-
1
-
-
77953787643
-
Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers
-
Ogata K, Mendell-Harary J, Tachibana M, Masumoto H, Oguma T, Kojima M, Kunitada S, Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010 50 743 753. doi: 10.1177/0091270009351883.
-
(2010)
J Clin Pharmacol
, vol.50
, pp. 743-753
-
-
Ogata, K.1
Mendell-Harary, J.2
Tachibana, M.3
Masumoto, H.4
Oguma, T.5
Kojima, M.6
Kunitada, S.7
-
2
-
-
84888362796
-
Edoxaban versus warfarin in patients with atrial fibrillation
-
ENGAGE AF-TIMI 48 Investigators
-
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM, ENGAGE AF-TIMI 48 Investigators Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013 369 2093 2104. doi: 10.1056/NEJMoa1310907.
-
(2013)
N Engl J Med
, vol.369
, pp. 2093-2104
-
-
Giugliano, R.P.1
Ruff, C.T.2
Braunwald, E.3
Murphy, S.A.4
Wiviott, S.D.5
Halperin, J.L.6
Waldo, A.L.7
Ezekowitz, M.D.8
Weitz, J.I.9
Špinar, J.10
Ruzyllo, W.11
Ruda, M.12
Koretsune, Y.13
Betcher, J.14
Shi, M.15
Grip, L.T.16
Patel, S.P.17
Patel, I.18
Hanyok, J.J.19
Mercuri, M.20
Antman, E.M.21
more..
-
3
-
-
85028458354
-
-
US Food and Drug Administration Accessed January 27, 2016
-
US Food and Drug Administration. Prescribing information for Savaysa (edoxaban) 2015. http://www.accessdata.fda.gov/drugsatfda-docs/label/2015/206316lbl.pdf. Accessed January 27, 2016.
-
(2015)
Prescribing Information for Savaysa (Edoxaban)
-
-
-
4
-
-
84977277398
-
-
product information. Accessed January 28, 2016
-
Lixiana: EPAR-product information 2015. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/002629/WC500189045.pdf. Accessed January 28, 2016
-
(2015)
Lixiana: EPAR
-
-
-
5
-
-
84860526602
-
Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation
-
Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S, Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost 2012 107 925 936. doi: 10.1160/TH11-08-0566.
-
(2012)
Thromb Haemost
, vol.107
, pp. 925-936
-
-
Salazar, D.E.1
Mendell, J.2
Kastrissios, H.3
Green, M.4
Carrothers, T.J.5
Song, S.6
Patel, I.7
Bocanegra, T.S.8
Antman, E.M.9
Giugliano, R.P.10
Kunitada, S.11
Dornseif, B.12
Shi, M.13
Tachibana, M.14
Zhou, S.15
Rohatagi, S.16
-
6
-
-
77957932391
-
Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis in Myocardial Infarction study 48 (ENGAGE AF-TIMI 48)
-
Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E, Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J 2010 160 635 641. doi: 10.1016/j.ahj.2010.06.042.
-
(2010)
Am Heart J
, vol.160
, pp. 635-641
-
-
Ruff, C.T.1
Giugliano, R.P.2
Antman, E.M.3
Crugnale, S.E.4
Bocanegra, T.5
Mercuri, M.6
Hanyok, J.7
Patel, I.8
Shi, M.9
Salazar, D.10
McCabe, C.H.11
Braunwald, E.12
-
7
-
-
23044505564
-
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
-
Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis
-
Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005 3 692 694. doi: 10.1111/j.1538-7836.2005.01204.x.
-
(2005)
J Thromb Haemost
, vol.3
, pp. 692-694
-
-
Schulman, S.1
Kearon, C.2
-
8
-
-
69849100157
-
The net clinical benefit of warfarin anticoagulation in atrial fibrillation
-
Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, Go AS, The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med 2009 151 297 305
-
(2009)
Ann Intern Med
, vol.151
, pp. 297-305
-
-
Singer, D.E.1
Chang, Y.2
Fang, M.C.3
Borowsky, L.H.4
Pomernacki, N.K.5
Udaltsova, N.6
Go, A.S.7
-
9
-
-
0141455302
-
A comparison of prediction equations for estimating glomerular filtration rate in adults without kidney disease
-
Lin J, Knight EL, Hogan ML, Singh AK, A comparison of prediction equations for estimating glomerular filtration rate in adults without kidney disease. J Am Soc Nephrol 2003 14 2573 2580
-
(2003)
J Am Soc Nephrol
, vol.14
, pp. 2573-2580
-
-
Lin, J.1
Knight, E.L.2
Hogan, M.L.3
Singh, A.K.4
-
10
-
-
65649142017
-
A new equation to estimate glomerular filtration rate
-
CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
-
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J, CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) A new equation to estimate glomerular filtration rate. Ann Intern Med 2009 150 604 612
-
(2009)
Ann Intern Med
, vol.150
, pp. 604-612
-
-
Levey, A.S.1
Stevens, L.A.2
Schmid, C.H.3
Zhang, Y.L.4
Castro, A.F.5
Feldman, H.I.6
Kusek, J.W.7
Eggers, P.8
Van Lente, F.9
Greene, T.10
Coresh, J.11
-
11
-
-
84896117299
-
Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-Analysis of randomised trials
-
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM, Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-Analysis of randomised trials. Lancet 2014 383 955 962. doi: 10.1016/S0140-6736(13)62343-0.
-
(2014)
Lancet
, vol.383
, pp. 955-962
-
-
Ruff, C.T.1
Giugliano, R.P.2
Braunwald, E.3
Hoffman, E.B.4
Deenadayalu, N.5
Ezekowitz, M.D.6
Camm, A.J.7
Weitz, J.I.8
Lewis, B.S.9
Parkhomenko, A.10
Yamashita, T.11
Antman, E.M.12
-
12
-
-
79959966844
-
Chronic kidney disease is associated with the incidence of atrial fibrillation: The Atherosclerosis Risk in Communities (ARIC) study
-
Alonso A, Lopez FL, Matsushita K, Loehr LR, Agarwal SK, Chen LY, Soliman EZ, Astor BC, Coresh J, Chronic kidney disease is associated with the incidence of atrial fibrillation: the Atherosclerosis Risk in Communities (ARIC) study. Circulation 2011 123 2946 2953. doi: 10.1161/CIRCULATIONAHA.111.020982.
-
(2011)
Circulation
, vol.123
, pp. 2946-2953
-
-
Alonso, A.1
Lopez, F.L.2
Matsushita, K.3
Loehr, L.R.4
Agarwal, S.K.5
Chen, L.Y.6
Soliman, E.Z.7
Astor, B.C.8
Coresh, J.9
-
13
-
-
84871970168
-
Impact of chronic kidney disease on risk of incident atrial fibrillation and subsequent survival in Medicare patients
-
Nelson SE, Shroff GR, Li S, Herzog CA, Impact of chronic kidney disease on risk of incident atrial fibrillation and subsequent survival in Medicare patients. J Am Heart Assoc 2012 1 e002097. doi: 10.1161/JAHA.112.002097.
-
(2012)
J Am Heart Assoc
, vol.1
, pp. e002097
-
-
Nelson, S.E.1
Shroff, G.R.2
Li, S.3
Herzog, C.A.4
-
14
-
-
84873569337
-
Incident atrial fibrillation and risk of end-stage renal disease in adults with chronic kidney disease
-
Bansal N, Fan D, Hsu CY, Ordonez JD, Marcus GM, Go AS, Incident atrial fibrillation and risk of end-stage renal disease in adults with chronic kidney disease. Circulation 2013 127 569 574. doi: 10.1161/CIRCULATIONAHA.112.123992.
-
(2013)
Circulation
, vol.127
, pp. 569-574
-
-
Bansal, N.1
Fan, D.2
Hsu, C.Y.3
Ordonez, J.D.4
Marcus, G.M.5
Go, A.S.6
-
15
-
-
77955872745
-
A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: The Euro Heart Survey
-
Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY, A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010 138 1093 1100. doi: 10.1378/chest.10-0134.
-
(2010)
Chest
, vol.138
, pp. 1093-1100
-
-
Pisters, R.1
Lane, D.A.2
Nieuwlaat, R.3
De Vos, C.B.4
Crijns, H.J.5
Lip, G.Y.6
-
16
-
-
84865041123
-
Stroke and bleeding in atrial fibrillation with chronic kidney disease
-
Olesen JB, Lip GY, Kamper AL, Hommel K, Køber L, Lane DA, Lindhardsen J, Gislason GH, Torp-Pedersen C, Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med 2012 367 625 635. doi: 10.1056/NEJMoa1105594.
-
(2012)
N Engl J Med
, vol.367
, pp. 625-635
-
-
Olesen, J.B.1
Lip, G.Y.2
Kamper, A.L.3
Hommel, K.4
Køber, L.5
Lane, D.A.6
Lindhardsen, J.7
Gislason, G.H.8
Torp-Pedersen, C.9
-
17
-
-
84872345697
-
Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Validation of the R(2)CHADS(2) index in the ROCKET AF
-
ROCKET AF Steering Committee and Investigators (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with Vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors in Atrial fibrillation) study cohorts
-
Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM, ROCKET AF Steering Committee and Investigators Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation 2013 127 224 232. doi: 10.1161/CIRCULATIONAHA.112.107128.
-
(2013)
Circulation
, vol.127
, pp. 224-232
-
-
Piccini, J.P.1
Stevens, S.R.2
Chang, Y.3
Singer, D.E.4
Lokhnygina, Y.5
Go, A.S.6
Patel, M.R.7
Mahaffey, K.W.8
Halperin, J.L.9
Breithardt, G.10
Hankey, G.J.11
Hacke, W.12
Becker, R.C.13
Nessel, C.C.14
Fox, K.A.15
Califf, R.M.16
-
18
-
-
84925689998
-
Anticoagulation therapy: Balancing the risks of stroke and bleeding in CKD
-
Qamar A, Bhatt DL, Anticoagulation therapy: balancing the risks of stroke and bleeding in CKD. Nat Rev Nephrol 2015 11 200 202. doi: 10.1038/nrneph.2015.14.
-
(2015)
Nat Rev Nephrol
, vol.11
, pp. 200-202
-
-
Qamar, A.1
Bhatt, D.L.2
-
19
-
-
84895433109
-
Warfarin, kidney dysfunction, and outcomes following acute myocardial infarction in patients with atrial fibrillation
-
Carrero JJ, Evans M, Szummer K, Spaak J, Lindhagen L, Edfors R, Stenvinkel P, Jacobson SH, Jernberg T, Warfarin, kidney dysfunction, and outcomes following acute myocardial infarction in patients with atrial fibrillation. JAMA 2014 311 919 928. doi: 10.1001/jama.2014.1334.
-
(2014)
JAMA
, vol.311
, pp. 919-928
-
-
Carrero, J.J.1
Evans, M.2
Szummer, K.3
Spaak, J.4
Lindhagen, L.5
Edfors, R.6
Stenvinkel, P.7
Jacobson, S.H.8
Jernberg, T.9
-
20
-
-
84946208087
-
Updated European heart rhythm association practical guide on the use of non-Vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation
-
Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P, Updated European Heart Rhythm Association practical guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 2015 17 1467 1507. doi: 10.1093/europace/euv309.
-
(2015)
Europace
, vol.17
, pp. 1467-1507
-
-
Heidbuchel, H.1
Verhamme, P.2
Alings, M.3
Antz, M.4
Diener, H.C.5
Hacke, W.6
Oldgren, J.7
Sinnaeve, P.8
Camm, A.J.9
Kirchhof, P.10
-
21
-
-
84916931073
-
2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: Executive summary: A report of the American College of cardiology/American Heart Association task force on practice guidelines and the heart rhythm society
-
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW, 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation 2014 130 2071 2104. doi: 10.1161/CIR.0000000000000040.
-
(2014)
Circulation
, vol.130
, pp. 2071-2104
-
-
January, C.T.1
Wann, L.S.2
Alpert, J.S.3
Calkins, H.4
Cigarroa, J.E.5
Cleveland, J.C.6
Conti, J.B.7
Ellinor, P.T.8
Ezekowitz, M.D.9
Field, M.E.10
Murray, K.T.11
Sacco, R.L.12
Stevenson, W.G.13
Tchou, P.J.14
Tracy, C.M.15
Yancy, C.W.16
-
22
-
-
84861725443
-
Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: The Swedish Atrial Fibrillation cohort study
-
Friberg L, Rosenqvist M, Lip GY, Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J 2012 33 1500 1510. doi: 10.1093/eurheartj/ehr488.
-
(2012)
Eur Heart J
, vol.33
, pp. 1500-1510
-
-
Friberg, L.1
Rosenqvist, M.2
Lip, G.Y.3
-
23
-
-
84934289246
-
Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: An analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial
-
Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM, Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet 2015 385 2288 2295. doi: 10.1016/S0140-6736(14)61943-7.
-
(2015)
Lancet
, vol.385
, pp. 2288-2295
-
-
Ruff, C.T.1
Giugliano, R.P.2
Braunwald, E.3
Morrow, D.A.4
Murphy, S.A.5
Kuder, J.F.6
Deenadayalu, N.7
Jarolim, P.8
Betcher, J.9
Shi, M.10
Brown, K.11
Patel, I.12
Mercuri, M.13
Antman, E.M.14
-
24
-
-
84895546812
-
Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: A RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial analysis
-
Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Siegbahn A, Yusuf S, Wallentin L, Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: a RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial analysis. Circulation 2014 129 961 970. doi: 10.1161/CIRCULATIONAHA.113.003628.
-
(2014)
Circulation
, vol.129
, pp. 961-970
-
-
Hijazi, Z.1
Hohnloser, S.H.2
Oldgren, J.3
Andersson, U.4
Connolly, S.J.5
Eikelboom, J.W.6
Ezekowitz, M.D.7
Reilly, P.A.8
Siegbahn, A.9
Yusuf, S.10
Wallentin, L.11
-
25
-
-
84869100588
-
Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: Insights from the Aristotle trial
-
Hohnloser SH, Hijazi Z, Thomas L, Alexander JH, Amerena J, Hanna M, Keltai M, Lanas F, Lopes RD, Lopez-Sendon J, Granger CB, Wallentin L, Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J 2012 33 2821 2830. doi: 10.1093/eurheartj/ehs274.
-
(2012)
Eur Heart J
, vol.33
, pp. 2821-2830
-
-
Hohnloser, S.H.1
Hijazi, Z.2
Thomas, L.3
Alexander, J.H.4
Amerena, J.5
Hanna, M.6
Keltai, M.7
Lanas, F.8
Lopes, R.D.9
Lopez-Sendon, J.10
Granger, C.B.11
Wallentin, L.12
-
26
-
-
80054071757
-
Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment
-
Fox KA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC, Paolini JF, Hankey GJ, Mahaffey KW, Patel MR, Singer DE, Califf RM, Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J 2011 32 2387 2394. doi: 10.1093/eurheartj/ehr342.
-
(2011)
Eur Heart J
, vol.32
, pp. 2387-2394
-
-
Fox, K.A.1
Piccini, J.P.2
Wojdyla, D.3
Becker, R.C.4
Halperin, J.L.5
Nessel, C.C.6
Paolini, J.F.7
Hankey, G.J.8
Mahaffey, K.W.9
Patel, M.R.10
Singer, D.E.11
Califf, R.M.12
-
27
-
-
84977273497
-
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Accessed January 28, 2016
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Lixiana: EPAR Public Assessment Report 2015. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-Assessment-report/human/002629/WC500189047.pdf. Accessed January 28, 2016.
-
(2015)
Lixiana: EPAR Public Assessment Report
-
-
|