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4. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP

Author

Pépin, Jean-Louis, primary, Georgiev, Ognian, additional, Tiholov, Rumen, additional, Attali, Valérie, additional, Verbraecken, Johan, additional, Buyse, Bertien, additional, Partinen, Markku, additional, Fietze, Ingo, additional, Belev, Georgi, additional, Dokic, Dejan, additional, Tamisier, Renaud, additional, Lévy, Patrick, additional, Lecomte, Isabelle, additional, Lecomte, Jeanne-Marie, additional, Schwartz, Jean-Charles, additional, Dauvilliers, Yves, additional, Attali, Valerie, additional, Bourgin, Patrice, additional, D’Ortho, Marie, additional, Gagnadoux, Frederic, additional, Meurice, Jean Claude, additional, Nguyen, Xuan Lan, additional, Pépin, Jean-Louis, additional, Hertegonne, Katrien, additional, Rodenstein, Daniel, additional, Ovesen, Jan, additional, Berg, Soren, additional, Polo, Olli, additional, Saaresranta, Tarja, additional, Hedner, Jan Anders, additional, Peker, Yuksel, additional, Randerath, W.J., additional, Rössner, Elke, additional, Borreguero, Diego Garcia, additional, Puertas Cuesta, Francisco Javier, additional, Duran-Cantolla, Joaquim, additional, Barbe, Ferran, additional, Romero, Dra Odile, additional, Ivanov, Yavor, additional, Metev, Hristo, additional, Petkova, Diana, additional, and Marku, Merita Ismajli, additional

Published
2021
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5. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial

Author

Dauvilliers, Yves, primary, Verbraecken, Johan, additional, Partinen, Markku, additional, Hedner, Jan, additional, Saaresranta, Tarja, additional, Georgiev, Ognian, additional, Tiholov, Rumen, additional, Lecomte, Isabelle, additional, Tamisier, Renaud, additional, Lévy, Patrick, additional, Scart-Gres, Catherine, additional, Lecomte, Jeanne-Marie, additional, Schwartz, Jean-Charles, additional, Pépin, Jean-Louis, additional, Attali, Valerie, additional, Bourgin, Patrice, additional, Gagnadoux, Frederic, additional, Baharloo, Farhad, additional, Berg, Soren, additional, Polo, Olli, additional, Hedner, Jan Anders, additional, Peker, Yeksel, additional, Blau, Alexander, additional, Borreguero, Diego Garcia, additional, Puertas Cuesta, Francisco Javier, additional, Belev, Georgi, additional, Ivanov, Yavor, additional, Metev, Hristo, additional, Petkova, Diana, additional, Dokic, Dejan, additional, Marku, Merita Ismajli, additional, Kaeva, Biserka Jokovska, additional, Jankovic, Slavko, additional, Kopitovic, Ivan, additional, and Vukcevic, Miodrag, additional

Published
2020
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7. INCREASING THE QUALITY OF FORMING OF SPINNING DETAILS OF ALUMINUM ALLOYS BY CONTROLLING THE RESIDUAL STRESSES IN THEIR SURFACE LAYER

Author

Leonov, Dimilyan, Lengerov, Angel, Krumov, Kalin, and Metev, Hristo

Subjects
non-destructive method, residual stresses, resistive method, spinning (cold flow turning)
Abstract

In the article are analyzed the effect of technological modes and processing parameters on the stress of spinning (cold flow turning) details of aluminum alloys. Аs the object of the study was used a detail of aluminum alloy AMg5, obtained after 3-stage spinning with intermediate heat treatments between the stages. As a control criterion was used non-destructive resistive electro contact method, based on the correlation between the integral electric and mechanical characteristics of metals and alloys – specific conductivity or electrical resistivity within the h-layer of the metal and the amount of deformation in the crystal lattice of the material due to the residual stresses.

Published
2023

8. SOLVING FUNCTIONAL-TECHNOLOGICAL PROBLEMS USING A NON-PARAMETRIC APPROACH FOR CONTROL OF MICROGEOMETRY OF THE SURFACES OF DETAILS

Author

Leonov, Dimilyan, Metev, Hristo, Krumov, Kalin, and Lengerov, Angel

Subjects
surface roughness, non-parametric method, graphic images, theory of experimental planning
Abstract

In the article considers the effect of surface roughness on the functioning of a specific mechanism. In case of proven dependence of the studied functional property of surface microgeometry, a process of optimization of the sought parameter is carried out, in which the methods of mathematical analysis and theoretic foundations of technology of appliance and mechanical engineering are used for the basis of the theoretical studies. As control parameters of the specified optimal microgeometry, deciding the given task, the so-called non-parametric criteria are used, namely graphical of certain surface-profile functions.

Published
2023

9. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

Busse, William W, primary, Bleecker, Eugene R, additional, FitzGerald, J Mark, additional, Ferguson, Gary T, additional, Barker, Peter, additional, Sproule, Stephanie, additional, Olsson, Richard F, additional, Martin, Ubaldo J, additional, Goldman, Mitchell, additional, Yañez, Anahí, additional, Fernández, Marcelo, additional, Tolcachier, Alberto, additional, Belloni, Juan, additional, Taborda, Jorge, additional, De Salvo, Maria, additional, Maspero, Jorge, additional, Victorio, Carlos, additional, Navarta, Miguel Chirino, additional, Grilli, Monica, additional, Rodríguez, Pablo, additional, Otaola, María, additional, Cambursano, Víctor, additional, Malamud, Patricia, additional, Stok, Ana, additional, Arce, German, additional, Roza, Osiris, additional, Scherbovsky, Fernando, additional, Elias, Pedro, additional, Saez, Maria Salazan, additional, Peters, Matthew, additional, Phillips, Martin, additional, Upham, John, additional, Gibson, Peter, additional, Thien, Francis, additional, Douglass, Jo, additional, Thomas, Paul, additional, Bardin, Philip, additional, Sajkov, Dimitar, additional, Hew, Mark, additional, Langton, David, additional, Pez, Andreia, additional, Fritscher, Carlos, additional, Hetzel, Jorge, additional, Mattos, Waldo, additional, Stelmach, Rafael, additional, Antila, Martti, additional, Fernandes, Ana Luisa, additional, Metev, Hristo, additional, Ivanov, Yavor, additional, Bogdanova, Aneliya, additional, Markova, Ana Dancheva, additional, Peneva, Marinka, additional, Veselinova, Rumyana, additional, Petkova, Tatyana, additional, Petrova, Vanushka, additional, Shopova, Elena, additional, Ivanova, Yuliya, additional, Yotsova, Rumyana, additional, Kirkova, Ginka, additional, Petrova, Galina, additional, Dachev, Svetoslav, additional, Sotirova, Kostadinka, additional, Stoyanova, Mariyana, additional, Yakov, Oleg, additional, Ilieva-Fartunova, Vanya, additional, Lemiere, Catherine, additional, Laviolette, Michel, additional, Yang, William, additional, Pek, Bonavuth, additional, Killorn, William Patrick, additional, Poirier, Claude, additional, Chouinard, Guy, additional, Melenka, Lyle, additional, Leigh, Richard, additional, Nair, Parameswaran, additional, Dorscheid, Delbert, additional, Martin, James, additional, Pavie, Juana, additional, Rosenblut, Andres, additional, Cartagena, Claudia, additional, Quilodran, Carlos, additional, Muñoz, Silvia, additional, Malkusova, Ivana, additional, Veverka, Josef, additional, Holub, Stanislav, additional, Mares, Jaroslav, additional, Kozel, Radovan, additional, Kopecka, Daniela, additional, Zindr, Vladimir, additional, Cerva, Pavel, additional, Chanez, Pascal, additional, Bourdin, Arnaud, additional, Devouassoux, Gilles, additional, Taille, Camille, additional, De Blay, Frédéric, additional, Goupil, Francois, additional, Leroyer, Christophe, additional, Gourcerol, Delphine, additional, Didi, Toufik, additional, Didier, Alain, additional, Garcia, Gilles, additional, Bonniaud, Philippe, additional, Vasram, Riazate Rossanaly, additional, Lommatzsch, Marek, additional, Harnest, Ulf, additional, Linnhoff, Anneliese, additional, Keller, Claus, additional, Hoheisel, Gerhard, additional, Förster, Karin, additional, Schultz, Thomas, additional, Schenkenberger, Isabelle, additional, Kirschner, Joachim, additional, Schmoller, Tibor, additional, Zielen, Stefan, additional, Kornmann, Marc, additional, Beck, Ekkehard, additional, Volgmann, Lutz, additional, Dichmann, Rolf, additional, Overlack, Axel, additional, Winkler, Jörg, additional, Mikloweit, Petra, additional, Ballenberger, Sabine, additional, Rolke, Mathias, additional, Korn, Stephanie, additional, Pabel, Helmut, additional, Hoffmann, Martin, additional, Feimer, Jan, additional, Rabe, Klaus, additional, Deckelmann, Regina, additional, Welte, Tobias, additional, Ohbayashi, Hiroyuki, additional, Hozawa, Soichiro, additional, Shimoda, Terufumi, additional, Yoshida, Makoto, additional, Nagakura, Toshikazu, additional, Kamei, Tadashi, additional, Sano, Yasuyuki, additional, Kagami, Shinichiro, additional, Takahashi, Hisaho, additional, Haida, Michiko, additional, Kimura, Goro, additional, Nakamura, Hiroyuki, additional, To, Yasuo, additional, Shinkai, Masaharu, additional, Shimokawaji, Tadasuke, additional, Kudo, Makoto, additional, Shijyubo, Noriharu, additional, Tochigi, Takao, additional, Kato, Motokazu, additional, Tanaka, Akihiko, additional, Gon, Yasuhiro, additional, Sasaki, Norihisa, additional, Ohdaira, Tetsuro, additional, Omori, Chiharu, additional, Takahashi, Toshiki, additional, Takeuchi, Satomi, additional, Nakajima, Kiyotaka, additional, Makita, Hironi, additional, Kaneko, Masahiro, additional, Furuta, Kenjiro, additional, Taniguchi, Masami, additional, Inobe, Yoshito, additional, Miki, Hiroshi, additional, Nakamura, Yoichi, additional, Miyazawa, Naoki, additional, Yano, Shuichi, additional, Iijima, Masayuki, additional, Yamato, Tsuyoshi, additional, Diaz, Javier, additional, Matsuno, Alberto, additional, Felix, Efrain, additional, Guerreros, Alfredo, additional, Daly, Alejandro, additional, Rodriguez Chariarse, Fernando, additional, Salazar, Danilo, additional, Castro, Socorro, additional, Chavez, William, additional, Estrella, Rolando, additional, Aquino, Teresita, additional, Atienza, Tito, additional, Samoro, Ronnie, additional, Isidro, Marie Grace Dawn, additional, Kuna, Piotr, additional, Antczak, Adam, additional, Bednarek, Michał, additional, Mądra-Rogacka, Danuta, additional, Hofman, Teresa, additional, Jutel, Marek, additional, Pisarczyk-Bogacka, Ewa, additional, Kot, Agata, additional, Mróz, Robert, additional, Czupryńska-Borkowska, Małgorzata, additional, Żurowska-Gębala, Małgorzata, additional, Dyczek, Andrzej, additional, Jasieniak-Pinis, Grażyna, additional, Wojnowski, Piotr, additional, Trębas-Pietraś, Ewa, additional, Dobryniewska, Małgorzata, additional, Stobiecki, Marcin, additional, Tarnowska-Matusiak, Marzenna, additional, Magner, Alina, additional, Kolczyński, Andrzej, additional, Kachel, Tomasz, additional, Bartuzi, Zbigniew, additional, Majorek-Olechowska, Bernadetta, additional, Śliwiński, Paweł, additional, Balicka, Violetta, additional, Hajoł, Elżbieta, additional, Stachera, Jacek, additional, Rachel, Marta, additional, Michnar, Marek, additional, Tałałaj, Jarosław, additional, Springer, Ewa, additional, Napora, Piotr, additional, Grzelewski, Tomasz, additional, Bijata-Bronisz, Renata, additional, Świderska, Anna, additional, Mincewicz, Grzegorz, additional, Sankowski, Zbigniew, additional, Fijołek, Tomasz, additional, Kwaśniewski, Artur, additional, Jerzyńska, Joanna, additional, Cygler, Jerzy, additional, Olesiejuk, Ryszard, additional, Von Steiner, Iwona, additional, Machowiak, Wojciech, additional, Filipek, Krzysztof, additional, Piskorz, Piotr, additional, Uhryn, Ewa, additional, Nittner-Marszalska, Marita, additional, Rybicka-Liszewska, Elżbieta, additional, Bodzenta-Łukaszyk, Anna, additional, Chełmińska, Marta, additional, Krupa-Borek, Izabella, additional, Skucha, Wojciech, additional, Płoszczuk, Anna, additional, Mihaescu, Traian, additional, Petrui, Ioan Dorin, additional, Savu, Angelica, additional, Apti, Ghiulten, additional, Toma, Claudia, additional, Trailescu, Ana, additional, Sokurenko, Sergei, additional, Trofimov, Vasiliy, additional, Leshchenko, Igor, additional, Shaporova, Natalia, additional, Ilyashevich, Inna, additional, Stitsenko, Irina, additional, Vizel, Alexander, additional, Ilkovich, Yulia, additional, Tikhanov, Dmitrii, additional, Goncharova, Svetlana, additional, Ezhov, Andrey, additional, Ignatova, Galina, additional, Izmozherova, Nadezhda, additional, Berdnikova, Nadezhda, additional, Goryachkina, Ludmila, additional, Popova, Veronika, additional, Bolieva, Laura, additional, Rebrov, Andrey, additional, Nosov, Vladimir, additional, Magnitskaya, Olga, additional, Nedogoda, Sergey, additional, Abrosimov, Vladimir, additional, Molotkov, Artem, additional, Reshedko, Galina, additional, Smirnov, Mikhail, additional, Osipenko, Marina, additional, Pavlysh, Elena, additional, Myasoedova, Svetlana, additional, Lenskaya, Liudmila, additional, Chistyakov, Valery, additional, Vishneva, Elena, additional, Uon, Liliya, additional, Zateyschikova, Anna, additional, Laleko, Svetlana, additional, Pak, Tatiana, additional, Bruning, Axel, additional, Naidoo, Visvakuren, additional, Reddy, Jeevren, additional, Van Zyl Smit, Richard, additional, Park, Hae-Sim, additional, Cho, Young Joo, additional, Cho, Sang-Heon, additional, Lee, Sang Haak, additional, Lee, Byung Jae, additional, Kim, Ju Sang, additional, Cho, You Sook, additional, Park, Choon-Sik, additional, Kim, Mi-Kyeong, additional, Koh, Young-Il, additional, Kim, Joo-Hee, additional, Lee, Sook Young, additional, Lee, Sang Pyo, additional, Park, Jung Won, additional, Yoo, Kwang Ha, additional, Yoon, Hyoungkyu, additional, Lee, Jaechun, additional, Hur, Gyu-Young, additional, Lee, Soo Keol, additional, Kim, HeeKyoo, additional, Ramos Barbón, David, additional, Laffond Yges, Elena, additional, Martínez Moragón, Eva, additional, Arias Guillen, Miguel, additional, Saura Vinuesa, Alberto, additional, Sánchez-Toril López, Fernando, additional, Velasco Garrido, José Luis, additional, García-Cosio Piqueras, Borja, additional, Pérez de Llano, Luis, additional, Valero Santiago, Antonio Luis, additional, Rubio, Myriam Calle, additional, Bjermer, Leif, additional, Lundbäck, Bo, additional, Gemicioglu, Bilun, additional, Bavbek, Sevim, additional, Ediger, Dane, additional, Erdinc, Munevver, additional, Hanta, Ismail, additional, Nayci, Sibel, additional, Arinc, Sibel, additional, Iashyna, Liudmyla, additional, Mostovoy, Yuriy, additional, Ostrovskyy, Mykola, additional, Kuryk, Lesia, additional, Lemko, Ivan, additional, Ospanova, Tetyana, additional, Moskalenko, Liubov, additional, Korzh, Oleksii, additional, Blazhko, Viktor, additional, Krakhmalova, Olena, additional, Romaniuk, Liliia, additional, Dytyatkovs'ka, Yevgeniya, additional, Yakovenko, Oleh, additional, Gavrysyuk, Volodymyr, additional, Burhan, Hassan, additional, Saralaya, Dinesh, additional, Scott, Stephen, additional, Morice, Alyn, additional, Jackson-Voyzey, Ewart, additional, Win, Thida, additional, Nasser, Shuab, additional, Harrison, Richard, additional, Chaudhuri, Rekha, additional, Nordstrom, Monica, additional, De, Pradip, additional, Masoli, Matthew, additional, Mansur, Adel, additional, Gunstone, Anthony, additional, Niven, Robert, additional, Harrison, Timothy, additional, Babu, Suresh, additional, Bhuchar, Subodh, additional, Kureishy, Shahrukh, additional, Zwetchkenbaum, John, additional, Kaplan, Lawrence, additional, Bleecker, Eugene, additional, Reyes, Santiago, additional, Fakih, Faisal, additional, Heuer, Marvin, additional, Klein, Ryan, additional, Marcus, Michael, additional, Hussain, Iftikhar, additional, Tanus, Tonny, additional, Raissy, Hengameh, additional, Alpizar, Sady, additional, Rodriguez, Hector, additional, Gleich, Gerald, additional, Bridges, Tracy, additional, Pouzar, Joe, additional, Steven, Gary, additional, Matz, Jonathan, additional, Krstevska, Shana, additional, Ziworitin, Dama, additional, Kaplan, Adolfo, additional, Sublett, James, additional, DeAngelo, James, additional, Darter, Amy, additional, Agaiby, John, additional, Hagan, John, additional, Davis, Enrique, additional, Siri, Dareen, additional, Mcevoy, Charlene, additional, Dharma, Chrisette, additional, Karimjee, Najmuddin, additional, Kelsen, Steven, additional, Frade, Manuel, additional, Silverthorn, Amy, additional, Kline, Joel, additional, Averill, Francis, additional, Ruiz, Jose, additional, Robinette, Emory, additional, Shaikh, Zeeshan, additional, Aguilar, Carlos, additional, Nish, William, additional, Alvarez, German, additional, Ismail, Younus, additional, Parikh, Purvi, additional, Leong, Mila, additional, Murphy, Dennis, additional, Garcia, Francisco, additional, Goldsobel, Alan, additional, Blanco, Antonio, additional, Campbell, Edward, additional, Perez, Guido, additional, Chupp, Geoffrey, additional, Bates, Toby, additional, Perez, Vandely, additional, Wenzel, Sally, additional, Shenoy, Kartik, additional, Katial, Rohit, additional, Bernstein, David, additional, Parikh, Neil, additional, Sims, William, additional, Ferguson, Gary, additional, Pham, David, additional, George, Anu, additional, Beasley, Richard, additional, Perez, Gilberto, additional, Garver, Robert, additional, Garcia-Portela, Miriam, additional, Wong, Stephen, additional, Soong, Weily, additional, Guillot, Richard, additional, Hudes, Golda, additional, Arif, Ahmed, additional, Binker, Josefa, additional, Villareal, Manuel, additional, Ziegner, Ulrike, additional, Ojile, Joseph, additional, Goswami, Sanjeev, additional, Piniella, Carlos, additional, Segal, Ilia, additional, Zafra, Heidi, additional, Lee, Mitchell, additional, Tarpay, Martha, additional, Panuto, John, additional, Merchant, Rajan, additional, Springsteen, Peter, additional, Scialla, Timothy, additional, Shapero, Paul, additional, Allen, Karen, additional, Moss, Mark, additional, Cruz, Humberto, additional, Rumbyrt, Jeffrey, additional, Boyd, Amy, additional, Nathan, Robert, additional, Bernstein, Jonathan, additional, Jacobs, Joshua, additional, Ginchansky, Elliot, additional, Johnston, Janice, additional, Baxter, Barbara, additional, Johnson II, Thomas, additional, Apaliski, Stephen, additional, Corder, Clinton, additional, Fuentes, David, additional, Diaz, Joseph, additional, Ngo, Chau, additional, and Le, Lan, additional

Published
2019
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13. Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)

Author

Barrera, Carlos M, primary, Mykietiuk, Analia, additional, Metev, Hristo, additional, Nitu, Mimi Floarea, additional, Karimjee, Najumuddin, additional, Doreski, Pablo Alexis, additional, Mitha, Ismail, additional, Tanaseanu, Cristina Mihaela, additional, Molina, Joseph McDermott, additional, Antonovsky, Yuri, additional, Van Rensburg, Dirkie Johanna, additional, Rowe, Brian H, additional, Flores-Figueroa, Jose, additional, Rewerska, Barbara, additional, Clark, Kay, additional, Keedy, Kara, additional, Sheets, Amanda, additional, Scott, Drusilla, additional, Horwith, Gary, additional, Das, Anita F, additional, Jamieson, Brian, additional, Fernandes, Prabhavathi, additional, and Oldach, David, additional

Published
2016
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14. Results from a Phase 3 trial in Moderate to Moderately Severe Community Acquired Bacterial Pneumonia (CABP) Treated As Outpatients With a New Oral Macrolide, Solithromycin

Author

Oldach, David, primary, Barrera, Carlos, additional, Rowe, Brian, additional, Nitu, Floarea Mimi, additional, Mykietiuk, Analia, additional, Metev, Hristo, additional, Laabs, Jessica, additional, Mitha, Ismail, additional, Tanaseanu, Cristina Mihaela, additional, McDermott Molina, Joseph, additional, Antonovsky, Yuri, additional, Van Rensburg, Dirkie Johanna, additional, Flores, Jose, additional, Sokolowska, Barbara, additional, Doreski, Alexis, additional, Das, Anita, additional, Clark, Kay, additional, Jamieson, Brian, additional, Sheets, Amanda, additional, Keedy, Kara, additional, and Fernandes, Prabhavathi, additional

Published
2015
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15. Characterization of Mycoplasma pneumoniae Infection and Outcomes in the SOLITAIRE-Oral, Global Phase 3 Clinical Trial for Solithromycin

Author

Oldach, David, primary, Metev, Hristo, additional, Mykietiuk, Analia, additional, Tanaseanu, Cristina Mihaela, additional, Das, Anita, additional, Jamieson, Brian, additional, Clark, Kay, additional, Sheets, Amanda, additional, Keedy, Kara, additional, Crabb, Donna, additional, Ratliff, Amy, additional, Waites, Ken, additional, and Fernandes, Prabhavathi, additional

Published
2015
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16. FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia

Author

Low, Donald E., File, Thomas M., Jr, Eckburg, Paul B., Talbot, George H., David Friedland, H., Lee, Jon, Llorens, Lily, Critchley, Ian A., Thye, Dirk A., Corral, Jorge, Giugno, Eduardo, Gonzalez Arzac, Maria del Rosario, Maurizi, Diego, Altclas, Javier, Ambasch, Germán, Jasovich, Abel, Minguez, Angel Ramon, Oliva, Maria Eugenia, Teglia, Osvaldo, Bergallo, Carlos, Mastruzzo, Maria Antonia, Isabel Morera, Graciana, Scapellato, Pabio Gustavo, Lamberghini, Ricardo, Mykietiuk, Analia, Remolif, Christian, Barros Monge, Manuel Jose, Enriqueta Campos Barker, Maria Isabel, Chernilo Steinmann, Sara Mireya, Gaete Gutierrez, Pablo Antonio, Muñoz Vejar, Sylvia Susana, Calvo Arellano, Mario Andres, Chahin Anania, Carolina Eugenia, Jauregui Cruz, Arturo, Amaya Tapia, Gerardo, Acuna Kaldman, Moises, Noriega, Eduardo, Matos Prado, Eduardo Demetrio, Ramos, Carlos, Andreeva, Irina, Abyshev, Rashad, Antonovsky, Yuri A., Balyuzek, Marina, Esina, Alla L., Gorelov, Alexander, Khrustalev, Oleg A., Kozlov, Roman S., Novozhenok, Vladislav, Popova, Veronika B., Sobchenko, Svetlana, Trofimov, Vasily, Yakovlev, Sergey, Zhidkov, Konstantin, Ambert, Luminta Gabriela, Fierbinteau, Carmen Georgeta, Ionescu, Valentina, Muresan, Mihai Marius, Tanaseanu, Cristina Mihaela, Georgiev, Ognian, Hodzhev, Valdimir, Marinov, Rosen, Metev, Hristo, Peneva, Marinka, Popov, Dimitar, Simeonova, Milkana, Krastins, Ivars, Lovcinovsk, Viktors, Silins, Viesturs, Svarcberga, Vita, Bargon, Joachim, Bauer, Thorsten, Bergmann, Rolf, Meyer, F.J., Mueller, Thomas, Welte, Tobias, Glaeser, Sven, Hammerl, Peter, Kern, Hartmut, Krueger, Stefan, Kujath, Peter, Lies, Achim, Schaberg, Tom, Schmalz, Oliver, Schütte, Wolfgang, Chazan, Ryszarda, Górecka, Dorota, Rogala, Barbara, Antczak, Adam, Grodzicki, Tomasz, JahnzRö, Karina, Milanowski, Janusz, Nalepa, Piotr, Wróbel-Rajzer, Malgorzata, Szelerska-Twardosz, Hanna, GrzelewskaRzymowska, Iwona, Kachel, Tomasz, Marciniak, Andrzej, Panaszek, Bernard, Szczeklik, Andrzej, Kozielski, Jerzy, Harat, Rafal, Jastrzebsk, Dariusz, Juszczak, Jacek, Labij, Violetta, Vetter, Norbert, Bolitschek, Josef, Eckmayr, Josef, Molnár, Sándor, Pápai-Székely, Zsolt, Szegedi, Janos, Vinkler, Ilona, Borscchivskyy, Mykhaylo, Dziublyk, Oleksandr, Dzyak, Georgiy V., Kraydaschenko, Oleg, Mostovoy, Yuriy M., Rudyk, Iurii S., Sushko, Viktor, Vizir, Vadim, Bhattacharya, Amal Kumar, Chakrapan, Mahabala, DʼSouza, George, Malpani, G.S., Mehta, Parthiv, Rao, K.N. Mohar, and Talwar, Deepak

Published
2011
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17. Evaluation of Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients.

Author

de Jong, Menno D., Ison, Michael G., Monto, Arnold S., Metev, Hristo, Clark, Carol, O'Neil, Brian, Elder, Jenna, McCullough, Amy, Collis, Phil, and Sheridan, William P.

Subjects
INFLUENZA treatment, ANTIVIRAL agents, PLACEBOS, INTRAVENOUS therapy, HOSPITAL patients, CLINICAL drug trials
Abstract

This placebo-controlled randomized clinical trial failed to demonstrate a clinical benefit of intravenous peramivir added to standard of care treatment in hospitalized patients with influenza but highlights the challenges of evaluating influenza antiviral agents in a hospital setting.Background. Seasonal influenza causes >200 000 annual hospitalizations in the United States. Current antiviral treatment options are limited to oral or inhaled agents. There is an urgent unmet need for intravenous antiviral treatments.Methods. Patients hospitalized with suspected influenza were randomized to 5-day treatment with intravenous peramivir (600 mg once daily) or placebo; all received the institution's standard of care (SOC) treatment. Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary end points.Results. Influenza infection was confirmed in 338 of 405 enrolled patients. At the time of a preplanned interim analysis, the primary efficacy analysis population comprised 121 patients who did not receive a concurrent neuraminidase inhibitor as part of the SOC. The median (95% confidence interval) time to clinical resolution was 42.5 (34.0–57.9) hours for peramivir versus 49.5 (40.0–61.9) hours for placebo (P = .97). A larger treatment effect was observed in patients with history of symptoms <48 hours or admitted to an intensive care unit. Greater reductions in viral shedding, based on median tissue culture infective dose, were observed in patients who received peramivir than in placebo recipients, although this difference was not statistically significant. The incidence and severity of adverse events and laboratory abnormalities were similar between the 2 treatment groups. The study was terminated for futility after a preplanned interim analysis.Conclusions. A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC. Peramivir was generally safe and well tolerated. These findings highlight the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting.Clinical Trials Registration. NCT00958776. [ABSTRACT FROM AUTHOR]

Published
2014
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