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1. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

Author: Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Koshlia, V., Fraiz, J., Krakhmalova, O., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.
Subjects: Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract: Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.
Published: 2017

2. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author: Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.
Subjects: Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract: Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.
Published: 2017

3. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

Author: Raymuno, S., Ramacciotti, E., Manenti, E., Freire, A., Fiss, E., Bizzacchi, J. Annichino, Lienart, F., Dive, A., Delforge, M., Blockmans, D., Soroka, N., Kamenova, Z., Kostadinova, M., Milanova, M., Pencheva, G., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Polonetsy, L., Pimanov, S., Mitkovskaya, N., Tokmakova, M., Dhar, A., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Douketis, J., Konig, J., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M. Arias, Lazcano, M. Opazo, Cardenas, S. Potthoff, Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Marusic, S., Vagic, J. Sikic, Skerk, V., Cermak, O., Gibson, C. Michael, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Arbetter, Douglas F., Yee, Megan K., Chlumsky, J., Chochola, J., Cizek, V., Goldhaber, Samuel Z., Hull, Russel, Hernandez, Adrian F., Huber, K., Lu, Shiao-ping, Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Nazliel, BİJEN, Bandman, Olga, Leeds, Janet M., Gold, Alex, Harrington, Robert A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Poy, C., Baker, R., Lang, P., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Coughlin, P., Finfer, S., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Rubinfeld, A., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Paleiron, N., Payot, L., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pernod, G., Pearl, R., Parthiban, K., Ortel, T., Ohaju, V., Pottier, P., Proust, A., Quere, I., Roy, P-M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Grandes, J., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Cepeda, J. M., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Van Dyk, C., Mitha, I., Engelbrecht, J., Breedt, J., Basson, M., Adler, D., Spisakova, M., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Amann, B., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Lupkovics, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Kalpachki, R., Grigorov, M., Dimov, B., Rocha, A., Goloshchekin, B., Berrouschot, J., Laszlo, Z., Rees, C., Overcash, J., Prokop, D., and Cohen, Alexander T.
Subjects: Relative risk reduction, Male, Pyridines, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Randomized controlled trial, Double-Blind Method, law, Medicine, Humans, 030212 general & internal medicine, Dosing, Enoxaparin, education, Aged, Aged, 80 and over, Venous Thrombosis, education.field_of_study, business.industry, Absolute risk reduction, Anticoagulants, Venous Thromboembolism, Hospitalization, chemistry, Concomitant, Betrixaban, Anesthesia, Benzamides, Female, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, Factor Xa Inhibitors
Abstract: The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients. The 80-mg betrixaban dose was halved to 40 mg among subjects with severe renal insufficiency and those receiving a concomitant strong P-glycoprotein inhibitor.This analysis assessed the pharmacokinetics, efficacy, and safety of full- (80 mg) and reduced-dose (40 mg) betrixaban relative to enoxaparin in the APEX trial.The median concentration of betrixaban among subjects administered the 80-mg dose was higher than that of the 40-mg dose (19 ng/mL vs 11 ng/mL, P.001). In the primary analysis cohort 1 (d-dimer ≥2× upper limit of normal), the primary efficacy outcome (asymptomatic proximal deep vein thrombosis, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism, or venous thromboembolism-related death) was significantly reduced among subjects treated with 80 mg of extended-duration betrixaban versus enoxaparin (6.27% [95/1516] vs 8.39% [130/1549], relative risk reduction=0.26 [0.04-0.42], P=.023), and similarly in the entire primary efficacy outcome population (4.87% [122/2506] vs 7.06% [181/2562], relative risk reduction=0.30 [0.13-0.44], P=.001). There was no difference in the primary outcome for subjects treated with 40 mg betrixaban vs enoxaparin across cohorts. In addition, there was no excess of major bleeding associated with either betrixaban dose compared with enoxaparin.The 80-mg betrixaban dose achieves higher plasma concentrations than the 40-mg dose and, in contrast to the 40-mg dose, is associated with improved efficacy across all cohorts relative to standard-dose enoxaparin without an excess risk of major bleeding in the management of medically ill subjects.
Published: 2016

4. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Author: Engelbrecht, J., Finfer, S., Van Dyk, C., Cohen, Alexander, Grandes, J., Cepeda, J. M., NAZLIEL, BİJEN, Cohen, Alexander T., Efrati, S., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Alekniene, B., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Mitha, I., Breedt, J., Basson, M., Adler, D., Spisakova, M., Prokop, D., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Goloshchekin, B., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Harrington, Robert A., Goldhaber, Samuel Z., Hull, Russell D., Popescu, M., Wiens, Brian L., Gold, Alex, Hernandez, Adrian F., Gibson, C. Michael, Harrington, Robert, Hull, Russell, Goldhaber, Samuel, Hernandez, Adrian, Ceresetto, Jose Manuel, Colquhoun, David, Pilger, Ernst, Polonetsky, Leonid, Podoleanu, C., Musetescu, R., Marin, I., Bojinca, M., Motte, Serge, Saraiva, Jose Francisco, Balogh, Z. E., Wrzesinski, K., Waldemar, K., Walasek, L., Raev, Dimitar, Mincheva, Valentina, Kahn, Susan, Sulik, P., Canon, Claudia Olivares, Malojcic, Branko, Mayer, Otto, Husted, Steen, Marandi, Toomas, Lassila, Riitta, Mottier, Dominique, Shaburishvili, Tamaz, Bauersachs, Rupert, Zeymer, Uwe, Hajko, Erik, Sobkowicz, B., Zeltser, David, Ageno, Walter, Krievins, Dainis, Bagdonas, Alfredas, Osores, Juan Lema, Tomkowski, Witold, Mot, Stefan, Panchenko, Elizaveta, Tan, Ru San, Gaspar, Ludovit, Jacobson, Barry, Monreal, Manuel, Ongen, Gul, Parkhomenko, Alexander, Uprichard, James, Pulkowski, G., Mirek-Bryniarska, E., Kucharski, L., Jastrzebski, D., Yusen, Roger, Grzelakowski, P., Merli, Geno, Gruenpeter, P., Gorecka, D., Gniot, J., Gaciong, Z., Fryze, W., Peacock, Frank, Schellong, Sebastian, Januzzi, James, Piovella, Franco, Cochet, Madeleine, Michalak, Nathan, Stepanchak, Maria, Spielman, Kathryn, Neal, Brandon, Florea, Ana, Chi, Gerald, Szlosek, Donald, Jain, Purva, Popma, Christopher, Korjian, Serge, Daaboul, Yazan, Halaby, Rim, Yanez, L. Toche, Lemor, Alejandro, Zacarkim, Marcelo, Romero, Gonzalo, Hernandez Elenes, Jesus Rosario, Alvarado, Alonso, Susheela, Ammu, Leitao, Meghan, Salas, M., Bandman, Olga, Horna, M., Strumph, Peter, Vinh, Nancy, Visona, A., Kostadinova, M., Vance, Annemarie, Moia, M., Wiens, Brian, Orlandini, F., Parisi, R., Pontaga, N., Smoak, Carey, Storgaard, M., Molteni, M., Castelino, Rennie, Goodman, Shelly, Stukena, I., Leeds, Janet, al-Khalidi, Hussein, Milanova, M., Karlo, L. Farjardo, Leimberger, Jeffrey, Phillips, Thomas, Rizos, T., Pencheva, G., Pomero, F., Francis, Charles, Novo, S., Pereyra, R. Cotrina, Tiefenbacher, C., Buller, Harry, Roberts, Robin, Prins, Martin, Weimar, C., Tuxen, C., Urhammer, S., Lember, M., Runev, N., Uuetoa, T., Spyropoulos, Alex, Carrier, Marc, Alkonyi, B., Lopes, Renato D., Horacek, T., Airaksinen, J., Honkaniemi, J., Pottier, P., Falukozy, J., Kaaja, R., Stoeva, N., Saarinen, J., Stoyanov, M., Pizzini, A., Devor, Adam, Tatlisumak, T., Kolls, Bradley, Dedrick, Joseph, Todd, Jamie, Jones, William Schuyler, Vikman, S., Agraou, B., Futo, L., Castillo Leon, R., Eapen, Zubin, Katona, A., Proust, A., Quere, I., Kirschner, R., Syulemzova, S., Valavicius, A., Todorov, G., Tokmakova, M., Dhar, A., Klimpe, S., Ahmad, Tariq, Brenna, J. Matthew, Douketis, J., Le Gal, G., Pearce, M., Susinskiene, D., Brito, Flavio, Provencher, S., Rozitis, V., Roy, P-M., Kroning, R., Gulack, Brian, Schmidt, J., Meza, James, Parikh, Kishan, Cooper, Lauren, Poskiene, R., Aquilanti, S., Lapp, H., Kristof, P., Lakatos, F., Laszlo, Z., Belhassane, A., Petrauskiene, R., Pagidipati, Neha, Simoneau, G., Verreault, S., Guimaraes, Patricia, Brisot, D., Perkins, Lynn M., De Geeter, G., Debourdeau, P., Alarcon, M. Arias, Lupkovics, G., Norviliene, R., Wilson, Matthew, Merkely, B., Lazcano, M. Opazo, Collier, Jeannie, Andras, C. Nagy, Cardenas, S. Potthoff, Butkovic-Soldo, S., Norvaisiene, R., Decoulx, E., Hayden, Nikieia, El Kouri, D., Car, S., Nemeth, L., Leizorovicz, Alain, Ciglenecki, N., Naudziunas, A., Datikashvili-David, I., Francetic, I., Jakopovic, M., Becker, Francois, Jennings, Lisa, Khabeishvili, G., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Griskeviciene, V., Kalinic-Grgorinic, H., Falvo, N., Khintibidze, I., Grange, C., Kobulia, B., Knezevic, A., Megreladze, I., Marusic, S., Papp, A., Pagava, Z., Lawall, H., Oliva, M., Paposhvili, K., Parody, M., Amann, B., Soltesz, P., Sudar, Z., Butkiene, Z., Szabo, G., Vagic, J. Sikic, Szegedi, N., Poy, C., Timar, G., Skerk, V., Cermak, O., Valco, J., Baker, R., Coughlin, P., Vertes, A., Rubinfeld, A., Elias, M., Berrouschot, J., Gafter, A., Hayek, T., Chlumsky, J., Lacroix, P., Messas, E., Chochola, J., Cizek, V., Basijokiene, V., Hussein, O., Dunaj, M., Dusek, J., Huber, K., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Francek, L., Havelka, J., Konig, J., Beyer-Westendorf, J., Herold, M., Holaj, R., Imberti, D., Landolfi, R., Blessing, E., Mathies, R., Schoenerr, H., Adzerikho, I., Koryk, V., Licka, M., Martinova, V., Horny, I., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Bizzacchi, J. Annichino, Fiss, E., Mismetti, P., Freire, A., Hubac, J., Jajtner, P., Manenti, E., Ramacciotti, E., Lembo, G., Raymuno, S., Rocha, A., Kolman, P., Lang, P., Bott, M., Dengler, T., Mikulova, J., Dimov, B., Podpera, I., Reiterer, P., Dziewas, R., Montaclair, K., Genth-Zotz, S., Hamann, F., Paleiron, N., Spacek, R., Payot, L., Vejvoda, J., Vyhnanek, M., Christensen, H., Salvi, A., Lodigiani, C., Pernod, G., Grigorov, M., Lassen, M., Mumoli, N., Kalpachki, R., Kamenova, Z., Schenone, A., Guy's and St Thomas' Hospital [London], Stanford Medicine, Stanford University, Brigham and Women's Hospital [Boston], Thrombosis Research Unit, University of Calgary, Portola Pharmaceuticals (Portola), PORTOLA PHARMACEUTICALS, Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute (DCRI - DURHAM), Duke University [Durham], Beth Israel Deaconess Medical Center [Boston, USA], Harvard Medical School [Boston] (HMS), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)
Subjects: Male, Pyridines, Medizin, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Ultrasonography, Venous Thrombosis, Factors de risc en les malalties, Medicine (all), Acute Disease, Adult, Aged, Benzamides, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Fibrin Fibrinogen Degradation Products, Hemorrhage, Hospitalization, Humans, Middle Aged, Pulmonary Embolism, Venous Thromboembolism, General Medicine, 3. Good health, Pulmonary embolism, Venous thrombosis, Cohort, medicine.medical_specialty, Patients, Risk factors in diseases, Placebo, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, Thromboembolism, medicine, Pacients, Betrixaban, Thromboprophylaxis, Acutely Ill Medical Patients, Tromboembolisme, business.industry, Settore MED/09 - MEDICINA INTERNA, ta3121, Population cohort, medicine.disease, Surgery, chemistry, Once daily, business
Abstract: Background\ud Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.\ud \ud Methods\ud Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.\ud \ud Results\ud A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).\ud \ud Conclusions\ud Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.)
Published: 2016

5. Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

Author: Scirica, B, Bhatt, D, Braunwald, E, Steg, P, Davidson, J, Hirshberg, B, Ohman, P, Frederich, R, Wiviott, S, Hoffman, E, Cavender, M, Udell, J, Desai, N, Mosenzon, O, Mcguire, D, Ray, K, Leiter, L, Raz, I, Abrahamsen, T, Grossman, M, Morin, S, Im, K, Gabovitch, D, Pricken, A, Buskila, A, Stahre, C, Price, D, Billing-Clason, S, Sabel, K, Monyak, J, Sjostrand, M, Wei, C, Lu, J, Miller, E, Raichlen, J, Fitt, S, Iqbal, N, Donovan, M, Aguilar-Salinas, C, Alvarsson, M, Amerena, J, Ardissino, D, Averkov, O, Avogaro, A, Barnett, A, Bretzel, R, Chiang, C, Codoceo, V, Corbalan, R, Dalby, A, Darius, H, Deerochanawong, C, Dellborg, M, Eliaschewitz, F, Garcia-Castillo, A, Gomis, R, Henry, P, Hoekstra, J, Jermendy, G, Kastelein, J, Keech, A, Kiss, R, Krempf, M, Laakso, M, Leitersdorf, E, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Medina, F, Moses, R, Nicolau, J, Opolski, G, Ophuis, T, Paolasso, E, Ruda, M, Kumar, K, Shestakova, M, Sheu, W, Smahelova, A, Bhupathiraju, B, Spinar, J, Sritata, P, Strojeck, K, Villena-Chavez, J, Jia, W, Huo, Y, Lowe, C, Awtry, E, Berger, C, Desai, A, Gelfand, E, Leeman, D, Link, M, Ruberg, F, Vita, J, Rost, N, Silverman, S, Greenberger, N, Lerch, M, Gersh, B, Nesto, R, Del Prato, S, Tuomilehto, J, Kelsey, S, Alvarisqueta, A, Cuadrado, J, Rista, L, Hermida, S, Baccaro, C, Luquez, C, Lagrutta, M, Maffei, L, Bartolacci, I, Montana, O, Cutuli, H, Berli, M, Lorenzatti, A, Frechtel, G, La Greca, R, Fretes, O, Diaz, M, Papini, N, Farias, E, Issa, C, Elbert, A, Lehman, R, Arya, M, Singh, B, Colquhoun, D, Jayasinghe, R, de Looze, F, Blombery, P, Ward, G, Szto, G, Abhayaratna, W, Borges, J, Russo, L, Felicio, J, Santos, F, Guimaraes, F, Castro, M, Rossi, P, Armaganijan, D, Leaes, P, Bandeira, F, Franken, M, Rassi, N, Rea, R, Zanella, M, Amodeo, C, Cesar, L, Betti, R, Chacra, A, Schmid, H, Bell, A, Syan, G, Zadra, R, Conter, H, Dumas, R, Borts, D, Dattani, I, Poirier, P, Cha, J, Dzongowski, P, Labonte, R, St Pierre, B, Gaudet, D, Kouz, S, Lamy, A, Tishler, S, Chehayeb, R, Bedard, J, Hramiak, I, Teitelbaum, I, Fortin, C, Woo, V, Conway, J, Mehta, P, Robinson, S, Sussex, B, Chiasson, J, Muirhead, N, Bose, S, Ouellet, A, Yale, J, Bhargava, R, Lau, D, Tobe, S, Perron, P, Sigalas, J, Bilodeau, L, Tytus, R, Achyuthan, G, Pearce, M, Steele, A, Bailey, G, Ma, P, St-Maurice, F, Rupka, D, Houlden, R, Bailey, A, Rewa, G, Sohal, P, Ting, R, Prieto, J, Rodriguez, M, Godoy, G, Larenas, G, Pincetti, C, Cobos, L, Saavedra, V, Varleta, P, Lucero, F, Kuzmanic, O, Acevedo, M, Aguirre, M, Florenzano, F, Ma, J, Bao, Y, Jiang, M, Xu, W, Shi, Y, Zheng, M, Li, Y, Dong, Y, Zhao, W, Sun, M, Lei, M, Wang, J, Pistek, Z, Rihacek, I, Kucera, D, Brada, M, Naplava, R, Karasova, J, Vlasicova, H, Skopecek, J, Spinarova, L, Raclavska, L, Sarbochova, R, Okenka, L, Racicka, E, Urbancova, K, Oznerova, M, Lorenc, Z, Wasserburger, B, Zahumensky, E, Grunfeldova, H, Hradec, J, Lukac, M, Svacina, S, Podzimek, J, Hemzsky, L, Mikulkova, I, Pavlickova, J, Brychta, T, Chochola, J, Couffinhal, T, Elbaz, M, Petit, C, Faller, B, Marechaud, R, Moulin, P, Fendri, S, Nazeyrollas, P, Wendisch, U, Busch, K, Klausmann, G, Duengen, H, Appel, K, Toursarkissian, N, Jung, T, Ott, P, Schenkenberger, I, Kuesters, D, Landers, B, Nischik, R, Fischer, H, Tschoepe, D, Paschen, B, Krause, K, Derwahl, K, Wenzl-Bauer, V, Hamann, A, Strotmann, H, Milek, K, Mueller, S, Chu, D, Tan, K, Kung, K, Tsang, C, Tomlinson, B, Koranyi, L, Kerenyi, Z, Benczur, B, Illyes, L, Hidvegi, T, Somogyi, A, Valco, J, Ferenczi, S, Rapi, J, Voros, P, Winkler, G, Sydo, T, Hetey, M, Simon, K, Penzes, J, Kempler, P, Bako, B, Lengyel, Z, Witmann, I, Dudas, M, Vandorfi, G, Takacs, J, Matoltsy, A, Ladanyi, E, Gyimesi, A, Sadikot, S, Parikh, K, Jain, S, Yajnik, C, Sosale, A, Shamanna, P, Srikanta, S, Shah, S, Srinivas, A, Banker, D, Shah, P, Sharda, A, Makkar, B, Rais, N, Mardikar, H, Mishra, A, Bhupati, S, Menon, J, Sathe, S, Gupta, R, Sharma, V, Darawsha, M, Herskovits, T, Hamoud, S, Nikolsky, E, Adawi, F, Zimlichman, R, Tsalihin, D, Wainstein, J, Klainman, E, Mosseri, M, Yerushalmi, Y, Karnieli, E, Knobler, H, Benchetrit, S, Tsur, A, Yagil, Y, Atar, S, Beberashvili, I, Fuchs, S, Stern, N, Pollak, A, Chajek-Shaul, T, Rozenman, Y, Biton, A, Bramucci, E, Fiscella, A, Grassia, V, Piatti, P, De Cosmo, S, Di Lorenzo, L, Merlini, P, Mannucci, E, Frontoni, S, Trevisan, R, Zenari, L, Lambiase, C, Salvioni, A, Silvestri, O, Ambrosio, G, Di Bartolo, P, Fattore, L, Presbitero, P, Calabrese, M, Evola, R, Gamba, M, Ibarra, M, Munoz, E, Sanchez, D, Herrera, C, Rios, J, Llamas, E, Esperon, G, Cantu, E, Fragoso, J, Gonzalez, J, Martinez, G, Padilla, F, Mier, G, Marmolejo, D, Ruiz, J, Portilla, N, Rosas, E, Machado, G, Ramos, J, Briones, I, van Hessen, M, Strikwerda, S, The, S, Kooy, A, Ronner, E, Nierop, P, Remmen, J, Groenemeijer, B, Hamer, B, Basart, D, van Lennep, H, Nieuwdorp, M, van Dijk, M, Kentgens, S, van Kempen, W, Hoogendijk, J, Spiering, W, Voors-Pette, C, Kose, V, de Waard, D, Gonkel, F, Kaasjager, H, Lingan, G, Agous, I, Kruik, H, Imholz, B, Pieterse, M, Manrique, H, Villena, J, Leon, L, Kundert, K, Minchola, J, Pinto, M, Heredia, J, Rodriguez, A, Guerreros, C, Berrospi, P, Zubiate, C, Allemant, A, Arbanil, H, Ponciano, W, Calderon, J, Lisson, R, Segura, L, Sidorowicz-Bialynicka, A, Sciborski, R, Fares, I, Mader, P, Skierkowska, J, Stasinska, T, Pomiecko, W, Skorski, M, Krzyzagorska, E, Polaszewska-Muszynska, M, Sowinski, D, Strojek, K, Rosinska-Migda, J, Romanczuk, P, Golebiowski, G, Kubica, J, Mazurek, T, Wojnowski, L, Pasternak, D, Stachlewski, P, Trzepla, E, Bogdanowicz, G, Uzunow, A, Potakowska, I, Miszczyszyn, Z, Waszyrowski, T, Smolenskaya, O, Lukyanov, Y, Vorokhobina, N, Khalimov, Y, Orlikova, O, Rebrov, A, Kukharchuk, V, Boldueva, S, Arkhipov, M, Zhelninova, T, Pavlysh, E, Antsiferov, M, Panov, A, Pavlova, M, Shustov, S, Demchenko, E, Galyavich, A, Malakhina, E, Semenova, O, Kobalava, Z, Kotova, S, Gavrisheva, I, Oschepkova, E, Karpov, Y, Sidorenko, B, Kislyak, O, Ametov, A, Dreval, A, Grineva, E, Mkrtumyan, A, Tyurina, T, Sazonova, O, Bonnici, F, Ranjith, N, Burgess, L, Nortje, H, Distiller, L, Mitha, I, Moore, R, Conradie, M, Horak, A, Pillay, S, Wellmann, H, Berg, E, Pillai, P, Padayachee, T, Corbett, C, Makan, H, Wing, J, Vawda, Z, Ebrahim, I, Mitha, E, Bhorat, A, Fernandez, J, Munoz, C, Cortada, J, Conde, A, Calvo, C, Extremera, B, Delgado, E, Masmiquel, L, Puig, J, Parreno, L, Mauricio, D, Redon, J, Brito, M, Lopez, C, de la Morera, J, Linderfalk, C, Larnefeldt, H, Olsson, A, Lonneborg, L, Ekelund, M, Samad, B, Borgencrantz, B, Nilsson, J, Berglund, O, Svensson, M, Mooe, T, Curiac, D, Albin, J, Angesjo, E, Lannemyr, O, Chen, J, Tien, K, Ueng, K, Lai, W, Yin, W, Hung, Y, Shyu, K, Hou, J, Lam, H, Laothavorn, P, Kuanprasert, S, Khovidhunkit, W, Benjasuratwong, Y, Chotinaiwattarakul, C, Mamanasiri, S, Suraamornkul, S, Pratipanawatr, T, Nitiyanant, W, Heller, S, Pieters, R, Strang, C, Bodalia, B, Middleton, A, Hall, T, Chapman, G, Calvert, J, Reed, R, Tam, D, Butcher, G, Jones, N, Takhar, A, Turner, W, Mcnally, D, Corey, O, Chapman, J, Mohr, S, Edwards, S, Ocampo, A, Kandath, D, Aude, Y, Ervin, W, Savin, V, Anderson, R, Littlefield, R, Oberoi, M, Platt, G, Yazdani, S, Mangoo-Karim, R, Walder, J, Gogia, H, Chandrashekhar, Y, Boccalandro, F, Rogers, W, Bilazarian, S, Zieve, F, Siage, Y, O'Connor, T, Mudaliar, S, Nikas, A, Giusti, R, Glover, R, Chilka, S, French, W, Roth, E, Singh, N, Christofferson, R, Stich, M, Dagogo-Jack, S, Allison, J, Zengotita, G, Ison, R, Iteld, B, Sulistio, M, Gonzalez, E, Gorman, T, Hage-Korban, E, Reddy, R, Byars, W, Antonishen, M, Benjamin, S, First, B, Rosado, J, Bruschetta, H, Poling, T, Rosendorff, C, Kerstein, H, Saba, F, Willis, J, Adams, K, Vazquez, E, Ellison, H, Kahn, B, Kereiakes, D, Powell, S, Raskin, P, Smith, K, Varma, S, Whittier, F, Casanova, R, Isserman, S, Kaye, W, Mcguinn, W, Bartkowiak, A, Dworkin, L, Labrador, C, Podlecki, D, Popovtzer, M, Aronoff, S, Ballantyne, C, Ortiz, E, Mora, A, Pitts, T, Reinhardt, S, Soucie, G, Wainwright, W, Henson, B, Sklaver, N, Arakaki, R, Brown, J, Chalavarya, G, Chochinov, R, Dixon, T, Kutner, M, Perlman, R, Raisinghani, A, Salacata, A, Awasty, V, Elinoff, V, George, W, LaRochelle-Gryseels, A, Mercado, A, Miller, G, Qureshi, M, Steljes, A, Wefald, F, Wilson, J, Chinn, J, Chuang, R, Comulada-Rivera, A, Hartman, I, Narayan, P, Pacheco, T, Weiss, R, Beavins, J, Creevy, J, Hamroff, G, Hodson, R, Kosinski, E, Krichmar, P, Patel, R, Schneider, R, Shapiro, J, Sharp, D, Speer, J, Stegemoller, R, Waxman, F, Chang, F, Braun, E, Eder, F, Minor, S, Albert, M, Carr, K, Diaczok, B, Gastman, I, Gupta, V, Longshaw, K, Gonzalez-Campoy, J, Raikhel, M, Thomas, J, Wood, K, Diab, I, Furda, J, Gelernt, M, Halter, M, House, B, Kaster, S, Raad, G, Stamatin, R, Barker, B, Blonder, R, Bloomberg, R, Calderon, R, Carrol, A, Comerota, A, Feinglos, M, Henderson, D, Kastelic, R, Stonesifer, L, Talano, J, Lee, P, Brosseau, J, Clark, W, Cohen, E, Fialkow, J, Horton, K, Kozman, H, Mcgill, J, Mihills, C, Poonawala, R, Shore, K, Tejada, L, Torres, R, Wright, W, Calatayud, G, Chandna, H, Drozdiak, R, Fink, R, Gill, R, Glandt, M, Gottlieb, D, Hack, T, Kay, J, Mansouri, V, Mcknight, T, Mostel, E, Schmidt, L, Seide, H, Sonel, E, Taylor, R, Velasquez, M, Bretton, E, Feldman, R, Hartman, A, Hershon, K, Leach, C, Martin, E, Mohiuddin, F, Naygandhi, Y, Riske, T, Schima, S, Uzoaga, E, Ward, H, Weinstock, R, Williams, T, Altschuller, A, Aoki, T, Blumenthal, S, Cash, A, Eisner, G, Gutmann, J, Hagan, M, Kabour, A, Markus, T, Mckenzie, W, Moursi, M, Mystkowski, P, Ovalle, F, Perkins, R, Popeil, L, Saniuk, R, Sierra, Y, Alvarado, O, Anderson, J, Bajaj, M, Blank, R, Chu, A, Levinsky, L, Levy, P, Osborne, J, Pavon, H, Sanderlin, D, Schaer, G, Zarich, S, Atassi, K, Bayron, C, Casagrande, M, Das, D, Gimness, M, Handel, F, Kinstrey, T, Leu, S, Osei, K, Nouel, J, Soltani, Z, Sussman, H, Chiu, K, Duda, R, Farnsworth, K, Lano, M, Lee, F, Levin, P, Pratt, S, Richwine, R, Ruiz-Rivera, L, Turner, J, Wood, J, Zigrang, W, Baquerizo, H, Colon, C, Demattia, J, Desai, V, Fitz-Patrick, D, Goral, S, Odhav, A, Prentiss, A, Ruff, C, Wu, W, Wyne, K, Abbott, L, Applegate, R, Cabral, J, Kotha, P, Ortega, P, Simmons, D, Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I, Desai N, Abrahamsen T, Grossman M, Morin S, Im K, Hoffman E, Gabovitch D, Pricken A, Buskila A, Stahre C, Price D, Billing-Clason S, Sabel K, Monyak J, Sjostrand M, Wei C, Lu J, Miller E, Raichlen J, Fitt S, Iqbal N, Donovan M, Davidson JA, Aguilar-Salinas C, Alvarsson M, Amerena J, Ardissino D, Averkov O, Avogaro A, Barnett A, Bretzel R, Chiang CE, Codoceo V, Corbalan R, Dalby A, Darius H, Deerochanawong C, Dellborg M, Eliaschewitz F, Garcia-Castillo A, Gomis R, Henry P, Hoekstra J, Jermendy G, Kastelein J, Keech A, Kiss R, Krempf M, Laakso M, Leiter L, Leitersdorf E, Lewis B, Litwak L, Lopez-Sendon J, Ma R, McGuire D, Medina F, Moses R, Nicolau JC, Opolski G, Ophuis TO, Paolasso E, Ruda M, Kumar KMP, Shestakova M, Sheu WHH, Smahelova A, Bhupathiraju BSR, Spinar J, Sritata P, Strojeck K, Villena-Chavez JE, Jia WP, Huo Y, Lowe C, Awtry E, Berger C, Desai AS, Gelfand E, Leeman D, Link M, Ruberg F, Vita J, Rost N, Silverman S, Greenberger NJ, Lerch MM, Gersh B, Nesto R, Del Prato S, Tuomilehto J, Kelsey S, Alvarisqueta A, Cuadrado J, Rista L, Hermida S, Baccaro C, Luquez C, Lagrutta M, Maffei L, Bartolacci I, Montana O, Cutuli H, Berli M, Lorenzatti A, Frechtel G, La Greca R, Fretes O, Diaz M, Papini NR, Farias E, Issa C, Elbert A, Lehman R, Arya M, Singh B, Colquhoun D, Jayasinghe R, de Looze F, Blombery P, Ward G, Szto G, Abhayaratna W, Borges J, Russo L, Felicio J, Santos F, Guimaraes F, Castro ML, Rossi P, Armaganijan D, Leaes P, Bandeira F, Franken M, Rassi N, Rea R, Zanella M, Amodeo C, Cesar L, Betti R, Chacra A, Schmid H, Bell A, Syan G, Zadra R, Conter H, Dumas R, Borts D, Dattani I, Poirier P, Cha J, Dzongowski P, Labonte R, St Pierre B, Gaudet D, Kouz S, Lamy A, Tishler S, Chehayeb R, Bedard J, Hramiak I, Teitelbaum I, Fortin C, Woo V, Conway J, Mehta P, Robinson S, Sussex B, Chiasson J, Muirhead N, Bose S, Ouellet A, Yale J, Bhargava R, Lau D, Tobe S, Perron P, Sigalas J, Bilodeau L, Tytus R, Achyuthan G, Pearce M, Steele A, Bailey G, Ma P, St-Maurice F, Rupka D, Houlden R, Bailey A, Rewa G, Sohal P, Ting R, Prieto J, Rodriguez M, Godoy G, Larenas G, Pincetti C, Cobos L, Saavedra V, Varleta P, Lucero F, Kuzmanic O, Acevedo M, Aguirre M, Florenzano F, Ma J, Bao Y, Jiang M, Xu W, Shi Y, Zheng M, Li Y, Dong Y, Zhao W, Sun M, Lei M, Wang J, Pistek Z, Rihacek I, Kucera D, Brada M, Naplava R, Karasova J, Vlasicova H, Skopecek J, Spinarova L, Raclavska L, Sarbochova R, Okenka L, Racicka E, Urbancova K, Oznerova M, Lorenc Z, Wasserburger B, Zahumensky E, Grunfeldova H, Hradec J, Lukac M, Svacina S, Podzimek J, Hemzsky L, Mikulkova I, Pavlickova J, Brychta T, Chochola J, Couffinhal T, Elbaz M, Petit C, Faller B, Marechaud R, Moulin P, Fendri S, Nazeyrollas P, Wendisch U, Busch K, Klausmann G, Duengen H, Appel K, Toursarkissian N, Jung T, Ott P, Schenkenberger I, Kuesters D, Landers B, Nischik R, Fischer H, Tschoepe D, Paschen B, Krause K, Derwahl K, Wenzl-Bauer V, Hamann A, Strotmann H, Milek K, Mueller S, Chu D, Tan K, Kung K, Tsang C, Tomlinson B, Koranyi L, Kerenyi Z, Benczur B, Illyes L, Hidvegi T, Somogyi A, Valco J, Ferenczi S, Rapi J, Voros P, Winkler G, Sydo T, Hetey M, Simon K, Penzes J, Kempler P, Bako B, Lengyel Z, Witmann I, Dudas M, Vandorfi G, Takacs J, Matoltsy A, Ladanyi E, Gyimesi A, Sadikot S, Parikh K, Jain S, Yajnik C, Sosale A, Shamanna P, Srikanta S, Shah S, Srinivas A, Banker D, Shah P, Sharda A, Makkar B, Rais N, Mardikar H, Mishra A, Bhupati S, Menon J, Sathe S, Gupta R, Sharma V, Darawsha M, Herskovits T, Hamoud S, Nikolsky E, Adawi F, Zimlichman R, Tsalihin D, Wainstein J, Klainman E, Mosseri M, Yerushalmi Y, Karnieli E, Knobler H, Benchetrit S, Tsur A, Yagil Y, Atar S, Beberashvili I, Fuchs S, Stern N, Pollak A, Chajek-Shaul T, Rozenman Y, Biton A, Bramucci E, Fiscella A, Grassia V, Piatti P, De Cosmo S, Di Lorenzo L, Merlini P, Mannucci E, Frontoni S, Trevisan R, Zenari L, Lambiase C, Salvioni A, Silvestri O, Ambrosio G, Di Bartolo P, Fattore L, Presbitero P, Calabrese M, Evola R, Gamba MA, Ibarra MOD, Munoz EC, Sanchez DR, Herrera CH, Rios JP, Llamas EB, Esperon GL, Cantu EG, Fragoso JN, Gonzalez JG, Martinez GR, Padilla FP, Mier GM, Marmolejo DH, Ruiz JG, Portilla NC, Rosas EL, Machado GM, Ramos JC, Briones IR, van Hessen MWJ, Strikwerda S, The SHK, Kooy A, Ronner E, Nierop PR, Remmen JJ, Groenemeijer BE, Hamer BJB, Basart DCG, van Lennep HWOR, Nieuwdorp M, van Dijk MPM, Kentgens S, van Kempen WW, Hoogendijk J, Spiering W, Voors-Pette C, Kose V, de Waard DEP, Gonkel F, Kaasjager HAH, Lingan GMR, Agous I, Kruik HJ, Imholz BPM, Pieterse M, Manrique H, Villena J, Leon L, Kundert K, Minchola J, Pinto M, Heredia J, Rodriguez A, Guerreros C, Berrospi P, Zubiate C, Allemant A, Arbanil H, Ponciano W, Calderon J, Lisson R, Segura L, Sidorowicz-Bialynicka A, Sciborski R, Fares I, Mader P, Skierkowska J, Stasinska T, Pomiecko W, Skorski M, Krzyzagorska E, Polaszewska-Muszynska M, Sowinski D, Strojek K, Rosinska-Migda J, Romanczuk P, Golebiowski G, Kubica J, Mazurek T, Wojnowski L, Pasternak D, Stachlewski P, Trzepla E, Bogdanowicz G, Uzunow A, Potakowska I, Miszczyszyn Z, Waszyrowski T, Smolenskaya O, Lukyanov Y, Vorokhobina N, Khalimov Y, Orlikova O, Rebrov A, Kukharchuk V, Boldueva S, Arkhipov M, Zhelninova T, Pavlysh E, Antsiferov M, Panov A, Pavlova M, Shustov S, Demchenko E, Galyavich A, Malakhina E, Semenova O, Kobalava Z, Kotova S, Gavrisheva I, Oschepkova E, Karpov Y, Sidorenko B, Kislyak O, Ametov A, Dreval A, Grineva E, Mkrtumyan A, Tyurina T, Sazonova O, Bonnici F, Ranjith N, Burgess L, Nortje H, Distiller L, Mitha I, Moore R, Conradie M, Horak A, Pillay S, Wellmann H, Berg E, Pillai P, Padayachee T, Corbett C, Makan H, Wing J, Vawda Z, Ebrahim I, Mitha E, Bhorat A, Fernandez JC, Munoz C, Cortada JB, Conde AC, Calvo C, Extremera BG, Delgado E, Masmiquel L, Puig JG, Parreno LD, Mauricio D, Redon J, Brito M, Lopez C, de la Morera JS, Linderfalk C, Larnefeldt H, Olsson A, Lonneborg L, Ekelund M, Samad B, Borgencrantz B, Nilsson J, Berglund O, Svensson M, Mooe T, Curiac D, Albin J, Angesjo E, Lannemyr O, Chiang C, Sheu W, Chen J, Tien K, Ueng K, Lai W, Yin W, Hung Y, Shyu K, Hou J, Lam H, Laothavorn P, Kuanprasert S, Khovidhunkit W, Benjasuratwong Y, Chotinaiwattarakul C, Mamanasiri S, Suraamornkul S, Pratipanawatr T, Nitiyanant W, Heller S, Ray K, Pieters R, Strang C, Bodalia B, Middleton A, Hall T, Chapman G, Calvert J, Reed R, Tam D, Butcher G, Jones N, Takhar A, Turner W, McNally D, Corey O, Chapman J, Mohr S, Edwards S, Bhatt D, Ocampo A, Kandath D, Aude Y, Ervin W, Savin V, Anderson R, Littlefield R, Oberoi M, Platt GE, Yazdani S, Mangoo-Karim R, Walder J, Gogia H, Chandrashekhar Y, Boccalandro F, Rogers W, Bilazarian S, Zieve F, Siage Y, O'Connor T, Mudaliar S, Nikas A, Giusti R, Glover R, Chilka S, French W, Roth E, Singh N, Christofferson R, Stich M, Dagogo-Jack S, Allison J, Zengotita GA, Ison R, Iteld B, Sulistio M, Gonzalez E, Gorman T, Hage-Korban E, Reddy R, Byars W, Antonishen M, Benjamin S, First B, Rosado J, Bruschetta H, Poling T, Rosendorff C, Kerstein HJ, Saba F, Willis J, Adams K, Vazquez EC, Ellison H, Kahn B, Kereiakes D, Powell S, Raskin P, Smith K, Varma S, Whittier F, Casanova R, Isserman S, Kaye W, McGuinn W, Bartkowiak A, Dworkin L, Labrador CA, Podlecki D, Popovtzer M, Aronoff S, Ballantyne C, Ortiz EG, Mora A, Pitts T, Reinhardt S, Soucie G, Wainwright W, Henson B, Sklaver N, Arakaki R, Brown J, Chalavarya G, Chochinov R, Dixon T, Kutner M, Perlman R, Raisinghani A, Salacata A, Awasty V, Elinoff V, George W, 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Feldman R, Hartman A, Hershon K, Leach CR, Martin E, Mohiuddin F, Naygandhi Y, Riske T, Schima S, Uzoaga ER, Ward H, Weinstock R, Williams T, Altschuller A, Aoki T, Blumenthal S, Cash A, Eisner G, Gutmann J, Hagan M, Kabour A, Markus T, McKenzie W, Moursi M, Mystkowski P, Ovalle F, Perkins R, Popeil L, Saniuk R, Sierra Y, Alvarado O, Anderson J, Bajaj M, Blank R, Chu A, Levinsky L, Levy P, Osborne J, Pavon H, Sanderlin D, Schaer G, Zarich S, Atassi K, Bayron C, Casagrande M, Das D, Gimness M, Handel F, Kinstrey T, Leu S, Osei K, Nouel JS, Soltani Z, Sussman H, Chiu K, Duda R, Farnsworth K, Lano M, Lee F, Levin P, Pratt S, Richwine R, Ruiz-Rivera L, Turner J, Wood J, Zigrang WD, Baquerizo HR, Colon CB, Demattia J, Desai V, Fitz-Patrick D, Goral S, Odhav A, Prentiss A, Ruff C, Wu W, Wyne K, Abbott LG, Applegate R, Cabral J, Kotha P, Ortega P, Simmons D, Scirica, B, Bhatt, D, Braunwald, E, Steg, P, Davidson, J, Hirshberg, B, Ohman, P, Frederich, R, Wiviott, S, Hoffman, E, Cavender, M, 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D, Kouz S, Lamy A, Tishler S, Chehayeb R, Bedard J, Hramiak I, Teitelbaum I, Fortin C, Woo V, Conway J, Mehta P, Robinson S, Sussex B, Chiasson J, Muirhead N, Bose S, Ouellet A, Yale J, Bhargava R, Lau D, Tobe S, Perron P, Sigalas J, Bilodeau L, Tytus R, Achyuthan G, Pearce M, Steele A, Bailey G, Ma P, St-Maurice F, Rupka D, Houlden R, Bailey A, Rewa G, Sohal P, Ting R, Prieto J, Rodriguez M, Godoy G, Larenas G, Pincetti C, Cobos L, Saavedra V, Varleta P, Lucero F, Kuzmanic O, Acevedo M, Aguirre M, Florenzano F, Ma J, Bao Y, Jiang M, Xu W, Shi Y, Zheng M, Li Y, Dong Y, Zhao W, Sun M, Lei M, Wang J, Pistek Z, Rihacek I, Kucera D, Brada M, Naplava R, Karasova J, Vlasicova H, Skopecek J, Spinarova L, Raclavska L, Sarbochova R, Okenka L, Racicka E, Urbancova K, Oznerova M, Lorenc Z, Wasserburger B, Zahumensky E, Grunfeldova H, Hradec J, Lukac M, Svacina S, Podzimek J, Hemzsky L, Mikulkova I, Pavlickova J, Brychta T, Chochola J, Couffinhal T, Elbaz M, Petit C, Faller B, Marechaud R, Moulin P, Fendri S, Nazeyrollas P, Wendisch U, Busch K, Klausmann G, Duengen H, Appel K, Toursarkissian N, Jung T, Ott P, Schenkenberger I, Kuesters D, Landers B, Nischik R, Fischer H, Tschoepe D, Paschen B, Krause K, Derwahl K, Wenzl-Bauer V, Hamann A, Strotmann H, Milek K, Mueller S, Chu D, Tan K, Kung K, Tsang C, Tomlinson B, Koranyi L, Kerenyi Z, Benczur B, Illyes L, Hidvegi T, Somogyi A, Valco J, Ferenczi S, Rapi J, Voros P, Winkler G, Sydo T, Hetey M, Simon K, Penzes J, Kempler P, Bako B, Lengyel Z, Witmann I, Dudas M, Vandorfi G, Takacs J, Matoltsy A, Ladanyi E, Gyimesi A, Sadikot S, Parikh K, Jain S, Yajnik C, Sosale A, Shamanna P, Srikanta S, Shah S, Srinivas A, Banker D, Shah P, Sharda A, Makkar B, Rais N, Mardikar H, Mishra A, Bhupati S, Menon J, Sathe S, Gupta R, Sharma V, Darawsha M, Herskovits T, Hamoud S, Nikolsky E, Adawi F, Zimlichman R, Tsalihin D, Wainstein J, Klainman E, Mosseri M, Yerushalmi Y, Karnieli E, Knobler H, Benchetrit S, Tsur A, Yagil Y, Atar S, Beberashvili I, Fuchs S, Stern N, Pollak A, Chajek-Shaul T, Rozenman Y, Biton A, Bramucci E, Fiscella A, Grassia V, Piatti P, De Cosmo S, Di Lorenzo L, Merlini P, Mannucci E, Frontoni S, Trevisan R, Zenari L, Lambiase C, Salvioni A, Silvestri O, Ambrosio G, Di Bartolo P, Fattore L, Presbitero P, Calabrese M, Evola R, Gamba MA, Ibarra MOD, Munoz EC, Sanchez DR, Herrera CH, Rios JP, Llamas EB, Esperon GL, Cantu EG, Fragoso JN, Gonzalez JG, Martinez GR, Padilla FP, Mier GM, Marmolejo DH, Ruiz JG, Portilla NC, Rosas EL, Machado GM, Ramos JC, Briones IR, van Hessen MWJ, Strikwerda S, The SHK, Kooy A, Ronner E, Nierop PR, Remmen JJ, Groenemeijer BE, Hamer BJB, Basart DCG, van Lennep HWOR, Nieuwdorp M, van Dijk MPM, Kentgens S, van Kempen WW, Hoogendijk J, Spiering W, Voors-Pette C, Kose V, de Waard DEP, Gonkel F, Kaasjager HAH, Lingan GMR, Agous I, Kruik HJ, Imholz BPM, Pieterse M, Manrique H, Villena J, Leon L, Kundert K, Minchola J, Pinto M, Heredia J, Rodriguez A, Guerreros C, Berrospi P, Zubiate C, Allemant A, Arbanil H, Ponciano W, Calderon J, Lisson R, Segura L, Sidorowicz-Bialynicka A, Sciborski R, Fares I, Mader P, Skierkowska J, Stasinska T, Pomiecko W, Skorski M, Krzyzagorska E, Polaszewska-Muszynska M, Sowinski D, Strojek K, Rosinska-Migda J, Romanczuk P, Golebiowski G, Kubica J, Mazurek T, Wojnowski L, Pasternak D, Stachlewski P, Trzepla E, Bogdanowicz G, Uzunow A, Potakowska I, Miszczyszyn Z, Waszyrowski T, Smolenskaya O, Lukyanov Y, Vorokhobina N, Khalimov Y, Orlikova O, Rebrov A, Kukharchuk V, Boldueva S, Arkhipov M, Zhelninova T, Pavlysh E, Antsiferov M, Panov A, Pavlova M, Shustov S, Demchenko E, Galyavich A, Malakhina E, Semenova O, Kobalava Z, Kotova S, Gavrisheva I, Oschepkova E, Karpov Y, Sidorenko B, Kislyak O, Ametov A, Dreval A, Grineva E, Mkrtumyan A, Tyurina T, Sazonova O, Bonnici F, Ranjith N, Burgess L, Nortje H, Distiller L, Mitha I, Moore R, Conradie M, Horak A, Pillay S, Wellmann H, Berg E, Pillai P, Padayachee T, Corbett C, Makan H, Wing J, Vawda Z, Ebrahim I, Mitha E, Bhorat A, Fernandez JC, Munoz C, Cortada JB, Conde AC, Calvo C, Extremera BG, Delgado E, Masmiquel L, Puig JG, Parreno LD, Mauricio D, Redon J, Brito M, Lopez C, de la Morera JS, Linderfalk C, Larnefeldt H, Olsson A, Lonneborg L, Ekelund M, Samad B, Borgencrantz B, Nilsson J, Berglund O, Svensson M, Mooe T, Curiac D, Albin J, Angesjo E, Lannemyr O, Chiang C, Sheu W, Chen J, Tien K, Ueng K, Lai W, Yin W, Hung Y, Shyu K, Hou J, Lam H, Laothavorn P, Kuanprasert S, Khovidhunkit W, Benjasuratwong Y, Chotinaiwattarakul C, Mamanasiri S, Suraamornkul S, Pratipanawatr T, Nitiyanant W, Heller S, Ray K, Pieters R, Strang C, Bodalia B, Middleton A, Hall T, Chapman G, Calvert J, Reed R, Tam D, Butcher G, Jones N, Takhar A, Turner W, McNally D, Corey O, Chapman J, Mohr S, Edwards S, Bhatt D, Ocampo A, Kandath D, Aude Y, Ervin W, Savin V, Anderson R, Littlefield R, Oberoi M, Platt GE, Yazdani S, Mangoo-Karim R, Walder J, Gogia H, Chandrashekhar Y, Boccalandro F, Rogers W, Bilazarian S, Zieve F, Siage Y, O'Connor T, Mudaliar S, Nikas A, Giusti R, Glover R, Chilka S, French W, Roth E, Singh N, Christofferson R, Stich M, Dagogo-Jack S, Allison J, Zengotita GA, Ison R, Iteld B, Sulistio M, Gonzalez E, Gorman T, Hage-Korban E, Reddy R, Byars W, Antonishen M, Benjamin S, First B, Rosado J, Bruschetta H, Poling T, Rosendorff C, Kerstein HJ, Saba F, Willis J, Adams K, Vazquez EC, Ellison H, Kahn B, Kereiakes D, Powell S, Raskin P, Smith K, Varma S, Whittier F, Casanova R, Isserman S, Kaye W, McGuinn W, Bartkowiak A, Dworkin L, Labrador CA, Podlecki D, Popovtzer M, Aronoff S, Ballantyne C, Ortiz EG, Mora A, Pitts T, Reinhardt S, Soucie G, Wainwright W, Henson B, Sklaver N, Arakaki R, Brown J, Chalavarya G, Chochinov R, Dixon T, Kutner M, Perlman R, Raisinghani A, Salacata A, Awasty V, Elinoff V, George W, LaRochelle-Gryseels A, Mercado A, Miller G, Qureshi M, Steljes A, Wefald F, Wilson J, Chinn J, Chuang RB, Comulada-Rivera A, Hartman I, Narayan P, Pacheco T, Weiss R, Beavins J, Creevy J, Hamroff G, Hodson R, Kosinski E, Krichmar P, Patel R, Schneider R, Shapiro J, Sharp D, Speer J, Stegemoller R, Waxman F, Chang FY, Braun E, Eder F, Minor S, Albert M, Carr KW, Diaczok B, Gastman I, Gupta V, Longshaw K, Gonzalez-Campoy JM, Raikhel M, Thomas J, Wood K, Diab I, Furda J, Gelernt M, Halter M, House B, Kaster S, Raad G, Stamatin R, Barker B, Blonder R, Bloomberg RJ, Calderon RB, Carrol A, Comerota A, Feinglos M, Henderson D, Kastelic R, Stonesifer LD, Talano J, Lee PV, Brosseau J, Clark W, Cohen E, Fialkow J, Horton K, Kozman H, McGill J, Mihills C, Poonawala R, Shore K, Tejada L, Torres R, Wright W, Calatayud G, Chandna H, Drozdiak R, Fink R, Gill R, Glandt M, Gottlieb DW, Hack T, Kay J, Mansouri V, McKnight T, Mostel E, Schmidt L, Seide H, Sonel E, Taylor R, Velasquez M, Bretton E, Feldman R, Hartman A, Hershon K, Leach CR, Martin E, Mohiuddin F, Naygandhi Y, Riske T, Schima S, Uzoaga ER, Ward H, Weinstock R, Williams T, Altschuller A, Aoki T, Blumenthal S, Cash A, Eisner G, Gutmann J, Hagan M, Kabour A, Markus T, McKenzie W, Moursi M, Mystkowski P, Ovalle F, Perkins R, Popeil L, Saniuk R, Sierra Y, Alvarado O, Anderson J, Bajaj M, Blank R, Chu A, Levinsky L, Levy P, Osborne J, Pavon H, Sanderlin D, Schaer G, Zarich S, Atassi K, Bayron C, Casagrande M, Das D, Gimness M, Handel F, Kinstrey T, Leu S, Osei K, Nouel JS, Soltani Z, Sussman H, Chiu K, Duda R, Farnsworth K, Lano M, Lee F, Levin P, Pratt S, Richwine R, Ruiz-Rivera L, Turner J, Wood J, Zigrang WD, Baquerizo HR, Colon CB, Demattia J, Desai V, Fitz-Patrick D, Goral S, Odhav A, Prentiss A, Ruff C, Wu W, Wyne K, Abbott LG, Applegate R, Cabral J, Kotha P, Ortega P, and Simmons D
Abstract: BACKGROUND: The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority); the results were similar in the "on-treatment" analysis (hazard ratio, 1.03; 95% CI, 0.91 to 1.17). The major secondary end point of a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group (12.8% and 12.4%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio, 1.02; 95% CI, 0.94 to 1.11; P=0.66). More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups (acute pancreatitis, 0.3% in the saxagliptin group and 0.2% in the placebo group; chronic pancreatitis, <0.1% and 0.1% in the two groups, respectively). CONCLUSIONS: DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was
Published: 2013

6. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus

Author: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I, Desai N, Abrahamsen T, Grossman M, Morin S, Im K, Hoffman E, Gabovitch D, Pricken A, Buskila A, Stahre C, Price D, Billing-Clason S, Sabel K, Monyak J, Sjostrand M, Wei C, Lu J, Miller E, Raichlen J, Fitt S, Iqbal N, Donovan M, Davidson JA, Aguilar-Salinas C, Alvarsson M, Amerena J, Ardissino D, Averkov O, Avogaro A, Barnett A, Bretzel R, Chiang CE, Codoceo V, Corbalan R, Dalby A, Darius H, Deerochanawong C, Dellborg M, Eliaschewitz F, Garcia-Castillo A, Gomis R, Henry P, Hoekstra J, Jermendy G, Kastelein J, Keech A, Kiss R, Krempf M, Laakso M, Leiter L, Leitersdorf E, Lewis B, Litwak L, Lopez-Sendon J, Ma R, McGuire D, Medina F, Moses R, Nicolau JC, Opolski G, Ophuis TO, Paolasso E, Ruda M, Kumar KMP, Shestakova M, Sheu WHH, Smahelova A, Bhupathiraju BSR, Spinar J, Sritata P, Strojeck K, Villena-Chavez JE, Jia WP, Huo Y, Lowe C, Awtry E, Berger C, Desai AS, Gelfand E, Leeman D, Link M, Ruberg F, Vita J, Rost N, Silverman S, Greenberger NJ, Lerch MM, Gersh B, Nesto R, Del Prato S, Tuomilehto J, Kelsey S, Alvarisqueta A, Cuadrado J, Rista L, Hermida S, Baccaro C, Luquez C, Lagrutta M, Maffei L, Bartolacci I, Montana O, Cutuli H, Berli M, Lorenzatti A, Frechtel G, La Greca R, Fretes O, Diaz M, Papini NR, Farias E, Issa C, Elbert A, Lehman R, Arya M, Singh B, Colquhoun D, Jayasinghe R, de Looze F, Blombery P, Ward G, Szto G, Abhayaratna W, Borges J, Russo L, Felicio J, Santos F, Guimaraes F, Castro ML, Rossi P, Armaganijan D, Leaes P, Bandeira F, Franken M, Rassi N, Rea R, Zanella M, Amodeo C, Cesar L, Betti R, Chacra A, Schmid H, Bell A, Syan G, Zadra R, Conter H, Dumas R, Borts D, Dattani I, Poirier P, Cha J, Dzongowski P, Labonte R, St Pierre B, Gaudet D, Kouz S, Lamy A, Tishler S, Chehayeb R, Bedard J, Hramiak I, Teitelbaum I, Fortin C, Woo V, Conway J, Mehta P, Robinson S, Sussex B, Chiasson J, Muirhead N, Bose S, Ouellet A, Yale J, Bhargava R, Lau D, Tobe S, Perron P, Sigalas J, Bilodeau L, Tytus R, Achyuthan G, Pearce M, Steele A, Bailey G, Ma P, St-Maurice F, Rupka D, Houlden R, Bailey A, Rewa G, Sohal P, Ting R, Prieto J, Rodriguez M, Godoy G, Larenas G, Pincetti C, Cobos L, Saavedra V, Varleta P, Lucero F, Kuzmanic O, Acevedo M, Aguirre M, Florenzano F, Ma J, Bao Y, Jiang M, Xu W, Shi Y, Zheng M, Li Y, Dong Y, Zhao W, Sun M, Lei M, Wang J, Pistek Z, Rihacek I, Kucera D, Brada M, Naplava R, Karasova J, Vlasicova H, Skopecek J, Spinarova L, Raclavska L, Sarbochova R, Okenka L, Racicka E, Urbancova K, Oznerova M, Lorenc Z, Wasserburger B, Zahumensky E, Grunfeldova H, Hradec J, Lukac M, Svacina S, Podzimek J, Hemzsky L, Mikulkova I, Pavlickova J, Brychta T, Chochola J, Couffinhal T, Elbaz M, Petit C, Faller B, Marechaud R, Moulin P, Fendri S, Nazeyrollas P, Wendisch U, Busch K, Klausmann G, Duengen H, Appel K, Toursarkissian N, Jung T, Ott P, Schenkenberger I, Kuesters D, Landers B, Nischik R, Fischer H, Tschoepe D, Paschen B, Krause K, Derwahl K, Wenzl-Bauer V, Hamann A, Strotmann H, Milek K, Mueller S, Chu D, Tan K, Kung K, Tsang C, Tomlinson B, Koranyi L, Kerenyi Z, Benczur B, Illyes L, Hidvegi T, Somogyi A, Valco J, Ferenczi S, Rapi J, Voros P, Winkler G, Sydo T, Hetey M, Simon K, Penzes J, Kempler P, Bako B, Lengyel Z, Witmann I, Dudas M, Vandorfi G, Takacs J, Matoltsy A, Ladanyi E, Gyimesi A, Sadikot S, Parikh K, Jain S, Yajnik C, Sosale A, Shamanna P, Srikanta S, Shah S, Srinivas A, Banker D, Shah P, Sharda A, Makkar B, Rais N, Mardikar H, Mishra A, Bhupati S, Menon J, Sathe S, Gupta R, Sharma V, Darawsha M, Herskovits T, Hamoud S, Nikolsky E, Adawi F, Zimlichman R, Tsalihin D, Wainstein J, Klainman E, Mosseri M, Yerushalmi Y, Karnieli E, Knobler H, Benchetrit S, Tsur A, Yagil Y, Atar S, Beberashvili I, Fuchs S, Stern N, Pollak A, Chajek-Shaul T, Rozenman Y, Biton A, Bramucci E, Fiscella A, Grassia V, Piatti P, De Cosmo S, Di Lorenzo L, Merlini P, Mannucci E, Frontoni S, Trevisan R, Zenari L, Lambiase C, Salvioni A, Silvestri O, Ambrosio G, Di Bartolo P, Fattore L, Presbitero P, Calabrese M, Evola R, Gamba MA, Ibarra MOD, Munoz EC, Sanchez DR, Herrera CH, Rios JP, Llamas EB, Esperon GL, Cantu EG, Fragoso JN, Gonzalez JG, Martinez GR, Padilla FP, Mier GM, Marmolejo DH, Ruiz JG, Portilla NC, Rosas EL, Machado GM, Ramos JC, Briones IR, van Hessen MWJ, Strikwerda S, The SHK, Kooy A, Ronner E, Nierop PR, Remmen JJ, Groenemeijer BE, Hamer BJB, Basart DCG, van Lennep HWOR, Nieuwdorp M, van Dijk MPM, Kentgens S, van Kempen WW, Hoogendijk J, Spiering W, Voors-Pette C, Kose V, de Waard DEP, Gonkel F, Kaasjager HAH, Lingan GMR, Agous I, Kruik HJ, Imholz BPM, Pieterse M, Manrique H, Villena J, Leon L, Kundert K, Minchola J, Pinto M, Heredia J, Rodriguez A, Guerreros C, Berrospi P, Zubiate C, Allemant A, Arbanil H, Ponciano W, Calderon J, Lisson R, Segura L, Sidorowicz-Bialynicka A, Sciborski R, Fares I, Mader P, Skierkowska J, Stasinska T, Pomiecko W, Skorski M, Krzyzagorska E, Polaszewska-Muszynska M, Sowinski D, Strojek K, Rosinska-Migda J, Romanczuk P, Golebiowski G, Kubica J, Mazurek T, Wojnowski L, Pasternak D, Stachlewski P, Trzepla E, Bogdanowicz G, Uzunow A, Potakowska I, Miszczyszyn Z, Waszyrowski T, Smolenskaya O, Lukyanov Y, Vorokhobina N, Khalimov Y, Orlikova O, Rebrov A, Kukharchuk V, Boldueva S, Arkhipov M, Zhelninova T, Pavlysh E, Antsiferov M, Panov A, Pavlova M, Shustov S, Demchenko E, Galyavich A, Malakhina E, Semenova O, Kobalava Z, Kotova S, Gavrisheva I, Oschepkova E, Karpov Y, Sidorenko B, Kislyak O, Ametov A, Dreval A, Grineva E, Mkrtumyan A, Tyurina T, Sazonova O, Bonnici F, Ranjith N, Burgess L, Nortje H, Distiller L, Mitha I, Moore R, Conradie M, Horak A, Pillay S, Wellmann H, Berg E, Pillai P, Padayachee T, Corbett C, Makan H, Wing J, Vawda Z, Ebrahim I, Mitha E, Bhorat A, Fernandez JC, Munoz C, Cortada JB, Conde AC, Calvo C, Extremera BG, Delgado E, Masmiquel L, Puig JG, Parreno LD, Mauricio D, Redon J, Brito M, Lopez C, de la Morera JS, Linderfalk C, Larnefeldt H, Olsson A, Lonneborg L, Ekelund M, Samad B, Borgencrantz B, Nilsson J, Berglund O, Svensson M, Mooe T, Curiac D, Albin J, Angesjo E, Lannemyr O, Chiang C, Sheu W, Chen J, Tien K, Ueng K, Lai W, Yin W, Hung Y, Shyu K, Hou J, Lam H, Laothavorn P, Kuanprasert S, Khovidhunkit W, Benjasuratwong Y, Chotinaiwattarakul C, Mamanasiri S, Suraamornkul S, Pratipanawatr T, Nitiyanant W, Heller S, Ray K, Pieters R, Strang C, Bodalia B, Middleton A, Hall T, Chapman G, Calvert J, Reed R, Tam D, Butcher G, Jones N, Takhar A, Turner W, McNally D, Corey O, Chapman J, Mohr S, Edwards S, Bhatt D, Ocampo A, Kandath D, Aude Y, Ervin W, Savin V, Anderson R, Littlefield R, Oberoi M, Platt GE, Yazdani S, Mangoo-Karim R, Walder J, Gogia H, Chandrashekhar Y, Boccalandro F, Rogers W, Bilazarian S, Zieve F, Siage Y, O'Connor T, Mudaliar S, Nikas A, Giusti R, Glover R, Chilka S, French W, Roth E, Singh N, Christofferson R, Stich M, Dagogo-Jack S, Allison J, Zengotita GA, Ison R, Iteld B, Sulistio M, Gonzalez E, Gorman T, Hage-Korban E, Reddy R, Byars W, Antonishen M, Benjamin S, First B, Rosado J, Bruschetta H, Poling T, Rosendorff C, Kerstein HJ, Saba F, Willis J, Adams K, Vazquez EC, Ellison H, Kahn B, Kereiakes D, Powell S, Raskin P, Smith K, Varma S, Whittier F, Casanova R, Isserman S, Kaye W, McGuinn W, Bartkowiak A, Dworkin L, Labrador CA, Podlecki D, Popovtzer M, Aronoff S, Ballantyne C, Ortiz EG, Mora A, Pitts T, Reinhardt S, Soucie G, Wainwright W, Henson B, Sklaver N, Arakaki R, Brown J, Chalavarya G, Chochinov R, Dixon T, Kutner M, Perlman R, Raisinghani A, Salacata A, Awasty V, Elinoff V, George W, LaRochelle-Gryseels A, Mercado A, Miller G, Qureshi M, Steljes A, Wefald F, Wilson J, Chinn J, Chuang RB, Comulada-Rivera A, Hartman I, Narayan P, Pacheco T, Weiss R, Beavins J, Creevy J, Hamroff G, Hodson R, Kosinski E, Krichmar P, Patel R, Schneider R, Shapiro J, Sharp D, Speer J, Stegemoller R, Waxman F, Chang FY, Braun E, Eder F, Minor S, Albert M, Carr KW, Diaczok B, Gastman I, Gupta V, Longshaw K, Gonzalez-Campoy JM, Raikhel M, Thomas J, Wood K, Diab I, Furda J, Gelernt M, Halter M, House B, Kaster S, Raad G, Stamatin R, Barker B, Blonder R, Bloomberg RJ, Calderon RB, Carrol A, Comerota A, Feinglos M, Henderson D, Kastelic R, Stonesifer LD, Talano J, Lee PV, Brosseau J, Clark W, Cohen E, Fialkow J, Horton K, Kozman H, McGill J, Mihills C, Poonawala R, Shore K, Tejada L, Torres R, Wright W, Calatayud G, Chandna H, Drozdiak R, Fink R, Gill R, Glandt M, Gottlieb DW, Hack T, Kay J, Mansouri V, McKnight T, Mostel E, Schmidt L, Seide H, Sonel E, Taylor R, Velasquez M, Bretton E, Feldman R, Hartman A, Hershon K, Leach CR, Martin E, Mohiuddin F, Naygandhi Y, Riske T, Schima S, Uzoaga ER, Ward H, Weinstock R, Williams T, Altschuller A, Aoki T, Blumenthal S, Cash A, Eisner G, Gutmann J, Hagan M, Kabour A, Markus T, McKenzie W, Moursi M, Mystkowski P, Ovalle F, Perkins R, Popeil L, Saniuk R, Sierra Y, Alvarado O, Anderson J, Bajaj M, Blank R, Chu A, Levinsky L, Levy P, Osborne J, Pavon H, Sanderlin D, Schaer G, Zarich S, Atassi K, Bayron C, Casagrande M, Das D, Gimness M, Handel F, Kinstrey T, Leu S, Osei K, Nouel JS, Soltani Z, Sussman H, Chiu K, Duda R, Farnsworth K, Lano M, Lee F, Levin P, Pratt S, Richwine R, Ruiz-Rivera L, Turner J, Wood J, Zigrang WD, Baquerizo HR, Colon CB, Demattia J, Desai V, Fitz-Patrick D, Goral S, Odhav A, Prentiss A, Ruff C, Wu W, Wyne K, Abbott LG, Applegate R, Cabral J, Kotha P, Ortega P, Simmons D, General Internal Medicine, Vascular Medicine, Other departments, Scirica, B, Bhatt, D, Braunwald, E, Steg, P, Davidson, J, Hirshberg, B, Ohman, P, Frederich, R, Wiviott, S, Hoffman, E, Cavender, M, Udell, J, Desai, N, Mosenzon, O, Mcguire, D, Ray, K, Leiter, L, Raz, I, Abrahamsen, T, Grossman, M, Morin, S, Im, K, Gabovitch, D, Pricken, A, Buskila, A, Stahre, C, Price, D, Billing-Clason, S, Sabel, K, 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Maffei, L, Bartolacci, I, Montana, O, Cutuli, H, Berli, M, Lorenzatti, A, Frechtel, G, La Greca, R, Fretes, O, Diaz, M, Papini, N, Farias, E, Issa, C, Elbert, A, Lehman, R, Arya, M, Singh, B, Colquhoun, D, Jayasinghe, R, de Looze, F, Blombery, P, Ward, G, Szto, G, Abhayaratna, W, Borges, J, Russo, L, Felicio, J, Santos, F, Guimaraes, F, Castro, M, Rossi, P, Armaganijan, D, Leaes, P, Bandeira, F, Franken, M, Rassi, N, Rea, R, Zanella, M, Amodeo, C, Cesar, L, Betti, R, Chacra, A, Schmid, H, Bell, A, Syan, G, Zadra, R, Conter, H, Dumas, R, Borts, D, Dattani, I, Poirier, P, Cha, J, Dzongowski, P, Labonte, R, St Pierre, B, Gaudet, D, Kouz, S, Lamy, A, Tishler, S, Chehayeb, R, Bedard, J, Hramiak, I, Teitelbaum, I, Fortin, C, Woo, V, Conway, J, Mehta, P, Robinson, S, Sussex, B, Chiasson, J, Muirhead, N, Bose, S, Ouellet, A, Yale, J, Bhargava, R, Lau, D, Tobe, S, Perron, P, Sigalas, J, Bilodeau, L, Tytus, R, Achyuthan, G, Pearce, M, Steele, A, Bailey, G, Ma, P, St-Maurice, F, Rupka, D, Houlden, R, Bailey, A, Rewa, G, Sohal, P, Ting, R, Prieto, J, Rodriguez, M, Godoy, G, Larenas, G, Pincetti, C, Cobos, L, Saavedra, V, Varleta, P, Lucero, F, Kuzmanic, O, Acevedo, M, Aguirre, M, Florenzano, F, Ma, J, Bao, Y, Jiang, M, Xu, W, Shi, Y, Zheng, M, Li, Y, Dong, Y, Zhao, W, Sun, M, Lei, M, Wang, J, Pistek, Z, Rihacek, I, Kucera, D, Brada, M, Naplava, R, Karasova, J, Vlasicova, H, Skopecek, J, Spinarova, L, Raclavska, L, Sarbochova, R, Okenka, L, Racicka, E, Urbancova, K, Oznerova, M, Lorenc, Z, Wasserburger, B, Zahumensky, E, Grunfeldova, H, Hradec, J, Lukac, M, Svacina, S, Podzimek, J, Hemzsky, L, Mikulkova, I, Pavlickova, J, Brychta, T, Chochola, J, Couffinhal, T, Elbaz, M, Petit, C, Faller, B, Marechaud, R, Moulin, P, Fendri, S, Nazeyrollas, P, Wendisch, U, Busch, K, Klausmann, G, Duengen, H, Appel, K, Toursarkissian, N, Jung, T, Ott, P, Schenkenberger, I, Kuesters, D, Landers, B, Nischik, R, Fischer, H, Tschoepe, D, Paschen, B, Krause, K, Derwahl, K, Wenzl-Bauer, V, Hamann, A, Strotmann, H, Milek, K, Mueller, S, Chu, D, Tan, K, Kung, K, Tsang, C, Tomlinson, B, Koranyi, L, Kerenyi, Z, Benczur, B, Illyes, L, Hidvegi, T, Somogyi, A, Valco, J, Ferenczi, S, Rapi, J, Voros, P, Winkler, G, Sydo, T, Hetey, M, Simon, K, Penzes, J, Kempler, P, Bako, B, Lengyel, Z, Witmann, I, Dudas, M, Vandorfi, G, Takacs, J, Matoltsy, A, Ladanyi, E, Gyimesi, A, Sadikot, S, Parikh, K, Jain, S, Yajnik, C, Sosale, A, Shamanna, P, Srikanta, S, Shah, S, Srinivas, A, Banker, D, Shah, P, Sharda, A, Makkar, B, Rais, N, Mardikar, H, Mishra, A, Bhupati, S, Menon, J, Sathe, S, Gupta, R, Sharma, V, Darawsha, M, Herskovits, T, Hamoud, S, Nikolsky, E, Adawi, F, Zimlichman, R, Tsalihin, D, Wainstein, J, Klainman, E, Mosseri, M, Yerushalmi, Y, Karnieli, E, Knobler, H, Benchetrit, S, Tsur, A, Yagil, Y, Atar, S, Beberashvili, I, Fuchs, S, Stern, N, Pollak, A, Chajek-Shaul, T, Rozenman, Y, Biton, A, Bramucci, E, Fiscella, A, Grassia, V, Piatti, P, De Cosmo, S, Di Lorenzo, L, Merlini, P, Mannucci, E, Frontoni, S, Trevisan, R, Zenari, L, Lambiase, C, Salvioni, A, Silvestri, O, Ambrosio, G, Di Bartolo, P, Fattore, L, Presbitero, P, Calabrese, M, Evola, R, Gamba, M, Ibarra, M, Munoz, E, Sanchez, D, Herrera, C, Rios, J, Llamas, E, Esperon, G, Cantu, E, Fragoso, J, Gonzalez, J, Martinez, G, Padilla, F, Mier, G, Marmolejo, D, Ruiz, J, Portilla, N, Rosas, E, Machado, G, Ramos, J, Briones, I, van Hessen, M, Strikwerda, S, The, S, Kooy, A, Ronner, E, Nierop, P, Remmen, J, Groenemeijer, B, Hamer, B, Basart, D, van Lennep, H, Nieuwdorp, M, van Dijk, M, Kentgens, S, van Kempen, W, Hoogendijk, J, Spiering, W, Voors-Pette, C, Kose, V, de Waard, D, Gonkel, F, Kaasjager, H, Lingan, G, Agous, I, Kruik, H, Imholz, B, Pieterse, M, Manrique, H, Villena, J, Leon, L, Kundert, K, Minchola, J, Pinto, M, Heredia, J, Rodriguez, A, Guerreros, C, Berrospi, P, Zubiate, C, Allemant, A, Arbanil, H, Ponciano, W, Calderon, J, Lisson, R, Segura, L, Sidorowicz-Bialynicka, A, Sciborski, R, Fares, I, Mader, P, Skierkowska, J, Stasinska, T, Pomiecko, W, Skorski, M, Krzyzagorska, E, Polaszewska-Muszynska, M, Sowinski, D, Strojek, K, Rosinska-Migda, J, Romanczuk, P, Golebiowski, G, Kubica, J, Mazurek, T, Wojnowski, L, Pasternak, D, Stachlewski, P, Trzepla, E, Bogdanowicz, G, Uzunow, A, Potakowska, I, Miszczyszyn, Z, Waszyrowski, T, Smolenskaya, O, Lukyanov, Y, Vorokhobina, N, Khalimov, Y, Orlikova, O, Rebrov, A, Kukharchuk, V, Boldueva, S, Arkhipov, M, Zhelninova, T, Pavlysh, E, Antsiferov, M, Panov, A, Pavlova, M, Shustov, S, Demchenko, E, Galyavich, A, Malakhina, E, Semenova, O, Kobalava, Z, Kotova, S, Gavrisheva, I, Oschepkova, E, Karpov, Y, Sidorenko, B, Kislyak, O, Ametov, A, Dreval, A, Grineva, E, Mkrtumyan, A, Tyurina, T, Sazonova, O, Bonnici, F, Ranjith, N, Burgess, L, Nortje, H, Distiller, L, Mitha, I, Moore, R, Conradie, M, Horak, A, Pillay, S, Wellmann, H, Berg, E, Pillai, P, Padayachee, T, Corbett, C, Makan, H, Wing, J, Vawda, Z, Ebrahim, I, Mitha, E, Bhorat, A, Fernandez, J, Munoz, C, Cortada, J, Conde, A, Calvo, C, Extremera, B, Delgado, E, Masmiquel, L, Puig, J, Parreno, L, Mauricio, D, Redon, J, Brito, M, Lopez, C, de la Morera, J, Linderfalk, C, Larnefeldt, H, Olsson, A, Lonneborg, L, Ekelund, M, Samad, B, Borgencrantz, B, Nilsson, J, Berglund, O, Svensson, M, Mooe, T, Curiac, D, Albin, J, Angesjo, E, Lannemyr, O, Chen, J, Tien, K, Ueng, K, Lai, W, Yin, W, Hung, Y, Shyu, K, Hou, J, Lam, H, Laothavorn, P, Kuanprasert, S, Khovidhunkit, W, Benjasuratwong, Y, Chotinaiwattarakul, C, Mamanasiri, S, Suraamornkul, S, Pratipanawatr, T, Nitiyanant, W, Heller, S, Pieters, R, Strang, C, Bodalia, B, Middleton, A, Hall, T, Chapman, G, Calvert, J, Reed, R, Tam, D, Butcher, G, Jones, N, Takhar, A, Turner, W, Mcnally, D, Corey, O, Chapman, J, Mohr, S, Edwards, S, Ocampo, A, Kandath, D, Aude, Y, Ervin, W, Savin, V, Anderson, R, Littlefield, R, Oberoi, M, Platt, G, Yazdani, S, Mangoo-Karim, R, Walder, J, Gogia, H, Chandrashekhar, Y, Boccalandro, F, Rogers, W, Bilazarian, S, Zieve, F, Siage, Y, O'Connor, T, Mudaliar, S, Nikas, A, Giusti, R, Glover, R, Chilka, S, French, W, Roth, E, Singh, N, Christofferson, R, Stich, M, Dagogo-Jack, S, Allison, J, Zengotita, G, Ison, R, Iteld, B, Sulistio, M, Gonzalez, E, Gorman, T, Hage-Korban, E, Reddy, R, Byars, W, Antonishen, M, Benjamin, S, First, B, Rosado, J, Bruschetta, H, Poling, T, Rosendorff, C, Kerstein, H, Saba, F, Willis, J, Adams, K, Vazquez, E, Ellison, H, Kahn, B, Kereiakes, D, Powell, S, Raskin, P, Smith, K, Varma, S, Whittier, F, Casanova, R, Isserman, S, Kaye, W, Mcguinn, W, Bartkowiak, A, Dworkin, L, Labrador, C, Podlecki, D, Popovtzer, M, Aronoff, S, Ballantyne, C, Ortiz, E, Mora, A, Pitts, T, Reinhardt, S, Soucie, G, Wainwright, W, Henson, B, Sklaver, N, Arakaki, R, Brown, J, Chalavarya, G, Chochinov, R, Dixon, T, Kutner, M, Perlman, R, Raisinghani, A, Salacata, A, Awasty, V, Elinoff, V, George, W, LaRochelle-Gryseels, A, Mercado, A, Miller, G, Qureshi, M, Steljes, A, Wefald, F, Wilson, J, Chinn, J, Chuang, R, Comulada-Rivera, A, Hartman, I, Narayan, P, Pacheco, T, Weiss, R, Beavins, J, Creevy, J, Hamroff, G, Hodson, R, Kosinski, E, Krichmar, P, Patel, R, Schneider, R, Shapiro, J, Sharp, D, Speer, J, Stegemoller, R, Waxman, F, Chang, F, Braun, E, Eder, F, Minor, S, Albert, M, Carr, K, Diaczok, B, Gastman, I, Gupta, V, Longshaw, K, Gonzalez-Campoy, J, Raikhel, M, Thomas, J, Wood, K, Diab, I, Furda, J, Gelernt, M, Halter, M, House, B, Kaster, S, Raad, G, Stamatin, R, Barker, B, Blonder, R, Bloomberg, R, Calderon, R, Carrol, A, Comerota, A, Feinglos, M, Henderson, D, Kastelic, R, Stonesifer, L, Talano, J, Lee, P, Brosseau, J, Clark, W, Cohen, E, Fialkow, J, Horton, K, Kozman, H, Mcgill, J, Mihills, C, Poonawala, R, Shore, K, Tejada, L, Torres, R, Wright, W, Calatayud, G, Chandna, H, Drozdiak, R, Fink, R, Gill, R, Glandt, M, Gottlieb, D, Hack, T, Kay, J, Mansouri, V, Mcknight, T, Mostel, E, Schmidt, L, Seide, H, Sonel, E, Taylor, R, Velasquez, M, Bretton, E, Feldman, R, Hartman, A, Hershon, K, Leach, C, Martin, E, Mohiuddin, F, Naygandhi, Y, Riske, T, Schima, S, Uzoaga, E, Ward, H, Weinstock, R, Williams, T, Altschuller, A, Aoki, T, Blumenthal, S, Cash, A, Eisner, G, Gutmann, J, Hagan, M, Kabour, A, Markus, T, Mckenzie, W, Moursi, M, Mystkowski, P, Ovalle, F, Perkins, R, Popeil, L, Saniuk, R, Sierra, Y, Alvarado, O, Anderson, J, Bajaj, M, Blank, R, Chu, A, Levinsky, L, Levy, P, Osborne, J, Pavon, H, Sanderlin, D, Schaer, G, Zarich, S, Atassi, K, Bayron, C, Casagrande, M, Das, D, Gimness, M, Handel, F, Kinstrey, T, Leu, S, Osei, K, Nouel, J, Soltani, Z, Sussman, H, Chiu, K, Duda, R, Farnsworth, K, Lano, M, Lee, F, Levin, P, Pratt, S, Richwine, R, Ruiz-Rivera, L, Turner, J, Wood, J, Zigrang, W, Baquerizo, H, Colon, C, Demattia, J, Desai, V, Fitz-Patrick, D, Goral, S, Odhav, A, Prentiss, A, Ruff, C, Wu, W, Wyne, K, Abbott, L, Applegate, R, Cabral, J, Kotha, P, Ortega, P, and Simmons, D
Subjects: Male, Adamantane, Dipeptidyl peptidase-4 inhibitor, Type 2 diabetes, Kaplan-Meier Estimate, Saxagliptin, chemistry.chemical_compound, 80 and over, glucose, saxagliptin, Aged, 80 and over, Medicine (all), Hazard ratio, 11 Medical And Health Sciences, General Medicine, Dipeptides, Middle Aged, Hospitalization, Cardiovascular Diseases, Female, Aged, Diabetes Mellitus, Type 2, Dipeptidyl-Peptidase IV Inhibitors, Double-Blind Method, Heart Failure, Humans, Hypoglycemia, Hypoglycemic Agents, Pancreatitis, Alogliptin, Type 2, medicine.drug, insulin, medicine.medical_specialty, General & Internal Medicine, Internal medicine, Diabetes mellitus, medicine, Empagliflozin, Diabetes Mellitus, Intensive care medicine, glycosylated hemoglobin, business.industry, Semaglutide, SAVOR-TIMI 53 Steering Committee and Investigators, medicine.disease, chemistry, placebo, business
Abstract: BACKGROUND: The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P
Published: 2013

7. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction

Author: Bonaca, MP, Bhatt, DL, Cohen, M, Steg, PG, Storey, RF, Jensen, EC, Magnani, G, Bansilal, S, Fish, MP, Im, K, Bengtsson, O, Ophuis, TO, Budaj, A, Theroux, P, Ruda, M, Hamm, C, Goto, S, Spinar, J, Nicolau, JC, Kiss, RG, Murphy, SA, Wiviott, SD, Held, P, Braunwald, E, Sabatine, MS, Morin, S, Dantzer, E, Acquilano, D, McGuire, RL, Gannon, JB, Gershman, E, Ahlbom, AM, Boberg, B, Abola, MT, Ardissino, D, Aylward, P, Corbalan, R, Dalby, A, Diaz, R, Hu, DY, Isaza, D, Kamensky, G, Kiss, R, Kontny, F, Lopez-Sendon, J, Medina, F, Montalescot, G, Nicolau, J, Paolasso, E, Parkhomenko, A, Van De Werf, F, Anderson, JL, White, HD, Verheugt, FWA, Pedersen, TR, DeMets, DL, Lowe, C, Arevalo, C, Awtry, E, Berger, C, Croce, K, Desai, A, Gelfand, E, Ho, C, Leeman, D, Link, M, Norden, A, Pande, A, Rost, N, Ruberg, F, Silverman, S, Singhal, A, Vita, J, Alvarisqueta, A, De Gennaro, N, Berli, M, Roude, AE, Di Gennaro, JA, Albisu, JF, Caccavo, A, Torres, M, Cuadrado, J, Bordoni, P, Cuello, J, Aviles, A, Glenny, A, Recoaro, R, Fernandez, R, Strada, BN, Fuentealba, V, Gallo, C, Duran, RG, Garcia, C, Hominal, M, Castoldi, M, Jure, H, Pacora, FF, Lorenzatti, A, Martinez, JM, Macin, S, Cocco, N, MacKinnon, I, Bagnato, MB, Marino, J, Cusimano, S, Arias, V, Focaccia, M, Muntaner, J, Mansilla, V, Poy, C, Prado, A, Paterlini, G, Montana, O, Camino, A, Sala, J, Luciani, C, Vico, M, Morell, Y, Dumont, C, Vottero, E, Zangroniz, P, Lescano, A, Morara, P, Marquez, LL, Patron, FR, Labarta, GB, Sivila, CD, Quiroga, AR, Maffei, L, Sassone, S, Rolandi, F, Vesentini, N, Carnero, G, Del Verme, S, Hershson, A, Figal, JC, Viso, ME, Hii, C, Smith, K, Singh, B, Acampo, M, Rogers, J, ODonoghue, M, Amerena, J, Long, A, Dart, A, Kay, S, Worthley, M, Nimmo, J, Lehman, R, Morrison, H, Dick, R, Savage, C, van Gaal, W, Park, M, Blombery, P, McCarthy, C, Oqueli, E, Hill, D, Sader, M, Vrachas, D, Purnell, P, Vibert, J, Collins, N, Gordon, A, Arstall, M, Rose, J, Aroney, C, Cleave, P, Fitzpatrick, M, Mackenzie, M, 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Pogurelska, O, Sirenko, Y, Rekovets, O, Kraiz, I, Kamenska, E, Tseluyko, V, Yakovleva, L, Yena, L, Artemenko, V, Koval, O, Kaplan, P, Karpenko, O, Nevolina, I, Bazilevych, A, Harbar, M, Rudenko, L, Beregova, O, Mostovyi, Y, Rasputina, L, Vatutin, M, Shevelok, A, Kovalenko, V, Polenova, N, Amosova, K, Tkachenko, L, Volkov, V, Zaprovalna, O, Storey, R, Thomas, M, Pell, A, Moriarty, A, Kinnin, M, Ahsan, A, Burton, J, ORourke, B, Young, J, Lang, C, Forbes, J, Rowlands, D, Hamill, S, Sprigings, D, Cadd, A, de Belder, M, Atkinson, B, Ramsey, M, Fagan, JC, Pye, M, Wright, L, Keeling, P, Hughes, D, Fraser, D, Phillips, H, Muthusamy, R, Lawan, M, Levy, T, Kennard, S, Bodalia, B, Mottram, J, Calvert, J, Brodie, K, Gunstone, A, Douglas, C, Trouton, T, Hunter, B, Gerber, R, Pepper, H, Mathur, A, Andiapen, M, Baumbach, A, Bowles, R, Hildick-Smith, D, McGregor, A, Loh, I, Plocky, J, Adams, K, Clemmer, K, Aggarwal, K, Burkhardt, V, Costa, M, Lemmertz, K, Anderson, J, York, T, Angiolillo, D, Green, E, Sperling, M, Vasquez, E, Aycock, G, Tatum, D, Amin, J, Davidson, A, Hendrix, E, Shepard, L, Strain, J, Michel, K, Talano, J, Szalanski, N, Berk, M, Ibarra, M, Bhagwat, R, Winterrowd, D, Bilazarian, S, Marsters, M, Blonder, R, Graf, L, Brilakis, E, Roesle, M, Byrd, L, Sullivan, A, Longo, J, Pennella, A, Westerhausen, D, Weil, R, Carr, K, Piazza, J, Carr, KW, Castello, R, Hawks, M, Chandna, H, Holly, D, Chandrashekhar, YS, Molinaro, N, Carter, M, Antonino, M, Kosmicki, D, Kelley, M, Richwine, R, Pazier, P, Glasgow, B, Bresee, S, Alexander, J, Concha, M, Martinez, E, Connelly, T, Schenks, R, Cooper, M, Garman, V, Condit, J, White, A, Fialkow, J, Mckercher, M, Luna, M, Soto, G, Prodafikas, J, Rambaud, B, Donovan, J, Mudd, D, Doty, W, Parsons, T, D'Urso, M, Bies, J, Han, J, Treadwell, M, Erickson, B, Dahl, P, Fattal, P, Braem, J, Felten, W, Prior, J, French, W, Barillas, O, Berger, R, Genova, E, Gelernt, M, Cockrell, D, Miller, G, Dumka, K, Gill, S, Elliot, S, Goldberg, R, Barrett, M, Gordon, P, Stern, L, Ayres, T, Rhule, V, Gupta, D, Holton, T, Haddad, T, Jain, J, Hakas, J, McSorley, J, Hamroff, G, Hollenweger, L, Wainwright, W, Jones, S, Casagrande, M, Casagrande, MG, Effat, M, Mardis, R, Henderson, D, Millard, D, Hermany, P, Meissner-Dengler, S, Hinchman, D, Luck, K, Hodson, R, Severson, L, Horwitz, P, Miller, K, Isserman, S, Moore, C, Jan, M, Bilyk, O, Kersh, R, DaCosta, A, Kim, E, Gonzales, C, Kmetzo, J, Taylor, D, Knutson, T, Belanger, B, Hage-Korban, E, Harrington, A, Murdock, D, Heiman, M, Dandekar, U, Khan, M, Khan, G, Lui, H, Holman, L, MacDonald, L, Derbyshire, S, Watkins, K, Mayer, N, Mitchell, B, McCullum, K, Delio-Cox, B, Mckay, R, Cloutier, J, McKenzie, M, Rodkey, K, McLaurin, B, Lack, A, Minisi, A, Jeter, D, Mitchell, R, Keane-Richmond, P, Stine, R, Bullivant, M, Morford, R, White, J, Oberoi, M, Geraldo-Abache, A, O'Dea, D, Mehta, R, Tang, N, Ong, S, Edwards, M, Osborne, J, Alonzo, C, Lev, V, Monroe, J, Popeil, L, Sorrentino, N, Portelli, J, Landi, T, Potu, R, Smith, N, Prashad, R, McDonough, C, Qureshi, M, Howe, A, Raikhel, M, Arsate, M, Rogers, W, Saag, L, Sangrigoli, R, Schwarz, L, Abu-Fadel, M, Hagee, A, Kinnaman, S, McDaniel, V, Wilson, V, Purcell, T, Roberts, J, Riofrio, K, Shah, U, Narang, S, Gredler, F, Knap, P, Shanes, J, Hansen, C, Sharma, M, Gibson, T, Sheldon, W, Bohn, A, Siegel, C, Tibbits, L, Singh, V, Nelson, M, Singh, N, Logwood, D, Randhawa, P, Vargas, B, Stegemoller, R, Cole, B, Aggarwal, R, Johnson, M, Steinhoff, J, Dunaway, B, Patel, K, Boomer, L, Taheri, H, Morgan, K, Tahirkheli, N, Santos, A, Thadani, U, Alexander, D, Bennett, W, Kelley, E, Thomas, J, Macnicholas, D, Varma, S, Evans, S, Vlastaris, A, Bittel, B, Voyce, S, Mack, B, Weiss, R, Fournier, T, Whitney, R, Orosco, C, Willis, J, VonGerichten, S, Wiseman, A, Sharrow, A, Wohns, D, Schuitema, J, Amin, M, Ramus, A, Wilson, W, Moeller, C, Newell, M, Tindell, L, Rivera, W, Kwierant, J, Bretton, E, Corbin, B, Labroo, A, Lopez, C, Brown, C, Craig, M, Lucca, M, Keinanen, T, Eisenberg, S, Fielding, M, Doorey, A, Squire, A, Suresh, D, Frost, J, Teklinski, A, Stone, B, Waksman, R, Griffin, S, Wharton, W, Blakely, J, Fishbein, G, Weller, C, Camp, A, Fisher, S, Meholick, A, Hejna, E, Anderson, R, Long, S, Parikh, S, Norton, N, Vijay, N, Washam, M, Smith, S, and Stepanov, N
Abstract: BACKGROUND The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established. We investigated the efficacy and safety of ticagrelor, a P2Y(12) receptor antagonist with established efficacy after an acute coronary syndrome, in this context. METHODS We randomly assigned, in a double-blind 1: 1: 1 fashion, 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily, ticagrelor at a dose of 60 mg twice daily, or placebo. All the patients were to receive low-dose aspirin and were followed for a median of 33 months. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. RESULTS The two ticagrelor doses each reduced, as compared with placebo, the rate of the primary efficacy end point, with Kaplan-Meier rates at 3 years of 7.85% in the group that received 90 mg of ticagrelor twice daily, 7.77% in the group that received 60 mg of ticagrelor twice daily, and 9.04% in the placebo group (hazard ratio for 90 mg of ticagrelor vs. placebo, 0.85; 95% confidence interval [CI], 0.75 to 0.96; P = 0.008; hazard ratio for 60 mg of ticagrelor vs. placebo, 0.84; 95% CI, 0.74 to 0.95; P = 0.004). Rates of TIMI major bleeding were higher with ticagrelor (2.60% with 90 mg and 2.30% with 60 mg) than with placebo (1.06%) (P < 0.001 for each dose vs. placebo); the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63%, 0.71%, and 0.60%, respectively. CONCLUSIONS In patients with a myocardial infarction more than 1 year previously, treatment with ticagrelor significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke and increased the risk of major bleeding. (Funded by AstraZeneca; PEGASUS-TIMI 54 ClinicalTrials.gov number, NCT01225562.)
Published: 2015

8. Extended thromboprophylaxis with betrixaban in acutely ill medical patients

Author: Cohen, A. T., Harrington, R. A., Goldhaber, S. Z., Hull, R. D., Wiens, B. L., Gold, A., Hernandez, A. F., Gibson, C. M., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M., Canon, C., Lazcano, M., Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Vagic, J., Skerk, V., Cermak, O., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Tiefenbacher, C., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, Raffaele, Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Leon, R., Pereyra, R., Karlo, L., Horna, M., Osores, J., Salas, M., Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Sala, L. A., Lopez, C., Bisbe, J., Guardiola, A., Cepeda, J. M., Cereto, F., Santos, E., Ferrer, R., Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Davis, M., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Farley, B., Fermann, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Kabler, H., Kao, C. K., Kazimir, M., Koura, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., Zakai, N., Landolfi R. (ORCID:0000-0002-7913-8576), Cohen, A. T., Harrington, R. A., Goldhaber, S. Z., Hull, R. D., Wiens, B. L., Gold, A., Hernandez, A. F., Gibson, C. M., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M., Canon, C., Lazcano, M., Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Vagic, J., Skerk, V., Cermak, O., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Tiefenbacher, C., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, Raffaele, Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Leon, R., Pereyra, R., Karlo, L., Horna, M., Osores, J., Salas, M., Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Sala, L. A., Lopez, C., Bisbe, J., Guardiola, A., Cepeda, J. M., Cereto, F., Santos, E., Ferrer, R., Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Davis, M., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Farley, B., Fermann, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Kabler, H., Kao, C. K., Kazimir, M., Koura, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., Zakai, N., and Landolfi R. (ORCID:0000-0002-7913-8576)
Abstract: BACKGROUND: Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. METHODS: Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated D-dimer level (cohort 1), patients with an elevated D-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. RESULTS: A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P = 0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P = 0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P = 0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P = 0.55). CONCLUSIONS: Among acutely ill medical patients with an elevated D-dimer level, there was no
Published: 2016

9. Helping overweight patients can result in new patient boom.

Author: Valco J
Published: 2010

10. What message will bring you the most new patients?

Author: Valco J
Published: 2007

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10 results on '"Valco, J."'

1. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

2. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

3. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

4. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

5. Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

6. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus

7. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction

8. Extended thromboprophylaxis with betrixaban in acutely ill medical patients

9. Helping overweight patients can result in new patient boom.

10. What message will bring you the most new patients?

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