a rare, serious disorder with a substantial reduction in low-density lipoprotein (LDL) receptor function, severely elevated LDL cholesterol, cardiovascular disease, and often death in childhood. Response to conventional drug therapies is modest. Monoclonal antibodies to proprotein convertase subtilisin/kexin 9 (PCSK9) reduce LDL cholesterol in heterozygous familial hypercholesterolemia. The effect in homozygous familial hypercholesterolemia is unknown and uncertain. We evaluated the efficacy and safety of AMG 145 in an open-label, single-arm, multicenter, dose-scheduling pilot study in patients with homozygous familial hypercholesterolemia. Methods and Results--Eight patients with LDL receptor-negative or -defective homozygous familial hypercholesterolemia on stable drug therapy were treated with subcutaneous 420 mg AMG 145 every 4 weeks for ≥12 weeks, followed by 420 mg AMG 145 every 2 weeks for an additional 12 weeks. All patients completed both treatment periods. Mean change from baseline in LDL cholesterol at week 12 was -16.5% (range, 5.2% to -43.6%; P=0.0781) and -13.9% (range, 39.9% to -43.3%; P=0.1484) with 4- and 2-week dosing, respectively. No reduction was seen in the 2 receptor-negative patients. Over the treatment periods, mean±SD LDL cholesterol reductions in the 6 LDL receptor-defective patients were 19.3+16% and 26.3±20% with 4- and 2-week dosing, respectively (P=0.0313 for both values), ranging from 4% to 48% with 2-week dosing. No serious side effects were reported. Conclusion--This study demonstrates significant and dose-related LDL cholesterol lowering with a PCSK9 monoclonal antibody in homozygous familial hypercholesterolemia patients with defective LDL receptor activity but no reduction in those who were receptor negative. [ABSTRACT FROM AUTHOR]

Published
2013
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42. Apoptosis in Neural Development and Disease.

Author

Nijhawan, Deepak, Honarpour, Narimon, and Wang, Xiaodong

Subjects
*APOPTOSIS, *NEURONS, *NEUROSCIENCES
Abstract

Deals with a study which examined cell death via apoptosis in mammalian disease and neural development. Biochemical mechanism of apoptosis; Cells involved in neural apoptosis; Neurodegenerative diseases that cause cell death.

Published
2000
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43. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial

Author

Macdonald, Peter, Cleland, John G F, Honarpour, Narimon, Metra, Marco, McMurray, John J V, Ezekowitz, Justin A, Ponikowski, Piotr, Johnston, James, Felker, G Michael, Adams, Kirkwood F, Tomcsányi, János, Serpytis, Pranas, Voors, Adriaan A, Monsalvo, Maria Laura, Malik, Fady I, Spinar, Jindrich, Goudev, Assen, Teerlink, John R, Solomon, Scott D, Vandekerckhove, Hans J, and Mitrovic, Veselin

Subjects
3. Good health
Abstract

BACKGROUND: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil. METHODS: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks. We assessed the maximum concentration of omecamtiv mecarbil in plasma (primary endpoint) and changes in cardiac function and ventricular diameters. This trial is registered with ClinicalTrials.gov, number NCT01786512. FINDINGS: From March 17, 2014, to March 5, 2015, we enrolled 150 patients in the fixed-dose omecamtiv mecarbil group and 149 in the pharmacokinetic-titration and placebo groups. Mean maximum concentration of omecamtiv mecarbil at 12 weeks was 200 (SD 71) ng/mL in the fixed-dose group and 318 (129) ng/mL in the pharmacokinetic-titration group. For the pharmacokinetic-titration group versus placebo group at 20 weeks, least square mean differences were as follows: systolic ejection time 25 ms (95% CI 18-32, p

45. Erratum to "Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency" [Eur J Heart Fail 2016;18:482-489].

Author

Anker, Stefan D., Schroeder, Stefan, Atar, Dan, Bax, Jeroen J., Ceconi, Claudio, Cowie, Martin R., Crisp, Adam, Dominjon, Fabienne, Ford, Ian, Ghofrani, Hossein‐Ardeschir, Gropper, Savion, Hindricks, Gerhard, Hlatky, Mark A., Holcomb, Richard, Honarpour, Narimon, Jukema, J. Wouter, Kim, Albert M., Kunz, Michael, Lefkowitz, Martin, and Floch, Chantal Le

Subjects
HEART failure, CLINICAL trials
Published
2016
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47. Cognitive Function in a Randomized Trial of Evolocumab.

Author

Giugliano, Robert P., Mach, François, Zavitz, Kenton, Kurtz, Christopher, Kyungah Im, Kanevsky, Estella, Schneider, Jingjing, Huei Wang, Keech, Anthony, Pedersen, Terje R., Sabatine, Marc S., Sever, Peter S., Robinson, Jennifer G., Honarpour, Narimon, Wasserman, Scott M., Ott, Brian R., Im, Kyungah, Wang, Huei, and EBBINGHAUS Investigators

Subjects
*COGNITIVE ability, *RANDOMIZED controlled trials, *LOW density lipoproteins, *STATINS (Cardiovascular agents), *CLINICAL trials, *THERAPEUTIC use of monoclonal antibodies, *ANTILIPEMIC agents, *ATHEROSCLEROSIS, *COMBINATION drug therapy, *COGNITION, *COMPARATIVE studies, *LONGITUDINAL method, *RESEARCH methodology, *MEDICAL cooperation, *MEMORY, *MONOCLONAL antibodies, *PSYCHOLOGICAL tests, *RESEARCH, *SELF-evaluation, *EVALUATION research, *BLIND experiment, *PSYCHOLOGY
Abstract

Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (P<0.001 for noninferiority; P=0.85 for superiority). There were no significant between-group differences in the secondary end points of scores for working memory (change in raw score, -0.52 in the evolocumab group and -0.93 in the placebo group), episodic memory (change in raw score, -1.53 and -1.53, respectively), or psychomotor speed (change in raw score, 5.2 msec and 0.9 msec, respectively). In an exploratory analysis, there were no associations between LDL cholesterol levels and cognitive changes. Conclusions In a randomized trial involving patients who received either evolocumab or placebo in addition to statin therapy, no significant between-group difference in cognitive function was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .). [ABSTRACT FROM AUTHOR]

Published
2017
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48. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial.

Author

COSMIC-HF Investigators, Teerlink, John R., Goudev, Assen, Macdonald, Peter, Metra, Marco, Mitrovic, Veselin, Ponikowski, Piotr, Serpytis, Pranas, Spinar, Jindrich, Tomcsányi, János, Vandekerckhove, Hans J., Voors, Adriaan A., Monsalvo, Maria Laura, Johnston, James, Honarpour, Narimon, Malik, Fady I., Adams, Kirkwood F Jr, Felker, G. Michael, McMurray, John J. V., and Solomon, Scott D.

Subjects
*MYOSIN, *CARDIAC contraction, *CONTRACTILITY (Biology), *HEART failure, *PHARMACOKINETICS, *RANDOMIZED controlled trials, *PHYSIOLOGY, *MUSCLE protein metabolism, *COMPARATIVE studies, *DOSE-effect relationship in pharmacology, *LEFT heart ventricle, *HEART physiology, *RESEARCH methodology, *MEDICAL cooperation, *MUSCLE proteins, *ORAL drug administration, *PEPTIDE hormones, *PEPTIDES, *RESEARCH, *STATISTICAL sampling, *UREA, *EVALUATION research, *VENTRICULAR remodeling, *STROKE volume (Cardiac output)
Abstract

Background: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil.Methods: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks. We assessed the maximum concentration of omecamtiv mecarbil in plasma (primary endpoint) and changes in cardiac function and ventricular diameters. This trial is registered with ClinicalTrials.gov, number NCT01786512.Findings: From March 17, 2014, to March 5, 2015, we enrolled 150 patients in the fixed-dose omecamtiv mecarbil group and 149 in the pharmacokinetic-titration and placebo groups. Mean maximum concentration of omecamtiv mecarbil at 12 weeks was 200 (SD 71) ng/mL in the fixed-dose group and 318 (129) ng/mL in the pharmacokinetic-titration group. For the pharmacokinetic-titration group versus placebo group at 20 weeks, least square mean differences were as follows: systolic ejection time 25 ms (95% CI 18-32, p<0·0001), stroke volume 3·6 mL (0·5-6·7, p=0·0217), left ventricular end-systolic diameter -1·8 mm (-2·9 to -0·6, p=0·0027), left ventricular end-diastolic diameter -1·3 mm, (-2·3 to 0·3, p=0·0128), heart rate -3·0 beats per min (-5·1 to -0·8, p=0·0070), and N-terminal pro B-type natriuretic peptide concentration in plasma -970 pg/mL (-1672 to -268, p=0·0069). The frequency of adverse clinical events did not differ between groups.Interpretation: Omecamtiv mecarbil dosing guided by pharmacokinetics achieved plasma concentrations associated with improved cardiac function and decreased ventricular diameter.Funding: Amgen. [ABSTRACT FROM AUTHOR]

Published
2016
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