Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients
| Autor: | Goldhaber, Sz, Leizorovicz, A, Kakkar, A, Haas, Sk, Merli, G, Weitz, Ji, Ceresetto, Jm, Kyrle, P, Gallus, A, Cools, F, Saraiva, J, Faucher, Jp, Chlumsky, J, Husted, S, Emmerich, J, Bauersachs, R, Zeltser, D, Prandoni, Paolo, Ghiraduzzi, A, Leiva, J, Sparby, Ja, Torbiki, A, Kobalava, Z, Jacobson, B, Suarez, C, Fu, M, Savas, I, Parkhomenko, A, Ansell, J, Landis, Jr, Elliott, Cg, Borris, Lc, Samama, Mm, Pinede, L, Becker, F, Coppere, B, Nony, P, Merah, A, Alves, M, Boulet, H, Loppinet, A, Nicol, C, Ohanessian, L, Roncato, C, Knabb, Rm, Liaw, D, Smith, K, Hess, T, Rossi, L, Chen, D, Doan, C, Doran, J, Matheis, E, Ballard, M, Tsarova, O, Levenstein, S, Tvedegaard, M, Akkal, Z, Jure, H, Mercado, Da, Zangroniz, P, Constantino, M, Bello, F, Giumelli, C, de Sagastizabal, D, Risso Patron, F, Ceresetto, J, Dran, R, Vita, N, Baratta, S, Ahuad Guerrero, R, Penchasky, D, Rubinfeld, A, Layden, M, Karrasch, J, Coughlin, P, Peters, M, Gibbs, H, Ward, Ch, Hahn, U, Pilger, E, Minar, E, El Allaf, D, Marechal, P, Motte, S, Verhamme, P, Wollaert, B, Duck, L, Freire, A, Piegas, L, Jorge, Jm, Guimaraes, H, Oliveira, M, Blacher, C, Leães, P, Toniolo, J, Okoshi, M, Rosa, Dd, Cunha, C, Lobo, S, Leader, R, Dhar, A, Tarabain, O, Miron, M, Brossoit, R, Kahn, S, Kassis, J, Douketis, J, Spencer, F, Faucher, J, Alarcon, Ma, Gutierrez Valenzuela, F, Bisbal Malig, C, Vejar, M, Jaramillo, N, Saaibi, D, Londono, D, Kolman, P, Reiterer, P, Ballek, L, Spacek, R, Soucek, M, Patek, F, Vitovec, M, Kovarova, K, Ceska, R, Podpera, I, Faber, J, Oestergaard, L, Vejby Christensen, H, Frost, L, Rasmussen, Sl, Tuxen, C, Ingerslev, J, Knudsen, T, Torp Pedersen, C, Pedersen, C, Nielsen, H, Mottier, D, Simoneau, G, Leduc, J, Lorcerie, B, Paleiron, N, Proust, A, Conri, C, Pernod, G, Mismetti, P, Achkar, A, Maignan, M, Harenberg, J, Beyer, J, Horacek, T, Lawall, H, Hecker, U, Hammerstingl, C, Weil, J, Fischer, D, Brachmann, J, Klepzig, H, Cheng, G, Soltesz, P, Schnabel, R, Futo, L, Jobbagy, L, Singh, P, Talwar, D, Bhadade, R, Bharani, A, Krishnamurthy, S, Goyal, A, Mehta, P, Samiuddin, M, D'Souza, G, Sinha, S, Sathe, P, Sethuraman, S, Jaganmani, S, Sundaram, P, Saxena, A, Mehta, M, Omar, A, Rajkumar, J, Jog, S, Kumar, S, Hayek, T, Hussein, O, Lahav, M, Efrati, S, Elias, M, Grossman, E, Lugassy, G, Porath, A, Porreca, E, Prandoni, P, Tosetto, A, Imberti, D, Pierfranceschi, G, Ghirarduzzi, A, Scannapieco, G, Testa, S, Ling, P, Yusoff, K, Yusof, Z, Lopez Rosas, E, Hernandez, I, Nanez Terreros, H, Flota, L, Campos, E, Alcocer, M, Viergever, P, Sparby, J, Cotrina, R, Salas, M, Pamo, O, Fajardo, L, Horna, M, Ulloa, V, Toce, L, Moncada, Z, Salazar, O, Habaluyas, R, Collado, F, Edmilao, M, Abola, T, Sevilla, R, Torbicki, A, Tracz, W, Kasprzak, J, Jastrzebski, D, Psuja, P, Hiczkiewicz, J, Piepiorka, M, Pulkowski, G, Tyszkiewicz, I, Kuc, K, Gordeev, I, Boyarkin, M, Privalov, D, Abrosimov, V, Reshetko, O, Goloshchekin, B, Vishnevsky, A, Boldueva, S, Kostenko, V, Mkrtchian, V, Chernichka, I, Belenkov, Y, Rodoman, G, Andreev, D, Shvarts, Y, Aleksandrov, O, Zadionchenko, V, Klochkov, O, Tay, J, Jagadesan, R, Basson, M, Siebert, R, Viljoen, J, Gray, T, Abdool Gaffar, M, Suh, G, In, K, Choi, D, Kim, S, Baek, S, Chung, H, Shin, J, Alvarez Sala, L, Cepeda, J, Ferrer, M, Mallibovsky, L, Garcia Morillo, J, Villalta, J, Gomez Cerezo, J, Capitán, F, Gonzalez Garrido, F, Guijarro, C, Jimenez, D, Richart, C, Elf, J, Ueng, K, Huang, T, Karan, A, Erten, N, Abrahamovych, O, Chopey, I, Gavrysiuk, V, Kraiz, I, Karpenko, A, Volkov, V, Denesyuk, V, Kharchenko, N, Tseluyko, V, Batushkin, V, Sushko, V, Yagensky, A, Ignatenko, G, Dziublyk, O, Cohen, A, Bareford, D, Kesteven, P, Mccollum, P, Das, S, Conrad, S, Botnick, W, Nathanson, A, Hamad, A, Fraiz, J, Goytia Leos, D, Fulmer, J, Mclaren, G, Streiff, M, Hahn, B, Ardolic, B, Klausner, H, Welch, M, Pullman, J, Phillips, D, Felt, J, Mitchell, G, Margolis, B, Pendleton, R, Mahesh, A, Barney, J, Shadan, F, Schuller, D, Joslin, S, Feldman, J, Pearl, R, Welker, J, Hazelrigg, M, Stevens, S, Siegel, M, Meade, A, Bates, J, Tahirkheli, N, Rosenberg, D, Dishman, K, Ikerd, T, Feldman, G, O'Connell, C, Vaince, U, Dabbagh, O, Eyster, E, Weinstein, G, Ginsberg, R, Fine, J, Tillinghast, A, Alabi, F, Nathan, R, Haught, H, Oliver, M. |
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| Přispěvatelé: | Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Thrombosis Research Institute (AKK), University College of London [London] (UCL), Institute for Experimental Oncology and Therapy Research (IEOTR), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Jefferson Medical College (JMC), Thomas Jefferson University Hospitals, Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), 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) |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Male
MESH: Pulmonary Embolism Placebo-controlled study MESH: Hospitalization Kaplan-Meier Estimate 030204 cardiovascular system & hematology law.invention MESH: Venous Thromboembolism chemistry.chemical_compound 0302 clinical medicine MESH: Aged 80 and over Randomized controlled trial law Risk Factors MESH: Risk Factors Medicine MESH: Double-Blind Method 030212 general & internal medicine MESH: Treatment Outcome Aged 80 and over MESH: Aged MESH: Middle Aged General Medicine Orvostudományok Venous Thromboembolism Middle Aged 3. Good health Pulmonary embolism Hospitalization Treatment Outcome Acute Disease MESH: Acute Disease Apixaban Female Respiratory Insufficiency MESH: Hemorrhage medicine.drug Adult medicine.medical_specialty Randomization MESH: Enoxaparin Pyridones Medicina Hemorrhage MESH: Anticoagulants MESH: Drug Administration Schedule Klinikai orvostudományok Drug Administration Schedule 03 medical and health sciences Double-Blind Method Internal medicine MESH: Pyridones Humans Risk factor Enoxaparin MESH: Kaplan-Meier Estimate Aged Heart Failure MESH: Humans business.industry Anticoagulants MESH: Adult medicine.disease MESH: Male Surgery chemistry Relative risk Betrixaban MESH: Heart Failure Pyrazoles business Pulmonary Embolism MESH: Female MESH: Pyrazoles MESH: Respiratory Insufficiency [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2011, 365 (23), pp.2167-77. ⟨10.1056/NEJMoa1110899⟩ Biblos-e Archivo. Repositorio Institucional de la UAM instname Goldhaber, S Z, Leizorovicz, A, Kakkar, A K, Haas, S K, Merli, G, Knabb, R M, Weitz, J I, ADOPT Trial Investigators & Husted, S 2011, ' Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients ', Briefings from the New England Journal of Medicine, vol. 365, no. 23, pp. 2167-77 . https://doi.org/10.1056/NEJMoa1110899 Goldhaber, S Z, Leizorovicz, A, Kakkar, A K, Haas, S K, Merli, G, Knabb, R M, Weitz, J I, ADOPT Trial Investigators & Pedersen, C 2011, ' Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients ', Briefings from the New England Journal of Medicine, vol. 365, no. 23, pp. 2167-77 . https://doi.org/10.1056/NEJMoa1110899 |
| ISSN: | 0028-4793 1533-4406 |
| DOI: | 10.1056/NEJMoa1110899⟩ |
| Popis: | The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin. METHODS: In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated. RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome - 2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P = 0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P = 0.04). CONCLUSIONS: In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin Supported by Bristol-Myers Squibb and Pfizer |
| Databáze: | OpenAIRE |
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