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2. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, GE, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Meyer, G, Segers, A, Shi, M, Wang, TF, Yeo, E, Zhang, G, Zwicker, JI, Weitz, JI, Büller, HR, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, PW, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, JW, Crowther, M, Roberts, RS, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, JC, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, MI, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, HM, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, CM, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Graduate School, CCA - Cancer Treatment and Quality of Life, Vascular Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, Other Research, Other departments, Neurology, APH - Societal Participation & Health, APH - Quality of Care, Coronel Institute of Occupational Health, ARD - Amsterdam Reproduction and Development, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, and ACS - Microcirculation

Subjects
Adult, Dalteparin, Male, Randomization, Pyridines, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Edoxaban, Neoplasms, medicine, Humans, Aged, Intention-to-treat analysis, Heparin, business.industry, Standard treatment, Low-Molecular-Weight, Anticoagulants, Cancer, Follow-Up Studies, Heparin, Low-Molecular-Weight, Intention to Treat Analysis, Middle Aged, Thiazoles, Venous Thromboembolism, General Medicine, medicine.disease, Thrombosis, chemistry, 030220 oncology & carcinogenesis, Anesthesia, Venous Thromboembolism, cancer, thrombosis, business, medicine.drug
Abstract

BACKGROUND Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials. gov number, NCT02073682.)

Published
2018

3. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, GE, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Wang, TF, Zwicker, JI, Weitz, JI, Büller, HR, Kamphuizen, PW, Eikelboom, JW, Roberts, RS, Wautrecht, JC, Tassoni, MI, Otten, HM, Rojas Hernandez, CM, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, GE, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Wang, TF, Zwicker, JI, Weitz, JI, Büller, HR, Kamphuizen, PW, Eikelboom, JW, Roberts, RS, Wautrecht, JC, Tassoni, MI, Otten, HM, and Rojas Hernandez, CM

Abstract

BACKGROUND: Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS: In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS: Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk,-3.4 percentage points; 95% CI,-7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS: Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin.

Published
2018

5. Endothelial cell activation in viral hemorrhagic fever

Author

Gorp, E.C.M. van, Suharti, C., Setiati, T.E., Cate, H. ten, Dolmans, W.M.V., Ende, A. van den, Mairuhu, R., Djokomoeljanto, R., Meer, J.W.M. van der, Brandjes, D.P.M., Gorp, E.C.M. van, Suharti, C., Setiati, T.E., Cate, H. ten, Dolmans, W.M.V., Ende, A. van den, Mairuhu, R., Djokomoeljanto, R., Meer, J.W.M. van der, and Brandjes, D.P.M.

Abstract

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Published
1999

6. Outpatient management of cancer-associated pulmonary embolism: A post-hoc analysis from the HOME-PE trial.

Author

Chaibi S, Roy PM, Guénégou AA, Tran Y, Hugli O, Penaloza A, Couturaud F, Tromeur C, Szwebel TA, Pernod G, Elias A, Ghuysen A, Benhamou Y, Falvo N, Juchet H, Nijkeuter M, Mairuhu R, Faber LM, Mahé I, Montaclair K, Planquette B, Jimenez D, Huisman MV, Klok FA, and Sanchez O

Subjects
Humans, Outpatients, Ambulatory Care, Risk Factors, Pulmonary Embolism complications, Pulmonary Embolism therapy, Neoplasms complications, Neoplasms therapy
Abstract

Introduction: Cancer-related pulmonary embolism (PE) is associated with poor prognosis. Some decision rules identifying patients eligible for home treatment categorize cancer patients at high risk of complications, precluding home treatment. We sought to assess the effectiveness and the safety of outpatient management of patients with low-risk cancer-associated PE., Methods: In the HOME-PE trial, hemodynamically stable patients with symptomatic PE were randomized to either triaging with Hestia criteria or sPESI score. We analyzed 3 groups of low-risk PE patients: 47 with active cancer treated at home (group 1), 691 without active cancer treated at home (group 2), and 33 with active cancer as the only sPESI criterion qualifying them for hospitalization (group 3). The main outcome was the composite of recurrent venous thromboembolism, major bleeding, and all-cause death within 30 days after randomization., Results: Patients treated at home had composite outcome rates of 4.3 % (2/47) for those with cancer vs. 1.0 % (7/691) for those without (odds ratio (OR) 4.98, 95%CI 1.15-21.49). Patients with cancer had rates of complications of 4.3 % when treated at home vs. 3.0 % (1/33) when hospitalized (OR 1.19, 95%CI 0.15-9.47). In multivariable analysis, active cancer was associated with an increased risk of complications for patients treated at home (OR 7.95; 95%CI 1.48-42.82). For patients with active cancer, home treatment was not associated with the primary outcome (OR 1.19, 95%CI 0.15-9.74)., Conclusions: Among patients treated at home, active cancer was a risk factor for complications, but among patients with active cancer, home treatment was not associated with adverse outcomes., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Olivier SANCHEZ reports a relationship with Bayer AG that includes: board membership, consulting or advisory, and speaking and lecture fees. Olivier SANCHEZ reports a relationship with Bristol Myers Squibb Co that includes: board membership, consulting or advisory, funding grants, and speaking and lecture fees. Olivier SANCHEZ reports a relationship with Pfizer France that includes: board membership, funding grants, and speaking and lecture fees. Olivier SANCHEZ reports a relationship with Sanofi Aventis France that includes: board membership, consulting or advisory, and speaking and lecture fees. Olivier SANCHEZ reports a relationship with Boston Scientific Corp that includes: board membership. Olivier SANCHEZ reports a relationship with Inari Medical Inc that includes: board membership, funding grants, and speaking and lecture fees. Olivier SANCHEZ reports a relationship with Boehringer Ingelheim Pharmaceuticals Inc that includes: board membership and funding grants. Olivier SANCHEZ reports a relationship with LEO Pharma France that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Published
2024
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