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2. Clinical-Functional Characteristics of Patients with Chronic Obstructive Pulmonary Disease Depending on the Parameters of the Red Branch of Blood and the Content of Soluble Transferrin Receptors

Author

Kovchun A., Kmita V., and Prystupa L.

Subjects
anemia of chronic disease, chronic obstructive pulmonary diseases, clinical and functional state, dyspnea, quality of life, soluble transferrin receptors, spirography, Medicine
Abstract

Introduction. Chronic obstructive pulmonary disease (COPD) was associated with polycythemia as a result of respiratory failure and regarded as a compensatory response of erythropoiesis to chronic hypoxia for a long time. Recent epidemiological studies have shown that anemia is observed in 17.0-24.0 % of patients with COPD and only 6.0-10.0 % of such patients have polycythemia Aim. To find out the clinical and functional features of COPD course, depending on the red branch of blood and content of soluble transferrin receptors (sTFR). Materials and methods. The study enrolled 202 patients aged >40 years with COPD who have signed the consent to participate in the study. The exclusion criteria were: severe concomitant diseases (pulmonary tuberculosis, oncopathology, alcohol and/or drug addiction, AIDS, heart failure – class ІІВ stage III, and decompensated liver failure, kidney failure, or other failures); defined source of bleeding (complications of peptic ulcer, nonspecific ulcerative colitis, chronic hemorrhoids, etc.); diagnosed true anemias (megaloblastic, aplastic, hemolytic); use of angiotensin-converting enzyme inhibitors; pregnancy or lactation; chronic administration of systemic corticosteroids. All examined patients underwent the general clinical, laboratory and instrumental examination. The degree of obstruction and severity of the disease were determined in accordance with GOLD (2014) recommendations: the degree of obstruction was determined by computer spirography (FEVp detected 15 minutes after inhalation of 400.0 mcg of salbutamol), the severity of dyspnea was determined by the modified Medical Research Council (mMRC), and quality of life was determined by COPD Assessment Test (CAT). Patients with COPD were divided into 4 study groups depending on the hemogram parameters and sTFR: 1 group included 144 patients without anemia, 2 group – 33 with anemia of chronic disease (ACD), 3 group – 12 with erythrocytosis, and 4 group – 13 with iron deficiency anemia (IDA). Statistical analysis of the results was performed using SPSS-21 program. Results. As a result of the detailed analysis of the anamnesis, objective examination and laboratory results in patients from group 4, the cause of IDA was established, namely, 5 patients were diagnosed with chronic non-atrophic gastritis, 4 had chronic gastroduodenitis, 2 had peptic ulcer of stomach, 1 had peptic ulcer of duodenum, and in 1 – chronic gastroduodenitis and chronic pancreatitis with exocrine insufficiency. It has been found that ACD is present in patients with COPD II – IV stage of obstruction and is not observe among COPD patients with degree I obstruction. It is established that the frequency of ACD increases according to the degree of obstruction and the severity of the disease. Patients with COPD with ACD and IDA had significantly lower levels of FEVj compared to patients without anemia and erythrocytosis. It was revealed that patients with COPD with ACD and COPD with IDA had a higher rate according to CAT and, lower quality of life compared with patients without anemia and erythrocytosis accordingly. As a result of the correlation analysis, it was found that there is negative correlation between the degree of obstruction and the results of mMRC (r = – 0.591; p = 0.001) and CAT (r = – 0.608; p = 0.001). Consequently, dyspnea significantly increases and the quality of life decreases in the patients with COPD and ACD with the increase of the degree of obstruction. The frequency of exacerbations was higher in patients with COPD and ACD compared with other groups. Conclusions. Anemia is detected in 22.7 % of patients with COPD, specifically, IDA – in 6.4 % of patients, and ACD – in 16.3 %. The frequency of ACH increases with the degree of obstruction and the severity of COPD. Patients with COPD with anemia (ACD or IDA) have significantly lower levels of FEVP dyspnea and quality of life are significantly worsened with the increase of the obstruction degree in patients with COPD and ACD. The frequency of exacerbations was higher in patients with COPD and ACD.

Published
2018
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8. Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

Author

Weinblatt, Michael E., Baranauskaite, Asta, Niebrzydowski, Jaroslaw, Dokoupilova, Eva, Zielinska, Agnieszka, Jaworski, Janusz, Racewicz, Artur, Pileckyte, Margarita, Jedrychowicz‐Rosiak, Krystyna, Cheong, Soo Yeon, Ghil, Jeehoon, Sokolovic, S., Mekic, M., Prodanovic, N., Gajic, B., Karaselimovic‐Dzambasovic, E., Pojskic, B., Toncheva, A., Dimitar, P., Rodina, L., Geneva‐Popova, M., Staykov, I., Stoilov, R., Podrazilova, L., Mosterova, Z., Simkova, G., Kopackova, J., Stejfova, Z., Vencovsky, J., Urbanova, Z., Janska, L., Galatíkova, D., Stropuviene, S., Sniuoliene, I., Sitek‐Ziolkowska, K., Rell‐Bakalarska, M., Kolasa, R., Daniluk, S., Sliwowska, B., Bartosik‐Twardowska, M., Brzezicki, J., Konieczny, M., Jeka, S., Choe, J., Bae, S., Kang, Y., Prystupa, L., Vyacheslav, Z., Gasanov, I., Yatsyshyn, R., Rekalov, D., Iaremenko, O., Stanislavchuk, M., and Tseluyko, V.

Published
2018
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9. Why We Stay

Author

Kachkovska, Vladyslava, Dudchenko, Iryna, Kovchun, Anna, and Prystupa, Lyudmyla

Published
2024
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14. Full Collection of Personal Narratives

Author

Lederman, Zohar, Ziara, Ola, Coghlan, Rachel, Sulaieva, Oksana, Shcherbakova, Anna, Dudin, Oleksandr, Kachkovska, Vladyslava, Dudchenko, Iryna, Kovchun, Anna, Prystupa, Lyudmyla, Nogovitsyna, Yuliya, Hussein, Ghaiath, Fausch, Kathryn, Kyaw, P. P., Ahmad, Ayesha, Sams, Richard W, Saeed, Handreen Mohammed, Riga, Artem, Maves, Ryan C., Dotsenko, Elizabeth, Deyneka, Irina, Regel, Eva V., and Voloshchuk, Vita

Published
2024
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17. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness

Author

Spyropoulos, A, Ageno, W, Albers, G, Elliott, C, Halperin, J, Hiatt, W, Maynard, G, Steg, P, Weitz, J, Suh, E, Spiro, T, Barnathan, E, Raskob, G, Douketis, J, Turpie, A, Schulman, S, Kearon, C, Linkins, L, Schellong, S, Bauer, K, Geerts, W, Roberts, R, Casais, P, Gallus, A, Karrasch, J, Eichinger-Hasenauer, S, Krivenchuk, V, Hadzovic-Dzuvo, A, Trbojevic, S, Lopes, R, Mincheva, V, Carrier, M, Dennis, R, Tudoric, N, Spinar, J, Nielsen, H, Marandi, T, Shaburishvili, T, Beyer-Westendorf, J, Vardas, P, Boda, Z, Brenner, B, Piovella, F, Krievins, D, Petrauskiene, B, Dejanova-Ilijevska, V, Virgen Carrillo, L, Middeldorp, S, Castillo Leon, R, Torbicki, A, Saraiva de Sousa, M, Dorobantu, M, Militaru, C, Yavelov, I, Vuckovic, B, Reuter, H, Basson, M, Monreal, M, Kucukoglu, S, Parkhomenko, A, Alikhan, R, Rosenberg, D, Yusen, R, Khorana, A, Tapson, V, Pollack, C, Hazelrigg, M, Jure, H, Alvarisqueta, A, Cartasegna, L, Hominal, M, Cursack, G, Alzogaray, M, Maillo, M, Parody, M, Caccavo, A, Dran, R, Muntaner, J, Casas, M, Schmidberg, J, Sarjanovich, R, Gabito, A, Garrido, M, Amuchastegui, M, Fernandez, A, Loureyro, J, Giumelli, C, Heazlewood, V, Colquhoun, D, White, H, Sabet, A, Bowler, S, Carroll, P, Khalafallah, A, Baker, R, Hedger, S, Simpson, F, Jackson, D, Chong, B, Siostrzonek, P, Gary, T, Hoppe, U, Dosta, N, Prystrom, A, Gorokhovsky, S, Yanushko, V, Skrahin, A, Kulik, A, Maslianski, B, Yakubtsevich, R, Timkin, I, Moguchaya, O, Tanaskovic, N, Miljkovic, S, Stojkovic, S, Kovacevic-Preradovic, T, Jovic, D, Basagic, E, Radjen, M, Mutapcic, M, Rizvanovic-Vojic, E, Galic, K, Terzic, I, Pojskic, B, Stevanovic, D, Cehajic, M, Rech, R, Annichino-Bizzacchi, J, Stelmach, R, Blanco, D, Castro, I, Backes, L, Saraiva, J, Ramacciotti, E, de Barros e Silva, P, Reis, G, Moreira Vieira, E, Leaes, P, Zimmermann, S, Van Bellen, B, Precoma, D, Luiz Silvestrini, T, Hernandes, M, Kyoleyan, M, Kalinova, T, Tiholov, R, Petrov, I, Mihov, A, Chompalova, B, Velikov, C, Pencheva, G, Atanasov, P, Raev, D, Kinova, E, Peltegov, V, Marchev, S, Siulemezova, S, Ayryanova, I, Grigorov, M, Naydenova, I, Koteva, N, Dimov, B, Runev, N, Getov, D, Metev, H, Donchev, K, Taseva, M, Hadzhieva, A, Benov, H, Stoyanov, M, Tisheva-Gospodinova, S, Mihaylova, N, Abadzhiev, S, Atzev, B, Georgiev, R, Mollov, M, Stoikov, A, Mazhdrakov, G, Karastanev, K, Dube, F, Roth, S, Mansour, S, Wu, C, Dolan, S, Pesant, Y, Pietrangelo, M, Dresser, G, Kahn, S, Kruisselbrink, R, Cadena Bonfanti, A, Botero, R, Quintero Ossa, A, Poveda, C, Cedano, J, Gomez Isaza, L, Villaquiran Torres, C, Gomez Mesa, J, Vargas Alonso, R, Espinosa, D, Rodriguez, J, Sanchez, G, Accini Mendoza, J, Gomez Florez, C, Cuervo Millan, F, Pesek, K, Horvat, D, Fuckar, K, Ruzic, A, Ostricki, B, Knezevic, A, Breitenfeld, T, Laganovic, M, Samodol, A, Sikic, J, Starcevic, B, Babic, Z, Samarzija, M, Milas, K, Votocek, S, Kvapil, M, Kolman, P, Bindas, P, Simon, V, Adamek, T, Svobodova, J, Gergely, L, Lastuvka, J, Macel, I, Navratil, K, Gregor, P, Lacnak, B, Janousek, J, Kellnerova, I, Hulinsky, V, Matusek, Z, Prucek, L, Dunaj, M, Pirchala, M, Vencour, D, Pavolko, M, Gorican, K, Fiksa, J, Tuxen, C, Meyer, C, Suppli Ulrik, C, Uuetoa, T, Otarishvili, N, Khintibidze, I, Emukhvari, N, Kipiani, Z, Gochitashvili, D, Mamatsashvili, M, Megreladze, I, Paposhvili, K, Agladze, R, Eradze, Z, Chelidze, K, Lominadze, S, Chukhrukidze, A, Chumburidze, V, Metreveli, S, Danelia, V, Orjonikidze, S, Kobulia, B, Nikolaishvili, G, Gvenetadze, R, Melia, A, Tsinamdzgvrishvili, B, Sekhniashvili, M, Sikharulidze, I, Meuser, M, Licka, M, Rauch-Kroehnert, U, Graf, K, Brachmann, J, Akin, I, Toumbis, M, Vassilikos, V, Konstantinides, S, Steiropoulos, P, Gogos, C, Andrikopoulos, G, Parthenakis, F, Karydi, P, Tsivgoulis, G, Mertzanos, G, Olympios, C, Karapanayiotides, T, Paraskevopoulou, E, Kifnidis, K, Hahalis, G, Skoutelis, A, Vadikolias, K, Nyirati, G, Nagy, L, Matoltsy, A, Komoly, S, Lippai, J, Kiss, K, Toth, K, Pozsegovits, K, Kiraly, C, Bereczki, D, Zolyomi, S, Szakal, I, Pall, D, Futo, L, Forster, T, Lovasz, O, Papp, A, Kiraly, Z, Pozsonyi, Z, Hajko, E, Kristof, P, Lakatos, F, Ples, Z, Kirschner, R, Lupkovics, G, Timar, G, Pinter, I, Kristof, T, Kis, E, Kovacs, A, Jakab, G, Palinkas, A, Muller, G, Turi, T, Horvath, C, Kondakor, I, Csanyi, A, Frankfurter, Z, Gurzo, M, Gafter-Gvili, A, Kuchuk, M, Azzam, Z, Elis, A, Halabi, M, Hussein, O, Blum, A, Tsoran-Rosenthal, I, Lishner, M, Hochberg-Klein, S, Caraco, Y, Atar, S, Elias, N, Gavish, D, Butnaru, A, Cosmi, F, Garbelotto, R, Giorgi Pierfranceschi, M, Simioni, L, Gronda, E, Pesci, A, D'Angelo, A, Fedele, F, Ghirarduzzi, A, Piovaccari, G, Lembo, G, Ria, L, Monaco, G, Brunelli, C, Tosetto, A, Capucci, A, Zanatta, N, Pistolesi, M, Mazzi, V, Testa, S, Scherillo, M, Di Biase, M, Antonicelli, R, Lodigiani, C, Nassiacos, D, Viksne, I, Lapkovska, Z, Rancane, G, Sime, I, Pontaga, N, Eglite, R, Puzule, S, Smolova, R, Butkiene, Z, Bagdonas, A, Raugaliene, R, Norkiene, S, Norviliene, R, Basijokiene, V, Stonkus, S, Griskeviciene, V, Miskiniene, A, Norvaisiene, R, Skripkauskiene, I, Jovkovska-Kaeva, B, Kochovska-Kamchevska, N, Antovski, A, Nechevska, L, Celeska, V, Ilievska-Poposka, B, Kostojchinoska, M, Donchovska, S, Kedev, S, Kuzmanovski, I, Bushletikj, O, Stojchev, S, Bakrachevski, N, Kuzmanovska, B, Angusheva, T, Llamas Esperon, G, Valdez Lopez, H, Medina Pech, C, Cortes Hernandez, M, Gans, S, Smulders, S, Swart, H, Boersma, W, Goosens, M, Hovens, M, Semplonius, G, Sohne, M, Lema Osores, J, Salas Perez, M, Rodriguez, A, Rios Oliva, C, Cotrina, R, Berrospi Argandona, P, Toce Yanez, L, Chavez Ayala, C, Mirek-Bryniarska, E, Goch, A, Skucha, W, Skorski, M, Miekus, P, Szyszka, A, Piotrowski, G, Gniot, J, Czerski, T, Debich, P, Zaluska, R, Bebenek, W, Wozakowska-Kaplon, B, Sciborski, R, Ilkowski, J, Wojnowski, P, Uscinska, E, Gaciong, Z, Bonek, R, Sobkowicz, B, Berkowski, P, Bejgier, K, Polonski, L, Kosior, D, Lata, S, Kolodziej, P, Gessek, J, Kachel, T, Talalaj, M, Musial, J, Lewczuk, J, Krysiak, W, Kucharski, L, Wysokinski, A, Minc, P, Martinez, J, Gregorio, T, Almeida, F, Monteiro, P, Stanciulescu, G, Mercea, C, Iosipescu, L, Ciobotaru, V, Crisu, D, Burca, M, Tudoran, M, Savu, A, Negrean, V, Cojocaru, C, Minescu, B, Popa, V, Blajan, D, Nastase-Melicovici, D, Fruntelata, A, Barbulescu, S, Lukinyh, L, Akhunova, S, Vishneva, E, Semenova, I, Nikolaev, K, Shaydyuk, O, Nilk, R, Shalnev, V, Apartsin, K, Goloshchekin, B, Shpagina, L, Khlevchuk, T, Arkhipov, M, Malygin, A, Shvarts, Y, Khaisheva, L, Popov, D, Kobalava, Z, Lipchenko, A, Shapovalova, Y, Zrazhevsky, K, Greshnova, I, Maslova, N, Karabenenko, A, Shogenov, Z, Budankova, E, Barbarash, O, Uspenskiy, Y, Kosmacheva, E, Berns, S, Kostenko, V, Zateyshchikov, D, Vishnevsky, A, Boldueva, S, Podzolkov, V, Sergeeva, E, Grinshtein, Y, Khrustalev, O, Bugrova, O, Repin, A, Andreev, D, Petrovic, P, Boskovic Matic, T, Apostolovic, S, Lazic, Z, Stankovic, D, Stankovic, A, Mitov, V, Sofronic, D, Kopitovic, I, Zdravkovic, V, Joksimovic, Z, Lazovic, N, Petrovic-Stanojevic, N, Ilic, A, Vujadinovic, O, Pencic-Popovic, B, Andjelkovic, N, Sekularac, N, Hinic, S, Radjen, G, Zivkovic, A, Putnikovic, B, Ivanov, I, Babic, R, Van Zyl, L, Hobson, B, Engelbrecht, J, Mitha, I, Siebert, H, Jacobson, B, Breedt, J, Prozesky, H, Ntsekhe, M, Bayat, J, Ellis, G, Tarr, G, Adler, D, Van Dyk, C, Ismail, S, Spargo, C, Abdool-Gaffar, M, Saaiman, J, Venter, K, Lorente Aroca, M, Fernandez Portales, F, Pedrajas Navas, J, Rodriguez Botaro, A, Santa Cruz Siminiani, A, Lopez Reyes, R, Bisbe i Company, J, Piedecausa Selfa, M, Velasco Garrido, J, Sobrino-Martinez, J, Munoz Delgado, G, Sala Llinas, E, Blanco Coronado, J, Almenar Bonet, L, Vida Gutierrez, M, Sanchez Lora, F, Sanchez Martinez, R, Calderon, E, Villalta Blanch, J, De la Hera Galarza, J, Bustamante Ruiz, A, Garcia-Fuster, M, Ripoll Vera, T, Alvarez-Sala Walter, L, Todoli Parra, J, Diaz Fernandez, J, Bosa Ojeda, F, Pellicer-Ciscar, C, Jara Palomares, L, Quiles Granado, J, Trigo Bautista, A, Ruiz Bustillo, S, Ordi Ros, J, Tolosa-Vilella, C, Marin Ortuno, F, Garcia Sanchez, F, Barba Martin, R, Segovia Cubero, J, Cuervas-Mons Martinez, V, Galan Montejano, M, Lopez Meseguer, M, Sener Comert, S, Koksal, N, Tertemiz, K, Ernam, D, Dursun, A, Yildiz, O, Rudenko, L, Abrahamovych, O, Goloborodko, A, Holovchenko, N, Kulyk, A, Yagensky, A, Batushkin, V, Zolotaikina, V, Kozyolkin, O, Faynyk, A, Maslovskyy, V, Petrovskyy, R, Koshlia, V, Chopey, I, Burmak, I, Malynovsky, Y, Voronkov, L, Karpenko, O, Dziublyk, O, Godlevska, O, Borovyk, V, Bezrodna, L, Serik, S, Ovsyannikova, N, Vynnychenko, L, Kopytsya, M, Rudkovskiy, V, Grishyna, O, Vyshnyvetskyy, I, Prystupa, L, Tseluyko, V, Perepeliuk, M, Koval, O, Sychov, O, Church, A, Goudie, A, Elliott, M, Ferguson, C, Welker, J, Kao, C, Bhagwat, R, Serota, H, Bozorgchami, H, Nambiar, R, Spilseth, S, Bhagwath, G, Syed, F, Morrow, L, Updegrove, J, Bercz, P, Kambo, V, Henderson, D, Wright, P, Dang, N, Nadar, V, Jaffrani, N, El-Shahawy, M, Grossman, C, Pearle, J, Weinstein, D, Galanis, T, Gazmuri, R, Kastelic, R, Martinez, R, Laman, D, Macchiavelli, A, Kmetzo, J, Thurm, C, Kayembe, T, Chandrashekhar, Y, Bassetti, D, Jaoude, P, Williams, H, Dewhurst, R, Naqvi, S, Burr, J, Rodriguez-Cintron, W, Jeanfreau, R, Kosinski, E, Ndukwu, I, Sotolongo, C, Daboul, N, Wilmer, C, Simon, P, Tak, T, Rees, C, Gupta, N, Lerner, R, Graffagnino, C, Reed, R, Alford, C, Mody, F, Wellmon, B, Hamroff, G, Rajan, R, Kaatz, S, Spyropoulos A. C., Ageno W., Albers G. W., Elliott C. G., Halperin J. L., Hiatt W. R., Maynard G. A., Steg P. G., Weitz J. I., Suh E., Spiro T. E., Barnathan E. S., Raskob G. E., Douketis J., Turpie A. G., Schulman S., Kearon C., Linkins L. A., Schellong S., Bauer K., Geerts W., Roberts R., Casais P., Gallus A., Karrasch J., Eichinger-Hasenauer S., Krivenchuk V., Hadzovic-Dzuvo A., Trbojevic S., Lopes R., Mincheva V., Carrier M., Dennis R., Tudoric N., Spinar J., Nielsen H., Marandi T., Shaburishvili T., Beyer-Westendorf J., Vardas P., Boda Z., Brenner B., Piovella F., Krievins D., Petrauskiene B., Dejanova-Ilijevska V., Virgen Carrillo L. R., Middeldorp S., Castillo Leon R. P., Torbicki A., Saraiva de Sousa M., Dorobantu M., Militaru C., Yavelov I., Vuckovic B., Reuter H., Basson M., Monreal M., Kucukoglu S., Parkhomenko A., Alikhan R., Rosenberg D., Yusen R., Khorana A., Tapson V., Pollack C., Hazelrigg M., Jure H., Alvarisqueta A., Cartasegna L., Hominal M., Cursack G., Alzogaray M., Maillo M., Parody M., Caccavo A., Dran R. D., Muntaner J. A., Casas M., Schmidberg J., Sarjanovich R., Gabito A., Garrido M., Amuchastegui M., Fernandez A., Loureyro J., Giumelli C., Heazlewood V., Colquhoun D., White H., Sabet A., Bowler S., Carroll P., Khalafallah A., Baker R., Hedger S., Simpson F. G., Jackson D., Chong B., Siostrzonek P., Gary T., Hoppe U., Dosta N., Prystrom A., Gorokhovsky S., Yanushko V., Skrahin A., Kulik A., Maslianski B., Yakubtsevich R., Timkin I., Moguchaya O., Tanaskovic N., Miljkovic S., Stojkovic S., Kovacevic-Preradovic T., Jovic D., Basagic E., Radjen M., Mutapcic M., Rizvanovic-Vojic E., Galic K., Terzic I., Pojskic B., Stevanovic D., Cehajic M., Rech R., Annichino-Bizzacchi J., Stelmach R., Blanco D., Castro I., Backes L. M., Saraiva J. F., Ramacciotti E., de Barros e Silva P. G. M., Reis G., Moreira Vieira E., Leaes P., Zimmermann S., Van Bellen B., Precoma D., Luiz Silvestrini T., Hernandes M. E., Kyoleyan M., Kalinova T., Tiholov R., Petrov I., Mihov A., Chompalova B., Velikov C., Pencheva G., Atanasov P., Raev D., Kinova E., Peltegov V., Marchev S., Siulemezova S., Ayryanova I. D., Grigorov M., Naydenova I., Koteva N., Dimov B., Runev N., Getov D., Metev H., Donchev K., Taseva M., Hadzhieva A., Benov H., Stoyanov M., Tisheva-Gospodinova S., Mihaylova N., Abadzhiev S., Atzev B., Georgiev R., Mollov M., Stoikov A., Mazhdrakov G., Karastanev K., Dube F., Roth S., Mansour S., Wu C., Dolan S., Pesant Y., Pietrangelo M., Dresser G., Kahn S., Kruisselbrink R., Cadena Bonfanti A., Botero R., Quintero Ossa A., Poveda C. M., Cedano J., Gomez Isaza L., Villaquiran Torres C., Gomez Mesa J., Vargas Alonso R., Espinosa D., Rodriguez J. M., Sanchez G., Accini Mendoza J. L., Gomez Florez C. C., Cuervo Millan F., Pesek K., Horvat D., Fuckar K., Ruzic A., Ostricki B., Knezevic A., Breitenfeld T., Laganovic M., Samodol A., Sikic J., Starcevic B., Babic Z., Samarzija M., Milas K., Votocek S., Kvapil M., Kolman P., Bindas P., Simon V., Adamek T., Svobodova J., Gergely L., Lastuvka J., Macel I., Navratil K., Gregor P., Lacnak B., Janousek J., Kellnerova I., Hulinsky V., Matusek Z., Prucek L., Dunaj M., Pirchala M., Vencour D., Pavolko M., Gorican K., Fiksa J., Tuxen C., Meyer C., Suppli Ulrik C., Uuetoa T., Otarishvili N., Khintibidze I., Emukhvari N., Kipiani Z., Gochitashvili D., Mamatsashvili M., Megreladze I., Paposhvili K., Agladze R., Eradze Z., Chelidze K., Lominadze S., Chukhrukidze A., Chumburidze V., Metreveli S., Danelia V., Orjonikidze S., Kobulia B., Nikolaishvili G., Gvenetadze R., Melia A., Tsinamdzgvrishvili B., Sekhniashvili M., Sikharulidze I., Meuser M., Licka M., Rauch-Kroehnert U., Graf K., Brachmann J., Akin I., Toumbis M., Vassilikos V., Konstantinides S., Steiropoulos P., Gogos C., Andrikopoulos G., Parthenakis F., Karydi P., Tsivgoulis G., Mertzanos G., Olympios C., Karapanayiotides T., Paraskevopoulou E., Kifnidis K., Hahalis G., Skoutelis A., Vadikolias K., Nyirati G., Nagy L., Matoltsy A., Komoly S., Lippai J., Kiss K., Toth K., Pozsegovits K., Kiraly C., Bereczki D., Zolyomi S., Szakal I., Pall D., Futo L., Forster T., Lovasz O., Papp A., Kiraly Z., Pozsonyi Z., Hajko E., Kristof P., Lakatos F., Ples Z., Kirschner R., Lupkovics G., Timar G., Pinter I., Kristof T., Kis E., Kovacs A., Jakab G., Palinkas A., Muller G., Turi T., Horvath C., Kondakor I., Csanyi A., Frankfurter Z., Gurzo M., Gafter-Gvili A., Kuchuk M., Azzam Z., Elis A., Halabi M., Hussein O., Blum A., Tsoran-Rosenthal I., Lishner M., Hochberg-Klein S., Caraco Y., Atar S., Elias N., Gavish D., Butnaru A., Cosmi F., Garbelotto R., Giorgi Pierfranceschi M., Simioni L., Gronda E., Pesci A., D'Angelo A., Fedele F., Ghirarduzzi A., Piovaccari G., Lembo G., Ria L., Monaco G. L., Brunelli C., Tosetto A., Capucci A., Zanatta N., Pistolesi M., Mazzi V., Testa S., Scherillo M., Di Biase M., Antonicelli R., Lodigiani C., Nassiacos D., Viksne I., Lapkovska Z., Rancane G., Sime I., Pontaga N., Eglite R., Puzule S., Smolova R., Butkiene Z., Bagdonas A., Raugaliene R., Norkiene S., Norviliene R., Basijokiene V., Stonkus S., Griskeviciene V., Miskiniene A., Norvaisiene R., Skripkauskiene I., Jovkovska-Kaeva B., Kochovska-Kamchevska N., Antovski A., Nechevska L., Celeska V., Ilievska-Poposka B., Kostojchinoska M., Donchovska S., Kedev S., Kuzmanovski I., Bushletikj O., Stojchev S., Bakrachevski N., Kuzmanovska B., Angusheva T., Llamas Esperon G., Valdez Lopez H., Medina Pech C., Cortes Hernandez M., Virgen Carrillo L., Gans S., Smulders S., Swart H., Boersma W., Goosens M., Hovens M., Semplonius G., Sohne M., Lema Osores J., Salas Perez M. D., Rodriguez A., Rios Oliva C., Cotrina R., Berrospi Argandona P., Toce Yanez L., Chavez Ayala C., Mirek-Bryniarska E., Goch A., Skucha W., Skorski M., Miekus P., Szyszka A., Piotrowski G., Gniot J., Czerski T., Debich P., Zaluska R., Bebenek W., Wozakowska-Kaplon B., Sciborski R., Ilkowski J., Wojnowski P., Uscinska E., Gaciong Z., Bonek R., Sobkowicz B., Berkowski P., Bejgier K., Polonski L., Kosior D., Lata S., Kolodziej P., Gessek J., Kachel T., Talalaj M., Musial J., Lewczuk J., Krysiak W., Kucharski L., Wysokinski A., Minc P., Martinez J., Gregorio T., Almeida F., Monteiro P., Stanciulescu G., Mercea C. D., Iosipescu L. C., Ciobotaru V., Crisu D., Burca M., Tudoran M., Savu A., Negrean V., Cojocaru C., Minescu B., Popa V., Blajan D., Nastase-Melicovici D., Fruntelata A., Barbulescu S., Lukinyh L., Akhunova S., Vishneva E., Semenova I., Nikolaev K. Y., Shaydyuk O., Nilk R., Shalnev V., Apartsin K., Goloshchekin B. 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C., Ageno W., Albers G. W., Elliott C. G., Halperin J. L., Hiatt W. R., Maynard G. A., Steg P. G., Weitz J. I., Suh E., Spiro T. E., Barnathan E. S., Raskob G. E., Douketis J., Turpie A. G., Schulman S., Kearon C., Linkins L. A., Schellong S., Bauer K., Geerts W., Roberts R., Casais P., Gallus A., Karrasch J., Eichinger-Hasenauer S., Krivenchuk V., Hadzovic-Dzuvo A., Trbojevic S., Lopes R., Mincheva V., Carrier M., Dennis R., Tudoric N., Spinar J., Nielsen H., Marandi T., Shaburishvili T., Beyer-Westendorf J., Vardas P., Boda Z., Brenner B., Piovella F., Krievins D., Petrauskiene B., Dejanova-Ilijevska V., Virgen Carrillo L. R., Middeldorp S., Castillo Leon R. P., Torbicki A., Saraiva de Sousa M., Dorobantu M., Militaru C., Yavelov I., Vuckovic B., Reuter H., Basson M., Monreal M., Kucukoglu S., Parkhomenko A., Alikhan R., Rosenberg D., Yusen R., Khorana A., Tapson V., Pollack C., Hazelrigg M., Jure H., Alvarisqueta A., Cartasegna L., Hominal M., Cursack G., Alzogaray M., Maillo M., Parody M., Caccavo A., Dran R. D., Muntaner J. A., Casas M., Schmidberg J., Sarjanovich R., Gabito A., Garrido M., Amuchastegui M., Fernandez A., Loureyro J., Giumelli C., Heazlewood V., Colquhoun D., White H., Sabet A., Bowler S., Carroll P., Khalafallah A., Baker R., Hedger S., Simpson F. G., Jackson D., Chong B., Siostrzonek P., Gary T., Hoppe U., Dosta N., Prystrom A., Gorokhovsky S., Yanushko V., Skrahin A., Kulik A., Maslianski B., Yakubtsevich R., Timkin I., Moguchaya O., Tanaskovic N., Miljkovic S., Stojkovic S., Kovacevic-Preradovic T., Jovic D., Basagic E., Radjen M., Mutapcic M., Rizvanovic-Vojic E., Galic K., Terzic I., Pojskic B., Stevanovic D., Cehajic M., Rech R., Annichino-Bizzacchi J., Stelmach R., Blanco D., Castro I., Backes L. M., Saraiva J. F., Ramacciotti E., de Barros e Silva P. G. M., Reis G., Moreira Vieira E., Leaes P., Zimmermann S., Van Bellen B., Precoma D., Luiz Silvestrini T., Hernandes M. E., Kyoleyan M., Kalinova T., Tiholov R., Petrov I., Mihov A., Chompalova B., Velikov C., Pencheva G., Atanasov P., Raev D., Kinova E., Peltegov V., Marchev S., Siulemezova S., Ayryanova I. D., Grigorov M., Naydenova I., Koteva N., Dimov B., Runev N., Getov D., Metev H., Donchev K., Taseva M., Hadzhieva A., Benov H., Stoyanov M., Tisheva-Gospodinova S., Mihaylova N., Abadzhiev S., Atzev B., Georgiev R., Mollov M., Stoikov A., Mazhdrakov G., Karastanev K., Dube F., Roth S., Mansour S., Wu C., Dolan S., Pesant Y., Pietrangelo M., Dresser G., Kahn S., Kruisselbrink R., Cadena Bonfanti A., Botero R., Quintero Ossa A., Poveda C. M., Cedano J., Gomez Isaza L., Villaquiran Torres C., Gomez Mesa J., Vargas Alonso R., Espinosa D., Rodriguez J. M., Sanchez G., Accini Mendoza J. L., Gomez Florez C. C., Cuervo Millan F., Pesek K., Horvat D., Fuckar K., Ruzic A., Ostricki B., Knezevic A., Breitenfeld T., Laganovic M., Samodol A., Sikic J., Starcevic B., Babic Z., Samarzija M., Milas K., Votocek S., Kvapil M., Kolman P., Bindas P., Simon V., Adamek T., Svobodova J., Gergely L., Lastuvka J., Macel I., Navratil K., Gregor P., Lacnak B., Janousek J., Kellnerova I., Hulinsky V., Matusek Z., Prucek L., Dunaj M., Pirchala M., Vencour D., Pavolko M., Gorican K., Fiksa J., Tuxen C., Meyer C., Suppli Ulrik C., Uuetoa T., Otarishvili N., Khintibidze I., Emukhvari N., Kipiani Z., Gochitashvili D., Mamatsashvili M., Megreladze I., Paposhvili K., Agladze R., Eradze Z., Chelidze K., Lominadze S., Chukhrukidze A., Chumburidze V., Metreveli S., Danelia V., Orjonikidze S., Kobulia B., Nikolaishvili G., Gvenetadze R., Melia A., Tsinamdzgvrishvili B., Sekhniashvili M., Sikharulidze I., Meuser M., Licka M., Rauch-Kroehnert U., Graf K., Brachmann J., Akin I., Toumbis M., Vassilikos V., Konstantinides S., Steiropoulos P., Gogos C., Andrikopoulos G., Parthenakis F., Karydi P., Tsivgoulis G., Mertzanos G., Olympios C., Karapanayiotides T., Paraskevopoulou E., Kifnidis K., Hahalis G., Skoutelis A., Vadikolias K., Nyirati G., Nagy L., Matoltsy A., Komoly S., Lippai J., Kiss K., Toth K., Pozsegovits K., Kiraly C., Bereczki D., Zolyomi S., Szakal I., Pall D., Futo L., Forster T., Lovasz O., Papp A., Kiraly Z., Pozsonyi Z., Hajko E., Kristof P., Lakatos F., Ples Z., Kirschner R., Lupkovics G., Timar G., Pinter I., Kristof T., Kis E., Kovacs A., Jakab G., Palinkas A., Muller G., Turi T., Horvath C., Kondakor I., Csanyi A., Frankfurter Z., Gurzo M., Gafter-Gvili A., Kuchuk M., Azzam Z., Elis A., Halabi M., Hussein O., Blum A., Tsoran-Rosenthal I., Lishner M., Hochberg-Klein S., Caraco Y., Atar S., Elias N., Gavish D., Butnaru A., Cosmi F., Garbelotto R., Giorgi Pierfranceschi M., Simioni L., Gronda E., Pesci A., D'Angelo A., Fedele F., Ghirarduzzi A., Piovaccari G., Lembo G., Ria L., Monaco G. L., Brunelli C., Tosetto A., Capucci A., Zanatta N., Pistolesi M., Mazzi V., Testa S., Scherillo M., Di Biase M., Antonicelli R., Lodigiani C., Nassiacos D., Viksne I., Lapkovska Z., Rancane G., Sime I., Pontaga N., Eglite R., Puzule S., Smolova R., Butkiene Z., Bagdonas A., Raugaliene R., Norkiene S., Norviliene R., Basijokiene V., Stonkus S., Griskeviciene V., Miskiniene A., Norvaisiene R., Skripkauskiene I., Jovkovska-Kaeva B., Kochovska-Kamchevska N., Antovski A., Nechevska L., Celeska V., Ilievska-Poposka B., Kostojchinoska M., Donchovska S., Kedev S., Kuzmanovski I., Bushletikj O., Stojchev S., Bakrachevski N., Kuzmanovska B., Angusheva T., Llamas Esperon G., Valdez Lopez H., Medina Pech C., Cortes Hernandez M., Virgen Carrillo L., Gans S., Smulders S., Swart H., Boersma W., Goosens M., Hovens M., Semplonius G., Sohne M., Lema Osores J., Salas Perez M. D., Rodriguez A., Rios Oliva C., Cotrina R., Berrospi Argandona P., Toce Yanez L., Chavez Ayala C., Mirek-Bryniarska E., Goch A., Skucha W., Skorski M., Miekus P., Szyszka A., Piotrowski G., Gniot J., Czerski T., Debich P., Zaluska R., Bebenek W., Wozakowska-Kaplon B., Sciborski R., Ilkowski J., Wojnowski P., Uscinska E., Gaciong Z., Bonek R., Sobkowicz B., Berkowski P., Bejgier K., Polonski L., Kosior D., Lata S., Kolodziej P., Gessek J., Kachel T., Talalaj M., Musial J., Lewczuk J., Krysiak W., Kucharski L., Wysokinski A., Minc P., Martinez J., Gregorio T., Almeida F., Monteiro P., Stanciulescu G., Mercea C. D., Iosipescu L. C., Ciobotaru V., Crisu D., Burca M., Tudoran M., Savu A., Negrean V., Cojocaru C., Minescu B., Popa V., Blajan D., Nastase-Melicovici D., Fruntelata A., Barbulescu S., Lukinyh L., Akhunova S., Vishneva E., Semenova I., Nikolaev K. Y., Shaydyuk O., Nilk R., Shalnev V., Apartsin K., Goloshchekin B. M., Shpagina L., Khlevchuk T., Arkhipov M., Malygin A., Shvarts Y., Khaisheva L., Popov D., Kobalava Z., Lipchenko A., Shapovalova Y., Zrazhevsky K., Greshnova I., Maslova N., Karabenenko A., Shogenov Z., Budankova E., Barbarash O., Uspenskiy Y., Kosmacheva E., Berns S., Kostenko V., Zateyshchikov D., Vishnevsky A., Boldueva S., Podzolkov V., Sergeeva E., Grinshtein Y., Khrustalev O., Bugrova O., Repin A., Andreev D., Petrovic P., Boskovic Matic T., Apostolovic S., Lazic Z., Stankovic D., Stankovic A., Mitov V., Sofronic D., Kopitovic I., Zdravkovic V., Joksimovic Z., Lazovic N., Petrovic-Stanojevic N., Ilic A., Vujadinovic O., Pencic-Popovic B., Andjelkovic N., Sekularac N., Hinic S., Radjen G., Zivkovic A., Putnikovic B., Ivanov I., Babic R., Van Zyl L., Hobson B., Engelbrecht J., Mitha I., Siebert H., Jacobson B., Breedt J., Prozesky H., Ntsekhe M., Bayat J., Ellis G., Tarr G., Adler D., Van Dyk C., Ismail S. M., Spargo C. E., Abdool-Gaffar M., Saaiman J., Venter K., Lorente Aroca M. L., Fernandez Portales F., Pedrajas Navas J., Rodriguez Botaro A., Santa Cruz Siminiani A., Lopez Reyes R., Bisbe i Company J., Piedecausa Selfa M., Velasco Garrido J., Sobrino-Martinez J., Munoz Delgado G., Sala Llinas E., Blanco Coronado J., Almenar Bonet L., Vida Gutierrez M., Sanchez Lora F., Sanchez Martinez R., Calderon E. J., Villalta Blanch J., De la Hera Galarza J. M., Bustamante Ruiz A., Garcia-Fuster M. J., Ripoll Vera T., Alvarez-Sala Walter L., Todoli Parra J. A., Diaz Fernandez J., Bosa Ojeda F., Pellicer-Ciscar C., Jara Palomares L., Quiles Granado J., Trigo Bautista A., Ruiz Bustillo S., Ordi Ros J., Tolosa-Vilella C., Marin Ortuno F., Garcia Sanchez F., Barba Martin R., Segovia Cubero J., Cuervas-Mons Martinez V., Galan Montejano M., Lopez Meseguer M., Sener Comert S., Koksal N., Tertemiz K., Ernam D., Dursun A. B., Yildiz O., Rudenko L., Abrahamovych O., Goloborodko A., Holovchenko N., Kulyk A., Yagensky A., Batushkin V., Zolotaikina V., Kozyolkin O., Faynyk A., Maslovskyy V., Petrovskyy R., Koshlia V., Chopey I., Burmak I., Malynovsky Y., Voronkov L., Karpenko O., Dziublyk O., Godlevska O., Borovyk V., Bezrodna L., Serik S., Ovsyannikova N., Vynnychenko L., Kopytsya M., Rudkovskiy V., Grishyna O., Vyshnyvetskyy I., Prystupa L., Tseluyko V., Perepeliuk M., Koval O., Sychov O., Church A., Goudie A., Elliott M., Ferguson C., Welker J., Kao C. K., Bhagwat R., Serota H., Bozorgchami H., Nambiar R., Spilseth S., Bhagwath G., Syed F., Morrow L., Updegrove J., Bercz P., Kambo V., Henderson D., Wright P., Dang N., Nadar V., Jaffrani N., El-Shahawy M., Grossman C. H., Pearle J., Weinstein D., Galanis T. P., Gazmuri R., Kastelic R., Martinez R., Laman D., Macchiavelli A., Kmetzo J., Thurm C., Kayembe T., Chandrashekhar Y., Bassetti D., Jaoude P., Williams H., Dewhurst R., Naqvi S., Burr J., Rodriguez-Cintron W., Jeanfreau R., Kosinski E., Ndukwu I. M., Sotolongo C., Daboul N., Wilmer C., Simon P., Tak T., Rees C., Gupta N., Lerner R., Graffagnino C., Reed R. M., Alford C. M., Mody F., Wellmon B., Hamroff G., Rajan R., and Kaatz S.

Abstract

BACKGROUND Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy. METHODS In this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma d-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding. RESULTS Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P = 0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23). CONCLUSIONS Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death

Published
2018

18. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness

Author

Spyropoulos A. C., Ageno W., Albers G. W., Elliott C. G., Halperin J. L., Hiatt W. R., Maynard G. A., Steg P. G., Weitz J. I., Suh E., Spiro T. E., Barnathan E. S., Raskob G. E., Douketis J., Turpie A. G., Schulman S., Kearon C., Linkins L. A., Schellong S., Bauer K., Geerts W., Roberts R., Casais P., Gallus A., Karrasch J., Eichinger-Hasenauer S., Krivenchuk V., Hadzovic-Dzuvo A., Trbojevic S., Lopes R., Mincheva V., Carrier M., Dennis R., Tudoric N., Spinar J., Nielsen H., Marandi T., Shaburishvili T., Beyer-Westendorf J., Vardas P., Boda Z., Brenner B., Piovella F., Krievins D., Petrauskiene B., Dejanova-Ilijevska V., Virgen Carrillo L. R., Middeldorp S., Castillo Leon R. P., Torbicki A., Saraiva de Sousa M., Dorobantu M., Militaru C., Yavelov I., Vuckovic B., Reuter H., Basson M., Monreal M., Kucukoglu S., Parkhomenko A., Alikhan R., Rosenberg D., Yusen R., Khorana A., Tapson V., Pollack C., Hazelrigg M., Jure H., Alvarisqueta A., Cartasegna L., Hominal M., Cursack G., Alzogaray M., Maillo M., Parody M., Caccavo A., Dran R. D., Muntaner J. A., Casas M., Schmidberg J., Sarjanovich R., Gabito A., Garrido M., Amuchastegui M., Fernandez A., Loureyro J., Giumelli C., Heazlewood V., Colquhoun D., White H., Sabet A., Bowler S., Carroll P., Khalafallah A., Baker R., Hedger S., Simpson F. G., Jackson D., Chong B., Siostrzonek P., Gary T., Hoppe U., Dosta N., Prystrom A., Gorokhovsky S., Yanushko V., Skrahin A., Kulik A., Maslianski B., Yakubtsevich R., Timkin I., Moguchaya O., Tanaskovic N., Miljkovic S., Stojkovic S., Kovacevic-Preradovic T., Jovic D., Basagic E., Radjen M., Mutapcic M., Rizvanovic-Vojic E., Galic K., Terzic I., Pojskic B., Stevanovic D., Cehajic M., Rech R., Annichino-Bizzacchi J., Stelmach R., Blanco D., Castro I., Backes L. M., Saraiva J. F., Ramacciotti E., de Barros e Silva P. G. M., Reis G., Moreira Vieira E., Leaes P., Zimmermann S., Van Bellen B., Precoma D., Luiz Silvestrini T., Hernandes M. E., Kyoleyan M., Kalinova T., Tiholov R., Petrov I., Mihov A., Chompalova B., Velikov C., Pencheva G., Atanasov P., Raev D., Kinova E., Peltegov V., Marchev S., Siulemezova S., Ayryanova I. D., Grigorov M., Naydenova I., Koteva N., Dimov B., Runev N., Getov D., Metev H., Donchev K., Taseva M., Hadzhieva A., Benov H., Stoyanov M., Tisheva-Gospodinova S., Mihaylova N., Abadzhiev S., Atzev B., Georgiev R., Mollov M., Stoikov A., Mazhdrakov G., Karastanev K., Dube F., Roth S., Mansour S., Wu C., Dolan S., Pesant Y., Pietrangelo M., Dresser G., Kahn S., Kruisselbrink R., Cadena Bonfanti A., Botero R., Quintero Ossa A., Poveda C. M., Cedano J., Gomez Isaza L., Villaquiran Torres C., Gomez Mesa J., Vargas Alonso R., Espinosa D., Rodriguez J. M., Sanchez G., Accini Mendoza J. L., Gomez Florez C. C., Cuervo Millan F., Pesek K., Horvat D., Fuckar K., Ruzic A., Ostricki B., Knezevic A., Breitenfeld T., Laganovic M., Samodol A., Sikic J., Starcevic B., Babic Z., Samarzija M., Milas K., Votocek S., Kvapil M., Kolman P., Bindas P., Simon V., Adamek T., Svobodova J., Gergely L., Lastuvka J., Macel I., Navratil K., Gregor P., Lacnak B., Janousek J., Kellnerova I., Hulinsky V., Matusek Z., Prucek L., Dunaj M., Pirchala M., Vencour D., Pavolko M., Gorican K., Fiksa J., Tuxen C., Meyer C., Suppli Ulrik C., Uuetoa T., Otarishvili N., Khintibidze I., Emukhvari N., Kipiani Z., Gochitashvili D., Mamatsashvili M., Megreladze I., Paposhvili K., Agladze R., Eradze Z., Chelidze K., Lominadze S., Chukhrukidze A., Chumburidze V., Metreveli S., Danelia V., Orjonikidze S., Kobulia B., Nikolaishvili G., Gvenetadze R., Melia A., Tsinamdzgvrishvili B., Sekhniashvili M., Sikharulidze I., Meuser M., Licka M., Rauch-Kroehnert U., Graf K., Brachmann J., Akin I., Toumbis M., Vassilikos V., Konstantinides S., Steiropoulos P., Gogos C., Andrikopoulos G., Parthenakis F., Karydi P., Tsivgoulis G., Mertzanos G., Olympios C., Karapanayiotides T., Paraskevopoulou E., Kifnidis K., Hahalis G., Skoutelis A., Vadikolias K., Nyirati G., Nagy L., Matoltsy A., Komoly S., Lippai J., Kiss K., Toth K., Pozsegovits K., Kiraly C., Bereczki D., Zolyomi S., Szakal I., Pall D., Futo L., Forster T., Lovasz O., Papp A., Kiraly Z., Pozsonyi Z., Hajko E., Kristof P., Lakatos F., Ples Z., Kirschner R., Lupkovics G., Timar G., Pinter I., Kristof T., Kis E., Kovacs A., Jakab G., Palinkas A., Muller G., Turi T., Horvath C., Kondakor I., Csanyi A., Frankfurter Z., Gurzo M., Gafter-Gvili A., Kuchuk M., Azzam Z., Elis A., Halabi M., Hussein O., Blum A., Tsoran-Rosenthal I., Lishner M., Hochberg-Klein S., Caraco Y., Atar S., Elias N., Gavish D., Butnaru A., Cosmi F., Garbelotto R., Giorgi Pierfranceschi M., Simioni L., Gronda E., Pesci A., D'Angelo A., Fedele F., Ghirarduzzi A., Piovaccari G., Lembo G., Ria L., Monaco G. L., Brunelli C., Tosetto A., Capucci A., Zanatta N., Pistolesi M., Mazzi V., Testa S., Scherillo M., Di Biase M., Antonicelli R., Lodigiani C., Nassiacos D., Viksne I., Lapkovska Z., Rancane G., Sime I., Pontaga N., Eglite R., Puzule S., Smolova R., Butkiene Z., Bagdonas A., Raugaliene R., Norkiene S., Norviliene R., Basijokiene V., Stonkus S., Griskeviciene V., Miskiniene A., Norvaisiene R., Skripkauskiene I., Jovkovska-Kaeva B., Kochovska-Kamchevska N., Antovski A., Nechevska L., Celeska V., Ilievska-Poposka B., Kostojchinoska M., Donchovska S., Kedev S., Kuzmanovski I., Bushletikj O., Stojchev S., Bakrachevski N., Kuzmanovska B., Angusheva T., Llamas Esperon G., Valdez Lopez H., Medina Pech C., Cortes Hernandez M., Virgen Carrillo L., Gans S., Smulders S., Swart H., Boersma W., Goosens M., Hovens M., Semplonius G., Sohne M., Lema Osores J., Salas Perez M. D., Rodriguez A., Rios Oliva C., Cotrina R., Berrospi Argandona P., Toce Yanez L., Chavez Ayala C., Mirek-Bryniarska E., Goch A., Skucha W., Skorski M., Miekus P., Szyszka A., Piotrowski G., Gniot J., Czerski T., Debich P., Zaluska R., Bebenek W., Wozakowska-Kaplon B., Sciborski R., Ilkowski J., Wojnowski P., Uscinska E., Gaciong Z., Bonek R., Sobkowicz B., Berkowski P., Bejgier K., Polonski L., Kosior D., Lata S., Kolodziej P., Gessek J., Kachel T., Talalaj M., Musial J., Lewczuk J., Krysiak W., Kucharski L., Wysokinski A., Minc P., Martinez J., Gregorio T., Almeida F., Monteiro P., Stanciulescu G., Mercea C. D., Iosipescu L. C., Ciobotaru V., Crisu D., Burca M., Tudoran M., Savu A., Negrean V., Cojocaru C., Minescu B., Popa V., Blajan D., Nastase-Melicovici D., Fruntelata A., Barbulescu S., Lukinyh L., Akhunova S., Vishneva E., Semenova I., Nikolaev K. Y., Shaydyuk O., Nilk R., Shalnev V., Apartsin K., Goloshchekin B. M., Shpagina L., Khlevchuk T., Arkhipov M., Malygin A., Shvarts Y., Khaisheva L., Popov D., Kobalava Z., Lipchenko A., Shapovalova Y., Zrazhevsky K., Greshnova I., Maslova N., Karabenenko A., Shogenov Z., Budankova E., Barbarash O., Uspenskiy Y., Kosmacheva E., Berns S., Kostenko V., Zateyshchikov D., Vishnevsky A., Boldueva S., Podzolkov V., Sergeeva E., Grinshtein Y., Khrustalev O., Bugrova O., Repin A., Andreev D., Petrovic P., Boskovic Matic T., Apostolovic S., Lazic Z., Stankovic D., Stankovic A., Mitov V., Sofronic D., Kopitovic I., Zdravkovic V., Joksimovic Z., Lazovic N., Petrovic-Stanojevic N., Ilic A., Vujadinovic O., Pencic-Popovic B., Andjelkovic N., Sekularac N., Hinic S., Radjen G., Zivkovic A., Putnikovic B., Ivanov I., Babic R., Van Zyl L., Hobson B., Engelbrecht J., Mitha I., Siebert H., Jacobson B., Breedt J., Prozesky H., Ntsekhe M., Bayat J., Ellis G., Tarr G., Adler D., Van Dyk C., Ismail S. M., Spargo C. E., Abdool-Gaffar M., Saaiman J., Venter K., Lorente Aroca M. L., Fernandez Portales F., Pedrajas Navas J., Rodriguez Botaro A., Santa Cruz Siminiani A., Lopez Reyes R., Bisbe i Company J., Piedecausa Selfa M., Velasco Garrido J., Sobrino-Martinez J., Munoz Delgado G., Sala Llinas E., Blanco Coronado J., Almenar Bonet L., Vida Gutierrez M., Sanchez Lora F., Sanchez Martinez R., Calderon E. J., Villalta Blanch J., De la Hera Galarza J. M., Bustamante Ruiz A., Garcia-Fuster M. J., Ripoll Vera T., Alvarez-Sala Walter L., Todoli Parra J. A., Diaz Fernandez J., Bosa Ojeda F., Pellicer-Ciscar C., Jara Palomares L., Quiles Granado J., Trigo Bautista A., Ruiz Bustillo S., Ordi Ros J., Tolosa-Vilella C., Marin Ortuno F., Garcia Sanchez F., Barba Martin R., Segovia Cubero J., Cuervas-Mons Martinez V., Galan Montejano M., Lopez Meseguer M., Sener Comert S., Koksal N., Tertemiz K., Ernam D., Dursun A. B., Yildiz O., Rudenko L., Abrahamovych O., Goloborodko A., Holovchenko N., Kulyk A., Yagensky A., Batushkin V., Zolotaikina V., Kozyolkin O., Faynyk A., Maslovskyy V., Petrovskyy R., Koshlia V., Chopey I., Burmak I., Malynovsky Y., Voronkov L., Karpenko O., Dziublyk O., Godlevska O., Borovyk V., Bezrodna L., Serik S., Ovsyannikova N., Vynnychenko L., Kopytsya M., Rudkovskiy V., Grishyna O., Vyshnyvetskyy I., Prystupa L., Tseluyko V., Perepeliuk M., Koval O., Sychov O., Church A., Goudie A., Elliott M., Ferguson C., Welker J., Kao C. K., Bhagwat R., Serota H., Bozorgchami H., Nambiar R., Spilseth S., Bhagwath G., Syed F., Morrow L., Updegrove J., Bercz P., Kambo V., Henderson D., Wright P., Dang N., Nadar V., Jaffrani N., El-Shahawy M., Grossman C. H., Pearle J., Weinstein D., Galanis T. P., Gazmuri R., Kastelic R., Martinez R., Laman D., Macchiavelli A., Kmetzo J., Thurm C., Kayembe T., Chandrashekhar Y., Bassetti D., Jaoude P., Williams H., Dewhurst R., Naqvi S., Burr J., Rodriguez-Cintron W., Jeanfreau R., Kosinski E., Ndukwu I. M., Sotolongo C., Daboul N., Wilmer C., Simon P., Tak T., Rees C., Gupta N., Lerner R., Graffagnino C., Reed R. M., Alford C. 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Gergely, L, Lastuvka, J, Macel, I, Navratil, K, Gregor, P, Lacnak, B, Janousek, J, Kellnerova, I, Hulinsky, V, Matusek, Z, Prucek, L, Dunaj, M, Pirchala, M, Vencour, D, Pavolko, M, Gorican, K, Fiksa, J, Tuxen, C, Meyer, C, Suppli Ulrik, C, Uuetoa, T, Otarishvili, N, Khintibidze, I, Emukhvari, N, Kipiani, Z, Gochitashvili, D, Mamatsashvili, M, Megreladze, I, Paposhvili, K, Agladze, R, Eradze, Z, Chelidze, K, Lominadze, S, Chukhrukidze, A, Chumburidze, V, Metreveli, S, Danelia, V, Orjonikidze, S, Kobulia, B, Nikolaishvili, G, Gvenetadze, R, Melia, A, Tsinamdzgvrishvili, B, Sekhniashvili, M, Sikharulidze, I, Meuser, M, Licka, M, Rauch-Kroehnert, U, Graf, K, Brachmann, J, Akin, I, Toumbis, M, Vassilikos, V, Konstantinides, S, Steiropoulos, P, Gogos, C, Andrikopoulos, G, Parthenakis, F, Karydi, P, Tsivgoulis, G, Mertzanos, G, Olympios, C, Karapanayiotides, T, Paraskevopoulou, E, Kifnidis, K, Hahalis, G, Skoutelis, A, Vadikolias, K, Nyirati, G, Nagy, L, Matoltsy, A, Komoly, S, Lippai, J, Kiss, K, Toth, K, Pozsegovits, K, Kiraly, C, Bereczki, D, Zolyomi, S, Szakal, I, Pall, D, Futo, L, Forster, T, Lovasz, O, Papp, A, Kiraly, Z, Pozsonyi, Z, Hajko, E, Kristof, P, Lakatos, F, Ples, Z, Kirschner, R, Lupkovics, G, Timar, G, Pinter, I, Kristof, T, Kis, E, Kovacs, A, Jakab, G, Palinkas, A, Muller, G, Turi, T, Horvath, C, Kondakor, I, Csanyi, A, Frankfurter, Z, Gurzo, M, Gafter-Gvili, A, Kuchuk, M, Azzam, Z, Elis, A, Halabi, M, Hussein, O, Blum, A, Tsoran-Rosenthal, I, Lishner, M, Hochberg-Klein, S, Caraco, Y, Atar, S, Elias, N, Gavish, D, Butnaru, A, Cosmi, F, Garbelotto, R, Giorgi Pierfranceschi, M, Simioni, L, Gronda, E, Pesci, A, D'Angelo, A, Fedele, F, Ghirarduzzi, A, Piovaccari, G, Lembo, G, Ria, L, Monaco, G, Brunelli, C, Tosetto, A, Capucci, A, Zanatta, N, Pistolesi, M, Mazzi, V, Testa, S, Scherillo, M, Di Biase, M, Antonicelli, R, Lodigiani, C, Nassiacos, D, Viksne, I, Lapkovska, Z, Rancane, G, Sime, I, Pontaga, N, Eglite, R, Puzule, S, Smolova, R, Butkiene, Z, Bagdonas, A, Raugaliene, R, Norkiene, S, Norviliene, R, Basijokiene, V, Stonkus, S, Griskeviciene, V, Miskiniene, A, Norvaisiene, R, Skripkauskiene, I, Jovkovska-Kaeva, B, Kochovska-Kamchevska, N, Antovski, A, Nechevska, L, Celeska, V, Ilievska-Poposka, B, Kostojchinoska, M, Donchovska, S, Kedev, S, Kuzmanovski, I, Bushletikj, O, Stojchev, S, Bakrachevski, N, Kuzmanovska, B, Angusheva, T, Llamas Esperon, G, Valdez Lopez, H, Medina Pech, C, Cortes Hernandez, M, Gans, S, Smulders, S, Swart, H, Boersma, W, Goosens, M, Hovens, M, Semplonius, G, Sohne, M, Lema Osores, J, Salas Perez, M, Rodriguez, A, Rios Oliva, C, Cotrina, R, Berrospi Argandona, P, Toce Yanez, L, Chavez Ayala, C, Mirek-Bryniarska, E, Goch, A, Skucha, W, Skorski, M, Miekus, P, Szyszka, A, Piotrowski, G, Gniot, J, Czerski, T, Debich, P, Zaluska, R, Bebenek, W, Wozakowska-Kaplon, B, Sciborski, R, Ilkowski, J, Wojnowski, P, Uscinska, E, Gaciong, Z, Bonek, R, Sobkowicz, B, Berkowski, P, Bejgier, K, Polonski, L, Kosior, D, Lata, S, Kolodziej, P, Gessek, J, Kachel, T, Talalaj, M, Musial, J, Lewczuk, J, Krysiak, W, Kucharski, L, Wysokinski, A, Minc, P, Martinez, J, Gregorio, T, Almeida, F, Monteiro, P, Stanciulescu, G, Mercea, C, Iosipescu, L, Ciobotaru, V, Crisu, D, Burca, M, Tudoran, M, Savu, A, Negrean, V, Cojocaru, C, Minescu, B, Popa, V, Blajan, D, Nastase-Melicovici, D, Fruntelata, A, Barbulescu, S, Lukinyh, L, Akhunova, S, Vishneva, E, Semenova, I, Nikolaev, K, Shaydyuk, O, Nilk, R, Shalnev, V, Apartsin, K, Goloshchekin, B, Shpagina, L, Khlevchuk, T, Arkhipov, M, Malygin, A, Shvarts, Y, Khaisheva, L, Popov, D, Kobalava, Z, Lipchenko, A, Shapovalova, Y, Zrazhevsky, K, Greshnova, I, Maslova, N, Karabenenko, A, Shogenov, Z, Budankova, E, Barbarash, O, Uspenskiy, Y, Kosmacheva, E, Berns, S, Kostenko, V, Zateyshchikov, D, Vishnevsky, A, Boldueva, S, Podzolkov, V, Sergeeva, E, Grinshtein, Y, Khrustalev, O, Bugrova, O, Repin, A, Andreev, D, Petrovic, P, Boskovic Matic, T, Apostolovic, S, Lazic, Z, Stankovic, D, Stankovic, A, Mitov, V, Sofronic, D, Kopitovic, I, Zdravkovic, V, Joksimovic, Z, Lazovic, N, Petrovic-Stanojevic, N, Ilic, A, Vujadinovic, O, Pencic-Popovic, B, Andjelkovic, N, Sekularac, N, Hinic, S, Radjen, G, Zivkovic, A, Putnikovic, B, Ivanov, I, Babic, R, Van Zyl, L, Hobson, B, Engelbrecht, J, Mitha, I, Siebert, H, Jacobson, B, Breedt, J, Prozesky, H, Ntsekhe, M, Bayat, J, Ellis, G, Tarr, G, Adler, D, Van Dyk, C, Ismail, S, Spargo, C, Abdool-Gaffar, M, Saaiman, J, Venter, K, Lorente Aroca, M, Fernandez Portales, F, Pedrajas Navas, J, Rodriguez Botaro, A, Santa Cruz Siminiani, A, Lopez Reyes, R, Bisbe i Company, J, Piedecausa Selfa, M, Velasco Garrido, J, Sobrino-Martinez, J, Munoz Delgado, G, Sala Llinas, E, Blanco Coronado, J, Almenar Bonet, L, Vida Gutierrez, M, Sanchez Lora, F, Sanchez Martinez, R, Calderon, E, Villalta Blanch, J, De la Hera Galarza, J, Bustamante Ruiz, A, Garcia-Fuster, M, Ripoll Vera, T, Alvarez-Sala Walter, L, Todoli Parra, J, Diaz Fernandez, J, Bosa Ojeda, F, Pellicer-Ciscar, C, Jara Palomares, L, Quiles Granado, J, Trigo Bautista, A, Ruiz Bustillo, S, Ordi Ros, J, Tolosa-Vilella, C, Marin Ortuno, F, Garcia Sanchez, F, Barba Martin, R, Segovia Cubero, J, Cuervas-Mons Martinez, V, Galan Montejano, M, Lopez Meseguer, M, Sener Comert, S, Koksal, N, Tertemiz, K, Ernam, D, Dursun, A, Yildiz, O, Rudenko, L, Abrahamovych, O, Goloborodko, A, Holovchenko, N, Kulyk, A, Yagensky, A, Batushkin, V, Zolotaikina, V, Kozyolkin, O, Faynyk, A, Maslovskyy, V, Petrovskyy, R, Koshlia, V, Chopey, I, Burmak, I, Malynovsky, Y, Voronkov, L, Karpenko, O, Dziublyk, O, Godlevska, O, Borovyk, V, Bezrodna, L, Serik, S, Ovsyannikova, N, Vynnychenko, L, Kopytsya, M, Rudkovskiy, V, Grishyna, O, Vyshnyvetskyy, I, Prystupa, L, Tseluyko, V, Perepeliuk, M, Koval, O, Sychov, O, Church, A, Goudie, A, Elliott, M, Ferguson, C, Welker, J, Kao, C, Bhagwat, R, Serota, H, Bozorgchami, H, Nambiar, R, Spilseth, S, Bhagwath, G, Syed, F, Morrow, L, Updegrove, J, Bercz, P, Kambo, V, Henderson, D, Wright, P, Dang, N, Nadar, V, Jaffrani, N, El-Shahawy, M, Grossman, C, Pearle, J, Weinstein, D, Galanis, T, Gazmuri, R, Kastelic, R, Martinez, R, Laman, D, Macchiavelli, A, Kmetzo, J, Thurm, C, Kayembe, T, Chandrashekhar, Y, Bassetti, D, Jaoude, P, Williams, H, Dewhurst, R, Naqvi, S, Burr, J, Rodriguez-Cintron, W, Jeanfreau, R, Kosinski, E, Ndukwu, I, Sotolongo, C, Daboul, N, Wilmer, C, Simon, P, Tak, T, Rees, C, Gupta, N, Lerner, R, Graffagnino, C, Reed, R, Alford, C, Mody, F, Wellmon, B, Hamroff, G, Rajan, R, and Kaatz, S

Subjects
Male, medicine.medical_specialty, Aftercare, Aged, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Hemorrhage, Humans, Kaplan-Meier Estimate, Middle Aged, Patient Discharge, Rivaroxaban, Treatment Outcome, Venous Thromboembolism, Venous Thrombosis, Hospitalization, Medicine (all), 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Medical illness, Internal medicine, Hospital discharge, Medicine, Venous Thrombosi, 030212 general & internal medicine, Thromboprophylaxis, business.industry, General Medicine, medicine.disease, Venous thrombosis, Increased risk, rivaroxaban, thromboprophylaxis, medical illness, business, Venous thromboembolism, Factor Xa Inhibitor, Human, medicine.drug
Abstract

Zateyshchikov, Dmitry A/0000-0001-7065-2045; Vyshnyvetskyy, Ivan/0000-0001-7228-3052; Bustillo, Sonia Ruiz/0000-0002-6074-914X; Maslovskyi, Valentyn/0000-0001-5184-1799; Ruzic, Alen/0000-0001-5031-2975; Nikolaev, Konstantin/0000-0003-4601-6203; Musial, Jacek/0000-0002-8994-0036; Malynovsky, Yaroslav V/0000-0002-9118-1104; Tsivgoulis, Georgios/0000-0002-0640-3797; Maslovskyi, Valentyn/0000-0001-5184-1799; Grinshtein, Yury/0000-0001-8847-235X; Shpagina, Lyubov/0000-0003-0871-7551; Yildiz, Oznur/0000-0002-5379-6829; Marchev, Sotir/0000-0001-9250-510X; Weitz, Jeffrey/0000-0002-1092-7550; Apartsin, Konstantin A/0000-0003-0577-9001; Reis, Gilmar/0000-0002-4847-1034; Baker, Ross/0000-0002-2728-6788; Koziolkin, Olexandr/0000-0001-9878-5798; Barbarash, Olga/0000-0002-4642-3610; Sala-Llinas, Ernest/0000-0002-6499-1638; Gallus, Alexander/0000-0001-7347-9989; lodigiani, corrado/0000-0002-9152-9385; Kosmacheva, Elena/0000-0001-8600-0199; Ramacciotti, Eduardo/0000-0002-5735-1333; Khorana, Alok/0000-0002-9509-0998; Giorgi-Pierfranceschi, Matteo/0000-0002-7988-9652; Torbicki, Adam/0000-0003-3475-8832; Abragamovic, Orest/0000-0001-6862-6809; Jara-Palomares, Luis/0000-0002-4125-3376; Prozesky, Hans/0000-0001-9715-3449; Andreev, Denis/0000-0002-0276-7374; Cuervas-Mons Martinez, Valentin/0000-0003-3086-9463; Apostolovic, Svetlana/0000-0001-9015-297X; Gregorio, Tiago/0000-0002-0131-9430; Sanchez Martinez, Rosario/0000-0003-0408-3029; Antonicelli, Roberto/0000-0002-5921-1828; Konstantinides, Stavros/0000-0001-6359-7279; Karapanayiotides, Theodoros/0000-0002-2357-7967; Repin, Alexey/0000-0001-7123-0645 WOS: 000445020900006 PubMed: 30145946 BACKGROUND Patients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy. METHODS In this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma n-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding. RESULTS Of the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23). CONCLUSIONS Rivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low. Janssen Research and Development; Daiichi SankyoDaiichi Sankyo Company Limited; Portola; Boehringer IngelheimBoehringer Ingelheim; JanssenJohnson & Johnson USAJanssen Biotech Inc; BayerBayer AG; BMS PfizerPfizer; Aspen; Sanofi; University of Cincinnati and Spectrum Health; PfizerPfizer; ATLAS Group (Colorado Prevention Center); Johnson JohnsonJohnson & Johnson USA; Ortho-McNeil-JanssenJohnson & Johnson USAJanssen Biotech Inc; Bayer/JanssenJohnson & Johnson USAJanssen Biotech IncBayer AG; MerckMerck & Company; AmgenAmgen Supported by Janssen Research and Development.r Dr. Spyropoulos reports receiving advisory board fees from Daiichi Sankyo and Portola, grant support, consulting fees, and advisory board fees from Boehringer Ingelheim and Janssen, consulting fees and advisory board fees from Bayer, and a stipend from ATLAS Group (Colorado Prevention Center); Dr. Ageno, receiving grant support and advisory board fees from Bayer and BMS Pfizer and advisory board fees from Portola, Daiichi Sankyo, Aspen, Boehringer Ingelheim, and Sanofi; Dr. Albers, receiving consulting fees from Bayer; Dr. Elliott, receiving fees for serving on a steering committee from Bayer and lecture fees from the University of Cincinnati and Spectrum Health; Dr. Halperin, receiving consulting fees from Boehringer Ingelheim, Daiichi Sankyo, Pfizer, ATLAS Group (Colorado Prevention Center), Johnson & Johnson, and Ortho-McNeil-Janssen; Dr. Hiatt, receiving grant support from Janssen and Bayer; Dr. Steg, receiving grant support and fees for serving on a steering committee from Bayer/Janssen, grant support and lecture fees from Merck, grant support, consulting fees, lecture fees, and fees for serving as cochair of the ODYSSEY outcomes trial and the SCORED trial from Sanofi, grant support and fees for serving as chair of the CLARIFY registry from Servier, consulting fees and fees for serving on the executive steering committee for the REDUCE IT trial from Amarin, consulting fees and lecture fees from Amgen, consulting fees, lecture fees, and fees for critical event committee work from Bristol-Myers Squibb, fees for serving on the executive steering committee of the REDUAL PCI trial from Boehringer Ingelheim, fees for critical event committee work from Pfizer, consulting fees and fees for serving on the executive steering committee for the PARADISE MI trial from Novartis, consulting fees from Regeneron and Lilly, and consulting fees and fees for serving as cochair of the THEMIS trial from AstraZeneca; Dr. Weitz, receiving consulting fees and honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Ionis, Janssen, Merck, Novartis, Pfizer and Portola; Dr. Suh and Dr. Barnathan, being employed by Janssen Research and Development and owning stock in Johnson & Johnson; Dr. Spiro, being employed by and owning shares in Bayer U.S.; and Dr. Raskob, receiving consulting fees from Bayer, BMS, Boehringer Ingelheim, Eli Lilly, Portola, and Novartis and consulting fees and honoraria from Daiichi Sankyo and Pfizer. No other potential conflict of interest relevant to this article was reported.

Published
2018

19. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

Author

Sands, B. E., Sandborn, W. J., Panaccione, R., O'Brien, C. D., Zhang, H., Johanns, J., Adedokun, O. J., Li, K., Peyrin-Biroulet, L., Van Assche, G., Danese, S., Targan, S., Abreu, M. T., Hisamatsu, T., Szapary, P., Brown S, Marano C., Connor, S, De Cruz, P, Ding, Nj, Florin, T, Hendy, P, Leong, R, Moore, G, Pavli, P, Sparrow, M, Gassner, S, Vogelsang, H, Baert, F, Colard, A, De Vos, M, D'Heygere, F, Ferrante, M, Louis, E, Staessen, D, Berova, T, Churchev, J, Draganova, R, Gancheva, D, Ivanova, N, Marinova, I, Markov, M, Nikolov, R, Tsonev, N, Vassileva, G, Afif, W, Berstein, C, Bressler, B, Jairath, V, Lachance, Jr, Singh, R, Tilbe, K, Komarek, V, Kozeluhova, J, Lukas, M, Volfova, M, Dahlerup, J, Altwegg, R, Beorchia, S, Bouguen, G, Cadiot, G, Dupas, Jl, Desreumaux, P, Flourie, B, Grimaud, Jc, Guillaud, O, Moreau, J, Roblin, X, Zerbib, F, Baumgart, D, Beckebaum, S, Bokemeyer, B, Ebert, M, Hasselblatt, P, Lügering, A, Maaser, C, Schiefke, I, Schreiber, S, Seidler, U, Altorjay, I, Kiss, Gg, Literati-Nagy, B, Patai, A, Pecsi, G, Salamon, A, Schnabel, R, Székely, A, Tulassay, Z, Varga, M, Fich, A, Fishman, S, Konikoff, F, Lichtenstein, L, Rainis, T, Sbeit, W, Schwartz, D, Annese, V, Biancone, L, Bossa, F, Costintino, R, Danese, S, Fries, W, Gasbarrini, A, Guidi, L, Kohn, A, Maconi, G, Rocca, R, Rogai, F, Villa, E, Zoli, G, Akiho, H, Aoyama, N, Arisawa, T, Hidaka, H, Hisamatsu, T, Horiki, N, Inaba, T, Inoue, S, Ishida, T, Ishida, H, Ishiguro, Y, Ishihara, S, Iwabuchi, M, Kato, J, Katsushima, S, Kobayashi, T, Kojima, Y, Kurihara, H, Masuo, T, Matsui, T, Matsumoto, T, Matsuoka, K, Mitsuyama, K, Motoya, S, Nakagawa, T, Nakai, K, Nakamura, S, Niihara, T, Ohnishi, Y, Ohta, A, Osada, T, Ryuichi, I, Sakai, Y, Sakata, Y, Sameshima, Y, Sano, K, Shibatoge, M, Shibuya, T, Suzuki, Y, Takeshima, F, Tanaka, S, Taruishi, M, Tokito, S, Ueo, T, Watanabe, K, Yamagami, H, Cheon, Jh, Cho, Kb, Knowles, Kim, Kim, Hj, Kim, Y, Lee, Km, Yang, Sk, D'Haens, G, Pierik, M, Gearry, R, Inns, S, Rowbotham, D, Schultz, M, Bochenek, A, Gawdis-Wojnarska, B, Kleczkowski, D, Leszczyszyn, J, Malecka-Panas, E, Mamos, A, Petryka, R, Regula, J, Rozciecha, J, Stefanuik, P, Wozniak-Stolarska, B, Cimpoeru, N, Craciun, E, Ovidiu, Cf, Goldis, E, Ionita-Radu, F, Lazar, D, Suciu, I, Abdulkhakov, R, Alikhanov, B, Apartsin, K, Bakulin, I, Belousova, E, Gofman, A, Grinevich, V, Kulyapin, A, Nizov, A, Osipenko, M, Simanenkov, V, Tkachev, A, Uspenskiy, Y, Valuyskikh, E, Jovanovic, I, Nagorni, A, Svorcan, P, Zdravkovic, N, Bunganic, I, Abrahamovych, O, Bilianskyi, L, Datsenko, O, Golovchenko, O, Kharchenko, N, Klymenko, V, Levchenko, O, Lozynskyy, Y, Murenets, N, Oliinyk, O, Prystupa, L, Pyrogovskyi, V, Reznikova, V, Rishko, I, Stanislavchuk, M, Vizir, V, Yatsyshyn, R, Arasaradnam, R, Bloom, S, Cummings, F, Iqbal, T, Irving, P, Kaser, A, Shonde, A, Subramanian, S, Aberra, F, Aguilar, H, Araya, V, Bakken, A, Beaulieu, D, Cappa, Ja, Chiorean, M, Cohen, N, Dryden, G, Duvall, G, Ehrlich, A, Eisner, M, Ertan, A, Fogel, R, Friedenberg, K, Gatof, D, Glover, S, Grosman, I, Gunaratnam, N, Gupta, N, Haynes, P, Hemaidan, A, Higgins, P, Hou, J, Hudesman, D, Iskandar, H, Jazrawi, S, Jones, M, Karnam, U, Khurana, S, Killpack, M, Kreines, M, Lawlor, G, Lee, S, Loftus, E, Lukin, Dj, Marcet, J, Mattar, M, Melmed, G, Minor, T, Mirkin, K, Mutlu, E, Nichols, M, Nudell, J, Rai, R, Ramos, C, Mcleod, Randall, Rausher, D, Ritter, T, Singh Saini, S, Salzberg, B, Saubermann, L, Scherl, E, Sedghi, S, Sellin, J, Shafran, I, Sorrentino, D, Suiter, D, Swaminath, A, Tiongco, F, Vrabie, R, Walp, K, Warner, N, Winstead, N, Wolf, Dc, Woods, J, Yen, E, Younes, Z., Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, Sands, Be, Sandborn, Wj, Panaccione, R, O'Brien, Cd, Zhang, H, Johanns, J, Adedokun, Oj, Li, K, Peyrin-Biroulet, L, Van Assche, G, Danese, S, Targan, S, Abreu, Mt, Hisamatsu, T, Szapary, P, and Marano, C

Subjects
Adult, Male, Infusions, [SDV]Life Sciences [q-bio], Injections, Subcutaneous, Anti-Inflammatory Agents, Ulcerative, Klinikai orvostudományok, Article, Injections, Maintenance Chemotherapy, Dose-Response Relationship, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, INFLIXIMAB, Colitis, Ulcerative, Dose-Response Relationship, Drug, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Patient Acuity, Remission Induction, Ustekinumab, ComputingMilieux_MISCELLANEOUS, ACTIVITY INDEXES, Subcutaneous, Orvostudományok, General Medicine, EFFICACY, Colitis, 3. Good health, INFECTIONS, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Drug, Intravenous
Abstract

The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore1 [range, 0 to 3] on any of the four Mayo scale components).The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).

Published
2019
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21. Indicators of iron exchanges in patients with chronic obstructive pulmonary diseases

Author

Kovchun, A. V., Kmyta, V. V., Medvedeva, I. M., and Prystupa, L. N.

Subjects
хроническое обструктивное заболевание легких, анемия хронического заболевания, сывороточное железо, ферритин, hemic and lymphatic diseases, chronic obstructive pulmonary disease, anemia of chronic disease, serum iron, ferritin, хронічне обструктивне захворювання легень, анемія хронічного захворювання, сироваткове залізо, феритин
Abstract

The purpose of the work is to analyze the main parameters of iron metabolism in patients with chronic obstructive pulmonary disease (COPD). Material and methods. The study included 202 COPD patients aged > 40 years. The patients were divided into 4 groups depending on the hemogram parameters: the 1 group consisted of 144 patients without anemia, the 2 group — 33 with anemia of chronic disease (ACD), the 3 group — 12 with erythrocytosis and the 4 group — 13 with iron deficiency anemia (IDA). All patients were examed by clinical, laboratory, instrumental studies. The complex of laboratory investigation included studies on the content of serum iron (SI), total iron binding capacity (TIBC), unsaturation iron binding capacity (UIBC), transferrin, ferritin, erythrocyte indices and color index.Results. Mean corpuscular volume score was lower in the group of patients with COPD and IDA and within the reference values among patients with COPD and ACD. The mean cell hemoglobin, mean cell hemoglobin concentration and color index were within reference values in COPD patients without anemia, with ACD and erythrocytosis, and decreased in patients with COPD and IDA. ACD in patients with COPD is normocytic and normochromic, IDA — microcytic and hypochromic. We have found that patients with COPD and IDA would have low SI and ferritin content, and high content of TIBC, UIBC and transferrin. In the group of patients with COPD and ACD, the SI content were found within the reference values and the low content of TIBC, UIBC and transferrin with high ferritin content. Conclusions. Anemia of chronic disease is observed in 16,3% of patients with chronic obstructive pulmonary disease and is normocytic and normochromic. Iron deficiency anemia in patients with chronic obstructive pulmonary disease manifests itself in 6,4% of patients. The low content of serum iron, total iron binding capacity, unsaturation iron binding capacity and transferrin with elevated ferritin level content in patients with chronic obstructive pulmonary disease is characteristic for anemia of chronic disease; low content of serum iron and ferritin, and increased content of total iron blinding capacity, unsaturation iron blinding capacity and transferrin is characteristic of iron deficiency anemia. Patients with chronic obstructive pulmonary disease without anemia and erythrocytosis have erythrocyte indices, color index, and iron exchange rates within the reference values., Цель работы — провести анализ основных показателей обмена железа у больных хронической обструктивной болезнью легких (ХОБЛ).Материал и методы. В исследование было включено 202 больных ХОБЛ в возрасте > 40 лет. Больные были распределены на четыре группы в зависимости от показателей гемограммы: 1‑ую группу составили 144 пациента без анемии, 2‑ую группу — 33 с анемией хронического заболевания (АХЗ), 3‑ю группу — 12 с эритроцитозом и 4‑ую группу — 13 с железодефицитной анемией (ЖДА). Всем обследованным пациентам проводили общеклинические, лабораторные и инструментальные исследования. В комплекс лабораторных исследований включали определение содержания сывороточного железа (СЖ), общей железосвязывающей способности сыворотки крови (ОЖСС), ненасыщенной железосвязывающей способности сыворотки крови (НЖСС), трансферрина, ферритина, эритроцитарных индексов и цветного показателя (ЦП).Результаты. Средний объём эритроцитов оказался ниже в группе больных ХОБЛ с ЖДА и в пределах референтных значений среди больных ХОБЛ с АХЗ. Среднее содержание гемоглобина в эритроците, средняя концентрация гемоглобина в объёме эритроцита и ЦП были в пределахреферентных значений у больных ХОБЛ без анемии, с АХЗ и эритроцитозом и снижены у больных с ХОБЛ и ЖДА. АХЗ у больных ХОБЛ является нормоцитарной и нормохромной, ЖДА — микроцитарной и гипохромной. Нами было установлено, что больные с ХОБЛ и ЖДА имеют низкий уровень СЖ и ферритина, высокий уровень ОЖСС, НЖСС и трансферрина. В группе больных ХОБЛ с АХЗ было обнаружено содержание СЖ в пределах референтных значений и низкое содержание ОЖСС, НЖСС и трансферрина, одновременно с высоким содержанием ферритина.Выводы. Анемия хронического заболевания наблюдается у 16,3% больных хронической обструктивной болезнью легких и является нормоцитарной и нормохромной. Железодефицитная анемия у больных хронической обструктивной болезнью легких обнаруживается у 6,4% больных. Низкое содержание сывороточного железа, общей железосвязывающей способности сыворотки крови, ненасыщенной железосвязывающей способности сыворотки крови и трансферрина одновременно с повышенным содержанием ферритина у больных хронической обструктивной болезнью легких характерно для анемии хронических заболеваний; низкое содержание сывороточного железа и ферритина, повышенное содержание общей железосвязывающей способности сыворотки крови, ненасыщенной железосвязывающей способности сыворотки крови и трансферрина характерно для железодефицитной анемии. Больные с хронической обструктивной болезнью легких без анемии и с эритроцитозом имеют эритроцитарные индексы, цветной показатель и показатели обмена железа в пределах референтных значений., Мета роботи — провести аналіз основних показників обміну заліза у хворих на хронічне обструктивне захворювання легень (ХОЗЛ).Матеріал і методи. У дослідження включено 202 хворих на ХОЗЛ віком > 40 років. Хворих було розподілено на чотири досліджувані групи залежно від показників гемограми: 1‑шу групу склали 144 пацієнти без анемії, 2‑гу групу — 33 із анемією хронічного захворювання (АХЗ), 3‑тю групу — 12 із еритроцитозом та 4‑ту групу — 13 із залізодефіцитною анемією (ЗДА). Всім обстеженим пацієнтам проводили загальноклінічні, лабораторні, інструментальні дослідження. До комплексу лабораторних обстежень включали дослідження вмісту сироваткового заліза (СЗ), загальної залізозв’язувальної здатності сироватки крові (ЗЗЗЗ), ненасиченої залізозв’язувальної здатності сироватки крові (НЗЗЗ), трансферину, феритину, еритроцитарних індексів та кольорового показника (КП).Результати. Середній oб’єм еритрoцитів виявився нижчим у групі хворих на ХОЗЛ із ЗДА та в межах референтних значень серед хворих на ХОЗЛ із АХЗ. Середній вміст гемoглoбіну в еритрoциті, середня кoнцентрація гемoглoбіну в oб’ємі еритрoцитів та КП були в межах референтних значень у хворих на ХОЗЛ без анемії, з АХЗ та еритроцитозом та знижені у хворих на ХОЗЛ із ЗДА. АХЗ у хворих на ХОЗЛ є нормоцитарною та нормохромною, ЗДА — мікроцитарною та гіпохромною. Нами було встановлено, що хворі на ХОЗЛ із ЗДА мали низький вміст СЗ та феритину, та високий вміст ЗЗЗЗ, НЗЗЗ та трансферину. У групі хворих на ХОЗЛ із АХЗ виявлено вміст СЗ у межах референтних значень та низький вміст ЗЗЗЗ, НЗЗЗ та трансферину одночасно із високим вмістом феритину. Висновки. Анемія хронічного захворювання спостерігається у 16,3% хворих на хронічне обструктивне захворювання легень та є нормоцитарною та нормохромною. Залізодефіцитна анемія у хворих на хронічне обструктивне захворювання легень виявляється у 6,4% хворих. Низький вміст сироваткового заліза, загальної залізозв’язувальної здатності сироватки крові, ненасиченої залізозв’язувальної здатності сироватки крові та трансферину одночасно з підвищеним вмістом феритину у хворих на хронічне обструктивне захворювання легень є характерним для анемії хронічного захворювання; низький вміст сироваткового заліза та феритину та підвищений вміст загальної залізозв’язувальної здатності сироватки крові, ненасиченої залізозв’язувальної здатності сироватки крові та трансферину є характерним для залізодефіцитної анемії. Хворі на хронічне обструктивне захворювання легень без анемії та з еритроцитозом мають еритроцитарні індекси, кольоровий показник та показники обміну заліза в межах референтних значень.

Published
2018

22. Why We Stay

Author

Kachkovska, Vladyslava, Dudchenko, Iryna, Kovchun, Anna, and Prystupa, Lyudmyla

Published
2023
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25. BCL1 polymorphism of glucocorticoids receptor gene and bronchial asthma

Author

Kmyta, V., Viktor Orlovskiy, Prystupa, L., and Prystupa, E.

Subjects
BclI поліморфізм, ген глюкокортикоїдного рецептора, ген глюкокортикоидного рецептора, glucocorticoid receptor gene, бронхиальная астма, bronchial asthma, BclI полиморфизм, Bcl1 polymorphism, бронхіальна астма
Abstract

Метою нашого дослідження було вивчення частоти алелів і генотипів Bcl1 поліморфізму гена глюкокортикоидного рецептора і зв'язку з поширеністю бронхіальної астми. Обстежено 188 хворих на бронхіальну астму та 95 практично здорових осіб. Bcl1 (rs41423247) поліморфізм 2-го екзонів визначали методом полімеразної ланцюгової реакції з подальшим аналізом довжини рестрикційних фрагментів по Fleury I. Статистичну обробку результатів проводили з використанням програми SPSS-17. Результати дослідження показали, що існує різниця в розподілі алельних варіантів гена між хворими з бронхіальною астмою і практично здоровими особами. Частота генотипів за Bcl1 поліморфізмом гена ГР у контролі становила: C / C, C / G, G / G - 0,421 / 0,453 / 0,126, а у хворих на бронхіальну астму - 0,228 / 0,426 / 0,346 відповідно (р = 0,001). Встановлено, що у гомозигот по мінорному аллелю G / G ризик виникнення бронхіальної астми в 5 разів вище в порівнянні з гомозиготами за основним аллелю. Доведено, що у жінок існує тенденція до збільшення ризику виникнення бронхіальної астми при наявності G / G генотипу (р = 0,016), а найвищий ризик розвитку існує у чоловіків з G / G генотипом. Таким чином, G / G генотип Bcl1 поліморфізму гена глюкокортикоидного рецептора асоційований з розвитком бронхіальної астми. Целью нашего исследования было изучение частоты аллелей и генотипов Bcl1 полиморфизма гена глюкокортикоидного рецептора и связи с распространенностью бронхиальной астмы. Обследовано 188 больных бронхиальной астмой и 95 практически здоровых лиц. Bcl1 (rs41423247) полиморфизм 2-го экзона определяли методом полимеразной цепной реакции с последующим анализом длины рестрикционных фрагментов по Fleury I. Статистическую обработку результатов проводили с использованием программы SPSS-17. Результаты исследования показали, что существует разница в распределении аллельных вариантов гена между больными с бронхиальной астмой и практически здоровыми лицами. Частота генотипов по Bcl1 полиморфизмом гена ГР в контроле составляла: C/C, C/G, G/G – 0,421/0,453/0,126, а у больных бронхиальной астмой – 0,228/0,426/0,346 соответственно (р=0,001). Установлено, что у гомозигот по минорному аллелю G/G риск возникновения бронхиальной астмы в 5 раз выше по сравнению с гомозиготами по основному аллелю. Доведено, что у женщин существует тенденция к увеличению риска возникновения бронхиальной астмы при наличии G/G генотипа (р=0,016), а самый высокий риск развития существует у мужчин с G/G генотипом. Таким образом, G/G генотип Bcl1 полиморфизма гена глюкокортикоидного рецептора ассоциирован с развитием бронхиальной астмы. The aim of our study was to investigate frequencies of alleles and genotypes of Bcl1 GR gene polymorphism and their correlation with prevalence of BA. Study involved 188 patients with BA and 95 healthy individuals. Bcl1 (rs41423247) polymorphism in exon 2 was determined by means of polymerase chain reaction with subsequent RFLP analysis (restriction fragment length polymorphism) by Fleury I. et al. with modifications. Statistical analysis of the results was performed using SPSS-17 program. The results showed statistically significant differences in genotypes distribution of BclI polymorphism of GR gene in the control group and in patients with BA. The frequency of genotypes distribution of Bcl1 polymorphism of GR gene were in controls: C/C, C/G, G/G - 0,421/ 0,453/0,126, and in patients with bronchial asthma - 0.228/0.426/0.346, respectively (p = 0.001). It was found out that G/G-homozygotes have a fivefold higher risk of BA than those homozygous for C/C regardless of gender. We demonstrated that BA risk in females, homozygous for the minor allele, is higher (p = 0.016) and men with G/G genotype of Bcl1 GR gene polymorphism have the highest risk of BA. Thus, G/G genotype of Bcl1 polymorphism of the glucocorticoid receptor gene is associated with the development of asthma.

Published
2015

27. Distribution of genotypes C825T polymorphism G-protein β3-subunit gene in patients with hypertension depending on body mass index.

Author

Prystupa, L. N., Moisejenko, I. O., Prystupa, L. N., and Moisejenko, I. O.

Abstract

The aim of the study was to investigate the frequency of genotypes of C825T polymorphism G-protein β3-subunit gene (GNB3) in patients with arterial hypertension (AH), depending on body mass index (BMI). The study involved 155 patients with verified diagnosis of AH (study group) and 50 healthy individuals (control group). The patients of the main group were divided into 3 groups according to BMI: I - 35 patients with normal body weight, II - 38 patients with overweight, III - 82 patients with obesity. We used general clinical, anthropometric, instrumental, molecular-genetic and statistical methods. Probability of differences in the frequency of alleles and genotypes was determined using χ²criteria. Pairwise comparison of groups was made using nonparametric Mann-Whitney test. The difference was considered statistically significant at p <0,05.Investigation of the distribution of genotypes C825T polymorphism GNB3 in patients with AH according to BMI showed statistically significant increase in the frequency of genotypes C / T and T / T and T allele in patients with overweight and obesity as compared with patients with normal body weight (χ² = 26 8; p <0.001). The risk of weight increase in AH patients with T allele carriers is 2,2 times higher than in C allele carriers. Association of C825T polymorphism of GNB3 with a tendency to obesity and overweight in patients withAH was proved.

Published
2015

37. [DISTRIBUTION OF GENOTYPES OF C825T POLYMORPHISM β3-SUBUNIT G-PROTEIN GENE IN PATIENTS WITH ARTERIAL HYPERTENSION ACCORDING THE DEGREE OF OBESITY]

Author

Moiseyenko, I., Prystupa, L., Garbuzova, V., Oksana Pogorielova, and Opolonskaya, N.

Subjects
Male, Gene Frequency, Genotype, Risk Factors, Hypertension, Humans, Female, Obesity, Heterotrimeric GTP-Binding Proteins, Polymorphism, Single Nucleotide, Genetic Association Studies
Abstract

Arterial hypertension (AH) and obesity - risk factors for cardiovascular diseases and their complications, leading to high morbidity and mortality. These nosologies notedly linked, because have common etiological factors, pathophysiological mechanisms and genetic determination. The aim this research was to analyze the distribution of genotypes of the C825T polymorphism of β3-subunit G-protein gene (GNB3) according the degree of obesity and to assess the risk of obesity in patients with AH. Patients were divided into three groups according the degree of obesity. We used clinical, anthropometric, instrumental, molecular-genetic and statistical methods. The significance of differences of alleles and genotypes frequency was determined by test χ². For comparing the groups used nonparametric Mann-Whitney and Kruskal-Wallis tests. A value of p0.05 was considered significant. Our research showed high frequency of T allele carriers and C/T genotype among patients with hypertension and obesity (χ² = 27,976, p0.001). In our study we observed the absence of statistically significantly difference (p = 0.677) of distribution of genotypes and alleles in patients with AH according the degree of obesity. The risk of obesity in T allele carriers was in 2.2 times higher than in C allele carriers in patients with AH. In summary, our study showed association of C825T polymorphism of the GNB3 with obesity, but did not prove the association this with the degree of obesity i patients with AH.

40. ER22/23EK AND TTH111I POLYMORPHISMS IN THE GLUCOCORTICOID RECEPTOR GENE IN PATIENTS WITH BRONCHIAL ASTHMA WITH REGARD TO THE AGE OF ONSET.

Author

Kachkovska V, Kovchun A, Kovchun V, Klisch I, Marchuk O, Dudchenko I, and Prystupa L

Subjects
Humans, Age of Onset, Alleles, Asthma genetics, Receptors, Glucocorticoid genetics
Abstract

The objective of the study was to evaluate the frequency of the ER22/23EK and Tth111I polymorphisms in the glucocorticoid receptor gene (GR) in patients with early-onset and late-onset asthma (BA) and to assess the risk of its phenotype's development. We examined 553 BA patients and 95 apparently healthy individuals. The patients were divided into 2 groups depending on the age of BA onset: Group I included 282 patients with late-onset asthma, and group II included 271 patients with early-onset asthma. The ER22/23EK (rs 6189/6190) and Tth111I (rs10052957) polymorphisms in the GR gene were determined using polymerase chain reaction-restriction fragment length polymorphism analysis. Statistical analysis of obtained results was performed using SPSS-17 program. The analysis of frequency of genotypes and alleles for the ER22/23EK polymorphism in the GR gene with regard to the age of BA onset demonstrated a significant difference between patients with early-onset and late-onset asthma (p = 0.035). A significant difference was revealed in the distribution of alleles and genotypes for the Tth111I polymorphism in the GR gene between patients with early-onset BA and late-onset BA (p = 0.006). No correlation was found between the ER22/23EK polymorphism in the GR gene and late-onset BA in all genetic models; also, there was a reduction in the risk of early-onset BA observed in the dominant and additive models. No association was demonstrated between the Tth111I polymorphism in the GR gene and late-onset asthma, while a statistically significant correlation was shown with the risk of early-onset asthma in the dominant and super-dominant models. We established a significant difference in the distribution of alleles and genotypes for the ER22/23EK and Tth111I polymorphisms in the GR gene with regard to onset age; also, we found no association between these polymorphic variants and the development of late-onset asthma, but revealed a protective role of the ER22/23EK polymorphism in the GR gene in the dominant and additive inheritance models and of Tth111I polymorphism in the GR gene - in the dominant and super-dominant models.

Published
2023

41. Trial of Intravenous Immune Globulin in Dermatomyositis.

Author

Aggarwal R, Charles-Schoeman C, Schessl J, Bata-Csörgő Z, Dimachkie MM, Griger Z, Moiseev S, Oddis C, Schiopu E, Vencovský J, Beckmann I, Clodi E, Bugrova O, Dankó K, Ernste F, Goyal NA, Heuer M, Hudson M, Hussain YM, Karam C, Magnolo N, Nelson R, Pozur N, Prystupa L, Sárdy M, Valenzuela G, van der Kooi AJ, Vu T, Worm M, and Levine T

Subjects
Adult, Creatine Kinase analysis, Double-Blind Method, Humans, Dermatomyositis drug therapy, Dermatomyositis therapy, Immunoglobulins, Intravenous administration & dosage, Immunoglobulins, Intravenous adverse effects, Immunoglobulins, Intravenous therapeutic use
Abstract

Background: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated., Methods: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ≥40) and major improvement (TIS ≥60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index., Results: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events., Conclusions: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.)., (Copyright © 2022 Massachusetts Medical Society.)

Published
2022
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42. Bcl1 polymorphism of glucocorticoid receptor gene in patients with bronchial asthma with obesity.

Author

Kmyta VV, Garbuzova VY, Prystupa EN, and Prystupa LN

Subjects
Adult, Alleles, Asthma complications, Asthma metabolism, Asthma pathology, Body Fat Distribution, Body Mass Index, Case-Control Studies, Female, Gene Frequency, Genotype, Humans, Male, Middle Aged, Obesity complications, Obesity metabolism, Obesity pathology, Receptors, Glucocorticoid metabolism, Asthma genetics, Deoxyribonucleases, Type II Site-Specific chemistry, Obesity genetics, Polymorphism, Restriction Fragment Length, Receptors, Glucocorticoid genetics
Abstract

The objective of this investigation was to analyze possible association between BclI polymorphism of glucocorticoid receptor gene and obesity in patients with bronchial asthma (BA). The study involved 188 patients with bronchial asthma and 95 apparently healthy adult individuals. Generally accepted assessments and examinations for BA diagnosis, and anthropometric, molecular-genetic and statistic methods of investigation were used in the research. It was found out that the patients with BA demonstrated higher body mass index (BMI) and higher ratio of fat centralization much more often, than the control group. Genotypes distribution for BclI polymorphism in patients with BA showed a statistically significant difference between patients with different BMI unlike the control group. Comparison of genotype frequency for BclI polymorphism in glucocorticoid receptor gene in individuals with different ratio of fat centralization in the control group and in the patients with BA separately showed statistically significant differences in the distribution of gene allelic variations only among the patients with BA. It was demonstrated that G/G genotype in the patients with visceral obesity was associated with BA.

Published
2016

43. [ROLE OF SLC2A9 AND ABCG2 GENE POLYMORPHISMS IN ORIGIN OF HYPERURICEMIA AND GOUT].

Author

Fadieieva A, Prystupa L, Pogorelova O, Kirichenko N, and Dudchenko I

Subjects
Asian People, Black People, Genetic Association Studies, Genetic Predisposition to Disease, Humans, Polymorphism, Genetic, White People, ATP Binding Cassette Transporter, Subfamily G, Member 2 genetics, Glucose Transport Proteins, Facilitative genetics, Gout genetics, Hyperuricemia genetics, Neoplasm Proteins genetics
Abstract

The polymorphisms V253I, Q126X, Q141K of SLC2A9 and ABCG2 genes were characterized. GCA и GTC haplotypes of Q126X and Q141K variants can be predictors of gout. The relationship of these polymorphisms with hyperuricaemia according to gender, metabolic syndrome components, with the response to allopurinol was analyzed. It has been established that Q141K polymorphism can directly modulate BCRP-mediated allopurinol and oxypurinol efflux, the K allele is associated with a lower reduction in serum uric acid in response to allopurinol treatment.

Published
2016

44. [ASSOCIATION OF CYCLIC CITRULLINATED PEPTIDE ANTIBODIES LEVEL WITH RHEUMATOID ARTHRITIS ACTIVITY BASED ON GLUCOCORTICOID RECEPTOR GENE BBL1 POLYMORPHISM].

Author

Prystupa L, Savchenko O, and Koroza S

Subjects
Adult, Aged, Arthritis, Rheumatoid blood, Arthritis, Rheumatoid immunology, Arthritis, Rheumatoid physiopathology, Blood Sedimentation, C-Reactive Protein genetics, C-Reactive Protein immunology, Case-Control Studies, Deoxyribonucleases, Type II Site-Specific chemistry, Female, Gene Expression, Genotype, Humans, Male, Middle Aged, Peptides, Cyclic blood, Peptides, Cyclic immunology, Receptors, Glucocorticoid immunology, Rheumatoid Factor genetics, Rheumatoid Factor immunology, Severity of Illness Index, Anti-Citrullinated Protein Antibodies blood, Arthritis, Rheumatoid genetics, Polymorphism, Restriction Fragment Length, Receptors, Glucocorticoid genetics
Abstract

The ambiguity of facts on connection between glucocorticoid receptor gene (GR) Bcl1 polymorphism in rheumatoid arthritis (RA) and its activity as well as lack of facts on its association with serological variants of the desease, makes ir reasonable to investigate its connections between cyclic citrullinated peptide antibodiss (ACCP) concentration and clinico-laboratorial parameters of RA (DAS 28 desease activity score, C-reactive protein concentration (CRP) and erythrocyte sedimentation rate (ESR) level based on GR gene Bcl1 polymorphism. Study involved 161 RA patients aged over 40 as well as 96 healthy individuals. Routine examination of RA diagnostics, anthropometric and molecular genetic methods were used in the research. Statistical analysis of the results was performed using SPSS-17 program. It has been proved that there is no significant difference in GR gene Bcl1 polymorphism distribution based on DAS 28 RA desease activity score, ACCP concentration and ESR level. However, we have found out that G/G genotype bearers have positive correlation relationship between ACCP titre and RA activity by laboratorial parameters (CRP, ESR),DAS 28 score and rheumatoid factor (RF) which has not been found in C/C and C/G genotype bearing patients. The above indicates the association of G/G genotype by GR gene Bcl1 polymorphism with clinico-laboratorial parameters of RA inflammatory activity. In course of the study we have identified the existance of correlation relationship between ACCP concentration and DAS 28 score of RA activity, CRP concentration and ESR level in individuals bearing G/G gene by GR gene Bcl11 polymorphism gene. The association between GR gene Bcl1 polymorphism and clinico-laboratorial parameters of RA inflammatory activity has not been found.

Published
2015

45. [DISTRIBUTION OF GENOTYPES OF C825T POLYMORPHISM β3-SUBUNIT G-PROTEIN GENE IN PATIENTS WITH ARTERIAL HYPERTENSION ACCORDING THE DEGREE OF OBESITY].

Author

Moiseyenko I, Prystupa L, Garbuzova V, Pogorielova O, and Opolonskaya N

Subjects
Female, Gene Frequency, Genotype, Humans, Hypertension pathology, Male, Obesity pathology, Polymorphism, Single Nucleotide, Risk Factors, Genetic Association Studies, Heterotrimeric GTP-Binding Proteins genetics, Hypertension genetics, Obesity genetics
Abstract

Arterial hypertension (AH) and obesity - risk factors for cardiovascular diseases and their complications, leading to high morbidity and mortality. These nosologies notedly linked, because have common etiological factors, pathophysiological mechanisms and genetic determination. The aim this research was to analyze the distribution of genotypes of the C825T polymorphism of β3-subunit G-protein gene (GNB3) according the degree of obesity and to assess the risk of obesity in patients with AH. Patients were divided into three groups according the degree of obesity. We used clinical, anthropometric, instrumental, molecular-genetic and statistical methods. The significance of differences of alleles and genotypes frequency was determined by test χ². For comparing the groups used nonparametric Mann-Whitney and Kruskal-Wallis tests. A value of p<0.05 was considered significant. Our research showed high frequency of T allele carriers and C/T genotype among patients with hypertension and obesity (χ² = 27,976, p <0.001). In our study we observed the absence of statistically significantly difference (p = 0.677) of distribution of genotypes and alleles in patients with AH according the degree of obesity. The risk of obesity in T allele carriers was in 2.2 times higher than in C allele carriers in patients with AH. In summary, our study showed association of C825T polymorphism of the GNB3 with obesity, but did not prove the association this with the degree of obesity i patients with AH.

Published
2015

46. [BCL1 POLYMORPHISM OF GLUCOCORTICOID RECEPTOR GENE AND RESPIRATORY DISEASES].

Author

Prystupa LN, Garbuzova VY, and Kmyta VV

Subjects
Alleles, Asthma drug therapy, Asthma metabolism, Asthma physiopathology, Cystic Fibrosis drug therapy, Cystic Fibrosis metabolism, Cystic Fibrosis physiopathology, Disease Progression, Gene Expression, Gene Frequency, Genetic Predisposition to Disease, Glucocorticoids therapeutic use, Humans, Lung metabolism, Lung physiopathology, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive metabolism, Pulmonary Disease, Chronic Obstructive physiopathology, Risk Factors, Tobacco Use Disorder physiopathology, Tobacco Use Disorder psychology, Asthma genetics, Cystic Fibrosis genetics, Polymorphism, Single Nucleotide, Pulmonary Disease, Chronic Obstructive genetics, Receptors, Glucocorticoid genetics
Abstract

The article analyses the results of investigating the connection between BCL1-polymorphism of glucocorticoid receptor gene and respiratory diseases. Its role in increasing sensitivity to glucocorticoids is proved here. The authors investigated the association of Bcl1 polymorphism with predisposition to bronchial asthma, chronic obstructive pulmonary disease, with the nicotine addiction degree and with progressing disorders of pulmonary function in cystic fibrosis.

Published
2015

47. [Effect of food deprivation on the proteolytic system in patients with atopic bronchial asthma concurrent with gastroduodenitis].

Author

Prystupa LN, Orlovs'kyĭ VF, and Kondrachuk SO

Subjects
Asthma complications, Asthma drug therapy, Cohort Studies, Duodenitis complications, Duodenitis drug therapy, Humans, Intestinal Mucosa drug effects, Intestinal Mucosa enzymology, Protease Inhibitors therapeutic use, Asthma physiopathology, Duodenitis physiopathology, Food Deprivation physiology, Peptide Hydrolases blood
Abstract

The article contains data on the state of the proteolysis system in the systemic blood flow and locally in the duodenal mucosa in those patients with bronchial asthma concurrent with gastroduodenitis. Results of fasting dietetic management versus medicamentous treatments showed a complete normalization of the protease-antiprotease imbalance with food deprivation.

Published
2001

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